| Date: Monday, June 12, 2023 |
| Time: 8am PDT (3pm GMT / 11pm HKT ) |
| Date: Thursday, June 8, 2023 |
| Time: 3:30pm EDT (7:30pm GMT // 3:30am HKT on June 9 ) |
— Prescription Drug User Fee Act (PDUFA) Target Action Date set for November 30, 2023 —
— NDA includes results from the Phase III FRESCO-2 and FRESCO clinical trials —
OSAKA, Japan, CAMBRIDGE, Massachusetts, HONG KONG, SHANGHAI &, FLORHAM PARK, New Jersey, Friday May 26, 2023 – Takeda (TSE:4502/NYSE:TAK) and HUTCHMED (China) Limited (Nasdaq/AIM:HCM, HKEX:13) (“HUTCHMED”) today announced that the U.S. Food and Drug Administration (“FDA”) has granted priority review of the New Drug Application (“NDA”) for fruquintinib, a highly selective and potent inhibitor of vascular endothelial growth factor receptors (“VEGFR”) -1, -2 and -3 for the treatment of adult patients with previously treated metastatic colorectal cancer (“CRC”). If approved, fruquintinib will be the first and only highly selective inhibitor of all three VEGF receptors approved in the U.S. for previously treated metastatic CRC.[1],[2] The Prescription Drug User Fee Act (PDUFA) goal date assigned by the FDA for this NDA is November 30, 2023.
“We are confident that fruquintinib has the potential to transform the treatment landscape for those living with previously treated metastatic colorectal cancer, as demonstrated by its strong clinical profile,” said Awny Farajallah, M.D., head of Global Medical Affairs Oncology at Takeda. “There are significant needs for patients with this disease in the U.S., and we believe fruquintinib has the potential to address these needs regardless of patients’ biomarker status. We look forward to continuing conversations with the FDA with the goal to make this therapy available to patients as soon as possible.”
The NDA for fruquintinib includes results from the Phase III FRESCO-2 trial along with data from the Phase III FRESCO trial conducted in China. FRESCO-2 is a global Phase III multi-regional clinical trial (MRCT) conducted in the U.S., Europe, Japan and Australia investigating fruquintinib plus best supportive care (“BSC”) vs placebo plus BSC in patients with previously treated metastatic CRC. The FRESCO-2 trial met its primary and key secondary endpoints, showing a significant and clinically meaningful improvement in overall survival (“OS”) and progression-free survival (“PFS”), respectively. Fruquintinib has been generally well tolerated in patients to date.
“The clinical benefit of fruquintinib has been confirmed in multiple ways, from global clinical studies to commercialization in China. We are pleased to have Takeda as our partner furthering development and commercialization of fruquintinib outside of China,” said Dr. Michael Shi, Head of R&D and Chief Medical Officer, HUTCHMED. “Today’s acceptance marks a significant advancement towards the goal of providing patients with previously treated metastatic colorectal cancer a much-needed therapeutic option, given the limited treatment options currently available to patients. This also supports our ongoing vision to design and develop differentiated molecules that help patients with high unmet needs globally.”
Fruquintinib is currently approved in China under the brand name ELUNATE®. Approval in China was based on the results of the FRESCO study, a Phase III pivotal registration trial of fruquintinib in 416 patients with metastatic CRC in China, published in The Journal of the American Medical Association, JAMA, in June 2018 (NCT02314819).[3] In March 2023, HUTCHMED and Takeda closed an exclusive licensing agreement to further the global development, commercialization and manufacture of fruquintinib outside of China.
Fruquintinib is a highly selective and potent oral inhibitor of VEGFR -1, -2 and -3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity with the intention of minimizing off-target toxicities, improving tolerability and providing more consistent target coverage. Fruquintinib has been generally well tolerated in patients to date and is being investigated in combinations with other anti-cancer therapies.
The FRESCO-2 study is a multi-regional clinical trial conducted in the U.S., Europe, Japan and Australia investigating fruquintinib plus BSC vs placebo plus BSC in patients with previously treated metastatic CRC. As previously disclosed, the 691-patient study met its primary endpoint of OS in patients with metastatic CRC who had progressed on standard chemotherapy and relevant biologic agents and who had progressed on, or were intolerant to, TAS-102 and/or regorafenib. In addition to OS, a statistically significant improvement in PFS, a key secondary endpoint, was observed. Fruquintinib has been generally well tolerated in patients to date. Summary results were initially presented at the European Society for Medical Oncology (ESMO) Congress in September 2022.[4] Additional details of the study may be found at clinicaltrials.gov, using identifier NCT04322539.
CRC is a cancer that starts in either the colon or rectum. According to the International Agency for Research on Cancer, CRC is the third most prevalent cancer worldwide, associated with 935,000 deaths in 2020.[5] In the U.S., it is estimated that 153,000 patients will be diagnosed with CRC and 53,000 deaths from the disease will occur in 2023.[6] In Europe, CRC was the second most common cancer in 2020 with approximately 520,000 new cases and 245,000 deaths. In Japan, CRC was the most common cancer with an estimated 148,000 new cases and 60,000 deaths in 2020.[6] Although early-stage CRC can be surgically resected, metastatic CRC remains an area of high unmet need with poor outcomes and limited treatment options. Some patients with metastatic CRC may benefit from personalized therapeutic strategies based on molecular characteristics; however, most patients have tumors that do not harbor actionable mutations.[7],[8],[9],[10],[11]
Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare disease, plasma-derived therapies, neuroscience, oncology and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.
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. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception it has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three oncology drugs now approved and marketed in China. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.
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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 a NDA for fruquintinib for the treatment of CRC with the FDA and the timing of such submission, the therapeutic potential of fruquintinib for the treatment of patients with CRC and the further clinical development of fruquintinib in this and other indications. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the timing and outcome of clinical studies and the sufficiency of clinical data to support NDA approval of fruquintinib for the treatment of patients with CRC or other indications in the U.S. or other jurisdictions such as Europe or Japan, its potential to gain approvals from regulatory authorities on an expedited basis or at all; the efficacy and safety profile of fruquintinib; HUTCHMED’s ability to fund, implement and complete its further clinical development and commercialization plans for fruquintinib; the timing of these events; each party’s ability to satisfy the terms and conditions under the license agreement; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials or the regulatory pathway for fruquintinib; Takeda’s ability to successfully develop and commercialize fruquintinib; 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 other drug products such as paclitaxel as combination therapeutics with fruquintinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of these therapeutics. Such forward-looking statements include, without limitation, statements regarding the plan to develop and commercialize fruquintinib under the license agreement; potential payments under the license agreement, including the upfront payment and any milestone or royalty payments; potential benefits of the license agreement; and HUTCHMED’s strategy, goals and anticipated milestones, business plans and focus. 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.
This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.
1 Xu X, et al. Efficacy and safety of regorafenib and fruquintinib as third-line treatment for colorectal cancer: a narrative review. Transl Cancer Res 2022;11(1):276-287. doi: 10.21037/tcr-20-3539
2 Sun Q, et al. (2014) Discovery of fruquintinib, a potent and highly selective small molecule inhibitor of VEGFR 1, 2, 3 tyrosine kinases for cancer therapy, Cancer Biol Ther. 2014 15:12, 1635-1645. Doi: 10.4161/15384047.2014.964087
3 Li J, Qin S, Xu RH, et al. Effect of Fruquintinib vs Placebo on Overall Survival in Patients With Previously Treated Metastatic Colorectal Cancer: The FRESCO Randomized Clinical Trial. JAMA. 2018;319(24):2486-2496. doi:10.1001/jama.2018.7855.
4 Dasari NA, et al. LBA25 – FRESCO-2: A global phase III multiregional clinical trial (MRCT) evaluating the efficacy and safety of fruquintinib in patients with refractory metastatic colorectal cancer. Ann Oncol. 2022 Sep;33(suppl_7): S808-S869. 10.1016/annonc/annonc1089.
5 Sung H, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;71(3):209-249. doi:10.3322/caac.21660
6 Siegel RL, al. Colorectal cancer statistics, 2023 [published online ahead of print, 2023 Mar 1]. CA Cancer J Clin. 2023;10.3322/caac.21772. doi:10.3322/caac.21772
7 Bando H, et al. Therapeutic landscape and future direction of metastatic colorectal cancer. Nat Rev Gastroenterol Hepatol (2023). Doi:10.1038/s41575-022-00736-1
8 D’Haene N, et al. Clinical application of targeted next-generation sequencing for colorectal cancer patients: a multicentric Belgian experience. Oncotarget. 2018;9(29):20761-20768. Published 2018 Apr 17. doi:10.18632/oncotarget.25099
9 Venderbosch, et al. (2014). Mismatch repair status and braf mutation status in metastatic colorectal cancer patients: A pooled analysis of the Cairo, Cairo2, coin, and Focus Studies. Clinical Cancer Research, 20(20), 5322–5330. https://doi.org/10.1158/1078-0432.ccr-14-0332
10 Koopman, M., et al. (2009). Deficient mismatch repair system in patients with sporadic advanced colorectal cancer. British Journal of Cancer, 100(2), 266–273. https://doi.org/10.1038/sj.bjc.6604867
11 Ahcene Djaballah S, et al. HER2 in Colorectal Cancer: The Long and Winding Road From Negative Predictive Factor to Positive Actionable Target. Am Soc Clin Oncol Educ Book. 2022;42:1-14. doi:10.1200/EDBK_351354
Hong Kong, Shanghai & Florham Park, NJ — Thursday, May 25, 2023: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated clinical data related to HUTCHMED’s novel investigational cancer therapies fruquintinib, surufatinib and HMPL-453 in 21 abstracts that will be presented at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 2-6, 2023 in Chicago, IL and online.
Fruquintinib: further analyses from the FRESCO-2 study and exploratory combination studies
Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptor (“VEGFR”)-1, -2 and -3.[1] Fruquintinib has been generally well tolerated in patients to date and is being investigated as a single agent and in combination with other anti-cancer therapies. 13 presentations and publications, including several investigator-initiated-trials (“IITs”), are listed in the table below.
Additional FRESCO-2 analyses: New analyses from the FRESCO-2 multi-regional clinical trial (MRCT) are being presented. FRESCO-2 is a key study supporting ongoing and upcoming submissions to the U.S., European and Japanese regulatory authorities for the treatment of previously treated metastatic colorectal cancer (“CRC”). FRESCO-2 results were first presented at the European Society for Medical Oncology Congress 2022. These new analyses add to the understanding of fruquintinib efficacy by specific lines of therapy as well as adverse events of special interest (“AESI”). In subgroup analyses by prior lines of therapies up to six or more and by prior treatment with approved agents, fruquintinib improved overall survival (“OS”) and progression free survival (“PFS”) for all subgroups and prior therapies, consistent with those of the intent-to-treat (“ITT”) population. Furthermore, during the study AESIs led to low rates of dose reduction (13.6% for patients who received fruquintinib vs 0.9% for patients who received placebo) and dose discontinuation (8.3% for patients who received fruquintinib vs 6.1% for patients who received placebo).
CRC real-world data: Results from a prospective, 3,005-patient Phase IV study to evaluate the safety of fruquintinib in real-world clinical practice in China are consistent with the fruquintinib safety profile observed in existing clinical studies, with no new or significant safety signals identified.
PD-1 combination in ccRCC: PFS results from an exploratory study of the fruquintinib and sintilimab (an anti-programmed cell death protein-1 [“PD-1”] antibody) combination in metastatic clear cell renal cell carcinoma (“ccRCC”) are available with longer term follow-up. At data cut-off on November 30, 2022, median PFS was 15.9 months in 20 previously treated patients. Median PFS was not reached when results from this study were initially presented at the 2021 Chinese Society of Clinical Oncology Annual Meeting (data cut-off on August 31, 2021). No new safety signals were observed. A Phase II/III trial of fruquintinib in combination with sintilimab as second-line treatment for locally advanced or metastatic ccRCC was initiated in October 2022 (NCT05522231).
IIT in 2L MSS CRC: A number of IITs are being presented, including initial results of an IIT for fruquintinib in combination with investigator’s choice of chemotherapy in second-line metastatic CRC with microsatellite-stable (MSS) phenotype. At median follow up of 8.4 months, median PFS was not reached in 31 efficacy evaluable patients, disease control rate (DCR) was 90.3% and objective response rate (ORR) was 48.4%. Five patients received reduced doses of fruquintinib.
Surufatinib: exploratory results in combination with other agents
Surufatinib is a small-molecule inhibitor of VEGFR-1, -2 and -3, fibroblast growth factor receptor (“FGFR”)-1 and colony-stimulating factor 1 receptor (CSF-1R). Seven related presentations and publications, including IITs, are listed in the table below.
PD-1 combinations: We conducted an open-label, multi-cohort, single-arm Phase II study of surufatinib plus toripalimab (an anti-PD-1 antibody) in several advanced solid tumors. We reported the results from the advanced thyroid cancer and endometrial cancer cohorts (NCT04169672). Amongst efficacy evaluable radioactive iodine-refractory differentiated thyroid cancer patients, median PFS was 10.9 months and median OS was not reached (median follow-up duration was 22.1 months). Amongst efficacy evaluable endometrial cancer patients, median PFS was 5.4 months and 12-month OS rate was 71.0% (median follow-up duration was 16.8 months). In both cohorts, the combination showed a tolerable safety profile.
Combo IITs: A number of IITs are being presented for surufatinib in combination with other agents, including with chemotherapy as well as with camrelizumab (an anti-PD-1 antibody) plus different chemotherapy regimens.
Preliminary results in an ongoing IIT in treatment of patients with naïve metastatic pancreatic adenocarcinoma (PDAC) showed median PFS of 8.8 months in patients who received a combination of surufatinib, camrelizumab, nab-paclitaxel and S-1, compared to 5.8 months in patients who received gemcitabine in combination with nab-paclitaxel. Markers of immune cells were observed in an analysis of tissue samples from 13 (out of 20) patients who received S 1 in combination with surufatinib, camrelizumab and nab-paclitaxel. The combination safety profiles were manageable.
The IIT in previously treated CRC study completed the dose escalation phase of the study in 12 patients and enrolled a further 36 patients in the dose expansion phase of the study. The investigators found the combination of surufatinib with camrelizumab, irinotecan and GM-CSF to be well tolerated with a manageable safety profile. Median PFS was 7.2 months (95% CI 3.7-10.7).
The IIT in previously treated, advanced driver-gene negative, non-squamous, non-small cell lung cancer (“NSCLC”) in combination with chemotherapy. This study complements Phase II results previously presented for the surufatinib and toripalimab combination in patients with treatment naïve advanced NSCLC with positive PD-L1 expression.
HMPL-453: first in human results
FGFRs regulate numerous cellular processes. Dysregulation of FGFR signaling due to receptor fusion, mutation or amplification is observed across multiple cancer types, making activated FGFRs an important therapeutic target. HMPL-453 is a highly potent and selective inhibitor of FGFR-1, -2, and -3. Preclinical data presented at the American Association for Cancer Research Annual Meeting 2023 (AACR 2023) showed that it has strong activity against FGFR-deregulated tumors, supporting investigation in patients with FGFR alterations (such as fusion and mutation) either as a single agent or in combination with PD-1 blockade.
Here we present first-in-human data for HMPL-453 in patients with previously treated advanced intrahepatic cholangiocarcinoma (IHCC) harboring FGFR2 fusions. A Phase II registration intent cohort is currently enrolling such patients (NCT04353375).
Further details including the full abstracts are available at meetings.asco.org, as summarized below.
ABSTRACT PRESENTATION DETAILS
| Abstract title | Presenter / Lead author | Presentation details |
|---|---|---|
| FRUQUINTINIB | ||
| Subgroup analyses of safety and efficacy by number and types of prior lines of treatment in FRESCO-2, a global phase III study of fruquintinib in patients with refractory metastatic colorectal cancer | Arvind Dasari, MD Anderson Cancer Center | Abstract # 3604 Poster Session Gastrointestinal Cancer–Colorectal and Anal Monday, June 5, 2023, 8 am CDT, Hall A |
| Analysis of fruquintinib adverse events of special interest from phase 3 of the FRESCO-2 study | Cathy Eng, Vanderbilt-Ingram Cancer Center | Abstract # 3601 Poster Session Gastrointestinal Cancer–Colorectal and Anal Monday, June 5, 2023, 8 am CDT, Hall A |
| A phase IV study to evaluate the safety of fruquintinib in Chinese real-world clinical practice | Jin Li, Tongji University Shanghai East Hospital | Abstract # e15568 Publication Only Gastrointestinal Cancer–Colorectal and Anal |
| Fruquintinib plus sintilimab in patients with either treatment-naive or previously first line treated metastatic clear-cell renal cell carcinoma (ccRCC): Results from a multicenter, single-arm phase 2 study | Dingwei Ye, Fudan University Shanghai Cancer Center | Abstract # e16514 Publication Only Genitourinary Cancer—Kidney and Bladder |
| Efficacy and safety of fruquintinib plus investigator’s choice of chemotherapy as second-line therapy in metastatic colorectal cancer: A multicenter, single-arm phase 2 trial | Wensi Zhao, Renmin Hospital of Wuhan University | Abstract # 3582 Poster Session Gastrointestinal Cancer–Colorectal and Anal Monday, June 5, 2023, 8 am CDT, Hall A |
| Fruquintinib plus oxaliplatin combined with S-1 (SOX) as neoadjuvant therapy for locally advanced gastric adenocarcinoma (FRUTINEOGA): a multicenter, phase II study. | Liucheng Wu, Guangxi Medical University Cancer Hospital | Abstract # e16063 Publication Only Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary |
| Association of neutrophil/lymphocyte ratio and IFN-γ with clinical response and survival in patients with MSS/pMMR mCRC treated with anti-PD-1 and VEGF inhibitors | Zhuqing Liu, Tongji University School of Medicine | Abstract # e14610 Publication Only Developmental Therapeutics—Immunotherapy |
| Efficacy and safety of radiation therapy combined with anti-angiogenic agents and immunotherapy for MSS/pMMR metastatic colorectal cancer: A real-world study | Zhenyu Lin, Tongji Medical College | Abstract # e15559 Publication Only Gastrointestinal Cancer—Colorectal and Anal |
| A phase II study of fruquintinib in the first- (1L) or second-line (2L) treatment of unresectable metastatic soft tissue sarcoma | Zhiguo Luo, Fudan University Shanghai Cancer Center | Abstract # e23547 Publication Only Sarcoma |
| Quality of life, effectiveness, and compliance of fruquintinib in the treatment of metastatic colorectal cancer: Results from a prospective real-world study. | Jun Zhang, Reijin Hospital | Abstract # e15557 Publication Only Gastrointestinal Cancer–Colorectal and Anal |
| Fruquintinib versus fruquintinib combined with PD-1 inhibitors for metastatic colorectal cancer: Real-world data | Lina He, Shanghai Jiao Tong University | Abstract # e15592 Publication Only Gastrointestinal Cancer–Colorectal and Anal |
| Phase II study of fruquintinib as second or further-line therapy for patients with advanced biliary tract cancer | Pengfei Zhang, West China Hospital | Abstract # e16161 Publication Only Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary |
| A phase I/IIa study of cetuximab combined with fruquintinib in the previously treated RAS/BRAF wild-type metastatic colorectal cancer: Results of the CEFRU study | Yong Li, Traditional Chinese Medicine Hospital of Guangdong | Abstract # e15558 Publication Only Gastrointestinal Cancer–Colorectal and Anal |
| SURUFATINIB | ||
| A multicenter, single-arm phase 2 study of surufatinib plus toripalimab for patients with locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer | Dongmei Ji, Fudan University Shanghai Cancer Center | Abstract # 6089 Poster Session Head and Neck Cancer Monday, June 5, 2023, 1:15 pm CDT, Hall A |
| A multicenter, single-arm, phase 2 study of surufatinib plus toripalimab for patients with advanced endometrial cancer | Guangwen Yuan, Cancer Hospital Chinese Academy of Medical Sciences | Abstract # 5609 Poster Session Gynecologic Cancer Monday, June 5, 2023, 1:15 pm CDT, Hall A |
| A phase 1b/2 study of surufatinib plus camrelizumab, nab-paclitaxel, and S-1 (NASCA) as first-line therapy for metastatic pancreatic adenocarcinoma (mPDAC) | Guanghai Dai, The Fifth Medical Center of the PLA General Hospital | Abstract # 4142 Poster Session Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary Monday, June 5, 2023, 8:00 am CDT, Hall A |
| A phase Ib/II study to evaluate surufatinib combined with camrelizumab and chemotherapy in the second-line treatment of advanced colorectal cancer: Phase Ib results | Sheng Li, Department of Oncology, Jiangsu Cancer Hospital | Abstract # 3555 Poster Session Gastrointestinal Cancer–Colorectal and Anal Monday, June 5, 2023, 8 am CDT, Hall A |
| Phase 1b/2 study of surufatinib in combination with docetaxel as second-line treatment of advanced driver-gene negative non-squamous non-small cell lung cancer (NSCLC) | Wei Jiang, Guangxi Medical University Cancer Hospital | Abstract # e21087 Publication Only Lung Cancer—Non-Small Cell Metastatic |
| Pathologic exploration of neuroendocrine differentiation in carcinomas | Yaru Wen, Cancer Hospital Chinese Academy of Medical Sciences | Abstract # e16238 Publication Only Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary |
| A phase II study of surufatinib in patients with osteosarcoma and soft tissue sarcoma who have failed in standard chemotherapy | Xing Zhang, Sun Yat-sen University Cancer Center | Abstract # e23540 Publication Only Sarcoma |
| HMPL-453 | ||
| A phase 2 study of HMPL-453, a selective FGFR tyrosine kinase inhibitor (TKI), in patients with previously treated advanced cholangiocarcinoma containing FGFR2 fusions | Jianming Xu, Fifth Medical Center, Chinese PLA General Hospital | Abstract # e16118 Publication Only Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary |
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. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception it has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three oncology drugs now approved and marketed in China. 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 fruquintinib, surufatinib, and HMPL-453, the further clinical development for fruquintinib, surufatinib, and HMPL-453, its expectations as to whether any studies on fruquintinib, surufatinib and HMPL-453 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 and the 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 fruquintinib, surufatinib and HMPL-453, including as a combination therapy, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential market of fruquintinib, surufatinib and HMPL-453 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.
[1] Sun Q, et al. (2014) Discovery of fruquintinib, a potent and highly selective small molecule inhibitor of VEGFR 1, 2, 3 tyrosine kinases for cancer therapy, Cancer Biol Ther. 2014 15:12, 1635-1645. Doi: 10.4161/15384047.2014.964087
Contacts
Investor Enquiries |
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| Mark Lee, Senior Vice President | +852 2121 8200 |
| Annie Cheng, Vice President | +1 (973) 306 4490 |
Media Enquiries |
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| Americas – Brad Miles, Solebury Strategic Communications |
+1 (917) 570 7340 (Mobile) bmiles@soleburystrat.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 |
+44 (20) 7886 2500 |
TR-1: Standard form for notification of major holding
| NOTIFICATION OF MAJOR HOLDINGS (to be sent to the relevant issuer and to the FCA in Microsoft Word format if possible) i | ||||||
| “>1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attached ii: | HUTCHMED (China) Limited | |||||
| 1b. Please indicate if the issuer is a non-UK issuer (please mark with an “X” if appropriate) | ||||||
| Non-UK issuer | X | |||||
| 2. Reason for the notification (please mark the appropriate box or boxes with an “X”) | ||||||
| An acquisition or disposal of voting rights | X | |||||
| An acquisition or disposal of financial instruments | ||||||
| An event changing the breakdown of voting rights | ||||||
| Other (please specify) iii: | ||||||
| 3. Details of person subject to the notification obligation iv | ||||||
| Name | Canada Pension Plan Investment Board | |||||
| City and country of registered office (if applicable) | Toronto, Canada | |||||
| 4. Full name of shareholder(s) (if different from 3.) v | ||||||
| Name | N/A | |||||
| City and country of registered office (if applicable) | N/A | |||||
| 5. Date on which the threshold was crossed or reached vi: | 15 May 2023 | |||||
| 6. Date on which issuer notified (DD/MM/YYYY): | 17/05/2023 | |||||
| 7. Total positions of person(s) subject to the notification obligation | ||||||
| % of voting rights attached to shares (total of 8. A) | % of voting rights through financial instruments (total of 8.B 1 + 8.B 2) |
Total of both in % (8.A + 8.B) | Total number of voting rights held in issuer (8.A + 8.B) vii | |||
| Resulting situation on the date on which threshold was crossed or reached | Less than 3% | |||||
|
Position of previous notification (if applicable) |
3.17 | 0.00 | 3.17 | |||
| 8. Notified details of the resulting situation on the date on which the threshold was crossed or reached viii | |||||||||
| A: Voting rights attached to shares | |||||||||
| Class/type of shares ISIN code (if possible) |
Number of voting rights ix | % of voting rights | |||||||
| Direct (DTR5.1) |
Indirect (DTR5.2.1) |
Direct (DTR5.1) |
Indirect (DTR5.2.1) |
||||||
| Ordinary Shares KYG4672N1198 |
|||||||||
|
|
|||||||||
| SUBTOTAL 8. A | Less than 3% | Less than 3% | |||||||
|
|
|||||||||
| B 1: Financial Instruments according to DTR5.3.1R (1) (a) | |||||||||
| Type of financial instrument | Expiration date x |
Exercise/ Conversion Period xi |
Number of voting rights that may be acquired if the instrument is exercised/converted. |
% of voting rights | |||||
|
|
|||||||||
| SUBTOTAL 8. B 1 | |||||||||
| B 2: Financial Instruments with similar economic effect according to DTR5.3.1R (1) (b) | |||||||||
| Type of financial instrument | Expiration date x |
Exercise/ Conversion Period xi |
Physical or cash Settlement xii | Number of voting rights | % of voting rights | ||||
| SUBTOTAL 8.B.2 | |||||||||
| 9. Information in relation to the person subject to the notification obligation (please mark the applicable box with an “X”) | ||||||
| Person subject to the notification obligation is not controlled by any natural person or legal entity and does not control any other undertaking(s) holding directly or indirectly an interest in the (underlying) issuer xiii | X | |||||
| Full chain of controlled undertakings through which the voting rights and/or the financial instruments are effectively held starting with the ultimate controlling natural person or legal entity (please add additional rows as necessary) xiv |
||||||
| Name xv | % of voting rights if it equals or is higher than the notifiable threshold | % of voting rights through financial instruments if it equals or is higher than the notifiable threshold | Total of both if it equals or is higher than the notifiable threshold | |||
| 10. In case of proxy voting, please identify: | ||||||
| Name of the proxy holder | N/A | |||||
| The number and % of voting rights held | N/A | |||||
| The date until which the voting rights will be held | N/A | |||||
| 11. Additional information xvi | ||||||
| Place of completion | London, UK | |||||
| Date of completion | 16 May 2023 | |||||
| Date: Tuesday, May 16, 2023 |
| Time: 9am ET / 1pm GMT/ (9pm HKT ) |
Hong Kong, Shanghai, & Florham Park, NJ: Friday, May 12, 2023: HUTCHMED (China) Limited (“HUTCHMED” or the “Company”) (Nasdaq/AIM: HCM; HKEX:13) today announces that all ordinary resolutions and special resolution put to its Annual General Meeting (“AGM”) held on May 12, 2023 were duly passed. The poll results of the resolutions were as follows:
|
Ordinary Resolutions |
Number of Votes (%)* |
Passed by Shareholders |
|||
|
For
|
Against
|
Withheld# |
|||
| 1. |
To consider and adopt the audited financial statements, and the reports of the directors and independent auditors for the year ended December 31, 2022.
|
571,825,129 (99.9999%) |
768 (0.0001%) |
17,055,535
|
Yes |
| 2(A). |
To re-elect Mr TO Chi Keung, Simon as a director.
|
561,123,049 (95.7385%) |
24,976,533 (4.2615%) |
2,781,850 | Yes |
| 2(B). |
To re-elect Dr Weiguo SU as a director.
|
587,563,585 (99.7835%) |
1,275,082 (0.2165%) |
42,765 | Yes |
| 2(C). |
To re-elect Mr CHENG Chig Fung, Johnny as a director.
|
586,799,765 (99.6540%) |
2,037,527 (0.3460%) |
44,140 | Yes |
| 2(D). |
To re-elect Dr Dan ELDAR as a director.
|
585,955,689 (99.5104%) |
2,882,978 (0.4896%) |
42,765 | Yes |
| 2(E). |
To re-elect Ms Edith SHIH as a director.
|
585,511,051 (99.4349%) |
3,327,616 (0.5651%) |
42,765 | Yes |
| 2(F). |
To re-elect Mr Lefei SUN as a director.
|
585,955,594 (99.5104%) |
2,883,073 (0.4896%) |
42,765 | Yes |
| 2(G). |
To re-elect Mr Paul Rutherford CARTER as a director.
|
588,835,909 (99.9998%) |
1,383 (0.0002%) |
44,140 | Yes |
| 2(H). |
To re-elect Mr Graeme Allan JACK as a director.
|
582,880,781 (99.4509%) |
3,218,176 (0.5491%) |
2,782,475 | Yes |
| 2(I). |
To re-elect Professor MOK Shu Kam, Tony as a director.
|
575,206,823 (97.6850%) |
13,631,844 (2.3150%) |
42,765 | Yes |
| 3. |
To re-appoint PricewaterhouseCoopers and PricewaterhouseCoopers Zhong Tian LLP as the auditors of the Company for Hong Kong financial reporting and U.S. financial reporting purposes, respectively, and to authorize the Directors to fix the auditors’ remuneration.
|
588,053,284 (99.8666%) |
785,368 (0.1334%) |
42,780 | Yes |
| Special Resolution | |||||
| 4. |
To grant a general mandate to the Directors to issue additional shares of the Company.^
|
580,202,630 (98.5334%) |
8,636,037 (1.4666%) |
42,765 | Yes |
| Ordinary Resolutions | |||||
| 5. |
To grant a general mandate to the Directors to repurchase shares of the Company.^
|
588,837,389 (99.9998%) |
1,278 (0.0002%) |
42,765 | Yes |
* Percentages rounded to 4 decimal places.
# # A vote withheld is not a vote in law and is not counted in the calculation of the proportion of the votes for and against a resolution.
^ The full text of Resolutions 4 and 5 are set out in the Notice of AGM.
Notes:
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. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception it has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three oncology drugs now approved and marketed in China. 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) 306 4490 |
Media Enquiries |
|
| Americas – Brad Miles, Solebury Strategic Communications |
+1 (917) 570 7340 (Mobile) bmiles@soleburystrat.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 |
+44 (20) 7886 2500 |
Hong Kong, Shanghai & Florham Park, NJ — Friday, May 12, 2023: HUTCHMED (China) Limited (“HUTCHMED” or the “Company”) (Nasdaq/AIM:HCM, HKEX:13) refers to its announcement on May 10, 2023 of the appointment of Professor Solange Peters as an Independent Non-executive Director, member of the Technical Committee and member of the Audit Committee of the Company with effect from the conclusion of the annual general meeting of the Company to be held on May 12, 2023 (“AGM”). The Company today announces that the effective date of such appointments will be deferred until a later date to be announced by the Company.
The Company also announces that Professor Mok Shu Kam, Tony will be appointed as member of the Audit Committee of the Company at the conclusion of the AGM, subject to Professor Mok being re-elected as a Director by the shareholders at the AGM.
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. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception it has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three oncology drugs now approved and marketed in China. For more information, please visit: www.hutch‑med.com or follow us on LinkedIn.
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. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, the risk that current or future appointees to HUTCHMED’s board of directors are not effective in their respective positions, the difficulty in locating and recruiting suitable candidates for its board of directors and the management difficulties which may arise from changes in HUTCHMED’s board of directors. 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 AІM and with The Stock Exchange of Hong Kong Limited. 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.
Contacts
Investor Enquiries |
|
| Mark Lee, Senior Vice President | +852 2121 8200 |
| Annie Cheng, Vice President | +1 (973) 306 4490 |
Media Enquiries |
|
| Americas – Brad Miles, Solebury Strategic Communications |
+1 (917) 570 7340 (Mobile) bmiles@soleburystrat.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 |
+44 (20) 7886 2500 |
Hong Kong, Shanghai & Florham Park, NJ — Wednesday, May 10, 2023: HUTCHMED (China) Limited (“HUTCHMED” or the “Company”) (Nasdaq/AIM:HCM, HKEX:13) today announces that that Professor Solange Peters is appointed as an Independent Non-executive Director, member of the Technical Committee and member of the Audit Committee of the Company with effect from the conclusion of the annual general meeting of the Company to be held on May 12, 2023. Professor Peters is a renowned scientist and educator who possesses expertise and extensive experience in oncology and immunology. The Board of HUTCHMED is of the view that Professor Peters will make significant contributions to the Company.
Mr Simon To, Chairman of HUTCHMED said “On behalf of the Board, I would like to extend a warm welcome to Professor Peters to the Company. We believe that her expertise in biopharmaceutical research in oncology and immunology would be of immense value to the Company and she would be instrumental in assisting the Company in achieving its goals.”
Professor Peters, aged 50, is the chair of medical oncology and thoracic malignancies in the Department of Oncology at the University Hospital of Lausanne in Lausanne, Switzerland. After completing her clinical education in medical oncology and molecular biology in Switzerland and Italy, she specialized in thoracic tumors, lung cancer, and pleural tumors. Professor Peters was the youngest president of the European Society for Medical Oncology (ESMO) for an extended period of three years from 2020 to 2022, and she is active in the educational programmes of ESMO, where she created the Women for Oncology Committee. Professor Peters was also a member of the board of directors of the International Association for the Study of Lung Cancer (IASLC) from 2013 to 2017.
Professor Peters is currently in charge of teaching and patient care in thoracic malignancies at Lausanne University, where she is building a translational programme in collaboration with the Swiss Federal Institute of Technology and the Ludwig Institute. Her main fields of interest are new biomarker discovery and validation in preclinical and clinical settings, multimodality strategies for locally advanced non-small cell lung cancer (NSCLC), as well as cancer immunotherapy. Her current research projects are mainly focused on innovative immunotherapy combinations and new immuno-modulating treatments across thoracic malignancies. She acts as the local principal investigator (PI) for lung trials opened at Lausanne Cancer Centre and is a co-PI of several other trials.
Professor Peters acts as the scientific committee chair and foundation council member of the ETOP IBCSG Partners Foundation. She was recently nominated as the strategic advisory board president of the Paris Saclay Cancer Cluster and is part of the board of directors of the Swiss National Cancer League. She is also the president of International Cancer Foundation. Professor Peters is also an independent director of Galenica AG, which is listed on the SIX Swiss Exchange.
Professor Peters has authored more than 500 peer-reviewed manuscripts and book chapters, acts as Associate Editor of the Annals of Oncology, Deputy Editor of Lung Cancer, and serves on the editorial board of several other oncology journals. She was the deputy editor of the Journal of Thoracic Oncology for ten years. She received both her doctorate in medicine and PhD from the University Hospital of Lausanne.
Save for the appointments listed above, Professor Peters has held no other directorships or partnerships during the period of five years prior to her appointment as a director of HUTCHMED. She does not have any relationship with any Directors, senior management or substantial or controlling shareholders of HUTCHMED. Professor Peters does not have any interest in the ordinary shares of HUTCHMED within the meaning of Part XV of the Securities and Futures Ordinance (Cap.571 of the Laws of Hong Kong). The initial term of the appointment of Professor Peters as an Independent Non-executive Director of the Company shall end at the next general meeting of the Company, subject to retirement in accordance with the Articles of Association of the Company and applicable legal and regulatory requirements. The initial term shall be automatically renewed for successive 12-month periods, unless she is not re-elected at the next general meeting or her appointment is otherwise terminated earlier by either party in writing. The director’s fees of Professor Peters as an Independent Non-executive Director, member of the Technical Committee and member of the Audit Committee of the Company under her appointment letter are US$76,000, US$8,000 and US$13,500 per annum respectively. Such fees are subject to review from time to time and proration for any incomplete year of service.
Save for the information disclosed above, there is no other information in relation to Professor Peters that is required to be disclosed pursuant to Rule 17 and Schedule 2(g) of the AІM Rules for Companies or Rule 13.51(2) of the HK Listing Rules and there are no other matters concerning the appointment of Professor Peters that are required to be brought to the attention of the shareholders of 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. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception it has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three oncology drugs now approved and marketed in China. For more information, please visit: www.hutch‑med.com or follow us on LinkedIn.
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. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, the risk that current or future appointees to HUTCHMED’s board of directors are not effective in their respective positions, the difficulty in locating and recruiting suitable candidates for its board of directors and the management difficulties which may arise from changes in HUTCHMED’s board of directors. 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 AІM and with The Stock Exchange of Hong Kong Limited. 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.
Contacts
Investor Enquiries |
|
| Mark Lee, Senior Vice President | +852 2121 8200 |
| Annie Cheng, Vice President | +1 (973) 306 4490 |
Media Enquiries |
|
| Americas – Brad Miles, Solebury Strategic Communications |
+1 (917) 570 7340 (Mobile) bmiles@soleburystrat.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 |
+44 (20) 7886 2500 |
| Date: May 10, 2023 (Wed) |
| Time: 3:40pm PDT (6:40pm EDT / 11:40pm BST // 6:40am HKT on May 11) |
Listen to Webcast replay |