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Hong Kong, Shanghai, & Florham Park, NJ — Thursday, September 30, 2021: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; HKEX: 13) hereby notifies the market that as at September 30, 2021, the issued share capital of HUTCHMED consisted of 864,417,280 ordinary shares of US$0.10 each, with each share carrying one right to vote and with no shares held in treasury.

 

The above figure of 864,417,280 may be used by shareholders as the denominator for the calculations by which they could determine if they are required to notify their interest in, or a change to their interest in, HUTCHMED under the Financial Conduct Authority’s Disclosure Guidance and Transparency Rules.

 

For illustrative purposes only, the 864,417,280 ordinary shares would be equivalent to 864,417,280 depositary interests (each equating to one ordinary share) which are traded on AIM or, if the depositary interests were converted in their entirety, equivalent to 172,883,456 American depositary shares (each equating to five ordinary shares) which are traded on Nasdaq.

 

About HUTCHMED

HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery, global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. A dedicated organization of over 1,400 personnel has advanced eleven cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved and marketed. For more information, please visit: www.hutch‑med.com or follow us on LinkedIn.

 

CONTACTS

Investor Enquiries
Mark Lee, Senior Vice President	+852 2121 8200
Annie Cheng, Vice President	+1 (973) 567 3786
Media Enquiries
Americas
Brad Miles, Solebury Trout	+1 (917) 570 7340 (Mobile) bmiles@troutgroup.com
Europe
Ben Atwell / Alex Shaw, FTI Consulting	+44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) HUTCHMED@fticonsulting.com
Asia
Joseph Chi Lo, Brunswick	+852 9850 5033 (Mobile)
Zhou Yi, Brunswick	+852 9783 6894 (Mobile) HUTCHMED@brunswickgroup.com
Nominated Advisor
Freddy Crossley / Atholl Tweedie, Panmure Gordon (UK) Limited	+44 (20) 7886 2500

 

Hong Kong, Shanghai & Florham Park, NJ — Wednesday, September 29, 2021: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM, HKEX: 13) announces that new and updated clinical data from several ongoing combination studies of surufatinib (SULANDA^® in China) or fruquintinib (ELUNATE^® in China) with PD-1 inhibitors were presented at the 24^th Chinese Society of Clinical Oncology (CSCO) Annual Meeting which has been taking place on September 25-29, 2021.

 

SURUFATINIB

Title:	A phase II study of surufatinib in combination with toripalimab in patients with advanced neuroendocrine carcinoma: an updated analysis
Lead Author	Lin Shen, MD, Peking University Cancer Hospital & Institute
Type:	Oral presentation
Session Number:	CSCO Innovation Presentation 1-Session 2-#13

Patients with advanced neuroendocrine carcinoma (“NEC”) have a poor prognosis and limited treatment options after first-line treatment. 5-year survival rates are low.[i] Surufatinib is approved for the treatment of patients with advanced or metastatic pancreatic and extra-pancreatic neuroendocrine tumors in China. Toripalimab is a monoclonal humanized IgG4 PD-1 antibody that previously demonstrated antitumor activity and safety in treating recurrent or metastatic neuroendocrine neoplasms (“NENs”).[ii] Results from a Phase II study of the combination of surufatinib with toripalimab was first presented at the 2021 American Society of Clinical Oncology Annual Meeting (ASCO 2021).[iii]

In this updated analysis, at later data cutoff date of July 30, 2021, all 21 enrolled patients were efficacy evaluable, with average duration of treatment of 4.9 months (range 1-19). Median overall survival (“OS”), reported for the first time, was 10.3 months (95% CI: 9.1-not reached). The median progression-free survival (“PFS”) was 4.14 months (95% CI: 1.5-5.5) and median duration of response (“DoR”) was 4.1 months (95% CI: 3.0-not reached). The confirmed objective response rate (“ORR”) was 23.8% (95% CI: 8.2-47.2) and disease control rate (“DCR”) was 71.4% (95% CI: 47.8-88.7).

All patients experienced treatment-related adverse events (“TRAEs”), including 9 (42.9%) who experienced grade 3 or above TRAEs. 1 (4.8%) patient reported treatment-related serious adverse events (“SAEs”). Hyperglycemia (3 [14.3%]), hypertension (2 [9.5%]) and hypertriglyceridemia (2 [9.5%]) were the most commonly (more than one patient) reported grade 3 or above TRAEs. There were no TRAEs that led to treatment discontinuation or treatment-related deaths.

This updated analysis demonstrated the rationale of surufatinib plus toripalimab in the second-line setting for the treatment of patients with advanced NEC. A randomized phase III study SURTORI-01 has been initiated to further confirm the efficacy and safety of this combination therapy.

 

FRUQUINTINIB

Title:	Fruquintinib plus sintilimab in patients with advanced endometrial cancer: a multicentre, open-label, single-arm, phase II clinical trial
Lead Author	Xiaohua Wu, MD, Fudan University Shanghai Cancer Center
Type:	Oral presentation
Session Number:	CSCO Innovation Presentation 2-Session 2-#9

Platinum-based systemic chemotherapy is the standard first-line treatment for advanced endometrial cancer (“EMC”). However, patients who progress following first-line chemotherapy have limited treatment options, and the prognosis remains poor. Therefore, an important unmet medical need remains in patients with advanced EMC. Chemotherapy ORR is approximately 16%, while anti-angiogenesis inhibitors and/or immune checkpoint inhibitors have demonstrated less than a 15% ORR, with the exception of EMC patients with high microsatellite instability or mismatch repair defects (about 16% of EMC patients).[iv] Fruquintinib is a highly selective vascular endothelial growth factor receptor (“VEGFR”) inhibitor and sintilimab is an anti-PD-1 monoclonal antibody. This Phase II study aims to assess the efficacy and safety of fruquintinib in combination with sintilimab for advanced EMC.

As of data cutoff date of August 31, 2021, 35 patients were enrolled, including 7 treatment-naïve and 28 pretreated patients. Of them, 29 were efficacy evaluable, 4 were treatment-naïve and 25 were pretreated. All 4 treatment-naïve patients experienced confirmed tumor response, for ORR of 100% (95% CI: 39.8-100.0), and median PFS was not reached. Among the 25 pretreated patients, the confirmed ORR was 32.0% (95% CI: 14.9-53.5), DCR was 92.0% (95% CI: 74.0-99.0) and the median PFS was 6.9 months (95% CI: 4.1-NR). Among the 19 proficient mismatch repair (pMMR) patients in pretreated cohort, the confirmed ORR was 36.8% (95% CI: 16.3-61.6), DCR was 94.7% (95% CI: 74.0-99.9), median PFS was 6.9 months (95% CI: 4.1-NR), and the median OS was not reached.

Among the 35 enrolled patients, 33 (94.3%) patients experienced TRAEs, including 17 (48.6%) who experienced grade 3 or above TRAEs. TRAEs of grade 3 or above that occurred in more than 10% of patients were hypertension (4 [11.4%]) and proteinuria (4 [11.4%]). 5 (14.3%) patients reported treatment-related SAEs. 2 patients experienced TRAEs that led to discontinuation of sintilimab while 1 patient each discontinued fruquinintinb alone or the fruquintinib and sintilimab combination.

Regulatory discussions for this combination in China are currently under discussions with regulators, which may lead to the initiation of a pivotal study before year end.

 

Title:	A phase II study of fruquintinib plus sintilimab in pretreated patients with advanced hepatocellular carcinoma
Lead Author	Shukui Qin, MD, Eastern Theater General Hospital, Qinhuai Medical Area
Type:	Oral presentation
Session Number:	CSCO Innovation Presentation 2-Session 1-#7

Patients with hepatocellular carcinoma (“HCC”), the most common type of liver cancer, have very limited treatment options. Combination use of VEGF targeting therapy with immunotherapy has demonstrated remarkable clinical benefits in first-line HCC, but its anti-tumor activity in second- or later line treatments is not established. This phase II study was performed to assess the combination of fruquintinib, a highly selective VEGFR inhibitor, with sintilimab, an anti-PD-1 antibody, in patients with advanced HCC who were treated with at least one prior line of treatment, including either sorafenib or lenvatinib. The combination demonstrated preliminary anti-tumor efficacy and durability in these patients.

As of data cutoff date of August 31, 2021, among 19 response-evaluable patients, the confirmed ORR was 31.6% (95% CI: 12.6-56.6), and the DCR was 89.5% (95% CI: 66.9-98.7). The median DoR was not reached. The median PFS was 6.9 months (95% CI: 4.1-not reached). With a median follow up of 7.4 months, the median OS was not reached.

Among 21 enrolled patients, 20 (95.2%) patients experienced TRAEs, including 7 (33.3%) who experienced grade 3 or above TRAEs. No TRAEs of grade 3 or above occurred in more than one patient. 4 (19.0%) patients reported treatment-related SAEs. TRAEs leading to fruquintinib discontinuation and sintilimab discontinuation were reported in 2 (9.5%) and 1 (4.8%) patient, respectively.

Registration plans for this combination regimen in China are currently under discussions with investigators.

 

Title:	Fruquintinib plus sintilimab in patients with advanced renal cell carcinoma: results from a phase II clinical trial
Lead Author	Dingwei Ye, MD, Fudan University Shanghai Cancer Center
Type:	Oral presentation
Session Number:	CSCO Innovation Presentation 2-Session 2-#13

In first-line clear-cell renal cell carcinoma (“ccRCC”), clinical benefits have been demonstrated for the combination of antiangiogenic therapy and immunotherapy. However, there is limited evidence on the benefits of this combination in the second-line setting. This phase II study aimed to evaluate the efficacy and safety of fruquintinib plus sintilimab in second-line treatment of ccRCC, which has shown encouraging anti-tumor efficacy and durability in these patients.

As of data cutoff date of August 31, 2021, all 20 enrolled patients were efficacy evaluable. 19 patients previously received VEGFR inhibitors, and 2 received interferon. The confirmed ORR was 55.0% (95% CI: 31.5-76.9) and DCR was 85.0% (95% CI: 62.1-96.8).  The median PFS was not reached with a median follow up of 8.2 months. PFS rate at 9 months was 63.6% (95% CI: 38.1-80.9). Median treatment time was 38.6 weeks, with the longest being over 50 weeks and ongoing.

All patients experienced TRAEs, including 9 (45%) who experienced grade 3 or above TRAEs. The most common (more than one patient) grade 3 or above TRAEs were increased amylase (3 [15.0%]), hypertriglyceridemia (3 [15.0%]), hypertension (2 [10.0%]) and lipase increased (2 [10.0%]). Treatment-related SAEs were reported in 2 patients (10.0%). There were no TRAEs that led to treatment discontinuation.

Registration plans for this combination regimen in China are currently under discussions with investigators.

 

About Surufatinib (SULANDA^® in China)

Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with VEGFR and FGFR, which both inhibit angiogenesis, and CSF-1R, which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies, where there may be synergistic anti-tumor effects.

HUTCHMED currently retains all rights to surufatinib worldwide.

 

About Fruquintinib (ELUNATE^® in China)

Fruquintinib is a highly selective and potent oral inhibitor of VEGFRs -1, -2 and -3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. The generally good tolerability in patients to date, along with fruquintinib’s low potential for drug-drug interaction based on preclinical assessment, suggests that it may also be highly suitable for combinations with other anti-cancer therapies.

HUTCHMED retains all rights to fruquintinib outside of China. In China, HUTCHMED is partnered with Eli Lilly and Company and is responsible for development and execution of all on-the-ground medical detailing, promotion and local and regional marketing.

 

About HUTCHMED

HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. A dedicated organization of over 1,400 personnel has advanced eleven cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved and marketed. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.

 

 

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by words like “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “pipeline,” “could,” “potential,” “first-in-class,” “designed to,” “objective,” “guidance,” “pursue,” or similar terms, or by express or implied discussions regarding potential drug candidates, potential indications for drug candidates or by discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that any of our drug candidates will be approved for sale in any market, or that any approvals which are obtained will be obtained at any particular time, or that any such drug candidates will achieve any particular revenue or net income levels. In particular, management’s expectations could be affected by, among other things: unexpected regulatory actions or delays or government regulation generally; the uncertainties inherent in research and development, including the inability to meet our key study assumptions regarding enrollment rates, timing and availability of subjects meeting a study’s inclusion and exclusion criteria and funding requirements, changes to clinical protocols, unexpected adverse events or safety, quality or manufacturing issues; the inability of a drug candidate to meet the primary or secondary endpoint of a study; the inability of a drug candidate to obtain regulatory approval in different jurisdictions or gain commercial acceptance after obtaining regulatory approval; global trends toward health care cost containment, including ongoing pricing pressures; uncertainties regarding actual or potential legal proceedings, including, among others, actual or potential product liability litigation, litigation and investigations regarding sales and marketing practices, intellectual property disputes, and government investigations generally; the impact of the COVID-19 pandemic or other health crises in China or globally on general economic, regulatory and political conditions; and general economic and industry conditions, including uncertainties regarding the effects of the persistently weak economic and financial environment in many countries and uncertainties regarding future global exchange rates. For further discussion of these and other risks, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.

 

[i]    Dasari A, Mehta K, Byers LA, Sorbye H, Yao JC. Comparative study of lung and extrapulmonary poorly differentiated neuroendocrine carcinomas: A SEER database analysis of 162,983 cases. Cancer. 2018;124(4):807-815. doi:10.1002/cncr.31124.

[ii]    Lu M, Zhang P, Zhang Y, et al. Efficacy, Safety, and Biomarkers of Toripalimab in Patients with Recurrent or Metastatic Neuroendocrine Neoplasms: A Multiple-Center Phase Ib Trial. Clin Cancer Res. 2020;26(10):2337-2345. doi:10.1158/1078-0432.CCR-19-4000.

[iii]   Shen L, Yu X, Lu M, et al.  Surufatinib in combination with toripalimab in patients with advanced neuroendocrine carcinoma: Results from a multicenter, open-label, single-arm, phase II trial. J Clin Oncol. 2021 39:15_suppl, e16199-e16199. doi: 10.1200/JCO.2021.39.15_suppl.e16199n.

[iv]   2019 ESMO, Discussant abstracts LBA62 and 994O; Le et al. NEJM. 2015; 372; 2509 -20; Ott et al. J Clin Oncol. 2017; 35(22): 2535; Fleming et al. J Clin Oncol 35, 2017 (suppl; abstr 5585); Hasegawa et al. J Clin Oncol (36, 2018 (suppl: abstr 5594), Le Science 2017; Oaknin, SGO 2019; 5594); Konstantinopoulos ASCO 2019.

Hong Kong, Shanghai & Florham Park, NJ –– Wednesday, September 29, 2021: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; HKEX:13) today announces that, further to its announcement in March 2021 and following receipt of regulatory approval, it has completed the sale of its entire indirect interest in Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited (“HBYS”), a non-core and non-consolidated over-the-counter (“OTC”) drug joint venture business, to GL Mountrose Investment Two Limited, a company controlled and managed by GL Capital Group (“GL Capital”).

 

The aggregate amount which will be received by HUTCHMED is approximately US$169 million in cash, representing about 22 times HBYS’ adjusted net profit attributable to HUTCHMED equity holders of US$7.7 million in 2020[i]. Of the proceeds, approximately US$127 million related to its shareholding in HBYS has been received. The balance of approximately US$42 million is related to expected upcoming distributions of declared dividends related to previously announced land compensation and prior year undistributed profits.

 

The transaction will allow HUTCHMED to focus the organization and resources on its primary aim of accelerating investment in the Oncology/Immunology assets in China and beyond.

 

About HUTCHMED

HUTCHMED (Nasdaq/AIM: HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. A dedicated organization of over 1,400 personnel has advanced eleven cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved and marketed. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.

 

About HBYS

HBYS was established in 2005 and focuses primarily on the manufacture, marketing and distribution of proprietary OTC pharmaceutical products. HBYS was HUTCHMED’s non-consolidated joint venture with Guangzhou Baiyunshan Pharmaceutical Holdings Company Limited. HUTCHMED had a 50% interest in HBYS through a holding company in which HUTCHMED had an 80% interest.

 

About GL Capital

GL Capital is a leading investment firm specializing in buyout and growth opportunities in China’s healthcare industry. The firm has over US$2 billion under management across both public and private equity, through USD and RMB-denominated funds.

Founded in 2010, GL Capital strives to be the partner-of-choice for leading healthcare companies, generate superior investment returns, and contribute to the sustainable development of China’s healthcare industry. For more information, please visit www.gl-investment.com.

 

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including its expectations as to the anticipated amount of proceeds, the intended use of proceeds and the anticipated closing date of the proposed transaction. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the amount and timely receipt of the final land compensation, satisfaction of the conditions precedent to the consummation of the proposed transaction (including the ability of the parties to secure regulatory approvals on the terms expected, at all or in a timely manner), the ability of the parties to complete the proposed transaction and the impact of the COVID-19 pandemic on general economic, regulatory and political conditions. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission, on AIM and with The Stock Exchange of Hong Kong Limited. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

 

[i]    HBYS’ adjusted net profit attributable to HUTCHMED equity holders (after 20% non-controlling interest) in 2020 of US$7.7 million is a non-GAAP measure which is 40% of HBYS’ 2020 net profit of US$91.3 million less US$72.0 million gain on land compensation, net of tax.

Hong Kong, Shanghai & Florham Park, NJ — Tuesday, September 21, 2021: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; HKEX: 13) today announces that it has initiated SURTORI-01, a Phase III study to evaluate the efficacy and safety of surufatinib (SULANDA^® in China) in combination with toripalimab compared with FOLFIRI to treat patients with advanced neuroendocrine carcinoma (“NEC”) who have progression of disease or intolerable toxicity after previous first-line chemotherapy. The first patient was dosed on September 18, 2021 in China. Toripalimab is marketed as TUOYI^® in China by Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”).

Professor Shen Lin, the lead principal investigator of the study and Vice President of Peking University Hospital and Cancer Institute, said: “There is a large unmet clinical need for patients with NEC, many of whom have a bleak prognosis. Following the encouraging preliminary data from the Phase II trial, we are excited to move into the next stage of development in combining the novel, oral angio-immuno kinase inhibitor surufatinib with the anti-PD-1 antibody toripalimab. We look forward to further testing the synergistic anti-tumor effects of this combination that could benefit NEC patients who have limited treatment options.”

At the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting, encouraging preliminary data from the Phase II trial were disclosed for the surufatinib and toripalimab combination[i]. For the 20 patients in the NEC cohort as of December 31, 2020, who received an average of 5 cycles of treatments and are efficacy evaluable, objective response rate (“ORR”) was 20% and disease control rate (“DCR”) was 70%. Median progression-free survival (“PFS”) was 3.9 months (95% CI: 1.3 – not reached). Grade 3 or higher treatment-related adverse events occurred in 33% of patients. Treatment related adverse events (“TRAEs”) were manageable, with surufatinib or toripalimab interruption occurred in 6 (28.6%) and 4 (19%) patients respectively. There were neither serious adverse events (“AEs”) nor AEs inducing treatment discontinuations or deaths. Updated data will be presented at the Chinese Society of Clinical Oncology (CSCO) 2021 Annual Meeting in late September.

The SURTORI-01 Phase III study is a randomized, controlled, open-label, multi-center study where approximately 200 patients are expected to be enrolled. For the study group, all patients will receive study treatment in 21-day cycle and the treatment will continue until there is a progression of disease, death, intolerable toxicity, or the end of study treatment (as other criteria specified in the protocol are met), whichever occurs first. The primary outcome measure is OS. The secondary outcome measures include PFS, ORR, duration of response (DoR), and DCR. Additional details may be found at clinicaltrials.gov, using identifier NCT05015621.

HUTCHMED is the sponsor of SURTORI-01 and responsible for all clinical and regulatory execution of the Phase III study. HUTCHMED and Junshi Biosciences are jointly funding the study.

Surufatinib is marketed in China under the brand name SULANDA^® for treating advanced neuroendocrine tumors (“NETs”).

 

About NEC

Neuroendocrine neoplasms (“NEN”) occur almost everywhere in the body but are most common in the gastrointestinal tract, pancreas, and lungs. NEC is one of the two common phenotypes of NEN. NECs are poorly differentiated, highly proliferating NENs, while NETs are well-differentiated, low-proliferating NENs. NECs are aggressive, fast-growing neoplasms that usually fail to express hormones or produce hormonal syndromes, and are not associated with hereditary tumor diseases.[ii]

 

About Surufatinib

Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptors (VEGFR) and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies, where there may be synergistic anti-tumor effects.

HUTCHMED currently retains all rights to surufatinib worldwide.

 

About Surufatinib Development

Extra-pancreatic NETs (“epNETs”) in China: On December 29, 2020, surufatinib was granted drug registration approval by the National Medical Products Administration of China (“NMPA”) for the treatment of epNET. Surufatinib is marketed in China under the brand name SULANDA^®. The approval was based on results from the SANET-ep study, a Phase III trial (clinicaltrials.gov identifier: NCT02588170) in patients with advanced epNETs conducted in China. The study met the pre-defined primary endpoint of PFS at a preplanned interim analysis, and was published in The Lancet Oncology[iii]. Median PFS was significantly longer for patients treated with surufatinib at 9.2 months, compared to 3.8 months for patients in the placebo group (HR 0.334; 95% CI: 0.223-0.499; p<0.0001). Surufatinib had an acceptable safety profile, with the most common treatment related adverse events of grade 3 or worse being hypertension (36% of surufatinib patients vs. 13% of placebo patients), proteinuria (19% vs. 0%) and anemia (5% vs. 3%).

Pancreatic NETs (“pNETs”) in China: On June 16, 2021, surufatinib was granted drug registration approval by the NMPA for the treatment of pNET. The approval was based on results from the SANET-p study, a Phase III trial (clinicaltrials.gov identifier: NCT02589821) in patients with advanced pNET in China. The pre-defined primary endpoint of PFS was met at a preplanned interim analysis and was published in The Lancet Oncology[iv], demonstrating that surufatinib reduces the risk of disease progression or death by 51% in patients, with a median PFS of 10.9 months compared to 3.7 months on placebo (HR 0.491; 95% CI: 0.391-0.755; p=0.0011). The safety profile of surufatinib was manageable and consistent with observations in prior studies.

Immunotherapy combinations: HUTCHMED entered into collaboration agreements to evaluate the safety, tolerability and efficacy of surufatinib in combination with anti-PD-1 monoclonal antibodies, including with tislelizumab (BGB-A317), TUOYI^® (toripalimab) and TYVYT^® (sintilimab), which are approved as monotherapies in China.

NETs in the U.S. and Europe: A U.S. Food and Drug Administration (“FDA”) New Drug Application (“NDA”) submission was accepted in June 2021, followed by a Marketing Authorisation Application (“MAA”) submission to the European Medicines Agency (“EMA”) validated in July 2021. The basis to support these filings includes the completed SANET-ep and SANET-p studies, along with existing data from surufatinib in U.S. epNET and pNET patients (clinicaltrials.gov identifier: NCT02549937). In the U.S., surufatinib was granted Fast Track Designations for development in pNET and epNET in April 2020, and Orphan Drug Designation for pNET in November 2019.

HUTCHMED has initiated an Expanded Access Protocol (EAP) in the U.S. to ensure patients with NET with limited therapeutic options have access to this treatment. Regulatory clearance of this protocol has been granted by the FDA and this program is open for site activation (clinicaltrials.gov identifier: NCT04814732).

 

About Toripalimab

Toripalimab is the first domestic anti-PD-1 monoclonal antibody to obtain marketing approval in China. So far, more than thirty company-sponsored clinical studies covering more than fifteen indications have been conducted globally including in China and the United States. On December 17, 2018, toripalimab was granted conditional approval from the NMPA for the second-line treatment of patients with unresectable or metastatic melanoma. In December 2020, toripalimab was successfully included in the updated National Reimbursement Drug List. In February 2021, toripalimab received NMPA’s conditional approval for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (“NPC”) after failure of at least two lines of prior systemic therapy. In April 2021, toripalimab received NMPA’s conditional approval for the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. In addition, toripalimab has been included in the Guidelines of the Chinese Society of Clinical Oncology (CSCO) for the Diagnosis and Treatment of Melanoma, Head and Neck Tumors, Urothelial Carcinoma and other indications.

In February 2021, the supplemental new drug application (the “sNDA”) of toripalimab in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic NPC was accepted for review by the NMPA. In March 2021, toripalimab received Breakthrough Therapy Designation for the first-line treatment of advanced mucosal melanoma by the NMPA. In July 2021, the sNDA for toripalimab in combination with platinum-containing chemotherapy as the first-line treatment for patients with locally advanced or metastatic esophageal squamous cell carcinoma was accepted for review by the NMPA.

In terms of international development, the first toripalimab Biological License Application (BLA) has been submitted to the FDA for the treatment of recurrent or metastatic NPC. The FDA has granted two Breakthrough Therapy designations for toripalimab in combination with chemotherapy for the first line treatment of recurrent or metastatic NPC and also for toripalimab monotherapy in second or third line treatment of recurrent or metastatic NPC. Additionally, FDA has granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and orphan drug designations for NPC, mucosal melanoma and soft tissue sarcoma.

 

About HUTCHMED

HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery, global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. A dedicated organization of over 1,400 personnel has advanced eleven cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved. For more information, please visit: www.hutch‑med.com or follow us on LinkedIn.

 

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including its expectations regarding the therapeutic potential of surufatinib for the treatment of patients with NEC and the further clinical development of surufatinib in this and other indications. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the sufficiency of clinical data to support NDA approval of surufatinib for the treatment of patients with NEC in the U.S., China and other jurisdictions such as the E.U., its potential to gain expeditious approvals from regulatory authorities, the safety profile of surufatinib, HUTCHMED’s ability to fund, implement and complete its further clinical development and commercialization plans for surufatinib, the timing of these events, and the impact of the COVID-19 pandemic on general economic, regulatory and political conditions. In addition, as certain studies rely on the use of capecitabine, tislelizumab, Tuoyi^®, and Tyvyt^® as combination therapeutics with surufatinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of these therapeutics. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission, on AIM and on The Stock Exchange of Hong Kong Limited. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

 

[i]    Shen L, Yu X, Lu M, et al. Surufatinib in combination with toripalimab in patients with advanced neuroendocrine carcinoma: Results from a multicenter, open-label, single-arm, phase II trial. J Clin Oncol. 39, 2021 (suppl 15; abstr e16199). doi: 10.1200/​JCO.2021.39.15_suppl.e16199.
[ii]    Klöppel G. Neuroendocrine Neoplasms: Dichotomy, Origin and Classifications. Visc Med. 2017 ;33(5):324-330. doi:10.1159/000481390.
[iii]   Xu J, Shen L, Zhou Z, et al. Surufatinib in advanced extrapancreatic neuroendocrine tumours (SANET-ep): a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2020;21(11):1500-1512. doi: 10.1016/S1470-2045(20)30496-4.
[iv]   Xu J, Shen L, Bai C, et al. Surufatinib in advanced pancreatic neuroendocrine tumours (SANET-p): a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2020; 21(11):1489-1499. doi: 10.1016/S1470-2045(20)30493-9.

 

CONTACTS

Investor Enquiries
Mark Lee, Senior Vice President	+852 2121 8200
Annie Cheng, Vice President	+1 (973) 567 3786
Media Enquiries
Americas
Brad Miles, Solebury Trout	+1 (917) 570 7340 (Mobile) bmiles@troutgroup.com
Europe
Ben Atwell / Alex Shaw, FTI Consulting	+44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) HUTCHMED@fticonsulting.com
Asia
Zhou Yi, Brunswick	+852 9783 6894 (Mobile) HUTCHMED@brunswickgroup.com
Nominated Advisor
Atholl Tweedie /Freddy Crossley, Panmure Gordon (UK) Limited	+44 (20) 7886 2500

 

— Following surufatinib launch in China in January 2021; NDA acceptance by the U.S. FDA for review in June 2021; and MAA validation by the EMA in July 2021 all for advanced neuroendocrine tumors —

 

Hong Kong, Shanghai & Florham Park, NJ — Monday, September 20, 2021: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; HKEX: 13) today announces that it has initiated a Japan registration-enabling bridging study for surufatinib to support the registration of surufatinib in the treatment of patients with advanced neuroendocrine tumors (“NETs”).  The first patient was dosed on September 15, 2021.

 

Based on dialogue with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), it was agreed that the surufatinib Japanese new drug application (“NDA”) for the treatment of advanced NETs include results from a pivotal study to be conducted in Japan, to complement the registration data package supporting the NDA to the U.S. Food and Drug Administration (“FDA”) (accepted for review in June 2021) and the Marketing Authorization Application (“MAA”) to the European Medicines Agency (“EMA”) (validated in July 2021). The basis for the NDA and the MAA includes data from a U.S. Phase I/II study, as well as the completed Phase III SANET-ep and SANET-p studies used to support marketing authorization in China in advanced NETs, where surufatinib is currently marketed under the brand name SULANDA^®.

 

This Japan study is a two-stage, open label study of surufatinib where approximately 34 patients are expected to be recruited. In Part 1 of the study, the safety and tolerability of surufatinib 300mg once daily after 28 days of treatment will be assessed in patients with relapsed/refractory non-hematological malignancies; pharmacokinetics (“PK”) and anti-tumor activity of surufatinib are secondary endpoints. In Part 2 of the study, efficacy will be assessed in patients with locally advanced or metastatic NETs; the primary outcome measure is objective response rate (ORR). The secondary outcome measures include disease control rate (DCR), progression free survival (“PFS”), duration of response (DoR), safety, and PK.

 

Surufatinib is the third potential new medicine discovered by HUTCHMED to enter into clinical development in Japan. A global Phase III registration study for fruquintinib, known as the FRESCO-2 study, is ongoing in patients with refractory metastatic colorectal cancer and is expected to enroll over 680 patients from over 150 sites in 14 countries, including Japan. A global single-arm, open-label study, known as the SAVANNAH study, is ongoing for savolitinib (partnered with AstraZeneca PLC) in combination with TAGRISSO^® in non-small cell lung cancer patients whose disease progressed following TAGRISSO^® due to MET amplification or overexpression.

 

About NETs

NETs form in cells that interact with the nervous system or in glands that produce hormones. They can originate in various parts of the body, most often in the gut or the lungs and can be benign or malignant. NETs are typically classified as pancreatic NET (“pNET”) or extra-pancreatic (non-pancreatic) NET (“epNET”).

According to Frost & Sullivan, there were 19,000 newly diagnosed cases of NET in the U.S. in 2020. Rates across the European Union (E.U.) appear largely similar to the U.S. This is supported by an analysis of global epidemiologic trends, which also show growth in the incidence of NETs worldwide.[i] Importantly, NETs are associated with a relatively long duration of survival compared to other tumors. As a result, there were approximately 140,000 estimated patients living with NET in France, Germany, Italy, Spain, and the United Kingdom in 2020.[ii] In Japan, approximately 6,700 people were diagnosed with gastro-entero-pancreatic neuroendocrine neoplasms in 2016.[iii]

 

About Surufatinib

Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptors (VEGFR) and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies, where there may be synergistic anti-tumor effects.

HUTCHMED currently retains all rights to surufatinib worldwide.

 

About Surufatinib Development

epNETs in China: On December 29, 2020, surufatinib was granted drug registration approval by the National Medical Products Administration of China (“NMPA”) for the treatment of epNET. Surufatinib is marketed in China under the brand name SULANDA^®. The approval was based on results from the SANET-ep study, a Phase III trial (clinicaltrials.gov identifier: NCT02588170) in patients with advanced epNETs conducted in China. The study met the pre-defined primary endpoint of PFS at a preplanned interim analysis, and was published in The Lancet Oncology[iv]. Median PFS was significantly longer for patients treated with surufatinib at 9.2 months, compared to 3.8 months for patients in the placebo group (HR 0.334; 95% CI: 0.223-0.499; p<0.0001). Surufatinib had an acceptable safety profile, with the most common treatment related adverse events of grade 3 or worse being hypertension (36% of surufatinib patients vs. 13% of placebo patients), proteinuria (19% vs. 0%) and anemia (5% vs. 3%).

 

pNETs in China: On June 16, 2021, surufatinib was granted drug registration approval by the NMPA for the treatment of pNET. The approval was based on results from the SANET-p study, a Phase III trial (clinicaltrials.gov identifier: NCT02589821) in patients with advanced pNET in China. The pre-defined primary endpoint of PFS was met at a preplanned interim analysis and was published in The Lancet Oncology[v], demonstrating that surufatinib reduces the risk of disease progression or death by 51% in patients, with a median PFS of 10.9 months compared to 3.7 months on placebo (HR 0.491; 95% CI: 0.391-0.755; p=0.0011). The safety profile of surufatinib was manageable and consistent with observations in prior studies.

 

Immunotherapy combinations: HUTCHMED entered into collaboration agreements to evaluate the safety, tolerability and efficacy of surufatinib in combination with anti-PD-1 monoclonal antibodies, including with tislelizumab (BGB-A317), TUOYI^® (toripalimab) and TYVYT^® (sintilimab), which are approved as monotherapies in China.

 

NETs in the U.S. and Europe: A FDA NDA submission was accepted in June 2021, followed by a MAA submission to the EMA validated in July 2021. The basis to support these filings includes the completed SANET-ep and SANET-p studies, along with existing data from surufatinib in U.S. epNET and pNET patients (clinicaltrials.gov identifier: NCT02549937). In the U.S., surufatinib was granted Fast Track Designations for development in pNET and epNET in April 2020, and Orphan Drug Designation for pNET in November 2019.

 

HUTCHMED has initiated an Expanded Access Protocol (EAP) in the U.S. to ensure patients with NET with limited therapeutic options have access to this treatment. Regulatory clearance of this protocol has been granted by the FDA and this program is open for site activation (clinicaltrials.gov identifier: NCT04814732).

 

About HUTCHMED

HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery, global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. A dedicated organization of over 1,400 personnel has advanced eleven cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved. For more information, please visit: www.hutch‑med.com or follow us on LinkedIn.

 

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including its expectations regarding the therapeutic potential of surufatinib for the treatment of patients with NET and the further clinical development of surufatinib in this and other indications. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the sufficiency of clinical data to support NDA approval of surufatinib for the treatment of patients with NET in the U.S., China, Japan and other jurisdictions such as the E.U., its potential to gain expeditious approvals from regulatory authorities, the safety profile of surufatinib, HUTCHMED’s ability to fund, implement and complete its further clinical development and commercialization plans for surufatinib, the timing of these events, and the impact of the COVID-19 pandemic on general economic, regulatory and political conditions. In addition, as certain studies rely on the use of capecitabine, tislelizumab, TUOYI^®, and TYVYT^® as combination therapeutics with surufatinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of these therapeutics. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission, on AIM and on The Stock Exchange of Hong Kong Limited. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

 

[i] Fraenkel M, Kim M, Faggiano A, de Herder WW, Valk GD; Knowledge NETwork. Incidence of gastroenteropancreatic neuroendocrine tumours: a systematic review of the literature. Endocr Relat Cancer. 2014;21(3):R153-R163. Published 2014 May 6. doi: 10.1530/ERC-13-0125.
[ii] According to Frost & Sullivan, in 2020, there were 19,000 newly diagnosed cases of NETs in the U.S. and an estimated 143,000 patients living with NETs. Report on file.
[iii] Masui T, Ito T, Komoto I, Uemoto S; JNETS Project Study Group. Recent epidemiology of patients with gastro-entero-pancreatic neuroendocrine neoplasms (GEP-NEN) in Japan: a population-based study. BMC Cancer. 2020;20(1):1104. Published 2020 Nov 14. doi: 10.1186/s12885-020-07581-y.
[iv] Xu J, Shen L, Zhou Z, et al. Surufatinib in advanced extrapancreatic neuroendocrine tumours (SANET-ep): a randomised, double-blind, placebo-controlled, phase 3 study [published online ahead of print, 2020 Sep 20]. Lancet Oncol. 2020; S1470-2045(20)30496-4. doi:10.1016/S1470-2045(20)30496-4.
[v] Xu J, Shen L, Bai C, et al. Surufatinib in advanced pancreatic neuroendocrine tumours (SANET-p): a randomised, double-blind, placebo-controlled, phase 3 study [published online ahead of print, 2020 Sep 20]. Lancet Oncol. 2020; S1470-2045(20)30493-9. doi: 10.1016/S1470-2045(20)30493-9.

 

CONTACTS

Investor Enquiries
Mark Lee, Senior Vice President	+852 2121 8200
Annie Cheng, Vice President	+1 (973) 567 3786
Media Enquiries
Americas
Brad Miles, Solebury Trout	+1 (917) 570 7340 (Mobile) bmiles@troutgroup.com
Europe
Ben Atwell / Alex Shaw, FTI Consulting	+44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) HUTCHMED@fticonsulting.com
Asia
Zhou Yi, Brunswick	+852 9783 6894 (Mobile) HUTCHMED@brunswickgroup.com
Nominated Advisor
Atholl Tweedie /Freddy Crossley, Panmure Gordon (UK) Limited	+44 (20) 7886 2500

 

Title:	An open-label, phase Ib/II study to evaluate the safety and efficacy of fruquintinib in combination with tislelizumab in patients with advanced triple negative breast cancer
Lead Author:	Debu Tripathy, MD, The University of Texas MD Anderson Cancer Center
Session:	ePoster
Presentation Number:	337TiP

 

Background

Immune checkpoint inhibitors (ICIs) have improved clinical outcomes in triple-negative breast cancer (TNBC), but many patients (pts) do not respond to ICIs or will develop resistance. Combining VEGFR inhibition may potentiate ICI efficacy by normalizing vascular immune crosstalk and improving immune effector cell infiltration. Tislelizumab (T) is a humanized, IgG4-variant monoclonal antibody against PD-1. Fruquintinib (F) is a novel, highly selective, oral, tyrosine kinase inhibitor of VEGFR-1, 2, 3. Safety and preliminary efficacy of F were demonstrated in metastatic breast cancer, including TNBC, in a phase 1 study in China (2009-013-00CH1) and in an ongoing phase 1/1b study in the US (2015-013-00US1). We hypothesize that the addition of F can potentially overcome resistance to ICI and improve TNBC activity.

 

Trial design

This is an open-label, phase 1b/2 study (NCT04579757) to assess the safety, PK and efficacy of F in combination with T in pts with locally advanced or metastatic TNBC independent of PD-L1 status, including both immunotherapy (IO) pre-treated and naïve pts. Pts must have progressed on 1-3 cytotoxic chemotherapies, have ECOG performance status 0 or 1, and an expected survival ≥12 weeks. The study consists of a safety lead-in (Part 1) and dose expansion phase (Part 2). The primary objective of Part 1 is to assess safety and tolerability and confirm the RP2D of F in combination with T. Safety will be assessed via dose limiting toxicities, treatment emergent adverse events, electrocardiograms, clinical lab abnormalities, and vital signs. The primary objective of Part 2 is to estimate the objective response rate (ORR) of F in combination with T per RECIST v1.1. Part 2 will include 2 expansion cohorts of ∼30 pts each: Cohort A: IO-treated; and B: IO-naïve. Demographics, efficacy, safety, and PK will be summarized using descriptive statistics. Antitumor activity, based on investigator-assessed overall response, and ORR will be calculated using the Clopper-Pearson method. Time to event variables will be summarized descriptively using the Kaplan-Meier method. No statistical hypothesis testing is planned.

 

Clinical trial identification

NCT04579757.

 

Editorial acknowledgement

Writing assistance was provided by Amy C. Porter, Ph.D. of Synchrogenix, LLC, a Certara Company, on behalf of HUTCHMED Internataional Corporation.

 

Legal entity responsible for the study

HUTCHMED International Corporation.

 

Funding

HUTCHMED International Corporation.

 

Disclosure

D. Tripathy: Financial Interests, Institutional, Funding: Novartis; Financial Interests, Institutional, Funding: Polyphor; Financial Interests, Personal, Advisory Role: Pfizer; Financial Interests, Personal, Advisory Role: Exact Sciences; Financial Interests, Personal, Advisory Role: GlaxoSmithKline; Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Personal, Advisory Role: OncoPep; Financial Interests, Personal, Advisory Role: Immunomedics. S.M. Ukrainskyj: Financial Interests, Personal, Full or part-time Employment: HUTCHMED International Corporation; Financial Interests, Personal, Full or part-time Employment: BMS; Financial Interests, Personal, Full or part-time Employment: Celgene. Z. Yang: Financial Interests, Personal, Full or part-time Employment: HUTCHMED International Corporation. M. Kania: Financial Interests, Personal, Full or part-time Employment: HUTCHMED International Corporation; Financial Interests, Personal, Stocks/Shares: HUTCHMED International Corporation; Financial Interests, Personal, Stocks/Shares: Eli Lilly; Financial Interests, Personal, Other, Travel expenses: HUTCHMED International Corporation. W. Schelman: Financial Interests, Personal, Stocks/Shares: HUTCHMED International Corporation; Financial Interests, Personal, Full or part-time Employment: HUTCHMED International Corporation. E. Hamilton: Financial Interests, Institutional, Funding: OncoMed, Genentech/Roche, Zymeworks, Rgenix, ArQule, Clovis, Silverback Therapeutics, Millenium, Acerta Pharma, Sermonix Pharmaceuticals, Torque, Black Diamond, Karyopharm, Infinity Pharmaceuticals, Curis, Syndax, Novartis, Boehringer Ingelheim, Immunomed; Financial Interests, Institutional, Advisory Role: Genentech/Roche, Boehringer Ingelheim, Novartis, Dantari, Lilly, Merck, Puma Biotechnology, Silverback Therapeutics, CytomX, Pfizer, Mersana, Black Diamond, H3 Biomedicine, Daiichi Sankyo, AstraZeneca, Arvinas, Deciphera Pharmaceuticals, Eisai, Seagen.

Hong Kong, Shanghai & Florham Park, NJ — Monday, September 13, 2021: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; HKEX: 13) today announces that the Center for Drug Evaluation of China’s National Medical Products Administration (“NMPA”) has granted Breakthrough Therapy Designation (“BTD”) to amdizalisib (HMPL-689), a highly selective and potent PI3Kδ inhibitor, for the treatment of relapsed or refractory follicular lymphoma (“FL”), a subtype of non-Hodgkin’s lymphoma (“NHL”).

NMPA grants BTD to new drugs that treat life-threatening diseases or serious conditions for which there are no effective treatment options, and where clinical evidence demonstrates significant advantages over existing therapies. Drug candidates with BTD may be considered for conditional approval and priority review when submitting a New Drug Application (NDA). This indicates that the development and review of amdizalisib for relapsed or refractory FL may be expedited, to address patients’ unmet needs more quickly.

Christian Hogg, CEO of HUTCHMED, said, “The granting of BTD to amdizalisib by the NMPA underscores the promising clinical value of this highly selective and potent PI3Kδ inhibitor. There is a clear need for new therapies in this treatment setting, particularly with regard to specific toxicities and suboptimal efficacy with existing treatments across different lymphoma subtypes. We look forward to important clinical data on amdizalisib being presented at the ESMO Congress next week and are continuing to accelerate global development of this novel therapy.”

Updated preliminary results from the ongoing Phase Ib expansion study in China will be presented as a Proffered Paper at the 2021 ESMO (European Society for Medical Oncology) Congress on September 20, 2021. To date, amdizalisib has been shown to be well tolerated, exhibiting dose-proportional pharmacokinetics (“PK”), a manageable toxicity profile, and single-agent clinical activity in relapsed/refractory B-cell lymphoma patients. Additional details may be found at clinicaltrials.gov, using identifier NCT03128164.

HUTCHMED has initiated an extensive, globally-focused clinical development pathway for amdizalisib. In April 2021, HUTCHMED initiated a Phase II registration study in China for amdizalisib in approximately 100 patients with relapsed or refractory FL and approximately 80 patients with marginal zone lymphoma (“MZL”). The trial is being conducted in over 35 sites in China. Additional details may be found at clinicaltrials.gov, using identifier NCT04849351.

Amdizalisib is also being evaluated in an ongoing Phase I/Ib study in the U.S. and Europe in patients with relapsed or refractory NHL (NCT03786926).

 

About PI3Kδ and NHL

PI3Kδ (phosphoinositide 3-kinase delta) is a lipid kinase that controls the activation of several important signaling proteins. Upon an antigen binding to B-cell receptors, PI3Kδ can be activated through the Lyn and Syk signaling cascade. The abnormal activation of B-cell receptor signaling is closely related to the development of B-cell type hematological cancers, which represent approximately 85% of all NHL cases. Therefore, PI3Kδ is considered a promising target for drugs that aim to treat certain hematologic cancers.

FL accounts for approximately 17% of NHL. In 2020, there were an estimated 16,000 and 13,000 new cases of FL in China and the U.S., respectively[i]^,[ii],[iii]. Patients with relapsed or refractory FL do not have curative treatment options and have a high unmet need for optimal therapeutic options.

 

About Amdizalisib

Amdizalisib (HMPL-689) is a novel, selective and potent oral inhibitor targeting the isoform PI3Kδ. Amdizalisib’s PK properties are favorable with good oral absorption, moderate tissue distribution and low clearance in preclinical PK studies, suggesting a low risk of drug accumulation and drug-to-drug interaction. Because of its high target selectivity and optimal PK profile, amdizalisib has the potential to demonstrate an optimal benefit-risk profile in this class.

HUTCHMED currently retains all rights to amdizalisib worldwide.

 

About HUTCHMED

HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery, global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. A dedicated organization of over 1,400 personnel has advanced eleven cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved. For more information, please visit: www.hutch‑med.com or follow us on LinkedIn.

 

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including its expectations regarding the therapeutic potential of amdizalisib for patients with FL, MZL and NHL, the further clinical development for amdizalisib, its expectations as to whether such studies would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates, timing and availability of subjects meeting a study’s inclusion and exclusion criteria, changes to clinical protocols or regulatory requirements, unexpected adverse events or safety issues, the ability of amdizalisib, including as a combination therapy, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions, to gain commercial acceptance after obtaining regulatory approval, the potential market of amdizalisib for a targeted indication, the sufficiency of funding and the impact of the COVID-19 pandemic on general economic, regulatory and political conditions. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

 

[i] Source: NCCN^® – https://www.nccn.org
[ii] Source: SEER – https://seer.cancer.gov/statfacts/html/follicular.html
[iii] Source: GLOBOCAN https://gco.iarc.fr/

 

CONTACTS

Investor Enquiries
Mark Lee, Senior Vice President	+852 2121 8200
Annie Cheng, Vice President	+1 (973) 567 3786
Media Enquiries
Americas
Brad Miles, Solebury Trout	+1 (917) 570 7340 (Mobile) bmiles@troutgroup.com
Europe
Ben Atwell / Alex Shaw, FTI Consulting	+44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) HUTCHMED@fticonsulting.com
Asia
Zhou Yi, Brunswick	+852 9783 6894 (Mobile) HUTCHMED@brunswickgroup.com
Nominated Advisor
Atholl Tweedie /Freddy Crossley, Panmure Gordon (UK) Limited	+44 (20) 7886 2500

 

— Follows important findings from the SAVANNAH study of this combination in lung cancer patients whose tumors harbor mutations or aberrations of EGFR and MET —

 

Hong Kong, Shanghai & Florham Park, NJ — Wednesday, September 8, 2021: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) and AstraZeneca PLC (“AstraZeneca”) (LSE/STO/Nasdaq:AZN) have initiated SANOVO, a China Phase III study of ORPATHYS^® (savolitinib), an oral, potent, and highly selective MET tyrosine kinase inhibitor (“TKI”), in combination with AstraZeneca’s third-generation, irreversible epidermal growth factor receptor (“EGFR”) TKI, TAGRISSO^® (osimertinib) as a first-line treatment in certain non-small cell lung cancer (“NSCLC”) patients whose tumors harbor EGFR mutation and overexpress MET. The first patient was dosed on September 7, 2021.

The Phase III trial is a blinded, randomized, controlled study in previously untreated patients with locally advanced or metastatic NSCLC with activating EGFR mutations and MET overexpression. The study will evaluate the efficacy and safety of TAGRISSO^® in combination with ORPATHYS^® comparing to TAGRISSO^® alone, a standard-of-care treatment option for these patients. The primary endpoint of the study is median progression free survival (“PFS”) as assessed by investigators. Other endpoints include median PFS assessed by an independent review committee, median overall survival (“OS”), objective response rate (“ORR”), duration of response (“DoR”), disease control rate (“DCR”), time to response (TTR), and safety. Additional details may be found at clinicaltrials.gov, using identifier NCT05009836.

 

About NSCLC, EGFR and MET Aberrations

Lung cancer is the leading cause of cancer death among men and women, accounting for about one-fifth of all cancer deaths.^[1]  More than a third of the world’s lung cancer patients are in China.^[2]  Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% classified as NSCLC.^[3] The majority of NSCLC patients are diagnosed with advanced disease while approximately 25-30% present with resectable disease at diagnosis.^[4],[5] For patients with resectable tumors, the majority of patients eventually develop recurrence despite complete tumor resection and adjuvant chemotherapy.^[6]

Approximately 10-25% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFR-mutated NSCLC.^[7],[8],[9]  These patients are particularly sensitive to treatment with an EGFR TKI which blocks the cell-signaling pathways that drive the growth of tumor cells.^[10]

MET is a tyrosine kinase receptor.^[11] Aberration of MET (amplification or overexpression) is present in both treatment naïve patients as well as being one of the primary mechanisms of acquired resistance to EGFR TKIs for metastatic EGFR-mutated NSCLC. ^[12],[13]

 

About Savolitinib (ORPATHYS^® in China)

Savolitinib is an oral, potent, and highly selective MET TKI that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations) or gene amplification.

Savolitinib is marketed in China under the brand name ORPATHYS^® for the treatment of patients with NSCLC with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy. It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers, as a single treatment and in combination with other medicines.

In 2011, following its discovery and initial development by HUTCHMED, AstraZeneca and HUTCHMED entered a global licensing agreement to jointly develop and commercialize savolitinib. Joint development in China is led by HUTCHMED, while AstraZeneca leads development outside of China. HUTCHMED is responsible for the marketing authorization, manufacturing and supply of savolitinib in China. AstraZeneca is responsible for the commercialization of savolitinib in China and worldwide. Sales of savolitinib are recognized by AstraZeneca.

 

Savolitinib development in NSCLC

Phase II study of savolitinib monotherapy in MET Exon 14 skipping alteration NSCLC (NCT02897479) – In June 2021, savolitinib was granted drug registration conditional approval by the National Medical Products Administration of China (NMPA) for MET Exon 14 skipping alteration NSCLC. The approval was based on the results of a Phase II study in China; results of this study were published in The Lancet Respiratory Medicine[14]. At a median follow up of 17.6 months, savolitinib demonstrated an ORR of 42.9% (95% confidence interval [CI] 31.1-55.3) and median PFS of 6.8 months (95% CI 4.2-9.6) in the overall trial population. DCR in the overall trial population was 82.9% (95% CI 72.0-90.8). The safety and tolerability profile of savolitinib was consistent with previous trials, and no new safety signals were identified. Continued approval is contingent upon the successful completion of a confirmatory trial in this patient population (NCT04923945).

 

TATTON Phase Ib/II expansion studies of savolitinib in combination with TAGRISSO^® in patients who have progressed following EGFR TKI treatment due to MET amplification (NCT02143466) – This global exploratory study in over 220 EGFR mutation positive NSCLC patients with MET amplified tumors following progression after treatment with any EGFR TKI. Results were published in Lancet Oncology^[15] and final analysis was presented at the World Conference on Lung Cancer^[16]. Three cohorts with patients treated following progression on first- or second-generation EGFR TKI demonstrated an ORR of 64.7-66.7% and a median PFS of 9.0-11.1 months. The cohort of patients treated following progression on a third-generation EGFR TKI demonstrated an ORR of 33.3% (95% CI 22.4-45.7), with a median PFS of 5.5 months (95% CI 4.1-7.7). The combination demonstrated encouraging anti-tumor activity and an acceptable risk-benefit profile.

 

SAVANNAH Phase II study of savolitinib in combination with TAGRISSO^® in patients who have progressed following TAGRISSO^® due to MET amplification or overexpression (NCT03778229) – This is a single-arm, open-label, global study in epidermal growth factor receptor (“EGFR”) mutation positive NSCLC patients with MET amplified/overexpressed tumors following progression after treatment with TAGRISSO^®, an EGFR TKI owned by AstraZeneca.

 

SACHI Phase III study of savolitinib in combination with TAGRISSO^® in patients who have progressed following EGFR TKI treatment due to MET amplification (NCT05015608) – This is a randomized, open-label study in China in EGFR mutation positive NSCLC patients with MET amplified tumors following progression after treatment with any EGFR TKI.

 

SANOVO Phase III study of savolitinib in combination with TAGRISSO^® in treatment-naïve patients with EGFR mutant positive NSCLC with MET overexpression (NCT05009836) – This is a randomized, blinded study in China in untreated, unresectable or metastatic patients with EGFR mutation positive NSCLC with MET positive tumors.

 

Savolitinib development in kidney cancer

SAVOIR randomized, controlled study of ORPATHYS^® monotherapy in MET-driven papillary renal cell carcinoma (“RCC”) (NCT03091192) – In May 2020, data from 60 patients in this global study of savolitinib monotherapy compared with sunitinib monotherapy in MET-driven papillary RCC was presented at the ASCO 2020 Program and published simultaneously in JAMA Oncology^[17]. Savolitinib demonstrated encouraging activity, including an ORR of 27% versus 7% for sunitinib, with no savolitinib responding patients experiencing disease progression at data cut-off, and an encouraging OS hazard ratio of 0.51 (95% CI: 0.21–1.17; p=0.110) with median not reached at data cut-off.

 

CALYPSO Phase I/II study of savolitinib in combination with IMFINZI^® PD-L1 inhibitor in RCC (NCT02819596) – The CALYPSO study is an investigator initiated open-label Phase I/II study of savolitinib in combination with IMFINZI^®, a PD-L1 antibody owned by AstraZeneca. The study is evaluating the safety and efficacy of the savolitinib /IMFINZI^® combination in patients with papillary RCC and clear cell RCC. An analysis of 41 patients enrolled in the PRCC cohort of in this study was presented at the 2021 ASCO Annual Meeting^[18], showing a confirmed response rate in 8 out of 14 MET-driven patients, or 57%, with a median DoR of 9.4 months, median PFS of 10.5 months and median OS of 27.4 months. No new safety signals were seen.

 

SAMETA Phase III study in combination with IMFINZI^® PD-L1 inhibitor in MET-driven, unresectable and locally advanced or metastatic PRCC (in planning) – Based on the encouraging results of the SAVOIR and CALYPSO studies, we are planning to initiate SAMETA, a global Phase III, open-label, randomized, controlled study of savolitinib plus IMFINZI^® versus sunitinib monotherapy versus IMFINZI^® monotherapy in patients with MET-driven, unresectable and locally advanced or metastatic PRCC.

 

Savolitinib development in gastric cancer

Phase II study of savolitinib monotherapy in advanced or metastatic MET amplified gastric cancer (“GC”) or adenocarcinoma of the gastroesophageal junction (“GEJ”) (NCT04923932) – This is an open-label, two-cohort, multi-center study to evaluate the efficacy, safety and pharmacokinetics (PK) of savolitinib in locally advanced or metastatic GC or GEJ patients whose disease progressed after at least one line of standard therapy.

 

Savolitinib development in other cancer indications

Savolitinib opportunities are also continuing to be explored in multiple other MET-driven tumor settings via investigator-initiated studies including colorectal cancer.

 

About TAGRISSO^®

TAGRISSO^® is a third-generation, irreversible EGFR TKI with clinical activity against central nervous system metastases. TAGRISSO^® (40mg and 80mg once-daily oral tablets) has been used to treat more than 325,000 patients across indications worldwide and AstraZeneca continues to explore TAGRISSO^® as a treatment for patients across multiple stages of EGFR-mutated NSCLC.

In Phase III trials, TAGRISSO^® is being tested in the neoadjuvant resectable setting (NeoADAURA), in the Stage III locally advanced unresectable setting (LAURA) and, in combination with chemotherapy, in the Stage III locally advanced or Stage IV metastatic settings (FLAURA2). AstraZeneca is also researching ways to address tumor mechanisms of resistance through the SACHI and SANOVO Phase III trials, as well as the SAVANNAH and ORCHARD Phase II trials, which test TAGRISSO^® given concomitantly with savolitinib, as well as other potential new medicines.

 

About HUTCHMED

HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. A dedicated organization of over 1,400 personnel has advanced eleven cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved and marketed. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.

 

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including its expectations regarding the therapeutic potential of ORPATHYS^® for the treatment of patients with NSCLC, the further clinical development of ORPATHYS^® in this and other indications, its expectations as to whether clinical studies of ORPATHYS^® would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the sufficiency of its data to support New Drug Application approval of ORPATHYS^® for the treatment of patients with NSCLC in China, its potential to gain expeditious approvals for ORPATHYS^® in other jurisdictions such as the U.S., E.U. or Japan, the safety profile of ORPATHYS^®, the potential for ORPATHYS^® to become a new standard of care for NSCLC patients, its ability to implement and complete its further clinical development plans for ORPATHYS^®, its potential commercial launch of ORPATHYS^® in China and other jurisdictions, the timing of these events, and the impact of the COVID-19 pandemic on general economic, regulatory and political conditions. In addition, as certain studies rely on the use of TAGRISSO^® and IMFINZI^® as combination therapeutics with ORPATHYS^®, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of TAGRISSO^® and IMFINZI^®. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission, on AIM and with The Stock Exchange of Hong Kong Limited. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

 

 

1. World Health Organization. International Agency for Research on Cancer. Lung Fact Sheet. Available at https://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf. Accessed June 2021.
2. World Health Organization. International Agency for Research on Cancer. Globocan China Fact Sheet 2020. Available at http://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf. Accessed June 2021.
3. LUNGevity Foundation. Types of Lung Cancer. Available at https://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer. Accessed June 2021.
4. Cagle P, et al. Lung Cancer Biomarkers: Present Status and Future Developments. Archives Pathology Lab Med. 2013;137:1191-1198.
5. Le Chevalier T, et al. Adjuvant Chemotherapy for Resectable Non-Small Cell Lung Cancer: Where is it Going? Ann Oncol. 2010;21:vii196-vii198.
6. Pignon J, et al. Lung Adjuvant Cisplatin Evaluation: A Pooled Analysis by the LACE Collaborative Group. J Clin Oncol. 2008;26:3552-3559.
7. Zhang YL, et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget. 2016;7(48):78985-78993. doi:10.18632/oncotarget.12587
8. Keedy V.L., et al. American Society of Clinical Oncology Provisional Clinical Opinion: Epidermal Growth Factor Receptor (EGFR) Mutation Testing for Patients with Advanced Non-Small Cell Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor Therapy. J Clin Oncol. 2011:29;2121-27.
9. Ellison G, et al. EGFR Mutation Testing in Lung Cancer: a Review of Available Methods and Their Use for Analysis of Tumour Tissue and Cytology Samples. J Clin Pathol. 2013:66;79-89.
10. Cross DA, et al. AZD9291, an Irreversible EGFR TKI, Overcomes T790M-Mediated Resistance to EGFR Inhibitors in Lung Cancer. Cancer Discov. 2014;4(9):1046-1061.
11. Organ SL, et al. An overview of the c-MET signaling pathway. Ther Adv Med Oncol 2011; 3(1Suppl): S7-S19.
12. Ramalingham SS, et al. Mechanisms of acquired resistance to first-line osimertinib: Preliminary data from the phase III FLAURA study.  Ann Oncol. 2018; 29, SUPPLEMENT 8, VIII740. DOI:https://doi.org/10.1093/annonc/mdy424.063
13. Sterlacci W, et al. MET overexpression and gene amplification: prevalence, clinico-pathological characteristics and prognostic significance in a large cohort of patients with surgically resected NSCLC. Virchows Arch. 2017;471(1):49-55. doi:10.1007/s00428-017-2131-1
14. Lu S, et al. Once-daily savolitinib in Chinese patients with pulmonary sarcomatoid carcinomas and other non-small-cell lung cancers harbouring MET exon 14 skipping alterations: a multicentre, single-arm, open-label, phase 2 study. Lancet Respir Med. 2021 Jun 21:S2213-2600(21)00084-9. doi: 10.1016/S2213-2600(21)00084-9.
15. Sequist LV, et al. Osimertinib plus savolitinib in patients with EGFR mutation-positive, MET-amplified, non-small-cell lung cancer after progression on EGFR tyrosine kinase inhibitors: interim results from a multicentre, open-label, phase 1b study. Lancet Oncol. 2020;21(3):373-386. doi:10.1016/S1470-2045(19)30785-5.
16. Han J, et al. FP14.03 Osimertinib + Savolitinib in pts with EGFRm MET-Amplified/Overexpressed NSCLC: Phase Ib TATTON Parts B and D Final Analysis. J Thorac Oncol. 2021;16(3S):S227-S228. doi: 10.1016/j.jtho.2021.01.146.
17. Choueiri TK, et al. Efficacy of Savolitinib vs Sunitinib in Patients With MET-Driven Papillary Renal Cell Carcinoma: The SAVOIR Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 Aug 1;6(8):1247-1255. doi: 10.1001/jamaoncol.2020.2218.
18. Suarez C, et al. Clinical activity of durvalumab and savolitinib in MET-driven, metastatic papillary renal cancer. J Clin Oncol 39, no. 15_suppl (May 20, 2021) 4511-4511. doi: 10.1200/JCO.2021.39.15_suppl.4511.

 

 

CONTACTS

Investor Enquiries
Mark Lee, Senior Vice President	+852 2121 8200
Annie Cheng, Vice President	+1 (973) 567 3786
Media Enquiries
Americas
Brad Miles, Solebury Trout	+1 (917) 570 7340 (Mobile) bmiles@troutgroup.com
Europe
Ben Atwell / Alex Shaw, FTI Consulting	+44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) HUTCHMED@fticonsulting.com
Asia
Zhou Yi, Brunswick	+852 9783 6894 (Mobile) HUTCHMED@brunswickgroup.com
Nominated Advisor
Atholl Tweedie /Freddy Crossley, Panmure Gordon (UK) Limited	+44 (20) 7886 2500

 

Hong Kong, Shanghai & Florham Park, NJ — Tuesday, September 7, 2021: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM, HKEX: 13) today announces that new analyses and updates on the ongoing studies of amdizalisib (PI3Kδ inhibitor HMPL-689), savolitinib (ORPATHYS^® in China) and fruquintinib (ELUNATE^® in China) will be presented at the upcoming 2021 European Society for Medical Oncology (“ESMO”) Virtual Congress taking place on September 16-21, 2021.
 

AMDIZALISIB (also known as HMPL-689)

Title:	A phase Ib study result of HMPL-689, a PI3Kδ inhibitor, in Chinese patients with relapsed/refractory lymphoma
Lead Author:	Junning Cao, MD, Fudan University Shanghai Cancer Center
Session:	Proffered Paper  – Haematological Malignancies
Presentation Number:	833O
Date & Time:	Monday, September 20, 2021 2:10 pm CEST
Location:	Channel 3

 

SAVOLITINIB

Title:	ORCHARD osimertinib + savolitinib interim analysis: A biomarker-directed phase II platform study in patients with advanced non-small cell lung cancer (NSCLC) whose disease has progressed on first-line (1L) osimertinib
Lead Author:	Helena Yu, MD, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College
Session:	ePoster
Presentation Number:	1239P
Date available:	Monday, September 13, 2021

 

FRUQUINTINIB

Title:	An open-label, phase Ib/II study to evaluate the safety and efficacy of fruquintinib in combination with tislelizumab in patients with advanced triple negative breast cancer
Lead Author:	Debu Tripathy, MD, The University of Texas MD Anderson Cancer Center
Session:	ePoster
Presentation Number:	337TiP
Date available:	Monday, September 13, 2021

 

About Amdizalisib

Amdizalisib (HMPL-689) is a novel, selective and potent oral inhibitor targeting the isoform PI3Kδ. Amdizalisib’s pharmacokinetics (“PK”) properties are favorable with good oral absorption, moderate tissue distribution and low clearance in preclinical PK studies, suggesting a low risk of drug accumulation and drug-to-drug interaction. Because of its high target selectivity and optimal PK profile, amdizalisib has the potential to demonstrate an optimal benefit-risk profile in this class.

HUTCHMED has initiated an extensive, globally-focused clinical development pathway for amdizalisib. In addition to the currently Phase II trial and the supportive Phase I trial in China, amdizalisib is also being evaluated in an ongoing Phase I/Ib study in the U.S. and Europe in patients with relapsed or refractory non-Hodgkin’s lymphoma (NHL).

HUTCHMED currently retains all rights to amdizalisib worldwide.

 

About Savolitinib (ORPATHYS^® in China)

Savolitinib is an oral, potent, and highly selective mesenchymal epithelial transition receptor (MET) tyrosine kinase inhibitor (TKI) that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations) or gene amplification.

Savolitinib is marketed in China under the brand name ORPATHYS^® for the treatment of patients with non-small cell lung cancer (NSCLC) with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy.  It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers, as a single treatment and in combination with other medicines.

In 2011, following its discovery and initial development by HUTCHMED, AstraZeneca and HUTCHMED entered a global licensing agreement to jointly develop and commercialize savolitinib. Joint development in China is led by HUTCHMED, while AstraZeneca leads development outside of China. HUTCHMED is responsible for the marketing authorization, manufacturing and supply of savolitinib in China. AstraZeneca is responsible for the commercialization of savolitinib in China and worldwide. Sales of savolitinib will be recognized by AstraZeneca.

 

About Fruquintinib (ELUNATE^® in China)

Fruquintinib is a highly selective and potent oral inhibitor of VEGFRs -1, -2 and -3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. The generally good tolerability in patients to date, along with fruquintinib’s low potential for drug-drug interaction based on preclinical assessment, suggests that it may also be highly suitable for combinations with other anti-cancer therapies.

HUTCHMED retains all rights to fruquintinib outside of China. In China, HUTCHMED is partnered with Eli Lilly and Company and is responsible for development and execution of all on-the-ground medical detailing, promotion and local and regional marketing.

 

About HUTCHMED

HUTCHMED (Nasdaq/AIM: HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. A dedicated organization of over 1,400 personnel has advanced eleven cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved and marketed. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.

 

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by words like “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “pipeline,” “could,” “potential,” “first-in-class,” “designed to,” “objective,” “guidance,” “pursue,” or similar terms, or by express or implied discussions regarding potential drug candidates, potential indications for drug candidates or by discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that any of our drug candidates will be approved for sale in any market, or that any approvals which are obtained will be obtained at any particular time, or that any such drug candidates will achieve any particular revenue or net income levels. In particular, management’s expectations could be affected by, among other things: unexpected regulatory actions or delays or government regulation generally; the uncertainties inherent in research and development, including the inability to meet our key study assumptions regarding enrollment rates, timing and availability of subjects meeting a study’s inclusion and exclusion criteria and funding requirements, changes to clinical protocols, unexpected adverse events or safety, quality or manufacturing issues; the inability of a drug candidate to meet the primary or secondary endpoint of a study; the inability of a drug candidate to obtain regulatory approval in different jurisdictions or gain commercial acceptance after obtaining regulatory approval; global trends toward health care cost containment, including ongoing pricing pressures; uncertainties regarding actual or potential legal proceedings, including, among others, actual or potential product liability litigation, litigation and investigations regarding sales and marketing practices, intellectual property disputes, and government investigations generally; the impact of the COVID-19 pandemic or other health crises in China or globally on general economic, regulatory and political conditions; and general economic and industry conditions, including uncertainties regarding the effects of the persistently weak economic and financial environment in many countries and uncertainties regarding future global exchange rates. For further discussion of these and other risks, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.

 

CONTACTS

Investor Enquiries
Mark Lee, Senior Vice President	+852 2121 8200
Annie Cheng, Vice President	+1 (973) 567 3786
Media Enquiries
Americas
Brad Miles, Solebury Trout	+1 (917) 570 7340 (Mobile) bmiles@troutgroup.com
Europe
Ben Atwell / Alex Shaw, FTI Consulting	+44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) HUTCHMED@fticonsulting.com
Asia
Zhou Yi, Brunswick	+852 9783 6894 (Mobile) HUTCHMED@brunswickgroup.com
Nominated Advisor
Atholl Tweedie /Freddy Crossley, Panmure Gordon (UK) Limited	+44 (20) 7886 2500

 

Hong Kong, Shanghai & Florham Park, NJ — Monday, September 6, 2021: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; HKEX: 13) today announces that the Company’s ordinary shares, which trade on The Stock Exchange of Hong Kong Limited (“HKEX”), are included in the Shanghai-Hong Kong Stock Connect and Shenzhen-Hong Kong Stock Connect programs, effective on September 6, 2021, according to announcements issued by the Shanghai Stock Exchange and the Shenzhen Stock Exchange.

 

The Stock Connect programs allow international and Mainland Chinese investors to trade securities in each other’s markets through the trading and clearing facilities of HKEX, Shanghai and Shenzhen Stock Exchanges. Qualified Mainland Chinese investors can access eligible Hong Kong shares (Southbound), while Hong Kong and overseas investors can trade eligible A shares (Northbound), subject to specified daily quotas.

 

Christian Hogg, CEO of HUTCHMED commented: “We are pleased to be included in the Stock Connect programs and that qualified Mainland Chinese investors will now have direct access to our shares through the Shanghai and Shenzhen Stock Exchanges.”

 

Hang Seng Indexes Company Limited announced on August 20, 2021, that HUTCHMED would be included as a constituent of several indexes including the Hang Seng Composite Index from September 6, 2021. Inclusion in the Hang Seng Composite Index is a key requirement for the Stock Connect scheme.

 

About HUTCHMED

HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery, global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. A dedicated organization of over 1,400 personnel has advanced eleven cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved. For more information, please visit: www.hutch‑med.com or follow us on LinkedIn.

 

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including its inclusion as a constituent stock of the Hang Seng Composite Index and its ability to meet the eligibility criteria for trading via the southbound trading link of Stock Connect. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding HUTCHMED’s financial condition and results of operations, general economic, regulatory and political conditions and the impact of COVID-19 on any of the foregoing. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission, on AIM and with HKEX. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

 

CONTACTS

Investor Enquiries
Mark Lee, Senior Vice President	+852 2121 8200
Annie Cheng, Vice President	+1 (973) 567 3786
Media Enquiries
Americas
Brad Miles, Solebury Trout	+1 (917) 570 7340 (Mobile) bmiles@troutgroup.com
Europe
Ben Atwell / Alex Shaw, FTI Consulting	+44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) HUTCHMED@fticonsulting.com
Asia
Zhou Yi, Brunswick	+852 9783 6894 (Mobile) HUTCHMED@brunswickgroup.com
Nominated Advisor
Atholl Tweedie /Freddy Crossley, Panmure Gordon (UK) Limited	+44 (20) 7886 2500

 

Hong Kong, Shanghai, & Florham Park, NJ: Thursday, September 2, 2021: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; HKEX: 13) announces that on September 1, 2021, it granted share options under the Share Option Scheme adopted by HUTCHMED in 2015 as refreshed in April 2020 (the “Share Option Scheme”) and conditional awards (“LTIP Awards”) under the Long Term Incentive Plan adopted by HUTCHMED in 2015 (“LTIP”).

 

Aimed at attracting and retaining top talent, the Remuneration Committee of HUTCHMED appointed an independent advisor to conduct a compensation benchmarking research on peer group U.S. and China biotech companies.  The Remuneration Committee comprehensively reviewed the compensation and share-based incentives policies of HUTCHMED and its subsidiaries (the “Group”) and established an attractive policy to ensure the Group is able to recruit and retain top talent. Vesting of share-based awards under the policy is in line with that peer group.

 

HUTCHMED granted share options under its Share Option Scheme to 18 employees to subscribe for a total of 1,086,000 Ordinary Shares represented by 217,200 American Depositary Shares (“ADSs”, each equating to five Ordinary Shares) subject to the acceptance of the grantee.  Details of such share options granted prescribed are as follows:

 

Date of grant	:	September 1, 2021
Exercise price of share options granted	:	US$39.74 per ADS (equivalent to HK$62.00 per Ordinary Share at the conversion rate HK$7.8=US$1) (such exercise price has been determined by reference to the price of the Ordinary Shares on The Stock Exchange of Hong Kong Limited (“HKEX”))
Number of share options granted	:	1,086,000 represented by 217,200 ADSs (five share options shall entitle the holder thereof to subscribe for one ADS)
Closing market price of ordinary shares at HKEX on the date of grant	:	US$39.74 per ADS (equivalent to HK$62.00 per Ordinary Share at the conversion rate HK$7.8=US$1)
Validity period of the share options	:	From September 1, 2021 to August 31, 2031

 

At the same time, HUTCHMED also granted three employees of the Group with non-performance LTIP Awards, and 119 employees of the Group with performance-related LTIP Awards.

 

None of the grantees is a director, chief executive nor substantial shareholder of the Company, or an associate (as defined under the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited) of any of them.

 

About HUTCHMED

HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery, global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. A dedicated organization of over 1,400 personnel has advanced eleven cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved and marketed. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.

 

Forward-Looking Statements

This announcement contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995.  Forward-looking statements involve risks and uncertainties.  Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.  For further discussion of these and other risks, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission, on AIM and on HKEX.  HUTCHMED undertakes no obligation to update or revise the information contained in this announcement, whether as a result of new information, future events or circumstances or otherwise.