Hong Kong, Shanghai, & Florham Park, NJ — Thursday, June 29, 2023: HUTCHMED (China) Limited (“HUTCHMED” or the “Company”) (Nasdaq/AIM: HCM; HKEX: 13) announces the following blocklisting six monthly return:
| 1. | Name of applicant: | HUTCHMED (China) Limited | ||
| 2. | Name of scheme: | (a) | Share Option Scheme conditionally adopted by HUTCHMED in 2005 (“2005 HUTCHMED Share Option Scheme”) | |
| (b) | Share Option Scheme conditionally adopted by HUTCHMED in 2015 (“2015 HUTCHMED Share Option Scheme”) | |||
| 3. | Period of return: | From December 29, 2022 to June 28, 2023 | ||
| 4. | Balance under scheme from previous return: | (a) | 2005 HUTCHMED Share Option Scheme: 883,300 ordinary shares of US$0.1 each | |
| (b) | 2015 HUTCHMED Share Option Scheme: 52,667,578 ordinary shares of US$0.1 each | |||
| 5. | The amount by which the block scheme has been increased, if the scheme has been increased since the date of the last return: | (a) | 2005 HUTCHMED Share Option Scheme: Nil | |
| (b) | 2015 HUTCHMED Share Option Scheme: Nil | |||
| 6. |
Number of securities issued/allotted under scheme during period:
|
(a) | 2005 HUTCHMED Share Option Scheme: 449,250 | |
| (b) | 2015 HUTCHMED Share Option Scheme: 936,860 | |||
| 7. | Balance under scheme not yet issued/allotted at end of the period: | (a) | 2005 HUTCHMED Share Option Scheme: 434,050 ordinary shares of US$0.1 each | |
| (b) | 2015 HUTCHMED Share Option Scheme: 51,730,718 ordinary shares of US$0.1 each | |||
| 8. | Number and class of securities originally listed and the date of admission: | 25,198,880 ordinary shares of US$0.1 each admitted on June 17, 2019 (to replace the Company’s previous block admission schemes following the Company’s share subdivision which took effect on May 30, 2019) | ||
| 9. | Total number of securities in issue at the end of the period: | 866,161,450 ordinary shares of US$0.1 each | ||
| Name of contact | Weiguo Su | |||
| Address of contact: | Level 18, The Metropolis Tower, 10 Metropolis Drive, Hung Hom, Kowloon, Hong Kong | |||
| Telephone number of contact: | +852 2121 8200 | |||
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.
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 / Daphne Zhang, Panmure Gordon |
+44 (20) 7886 2500 |
Hong Kong, Shanghai & Florham Park, NJ — Monday, June 26, 2023: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; SEHK:13) will be announcing its interim results for the six months ended June 30, 2023 on Monday, July 31, 2023 at 7:00 am Eastern Daylight Time (EDT) / 12:00 noon British Summer Time (BST) / 7:00 pm Hong Kong Time (HKT).
Analysts and investors are invited to join a conference call and audio webcast presentation with Q&A, conducted by HUTCHMED management.
The conference call and audio webcast will take place at 8:00 am EDT / 1:00 pm BST / 8:00 pm HKT on Monday, July 31, 2023 and will be webcast live via the company website at www.hutch-med.com/event/. The presentation will be available for downloading before the conference call begins. Details of the conference call dial-in will be provided in the financial results announcement and on the company website. A replay will also be available on the website shortly after the event.
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 |
| Job Title: | CRA Line Manager (AD) |
| Job Title: | Clinical Operation |
| Location: | Beijing |
— Publication shows FRESCO-2 demonstrated treatment with fruquintinib reduced the risk of death by 34% in previously treated metastatic colorectal cancer (0.66 HR) —
— Data support regulatory submissions in the U.S., Europe and Japan during 2023 —
Hong Kong, Shanghai, Florham Park, NJ, Osaka, Japan & Cambridge, MA — Friday, June 16, 2023: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM, HKEX:13) and Takeda (TSE:4502, NYSE:TAK) today announced that results of the Phase III FRESCO‑2 study evaluating fruquintinib in patients with previously treated metastatic colorectal cancer (“CRC”) were published in The Lancet.
The publication provides details of the FRESCO-2 study results as of June 24, 2022. Summary results from this cut-off date were presented on September 12, 2022, at the European Society for Medical Oncology Congress 2022 (“ESMO22”).
Fruquintinib is a highly selective and potent inhibitor of vascular endothelial growth factor receptors (“VEGFR”) -1, -2 and -3. 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 study met its primary and key secondary endpoints, demonstrating that treatment with fruquintinib resulted in a statistically significant and clinically meaningful improvement in overall survival (“OS”) and progression-free survival (“PFS”), respectively. The safety profile of fruquintinib in FRESCO-2 was consistent with previously reported fruquintinib studies.
FRESCO-2 was a key study supporting regulatory submissions to the U.S. Food and Drug Administration (“FDA”) for fruquintinib for the treatment of previously treated metastatic CRC, which was accepted for review and granted Priority Review in May 2023. Filing of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) and an NDA to the Japan Pharmaceuticals and Medical Devices Agency (PMDA) are planned in 2023.
In March 2023, HUTCHMED and Takeda closed an exclusive license agreement to further the global development, commercialization and manufacture of fruquintinib outside of China.
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 more than 935,000 deaths in 2020.[i] 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.[ii] 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 2020.1 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.[iii],[iv],[v],[vi],[vii]
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.
Fruquintinib was approved for marketing by the China National Medical Products Administration (NMPA) in September 2018 and commercially launched in China in November 2018 under the brand name ELUNATE®. It has been included in the China National Reimbursement Drug List (NRDL) since January 2020. ELUNATE® is indicated for the treatment of patients with metastatic CRC who have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan, including those who have previously received anti-VEGF therapy and/or anti-EGFR therapy (RAS wild type). Approval in China is supported by 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).[viii]
HUTCHMED markets fruquintinib in China in partnership with Eli Lilly and Company.
The safety and efficacy of fruquintinib for the following investigational uses have not been established and there is no guarantee that it will receive health authority approval or become commercially available in any country for the uses being investigated.
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 (NCT04322539). The study met its primary and key secondary endpoints, demonstrating that treatment with fruquintinib resulted in a statistically significant and clinically meaningful improvement in OS and PFS, respectively. Results from the study were presented at ESMO in September 2022 and subsequently published in The Lancet.[ix],[x]
The median OS was 7.4 months for the 461 patients treated with fruquintinib compared with 4.8 months for the 230 patients in the placebo group (hazard ratio [“HR”] 0.66; 95% confidence interval [“CI”] 0.55–0.80; p<0.001). The median PFS was 3.7 months for patients treated with fruquintinib compared with 1.8 months for patients in the placebo group (HR 0.32; 95% CI 0.27–0.39; p<0.001). The disease control rate (“DCR”) was 56% in the fruquintinib group compared with 16% for patients in the placebo group (95% CI, 32.8-46.0; p<0.001). Median duration of follow-up was approximately 11 months for patients in both groups.
The safety profile of fruquintinib in FRESCO-2 was consistent with previously reported fruquintinib studies. Grade 3 or higher adverse events occurred in 63% (286/456) of patients who received fruquintinib plus BSC, compared to 50% (116/230) of patients who received placebo plus BSC. Grade 3 or higher adverse events that occurred in ≥ 5% of patients who received fruquintinib were hypertension (14% vs 1% in the placebo group), asthenia (8% vs 4% in the placebo group) and hand-foot syndrome (6% vs 0% in the placebo group). Adverse events leading to discontinuation occurred in 20% of patients who received fruquintinib, compared to 21% of patients who received placebo.
Gastric Cancer in China: The FRUTIGA study is a randomized, double-blind, Phase III study in China to evaluate fruquintinib combined with paclitaxel compared with paclitaxel monotherapy, for second-line treatment of advanced gastric cancer or gastroesophageal junction adenocarcinoma (NCT03223376). Topline results were announced in November 2022. The trial met one of the primary endpoints of statistically significant improvement in PFS, which is clinically meaningful. The other primary endpoint of OS was not statistically significant per the pre-specified statistical plan, although there was a numerical improvement in median OS. Fruquintinib also demonstrated a statistically significant improvement in secondary endpoints including objective response rate (ORR), DCR, and improved duration of response (DoR). The safety profile of fruquintinib in FRUTIGA was consistent with previously reported studies. Full detailed results are expected to be disclosed at an upcoming scientific meeting.
HUTCHMED is also developing fruquintinib for the treatment of multiple solid tumor cancers in combination with PD-1 monoclonal antibodies for the treatment of endometrial and other solid tumors.
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.
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 diseases, plasma-derived therapies, oncology, neuroscience 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 https://www.takeda.com.
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 New Drug Application (“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.
For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.
The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.
This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could” “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.
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.
Reference
[i] 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.
[ii] Siegel RL, et al. Colorectal cancer statistics, 2023 [published online ahead of print, 2023 Mar 1]. CA Cancer J Clin. 2023;73(3):233-254. DOI:10.3322/caac.21772.
[iii] Bando H, et al. Therapeutic landscape and future direction of metastatic colorectal cancer. Nat Rev Gastroenterol Hepatol. 2023;20(5):306-322. DOI:10.1038/s41575-022-00736-1.
[iv] 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.
[v] Venderbosch, et al. 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 Res.2014;20(20), 5322–5330. DOI:10.1158/1078-0432.ccr-14-0332.
[vi] Koopman, M., et al. Deficient mismatch repair system in patients with sporadic advanced colorectal cancer. Br J Cancer, 2009;100(2), 266–273. DOI:10.1038/sj.bjc.6604867.
[vii] 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.
[viii] Li J, 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.
[ix] 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. DOI:10.1016/annonc/annonc1089.
[x] Dasari NA, et al. Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer (FRESCO-2): an international, multicentre, randomised, double-blind, phase 3 study [published online ahead of print, 2023 Jun 15]. Lancet. 2023. DOI: 10.1016/S0140-6736(23)00772-9.
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 |
— Application Includes Data from Phase III FRESCO-2 and FRESCO Clinical Trials, which Demonstrated Superiority of Fruquintinib Plus Best Supportive Care (“BSC”) vs. Placebo plus BSC for Adult Patients with Previously Treated Metastatic Colorectal Cancer
Osaka, Cambridge, MA, Hong Kong, Shanghai & Florham Park, NJ — Thursday, June 15, 2023: – Takeda (TSE:4502/NYSE:TAK) and HUTCHMED (China) Limited (Nasdaq/AIM: HCM, HKEX: 13) (“HUTCHMED”) today announced that the European Medicines Agency (“EMA”) has validated and accepted for regulatory review the marketing authorization application (“MAA”) 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 E.U. for previously treated metastatic CRC.1,2
“European patients with metastatic colorectal cancer have not benefitted from a treatment advancement in over a decade,” said Awny Farajallah, M.D., head of Global Medical Affairs Oncology at Takeda. “We are thrilled to have submitted the marketing authorization application to the EMA, bringing us one step closer to potentially offering this innovative therapy to patients with advanced disease. We believe fruquintinib has the potential to address the longstanding unmet need for patients with previously treated metastatic colorectal cancer regardless of their biomarker status, and we look forward to working with the regulators throughout the process.”
The MAA 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 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.
“Based on fruquintinib’s clinical profile to date, we are optimistic about its potential as a choice for patients and physicians in the E.U. who find treatment options to be limited for previously treated metastatic colorectal cancer,” said Dr. Michael Shi, Head of R&D and Chief Medical Officer, HUTCHMED. “We believe the EMA validation of the marketing authorization application for fruquintinib represents an exciting initial step toward advancing treatment for patients in Europe and look forward to supporting Takeda as it pursues this goal.”
The validation follows the acceptance by the U.S. Food and Drug Administration (“FDA”) of a new drug application (“NDA”), announced on May 25, 2023, which was granted Priority Review and assigned Prescription Drug User Fee Act (PDUFA) goal date of November 30, 2023. Submission of an NDA to the Japan Pharmaceuticals and Medical Devices Agency (PMDA) is also planned in 2023. 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 more than 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 2020.5 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.
For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws. The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.
This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could” “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.
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 MAA for fruquintinib for the treatment of CRC with the EMA 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 MAA approval of fruquintinib for the treatment of patients with CRC or other indications in the E.U. or other jurisdictions such as the U.S. 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.
Reference
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. 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, 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. doi: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, et al. Colorectal cancer statistics, 2023 [published online ahead of print, 2023 Mar 1]. CA Cancer J Clin. 2023; 73(3):233-254. doi:10.3322/caac.21772.
7 Bando H, et al. Therapeutic landscape and future direction of metastatic colorectal cancer. Nat Rev Gastroenterol Hepatol. 2023;20(5):306-322. 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. 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 Res. 2014;20(20):5322–5330. doi:10.1158/1078-0432.ccr-14-0332.
10 Koopman, M., et al. Deficient mismatch repair system in patients with sporadic advanced colorectal cancer. Br J Cancer. 2009;100(2):266–273. doi: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.
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, June 9, 2023: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated clinical data related to two novel investigational hematological malignancy therapies, HMPL-306 and amdizalisib, will be presented at the upcoming European Hematology Association (“EHA”) Annual Meeting, taking place June 8-11, 2023 in Frankfurt, and the 17th International Conference on Malignant Lymphoma (“ICML”) taking place June 13-17, 2023 in Lugano.
HMPL-306: first in human results
| Title: | A phase 1 study of HMPL-306, a dual inhibitor of mutant isocitrate dehydrogenase (IDH) 1 and 2, in pts with relapsed/refractory myeloid hematological malignancies harboring IDH1 and/or 2 mutations |
| Lead Author: | Lijuan Hu, MD, Peking University People’s Hospital |
| Meeting: | EHA poster presentation |
| Session: | Myeloproliferative neoplasms – Clinical |
| Abstract # & Link: | Abstract #P539 |
Mutations in isocitrate dehydrogenase (“IDH”) 1/2 are frequently identified in various cancers, such as acute myeloid leukemia (“AML”), cholangiocarcinoma, chondrosarcoma and glioma. Mutant IDHs cause accumulated 2-hydroxyglutarate, leading to blockage of cell differentiation, thereby inducing malignant transformation. Mutant IDH isoform switching, from mutant IDH1 to mutant IDH2 and vice versa, have been reported as a mechanism of acquired resistance to IDH inhibition in AML and cholangiocarcinoma, as well as cases initially carrying co-existing mutations.
Preclinical data presented at the American Association for Cancer Research Annual Meeting 2023 (AACR 2023) demonstrated that HMPL-306 is a potent, durable, dual inhibitor of IDH1/2 mutation that crosses the blood brain barrier and affects pharmacodynamic (“PD”) markers that lead to the differentiation of immature malignant cells to mature normal cells. It is being evaluated in clinical trials (NCT04272957, NCT04762602, NCT04764474).
This first-in-human, dose-escalation study data presents HMPL-306 in patients with relapsed/refractory myeloid hematological malignancies harboring IDH1 and/or IDH2 mutations. Based on PD, pharmacokinetic (“PK”), and preliminary clinical findings, a recommended Phase II dose was nominated for the dose expansion phase of the study.
Amdizalisib: updates from Phase Ib
| Title: | Updated results from a phase 1b study of amdizalisib, a novel inhibitor of phosphoinositide 3-kinase-delta (PI3Kδ), in patients with relapsed or refractory lymphoma |
| Lead Author: | Junning Cao, MD, Fudan University Shanghai Cancer Center |
| Meeting: | ICML Publication |
| Session: | Phase I-II trials |
| Abstract #: | Abstract #653 |
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. Amdizalisib is currently being evaluated in a Phase II registration trial in relapsed or refractory follicular lymphoma (“FL”) and marginal zone lymphoma (“MZL”) as a single agent (NCT04849351), as well as in combination with tazemetostat (a methyltransferase inhibitor of EZH2) in patients with relapsed or refractory lymphoma in a Phase II study in China (NCT05713110).
Here we report updated results from a Phase Ib study of amdizalisib in patients with various subtypes of non‑Hodgkin’s lymphoma (“NHL”). In this update, more mature data were available from the FL cohorts, at median follow-up duration of 22.1 months. Median duration of response (“DoR”) and progression free survival (“PFS”) were not reached for the 26 efficacy evaluable patients in the FL cohort. PFS and DoR from the MZL cohort were presented for the first time, at median follow-up duration of 20.3 months. Median DoR was not reached and median PFS was 26.8 months for the 16 efficacy evaluable patients in the MZL cohort. Safety data were reported from 153 patients with median exposure duration of 8.7 months. The most common treatment emergent adverse events (TEAEs) of Grade ≥3 (≥5%) were pneumonia (15.7%), neutrophil count decreased (12.4%), lipase increased (7.8%), and rash (5.9%). The treatment discontinuation rate due to adverse events was 11.8%.
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 HMPL-306 and amdizalisib, the further clinical development for HMPL-306 and amdizalisib, its expectations as to whether any studies on HMPL-306 and amdizalisib 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 HMPL-306 and amdizalisib, 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 HMPL-306 and 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.
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: Tuesday, June 6, 2023: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; HKEX: 13) announces that on June 5, 2023, it granted conditional awards (“LTIP Awards”) under the Long Term Incentive Plan adopted by HUTCHMED in 2015 (“LTIP”) and share options under the Share Option Scheme adopted by HUTCHMED in 2015 (the “Share Option Scheme”).
Aimed at attracting and retaining top talent, the Remuneration Committee of HUTCHMED appointed an independent advisor to conduct a compensation benchmarking research on selected peer group 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.
1. Performance-related LTIP Award for the HUTCHMED Financial Year 2023 (“Performance LTIP Awards”) – award based on a maximum cash amount, which amount is determined by the achievement of performance targets for the financial year ending December 31, 2023. The performance targets are determined by the Remuneration Committee of HUTCHMED based on the strategic objectives of HUTCHMED.
The shares, to be purchased by the trustee following determination of the cash amount based on actual achievement of performance targets, will then be held by the trustee until the related underlying LTIP Awards are vested. Vesting will occur two business days after the date of announcement of the annual results of HUTCHMED for the financial year ending December 31, 2025. Vesting will also depend upon the continued employment of the award holder with the Group and will otherwise be at the discretion of the Board of Directors of HUTCHMED.
HUTCHMED has granted the Performance LTIP Awards to the following Executive Directors, being persons discharging managerial responsibility (“PDMR”) under the UK Market Abuse Regulation:
| Award Holder | Maximum amount for the Performance LTIP Awards | |
| Dr Weiguo Su (Executive Director, Chief Executive Officer and Chief Scientific Officer) | US$3,289,770 | |
| Mr Johnny Cheng (Executive Director and Chief Financial Officer) | US$698,224 |
An additional 839 employees of the Group have simultaneously been granted Performance LTIP Awards.
2. Share Option Scheme
HUTCHMED granted share options under its Share Option Scheme to 68 employees to subscribe for a total of 1,221,900 ordinary shares with par value US$0.10 each in the share capital of the Company (“Ordinary Shares”) represented by 244,380 American Depositary Shares (“ADSs”) (each equivalent to five Ordinary Shares) subject to the acceptance of the grantee. Details of such share options granted are as follows:
| Date of grant | : | June 5, 2023 |
| Exercise price of share options granted | : |
US$12.51 per ADS (equivalent to HK$19.52 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 | : |
1,221,900 represented by 244,380 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$12.51 per ADS (equivalent to HK$19.52 per Ordinary Share at the conversion rate HK$7.8=US$1)
|
| Exercise period of the share options | : |
From June 5, 2023 to June 4, 2033
|
| Vesting period of the share options | : |
The share options will vest at 25% on each of the first, second, third and fourth anniversaries of the date of grant of the share options.
|
| Performance targets | : |
No performance targets are stipulated in the option grants. One of the main purposes of the Share Option Scheme is to retain key talent and acknowledge and reward their contribution to the Group. The share options vest over a time period of four years and only vest if the grantee remains an employee of the Group. The Share Option Scheme provides the grantees with an opportunity to become owners of the Company, which aligns their interests with those of other shareholders.
|
| Clawback mechanism | : |
The share options are not currently subject to any clawback arrangements. The Company is actively considering such arrangements in light of the new proposed listing standards which would require most US-listed companies to adopt a policy providing for the recoupment of excess incentive-based compensation received by current or former executive officers due to certain misstatements of the company’s financial reports. The proposed listing standards, when they become effective, will apply to the Company as a foreign private issuer listed on Nasdaq.
Having considered that (i) the share options to the grantees are partly a recognition for their past contributions to the Group; (ii) the share options are subject to a total vesting period of four years; and (iii) the share option scheme provides for circumstances under which the share options or any part thereof shall lapse in the event that grantees cease to be employed or engaged by the Group due to any misconduct or any other conduct which would justify the termination of their employment or appointment for cause, the Remuneration Committee and the Board consider that an additional clawback provision is not necessary at this stage. |
HUTCHMED has granted share options to the following Executive Director, being PDMR under the UK Market Abuse Regulation, as well as other eligible employees, as outlined below:
| Grantees | Number of share options | |
| Mr Johnny Cheng (Executive Director and Chief Financial Officer) | 61,700 share options represented by 12,340 ADSs | |
| Other eligible employees | 1,160,200 share options represented by 232,040 ADSs | |
| Total | 1,221,900 share options represented by 244,380 ADSs |
As at the date of this announcement, the number of share options available for future grant under the scheme mandate of the Share Option Scheme is 12,426,943.
The notification set out below is provided in accordance with the requirements of the UK Market Abuse Regulation.
Mr Johnny Cheng
| 1 | Details of the person discharging managerial responsibilities/person closely associated | |||||
| a) | Name | Mr Johnny Cheng | ||||
| 2 | Reason for the notification | |||||
| a) | Position/status | Executive Director and Chief Financial Officer | ||||
| b) | Initial notification/Amendment | Initial notification | ||||
| 3 | Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor | |||||
| a) | Name | HUTCHMED (China) Limited | ||||
| b) | LEI | 2138006X34YDQ6OBYE79 | ||||
| 4 | Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted | |||||
| a) |
Description of the financial instrument, type of instrument Identification code |
Share option over American Depositary Share (each equating to five Ordinary Shares of US$0.10) Share option over American Depositary Share with ADS ISIN: US44842L1035 |
||||
| b) | Nature of the transaction |
Grant of options in respect of 61,700 Ordinary Shares represented by 12,340 ADSs under the Share Option Scheme. The share options granted are exercisable subject to a vesting schedule of 25% on each of the first, second, third and fourth anniversaries of the effective date of grant. |
||||
| c) | Price(s) and volume(s) |
|
||||
| d) | Aggregated information
|
N/A | ||||
| e) | Date of the transaction | 2023-06-05 | ||||
| f) | Place of the transaction | Outside a trading venue | ||||
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. 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.
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 |