Conference call and audio webcast presentation for analysts and investors.
| Presentation and First Q&A session*: Wednesday, May 26, 2021 |
| Time: 8 am EDT / 1pm BST/ 8pm HKT |
|
* For investors based in Asia: |
| Second Q&A session: Thursday, May 27, 2021 |
| Time: 12:00 noon HKT |
To participate by phone, please use one of the following numbers.
Participant Access Code is :
| United Kingdom (Toll-Free) | 0800 026 1542 |
| United Kingdom (Toll) | +44 203 194 0569 |
| United States (Toll-Free) | 1 855 824 5644 |
| United States (Toll) | +1 646 722 4977 |
| China (Toll-Free) | 800 988 0563 |
| China (Toll) | 400 821 0637 |
| Hong Kong | +852 3027 6500 |
| Singapore (Toll-Free) | 800 120 6853 |
| Switzerland (Toll-Free) | 0800 800 732 |
– HUTCHMED will review these highlights as part of its company update audio call and webcast on Wednesday, May 26 at 8 a.m. EDT to discuss data disclosures, its PD-1/L1 combination study strategy and provide a corporate update –
Hong Kong, Shanghai & Florham Park, NJ — Thursday, May 20, 2021: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM) today announces that new analyses and updates on the ongoing studies of savolitinib, surufatinib, fruquintinib and HMPL-306 will be presented at the upcoming ASCO21 Virtual Scientific Program, taking place on June 4-8, 2021.
Aspects of these clinical data disclosures, alongside its PD-1/L1 combination study strategy and corporate update will be discussed part of the previously announced call. For more details, please visit: https://www.hutch-med.com/event/.
| Title: | Clinical activity of durvalumab and savolitinib in MET-driven, metastatic papillary renal cancer |
| Lead Author: | Cristina Suárez, MD, Hospital Univ. Vall D Hebron General |
| Session: | Poster Discussion Session: Genitourinary Cancer—Kidney and Bladder |
| Abstract Number: | 4511 |
| Title: | Interim analysis results of surufatinib in U.S. patients with neuroendocrine tumors (NETs). |
| Lead Author: | Scott Paulson, MD, Baylor Sammons Cancer Center |
| Session: | Poster Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary |
| Abstract Number: | 4114 |
| Title: | Surufatinib in combination with toripalimab in patients with advanced neuroendocrine carcinoma: results from a multicenter, open-label, single-arm, phase II trial |
| Lead Author: | Lin Shen, MD, Peking University Cancer Hospital & Institute |
| Session: | Online publication only |
| Abstract Number: | e16199 |
| Title: | Phase II trial of surufatinib plus toripalimab for disease progression after first-line chemotherapy with platinum and fluoropyrimidine in advanced gastric or gastroesophageal junction adenocarcinoma |
| Lead Author: | Lin Shen, MD, Peking University Cancer Hospital & Institute |
| Session: | Online publication only |
| Abstract Number: | e16040 |
| Title: | A single-arm, multi-center, open-label phase 2 trial of surufatinib in patients with unresectable or metastatic biliary tract cancer. |
| Lead Author: | Yuxian Bai, MD, PhD, Harbin Medical University Cancer Hospital |
| Session: | Online publication only |
| Abstract Number: | e16123 |
| Title: | Subgroup analysis by Ki-67 and baseline CgA of the randomized, placebo-controlled phase 3 study of surufatinib in advanced well-differentiated pancreatic neuroendocrine tumors (SANET-p) |
| Lead Author: | Xianjun Yu, MD, Fudan University Shanghai Cancer Center |
| Session: | Poster Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary |
| Abstract Number: | 4111 |
| Title: | An open-label phase 1b/2 study of surufatinib in combination with tislelizumab in subjects with advanced solid tumors |
| Lead Author: | Arvind Dasari, MD, MS, MD Anderson Cancer Center |
| Session: | Poster Session: Developmental Therapeutics—Immunotherapy |
| Abstract Number: | TPS2677 |
| Title: | Preliminary results of a phase 1b study of fruquintinib plus sintilimab in advanced colorectal cancer |
| Lead Author: | Ye Guo, MD, Shanghai East Hospital |
| Session: | Poster Discussion Session: Gastrointestinal Cancer—Colorectal and Anal |
| Abstract Number: | 2514 |
| Title: | A phase Ib trial of assessing the safety and preliminary efficacy of a combination therapy of Geptanolimab (GB 226) plus Fruquintinib in patients with metastatic colorectal cancer (mCRC) |
| Lead Author: | Yanzhi Cui, MD, Tumour Institute, Fourth Hospital of Hebei Medical University |
| Session: | Online publication only |
| Abstract Number: | e15551 |
| Title: | A multicenter open-label phase 1 study evaluating the safety and tolerability of HMPL-306 in patients with locally advanced or metastatic solid tumors with IDH mutations. |
| Lead Author: | Filip Janku, MD, MD Anderson Cancer Center |
| Session: | Poster Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology |
| Abstract Number: | TPS3159 |
Savolitinib is an oral, potent, and highly selective small molecule inhibitor of MET, a receptor tyrosine kinase which has been shown to function abnormally in many types of solid tumors promoting tumor growth, angiogenesis, and metastasis. Savolitinib has been studied in over 1,100 patients to date. In clinical studies, it has shown promising clinical efficacy in patients with MET gene alterations in multiple tumor types with an acceptable safety profile.
In 2011, HUTCHMED entered into a global licensing and joint development and commercialization agreement with AstraZeneca PLC (LSE/STO/NYSE: AZN) for savolitinib. Savolitinib’s global development plan includes non-small cell lung cancer (NSCLC) and kidney cancer, and additional MET-driven tumors are being explored.
Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptor (“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.
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.
HMPL-306 is HUTCHMED’s ninth innovative oncology drug candidate that it has discovered that has entered clinical development and the sixth to enter global clinical development. Cytoplasmic mutant IDH1 and mitochondrial mutant IDH2 have been known to switch to the other form when targeted by an inhibitor of IDH1 mutant alone or IDH2 mutant alone. By targeting both IDH1 and IDH2 mutations, HMPL-306 could potentially provide therapeutic benefits in cancer patients harboring either IDH mutation, and may address acquired resistance to IDH inhibition through isoform switching.
HUTCHMED currently retains all rights to HMPL-306 worldwide.
HUTCHMED (Nasdaq/AIM: HCM) (formerly Hutchison China MediTech) 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 1,200 personnel has advanced ten cancer drug candidates from in-house discovery into clinical studies around the world, with its first two oncology drugs now approved and launched. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.
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 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.
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 |
– HUTCHMED will hold a webcast on Wednesday, May 26 at 8 a.m. EDT to provide updates on recent progress and upcoming milestones –
Hong Kong, Shanghai & Florham Park, NJ — Monday, May 17, 2021: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM) today announces that it will host a virtual investor update event on Wednesday, May 26, 2021. Members of the senior management team will provide updates on product launches in China, preparations for US commercialization, R&D, as well as a review of new data presented at the 2021 ASCO Annual Meeting.
Analysts and investors are invited to join a conference call and audio webcast presentation. The event will take place at 8:00 a.m. Eastern Daylight Time / 1:00 p.m. British Summer Time (BST) / 8:00 p.m. Hong Kong Time (HKT) on Wednesday, May 26. A first Q&A session will immediately follow the prepared remarks. For Asian investors, a recording of the webcast will be available for viewing the following morning and a second Q&A session will start at 12:00 noon HKT on Thursday, May 27.
The event will be webcast live and can be accessed at www.hutch-med.com/event. Investors interested in listening to the live webcast should log on before the start time to download any software required. A replay of the event will be available shortly thereafter for approximately 90 days.
HUTCHMED (Nasdaq/AIM: HCM) (formerly Hutchison China MediTech) 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 1,200 personnel has advanced ten cancer drug candidates from in-house discovery into clinical studies around the world, with its first two oncology drugs now approved and launched. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.
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. 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 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.
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 — Friday, May 7, 2021: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM) today announces that Mr Christian Hogg, Chief Executive Officer of HUTCHMED, will participate in a virtual fireside chat at the Bank of America 2021 Health Care Conference on Tuesday, May 11, 2021 at 8:00 a.m. Eastern Daylight Time (EDT).
The discussion will be webcast live and can be accessed at www.hutch-med.com/event. Investors interested in listening to the live webcast should log on before the start time to download any software required. A replay of the event will be available shortly thereafter for approximately 90 days.
Members of the senior management team will also attend virtual one-on-one meetings at the Bank of America Health Care Conference, as well as during the following other conferences:
HUTCHMED (Nasdaq/AIM: HCM) (formerly Hutchison China MediTech) 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 1,200 personnel has advanced ten cancer drug candidates from in-house discovery into clinical studies around the world, with its first two oncology drugs now approved and launched. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.
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. 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 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.
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 |
| Date: Tuesday, May 11, 2021 |
| Time: 8:00 a.m. Eastern Daylight Time (EDT) |
| Date: Wednesday, June 9, 2021 |
| Time: 8am Eastern Daylight Time (EDT) |
| Date: Friday, June 4, 2021 |
| Time: 8:30 a.m. Eastern Daylight Time (EDT) |
Hong Kong, Shanghai, & Florham Park, NJ — Tuesday, May 4, 2021: HUTCHMED (China) Limited (Nasdaq/AIM: HCM), formerly known as Hutchison China MediTech Limited, announces that, further to its “Results of Annual General Meeting” announcement released on Wednesday, April 28, 2021, the Registrar of Companies in the Cayman Islands has issued a replacement certificate of incorporation on Thursday, April 29, 2021 in the name of HUTCHMED (China) Limited (“HUTCHMED”) so the new name of the Company is now effective from April 29, 2021.
Trading in the shares of HUTCHMED will commence under the new name HUTCHMED (China) Limited with effect from 8:00 am UK time on Wednesday, May 5, 2021. The stock market ticker symbol, depositary interests ISIN and American depositary shares’ ISIN and CUSIP of the Company remain unchanged.
As disclosed in the 2020 final results announcement, the website of the Company has already changed to www.hutch-med.com with effect from March 4, 2021. The information required pursuant to AIM Rule 26 is available at this website.
This name change is a consolidation of the two corporate identities that we have used since our inception, under a single and ubiquitous corporate identity that captures the history and brand equity we have built over the past twenty years. For more information, please visit www.hutch-med.com/chi-med-becomes-hutchmed.
Shareholders should note that their shareholding will not be affected by the change of name of the Company and the existing share certificates should be retained as they will remain valid for all purposes and no new share certificates will be issued.
The change of name was approved at the annual general meeting held on Wednesday, April 28, 2021.
HUTCHMED (Nasdaq/AIM: HCM) 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 1,200 personnel has advanced ten cancer drug candidates from in-house discovery into clinical studies around the world, with its first two oncology drugs now approved and launched. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.
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 |
– First NDA submission by HUTCHMED in the U.S.; product launch preparations underway –
Hong Kong, Shanghai & Florham Park, NJ — Monday, May 3, 2021: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM) today announces that it completed the rolling submission of a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for surufatinib for the treatment of pancreatic and extra-pancreatic (non-pancreatic) neuroendocrine tumors (“NETs”).
Dr. Marek Kania, Managing Director and Chief Medical Officer of HUTCHMED International Corporation, said, “HUTCHMED is developing six novel oncology drug candidates internationally and this surufatinib NDA represents our first ever in the United States. Having successfully launched surufatinib in China early this year, we are now looking forward, subject to its approval, to being able to provide access to this important new therapeutic option for NETs patients in the U.S. and beyond. Our surufatinib NDA submission to the FDA was completed by our rapidly expanding international team of over 70 personnel based mainly in the U.S., working side by side with our discovery and development colleagues in China.”
The NDA is supported by data from two positive Phase III studies of surufatinib in NET in China (SANET-p[1] and SANET-ep[2]), and by data from a surufatinib study conducted in the U.S. in patients with pancreatic and extra-pancreatic NET. HUTCHMED previously announced that it had reached an agreement with the FDA during a pre-NDA meeting, whereby these studies may serve as the basis to support an NDA submission. Fast Track Designations granted in April 2020 by the FDA have permitted HUTCHMED to submit sections of the NDA on a rolling basis. Filing acceptance of the NDA is subject to the FDA’s review of the complete application. The data package will also be used to file a Marketing Authorization Application (“MAA”) to the European Medicines Agency (“EMA”) in 2021, based on scientific advice from the EMA’s Committee for Medicinal Products for Human Use.
HUTCHMED initiated an Expanded Access Protocol (EAP) in the U.S. to ensure patients with NET and 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).
In addition to the two Fast Track Designations for surufatinib development in pancreatic and extra-pancreatic NET granted by the FDA in April 2020, Orphan Drug Designation for pancreatic NET was also granted in November 2019.
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 NET (“epNET”).
According to Frost & Sullivan, there were 19,000 newly diagnosed cases of NET in the U.S. in 2020. Importantly, NETs are associated with a relatively long duration of survival compared to other tumors. As a result, there were approximately 143,000 estimated patients living with NET in the U.S. in 2020.[3]
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.
NETs in the U.S. and Europe: 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. A U.S. FDA NDA rolling submission was initiated in December 2020, to be followed by a MAA submission to the EMA in Europe. 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).
epNETs in China: On December 30, 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 progression-free survival (“PFS”) at a preplanned interim analysis. The positive results of this trial were highlighted in an oral presentation at the 2019 ESMO Congress and published in The Lancet Oncology in September 2020.[4] 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: In 2016, we initiated the SANET-p study, which is a pivotal Phase III study in patients with low- or intermediate-grade, advanced pNET in China. It was terminated early as the pre-defined primary endpoint of PFS was met (clinicaltrials.gov identifier: NCT02589821) at a preplanned interim analysis, leading to a second NDA accepted by the NMPA in September 2020. The positive results of this study were presented at the 2020 ESMO Virtual Congress and published simultaneously in The Lancet Oncology[5], demonstrating that surufatinib reduces the risk of disease progression or death by 51% in patients, with 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.
Biliary tract cancer in China: In March 2019, we initiated a Phase IIb/III study comparing surufatinib with capecitabine in patients with advanced biliary tract cancer whose disease progressed on first-line chemotherapy. The primary endpoint is overall survival (OS) (clinicaltrials.gov identifier: NCT03873532).
Immunotherapy combinations: We have 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.
HUTCHMED (Nasdaq/AIM: HCM) (formerly Hutchison China MediTech Limited) 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 1,200 personnel has advanced ten cancer drug candidates from in-house discovery into clinical studies around the world, with its first two oncology drugs now approved and launched. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.
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 submission of an NDA for surufatinib for the treatment of NET with the FDA and the timing of such submission, 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 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 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.
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 |
[1] Surufatinib in advanced neuroendocrine tumors – pancreatic.
[2] Surufatinib in advanced neuroendocrine tumors – extra-pancreatic (non-pancreatic).
[3] 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. The current incidence to prevalence ratio in China is estimated at 4.4, lower than the 7.4 ratio in the U.S. due to lower access to treatment options.
[4] 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.
[5] 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.