— If approved in the European Union, fruquintinib will be the first novel targeted therapy for metastatic colorectal cancer regardless of biomarker status in over a decade —
— Positive opinion based on results from FRESCO‑2 Phase III clinical trial —
Hong Kong, Shanghai & Florham Park, NJ — Friday, April 26, 2024: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that its partner Takeda (TSE:4502/NYSE:TAK) received notification that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) has recommended the approval of fruquintinib for the treatment of adult patients with previously treated metastatic colorectal cancer (“CRC”).
The European Commission (EC) will consider the CHMP positive opinion when determining the potential marketing authorization for fruquintinib for metastatic CRC throughout the European Union (“EU”), Norway, Liechtenstein and Iceland. If approved, fruquintinib will be the first and only selective inhibitor of all three vascular endothelial growth factor receptors (“VEGFR”) approved in the EU for previously treated metastatic CRC. [1],[2] Takeda has the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside of mainland China, Hong Kong and Macau.
“Through our partnership with HUTCHMED, we have made strides in expanding access to fruquintinib to eligible patients. With this positive CHMP opinion for fruquintinib, we are one step closer to potentially offering patients in the EU an oral, chemotherapy‑free option that can provide a significant survival benefit,” said Awny Farajallah, M.D., Chief Medical Officer, Oncology at Takeda. “We look forward to the European Commission’s official decision in the near future.”
“HUTCHMED has a strong track record of developing innovative oncology medicines for patients in need. People living with metastatic CRC in the EU currently have limited treatment options available to them, which can lead to poor outcomes. We are pleased with our partner Takeda’s progress toward redefining the treatment landscape and helping to address a significant unmet need for those affected by metastatic CRC in Europe,” said Weiguo Su, PhD, Chief Executive Officer and Chief Scientific Officer of HUTCHMED. “This novel oncology medicine has had a profound impact for patients in China over the last five years. Since entering our partnership with Takeda we have seen this impact extended with its approval and launch in the U.S. and, pending approval by the European Commission, we look forward to the medicine having a positive effect for patients in Europe too.”
The CHMP’s positive opinion was primarily based on results from the Phase III multi‑regional FRESCO‑2 trial, which supported the Marketing Authorisation Application (“MAA”). The MAA was validated and accepted for review by the EMA in June 2023.
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. In Europe, CRC was the second most common cancer in 2020, with approximately 520,000 new cases and 245,000 deaths.[3] 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 2024.[4] In Japan, CRC was the most common cancer, with an estimated 148,000 new cases and 60,000 deaths, in 2020.3 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.[5],[6],[7],[8],[9]
FRESCO‑2 is a multi‑regional clinical trial conducted in the U.S., Europe, Japan and Australia investigating fruquintinib plus best supportive care (“BSC”) versus placebo plus BSC in patients with previously treated mCRC (NCT04322539). FRESCO-2 met all of its primary and key secondary endpoints, demonstrating statistically significant and clinically meaningful improvement in overall survival (OS) and progression-free survival (PFS), with consistent benefit among patients treated with fruquintinib, regardless of the prior types of therapies they received. Fruquintinib demonstrated a manageable safety profile in FRESCO‑2, consistent with previously reported fruquintinib studies. Adverse reactions leading to treatment discontinuation occurred in 20% of patients treated with fruquintinib plus BSC versus 21% of those treated with placebo plus BSC. Results from the study were presented at the European Society for Medical Oncology Congress (ESMO) in September 2022 and subsequently published in The Lancet in June 2023.[10],[11]
Fruquintinib is a selective oral inhibitor of VEGFR‑1, ‑2 and ‑3. VEGFR inhibitors play a pivotal role in inhibiting tumor angiogenesis. Fruquintinib was designed to have enhanced selectivity that limits off‑target kinase activity, allowing for high drug exposure, sustained target inhibition, and flexibility for its potential use as part of a combination therapy. Fruquintinib has demonstrated a manageable safety profile and is being investigated in combinations with other anti‑cancer therapies.
Takeda has the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside of mainland China, Hong Kong and Macau. Fruquintinib received approval in the U.S. in November 2023, where it is marketed by Takeda under the brand name FRUZAQLA®. The U.S. approval was based on data from two large, randomized, controlled Phase III trials, the multi‑regional FRESCO‑2 trial and the FRESCO trial conducted in China, showing consistent benefit among a total of 734 patients treated with fruquintinib. Safety profiles were consistent across trials.
In addition to the submission to the EMA, a submission to the Japan Pharmaceuticals and Medical Devices Agency (PMDA) took place in September 2023.
Fruquintinib is approved for marketing in China, where it is co‑marketed by HUTCHMED and Eli Lilly and Company under the brand name ELUNATE®. It was included in the China National Reimbursement Drug List (NRDL) in January 2020. The approval was based on data from the FRESCO study, a Phase III pivotal registration trial of fruquintinib in 416 patients with metastatic colorectal cancer in China, which were published in The Journal of the American Medical Association, JAMA. Since its launch in China and as of mid‑2023, more than 80,000 colorectal cancer patients have been treated with fruquintinib.
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 medicines marketed in China, the first of which is also marketed in the U.S. For more information, please visit: www.hutch‑med.com or follow us on LinkedIn.
U.S. IMPORTANT SAFETY INFORMATION
The most common adverse reactions (incidence ≥20%) following treatment with FRUZAQLA included hypertension, palmar-plantar erythrodysesthesia (hand-foot skin reactions), proteinuria, dysphonia, abdominal pain, diarrhea, and asthenia.
DRUG INTERACTIONS: Avoid concomitant administration of FRUZAQLA with strong or moderate CYP3A inducers.
To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-844-662-8532 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see FRUZAQLA (fruquintinib) full Prescribing Information.
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, including its expectations regarding the review of a MAA for fruquintinib for the treatment of patients with CRC with the EMA and the timing of such review, the therapeutic potential of fruquintinib for the treatment of such 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 sufficiency of clinical data to support MAA approval of fruquintinib for the treatment of patients with CRC or other indications in the EU or other jurisdictions such as Japan, its potential to gain approvals from regulatory authorities, the 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; and Takeda’s ability to successfully develop and commercialize fruquintinib. In addition, as certain studies rely on the use of other drug products as combination therapeutics with fruquintinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of these therapeutics. Existing and prospective investors are cautioned not to place undue reliance on these forward‑looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission, on AIM and on The Stock Exchange of Hong Kong Limited. HUTCHMED undertakes no obligation to update or revise the information contained in this announcement, whether as a result of new information, future events or circumstances or otherwise.
This announcement 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.
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (as it forms part of retained EU law as defined in the European Union (Withdrawal) Act 2018).
Investor Enquiries |
+852 2121 8200 / ir@hutch‑med.com |
Media Enquiries |
|
| Ben Atwell / Alex Shaw, FTI Consulting | +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.com |
| Zhou Yi, Brunswick | +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com |
Nominated Advisor |
|
| Atholl Tweedie / Freddy Crossley / Daphne Zhang, Panmure Gordon | +44 (20) 7886 2500 |
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. (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] 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.
[4] American Cancer Society. Cancer Facts & Figures 2024. Atlanta, American Cancer Society; 2024.
[5] 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.
[6] 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.
[7] Venderbosch S, 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.
[8] 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.
[9] 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.
[10] 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.
[11] Dasari NA, et al. Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer (FRESCO‑2): an international, multicentre, randomised, double‑blind, Phase III study. Lancet. 2023;402(10395):41‑53. doi:10.1016/S0140‑6736(23)00772‑9.
Hong Kong, Shanghai & Florham Park, NJ — Monday, April 22, 2024: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; SEHK:13) announces that the non-performance based awards granted under the Long Term Incentive Plan (“LTIP”) on April 20, 2020 to the following persons discharging managerial responsibilities were vested on April 20, 2024:-
| Award Holder | Number of American depositary shares (“ADS”) | |
| Mr Simon To (Executive Director) | 2,3971 | |
| Dr Dan Eldar (Non-executive Director (“NED”)) | 2,397 | |
| Ms Edith Shih (NED) | 2,3972 | |
| Mr Paul Carter (Independent Non-executive Director (“INED”)) | 2,0383 | |
| Mr Graeme Jack (INED) | 2,397 | |
| Professor Tony Mok (INED) | 2,397 |
Notes:
The notifications set out below are provided in accordance with the requirements of the UK Market Abuse Regulation.
(a) Dr Dan Eldar
| 1 | Details of the person discharging managerial responsibilities/person closely associated | |||||
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a) |
Name |
Dr Dan Eldar |
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| 2 | Reason for the notification | |||||
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a) |
Position/status |
Non-Executive Director |
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b) |
Initial notification/Amendment |
Initial notification |
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| 3 | Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor | |||||
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a) |
Name |
HUTCHMED (China) Limited |
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b) |
LEI |
2138006X34YDQ6OBYE79 |
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| 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 | |||||
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a) |
Description of the financial instrument, type of instrument
Identification code |
ADS each representing five Ordinary Shares of US$0.10
ADS ISIN: US44842L1035 |
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b) |
Nature of the transaction |
Vesting of awards granted on April 20, 2020 under HUTCHMED’s LTIP |
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c) |
Price(s) and volume(s) |
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| d) |
Aggregated information
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N/A |
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e) |
Date of the transaction |
2024-04-20 |
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f) |
Place of the transaction |
Outside a trading venue |
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(b) Mr Paul Carter
| 1 | Details of the person discharging managerial responsibilities/person closely associated | |||||
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a) |
Name |
Mr Paul Carter |
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| 2 | Reason for the notification | |||||
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a) |
Position/status |
Independent Non-Executive Director |
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b) |
Initial notification/Amendment |
Initial notification |
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| 3 | Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor | |||||
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a) |
Name |
HUTCHMED (China) Limited |
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b) |
LEI |
2138006X34YDQ6OBYE79 |
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| 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 |
ADS each representing five Ordinary Shares of US$0.10
ADS ISIN: US44842L1035 |
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|
b) |
Nature of the transaction |
Vesting of awards granted on April 20, 2020 under HUTCHMED’s LTIP |
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c) |
Price(s) and volume(s) |
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| d) |
Aggregated information
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N/A |
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e) |
Date of the transaction |
2024-04-20 |
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f) |
Place of the transaction |
Outside a trading venue |
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(c) Mr Graeme Jack
| 1 | Details of the person discharging managerial responsibilities/person closely associated | |||||
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a) |
Name |
Mr Graeme Jack |
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| 2 | Reason for the notification | |||||
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a) |
Position/status |
Independent Non-Executive Director |
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b) |
Initial notification/Amendment |
Initial notification |
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| 3 | Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor | |||||
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a) |
Name |
HUTCHMED (China) Limited |
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|
b) |
LEI |
2138006X34YDQ6OBYE79 |
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| 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 |
ADS each representing five Ordinary Shares of US$0.10
ADS ISIN: US44842L1035 |
||||
|
b) |
Nature of the transaction |
Vesting of awards granted on April 20, 2020 under HUTCHMED’s LTIP |
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|
c) |
Price(s) and volume(s) |
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| d) |
Aggregated information
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N/A |
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e) |
Date of the transaction |
2024-04-20 |
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f) |
Place of the transaction |
Outside a trading venue |
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(d) Professor Tony Mok
| 1 | Details of the person discharging managerial responsibilities/person closely associated | |||||
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a) |
Name |
Professor Tony Mok |
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| 2 | Reason for the notification | |||||
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a) |
Position/status |
Independent Non-Executive Director |
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b) |
Initial notification/Amendment |
Initial notification |
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| 3 | Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor | |||||
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a) |
Name |
HUTCHMED (China) Limited |
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b) |
LEI |
2138006X34YDQ6OBYE79 |
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| 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 |
ADS each representing five Ordinary Shares of US$0.10
ADS ISIN: US44842L1035 |
||||
|
b) |
Nature of the transaction |
Vesting of awards granted on April 20, 2020 under HUTCHMED’s LTIP |
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|
c) |
Price(s) and volume(s) |
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| d) |
Aggregated information
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N/A |
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|
e) |
Date of the transaction |
2024-04-20 |
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f) |
Place of the transaction |
Outside a trading venue |
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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 medicines marketed in China, the first of which is also marketed in the U.S. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.
Investor Enquiries |
+852 2121 8200 / +1 973 306 4490 / ir@hutch-med.com |
Media Enquiries |
|
| Ben Atwell / Alex Shaw, FTI Consulting | +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) HUTCHMED@fticonsulting.com |
| Zhou Yi, Brunswick | +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com |
Nominated Advisor |
|
| Atholl Tweedie / Freddy Crossley / Daphne Zhang, Panmure Gordon |
+44 (20) 7886 2500 |
| Date: Friday, May 10, 2024 |
| Time: 5:00 pm Hong Kong Time (10:00 am London Time) |
| Location:1st Floor, Harbour Grand Kowloon, 20 Tak Fung Street, Hung Hom, Kowloon, Hong Kong |
Hong Kong, Shanghai, & Florham Park, NJ — Monday, April 8, 2024: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; HKEX: 13) today announces that its 2023 Annual Report, together with the Notice of Annual General Meeting and the Form of Proxy (“AGM Materials”), will be posted on April 9, 2024 to those shareholders who have elected to receive the AGM Materials in printed form. The documents can also be accessed from the HUTCHMED website (www.hutch-med.com).
The 2024 Annual General Meeting (“AGM”) will be an electronic/hybrid meeting to be held at 1st Floor, Harbour Grand Kowloon, 20 Tak Fung Street, Hung Hom, Kowloon, Hong Kong on Friday, May 10, 2024 at 5:00 pm Hong Kong Time (10:00 am London Time), with online access through an online platform as detailed in the AGM Materials.
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 medicines marketed in China, the first of which is also marketed in the U.S. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.
| Investor Enquiries | +852 2121 8200 / ir@hutch-med.com |
| Media Enquiries | |
| Ben Atwell / Alex Shaw, FTI Consulting | +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.com |
| 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 — Friday, April 5, 2024: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the upcoming American Association of Cancer Research (“AACR”) Annual Meeting 2024, taking place on April 5-10, 2024 in San Diego, California.
Initial preclinical data will be presented for HMPL-506, a novel, highly potent and differentiated menin-MLL inhibitor for the treatment of certain types of acute leukemia. Compared with five other menin inhibitors in clinical development, HMPL-506 showed the stronger inhibitory potency in MLL-rearranged and NPM1 mutant leukemia cell line models. Furthermore, HMPL-506 in combination with azacytidine, venetoclax or gilteritinib synergistically improved the anti-tumor effect against MLL-rearranged leukemias both in vitro and in vivo. The investigational drug candidate displayed favorable pharmacokinetic profiles, high selectivity and low risk of cardiac toxicity. A Phase I study of HMPL-506 is planned for the second half of 2024.
Initial preclinical data will also be presented for HMPL-A067 (HMA800067), a novel CD38-targeting antibody-drug conjugate (ADC) in which daratumumab was conjugated with cytotoxic payload Monomethyl auristatin E (MMAE) via a novel linker. It demonstrated significant superior anti-tumor activity to daratumumab, including in several B-cell malignancies models with resistance to daratumumab treatment.
Other presentations include preclinical data on the ERK 1/2 inhibitor, HMPL-295; early clinical data on the Syk inhibitor, sovleplenib, in lymphoma patients; additional clinical data from global studies of VEGFR inhibitor, fruquintinib, and MET inhibitor, savolitinib; and several investigator-initiated studies of fruquintinib and VEGFR/CSF-1R/FGFR inhibitor, surufatinib.
Details of the presentations are as follows:
| Abstract title | Presenter / Lead author | Presentation details |
SPONSORED STUDIES |
||
| HMPL-506, a novel, highly potent and differentiated menin-MLL inhibitor for the treatment of MLL-rearranged and NPM1mutant acute leukemia in preclinical models | Min Cheng, HUTCHMED, Shanghai, China | #2113 Poster Session (PO.ET07.02 – Pharmacodynamic Biomarkers of Drug Response) Monday, April 8, 2024 |
| HMPL-A067 (HMA800067), a novel CD38-targeting antibody-drug conjugate (ADC), demonstrated superior anti-tumor activity to daratumumab in preclinical B-cell malignancies models | Yan Xu, HUTCHMED, Shanghai, China | #1890 Poster Session (PO.ET01.02 – Antibody-Drug Conjugates and Bispectific Antibodies) Monday, April 8, 2024 |
| Preclinical characterization of HMPL-295, a potent and selective ERK1/2 inhibitor | Jia Hu, HUTCHMED, Shanghai, China | #1661 Poster Session (PO.MCB03.01 – Cell Signaling Components as Therapeutic Targets) Monday, April 8, 2024 |
| Targeting YAP1/TEAD signaling re-sensitizes MAPK/ERK pathway inhibitors in KRAS-driven cancer cells | Xianwen Yang, HUTCHMED, Shanghai, China | #1931 Poster Session (PO.ET03.04 – Drug Resistance 2: Ras GTPase) Monday, April 8, 2024 |
| Safety and Efficacy of Sovleplenib (HMPL-523), a Syk Inhibitor, in Patients with Relapsed or Refractory Lymphoma |
Paolo Strati, The University of Texas MD Anderson Cancer Center, USA | #CT144 Poster Session (PO.CT01.03 – Phase 0 and Phase I Clinical Trials) Monday, April 8, 2024 |
| Early carcinoembryonic antigen (CEA) dynamics to predict the efficacy of fruquintinib (F) + best supportive care (BSC) in patients with metastatic colorectal cancer (mCRC) enrolled in FRESCO-2 | Stefano Lonardi, Veneto Institute of Oncology IOV-IRCCS Padua, Italy | #6408 Poster Session (PO.CL01.10 – Predictive Biomarkers 5) Tuesday, April 9, 2024 |
| Savolitinib (savo) + osimertinib (osi) vs savo + placebo (PBO) in patients (pts) with EGFR-mutated (EGFRm), MET-amplified advanced NSCLC with progression on osi | James Chih-Hsin Yang, National Taiwan University Hospital and National Taiwan University Cancer Centre, Taipei, Taiwan | #CT251 Poster Session (PO.CL01.10 – Predictive Biomarkers 5) Tuesday, April 9, 2024 |
INVESTIGATOR-INITIATED STUDIES |
||
| Enhanced anticancer efficacy via ROS-dependent ferroptosis: synergy between surufatinib and cisplatin in small cell lung cancer | Xiaolin Li, First Affiliated Hospital of Nanjing Medical University, Nanjing, China | #2122 Poster Session (PO.ET07.02 – Pharmacodynamic Biomarkers of Drug Response) Monday, April 8, 2024 |
| Efficacy and underlying mechanisms of surufatinib in non-small cell lung cancer treatment | Yanfang Zheng, Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Guangzhou, China | #2126 Poster Session (PO.ET07.02 – Pharmacodynamic Biomarkers of Drug Response) Monday, April 8, 2024 |
| Enhancing Radiosensitivity in Biliary Tract Cancer: The Dual Role of Surufatinib in Tumor Suppression and Macrophage Reprogramming | Hong Ma, Wuhan Union Hospital, Wuhan, China | #2127 Poster Session (PO.ET07.02 – Pharmacodynamic Biomarkers of Drug Response) Monday, April 8, 2024 |
| Surufatinib treatment in pancreatic cancer: unveiling the role of GPR34 in TAMs and enhancing immunotherapy efficacy | Jihui Hao / Song Gao, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China | #2128 Poster Session (PO.ET07.02 – Pharmacodynamic Biomarkers of Drug Response) Monday, April 8, 2024 |
| Efficacy and Underlying Mechanisms of Surufatinib Combined with PD-1 Monoclonal Antibody and Chemotherapy in Pancreatic Cancer | Guanghai Dai / Ru Jia, Chinese PLA General Hospital (CPLAGH), Beijing, China | #2129 Poster Session (PO.ET07.02 – Pharmacodynamic Biomarkers of Drug Response) Monday, April 8, 2024 |
| Optimizing the treatment schedule of radiotherapy combined with VEGFR-TKIs and PD-(L) 1 inhibitors in metastatic colorectal cancer | Tao Zhang / Zhenyu Lin, Cancer Center, Union Hospital Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China | #3827 Poster Session (PO.CL10.04 – Outcome Investigation with Real World Data) Monday, April 8, 2024 |
| Clinical and epidemiological profile of neuroendocrine differentiation- A hospital-based retrospective study | Susheng Shi / Yaru Wen, Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China | #4630 Poster Session (PO.ET06.04 – Molecular Classification of Tumors for Diagnostics, Prognostics, and Therapeutic Outcomes) Tuesday, April 9, 2024 |
| Epidemiological characteristics and treatment strategies of gastric cancer with neuroendocrine differentiation (NED) | Jun Zhang, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China | #4864 Poster Session (PO.PS01.08 – Descriptive Epidemiology and Statistical and Epidemiological Methodology) Tuesday, April 9, 2024 |
| Initial efficacy of surufatinib plus sintilimab and IBI310 for patients with high-grade advanced-neuroendocrine neoplasm: A multicenter, single arm phase 2 study | Lin Shen / Ming Lu, Peking University Cancer Hospital and Institute, Beijing, China | #CT266 Poster Session (PO.CT02.02 – Phase II Clinical Trials 2) Tuesday, April 9, 2024 |
HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery, global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. 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, HUTCHMED has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also marketed in the U.S. For more information, please visit: www.hutch‑med.com or follow us on LinkedIn.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including but not limited to its expectations regarding the therapeutic potential of fruquintinib, savolitinib, surufatinib, sovleplenib, HMPL-295, HMPL-506 and HMA800067, the further clinical development for fruquintinib, savolitinib, surufatinib, sovleplenib, HMPL-295, HMPL-506 and HMA800067, its expectations as to whether any studies on fruquintinib, savolitinib, surufatinib, sovleplenib, HMPL-295, HMPL-506 and HMA800067 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. 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, savolitinib, surufatinib, sovleplenib, HMPL-295, HMPL-506 and HMA800067, including as combination therapies, 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 markets of fruquintinib, savolitinib, surufatinib, sovleplenib, HMPL-295, HMPL-506 and HMA800067 for a targeted indication, and the sufficiency of funding. In addition, as certain studies rely on the use of nab-paclitaxel, sintilimab, toripalimab, pemetrexed, platinum, etoposide or cisplatin as combination therapeutics, such risks and uncertainties include assumptions regarding their safety, efficacy, supply and continued regulatory approval. 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.
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.
— NDA accepted and both fruquintinib and sintilimab granted Priority Review, following Breakthrough Therapy designation in July 2023 —
— First regulatory filing for fruquintinib for use in combination with a leading immune checkpoint inhibitor —
Hong Kong, Shanghai & Florham Park, NJ — Tuesday, April 2, 2024: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) and Innovent Biologics, Inc. (“Innovent”) (HKEX:1801) today jointly announce that the New Drug Application (“NDA”) for the combination of fruquintinib and sintilimab for the treatment of patients with advanced endometrial cancer with pMMR1 or non-MSI-H2 tumors that have failed prior systemic therapy but are not candidates for curative surgery or radiation has been accepted and granted priority review by the China National Medical Products Administration (“NMPA”).
The NDA is supported by data from FRUSICA-1, the endometrial cancer registration cohort of a multi-center, open-label Phase II study investigating fruquintinib in combination with sintilimab in endometrial cancer patients who experienced disease recurrence, disease progression or intolerable toxicity with treatment on platinum-based doublet chemotherapy. The primary endpoint was independent review committee (IRC) assessed objective response rate (ORR), with secondary endpoints including disease control rate (DCR), duration of response (DoR), progression free survival (PFS), overall survival (OS), as well as pharmacokinetic (PK) assessments. Data from FRUSICA-1 will be submitted for presentation at an upcoming medical conference. Additional details may be found at clinicaltrials.gov, using identifier NCT03903705.
“This is the first regulatory filing for the combination of fruquintinib and the immune checkpoint inhibitor sintilimab. It also represents an important step closer to reshaping the treatment landscape for this challenging disease in China,” said Dr. Michael Shi, Head of R&D and Chief Medical Officer of HUTCHMED. “Endometrial cancer remains one of the most common gynecological malignancies. We look forward to bringing this much-awaited treatment advancement to endometrial cancer patients to improve their treatment outcome.”
“TYVYT® (sintilimab injection), as a backbone therapy in immuno-oncology, in combination with an anti-angiogenetic drug, may improve the prognosis for endometrial cancer patients in China,” said Dr. Hui Zhou, Senior Vice President of Innovent. “We are excited about the NDA acceptance and priority review designation, which increases our potential to bring a new treatment option to endometrial cancer patients, and concurrently strengthens the leadership position of TYVYT® in China.”
The NMPA granted Breakthrough Therapy designation to the combination of fruquintinib and sintilimab for this potential indication in July 2023. The NMPA granted this designation to this combination as a new treatment that could target a serious condition for which there are no effective treatment options, and where clinical evidence demonstrates substantial advantages over existing therapies.
Endometrial cancer is a type of cancer that begins in the uterus. Globally, an estimated 417,000 people were diagnosed with endometrial cancer and it caused approximately 97,000 deaths in 2020.3 Іn China, an estimated 82,000 people were diagnosed with endometrial cancer, causing approximately 17,000 deaths in 2020.4 Although early-stage endometrial cancer can be surgically resected, recurrent and/or metastatic endometrial cancer remains an area of high unmet need with poor outcomes and limited treatment options.5,6,7
Fruquintinib is a selective oral inhibitor of vascular endothelial growth factor receptor (“VEGFR”)-1, -2 and -3. VEGFR inhibitors play a pivotal role in inhibiting tumor angiogenesis. Fruquintinib was designed to have enhanced selectivity that limits off-target kinase activity, allowing for high drug exposure, sustained target inhibition, and flexibility for its potential use as part of a combination therapy. Fruquintinib has demonstrated a manageable safety profile and is being investigated in combinations with other anti-cancer therapies.
Fruquintinib is approved for marketing for the treatment of patients with metastatic colorectal cancer who have previously received fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy, and those who have previously received or are not suitable for receiving anti-vascular endothelial growth factor (“VEGF”) therapy or anti-epidermal growth factor receptor (“EGFR”) therapy (RAS wild-type) in China, where it is co-developed and co-marketed by HUTCHMED and Eli Lilly and Company under the brand name ELUNATE®. It was included in the China National Reimbursement Drug List (“NRDL”) in January 2020. The approval was based on data from the FRESCO study, a Phase III pivotal registration trial of fruquintinib in 416 patients with metastatic colorectal cancer in China, which were published in The Journal of the American Medical Association, JAMA. Since its launch in China and as of mid-2023, fruquintinib has benefited more than 80,000 colorectal cancer patients.
Fruquintinib received approval for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine, oxaliplatin, and irinotecan‑based chemotherapy, an anti‑VEGF therapy, and, if RAS wild‑type and medically appropriate, an anti-EGFR therapy in the United States in November 2023, where it is marketed by Takeda under the brand name FRUZAQLA™. The approval was based on data from two large Phase III trials: the multi-regional FRESCO-2 trial, data from which were published in The Lancet, along with the FRESCO trial conducted in China. The trials investigated fruquintinib plus best supportive care versus placebo plus best supportive care in patients with previously treated metastatic colorectal cancer. Both FRESCO and FRESCO-2 met their primary and key secondary efficacy endpoints and showed consistent benefit among a total of 734 patients treated with fruquintinib. Safety profiles were consistent across trials. Takeda has the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside of mainland China, Hong Kong and Macau.
Sintilimab, marketed as TYVYT® (sintilimab injection) in China, is a PD-1 immunoglobulin G4 monoclonal antibody co-developed by Innovent and Eli Lilly and Company. Sintilimab is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells.8
In China, sintilimab has been approved and included in the NRDL for seven indications. The updated NRDL reimbursement scope for TYVYT® (sintilimab injection) includes:
Besides, the combination of sintilimab and fruquintinib for the treatment of patients with advanced endometrial cancer with pMMR or non-MSI-H tumors that have failed prior systemic therapy but are not candidates for curative surgery or radiation has been accepted and granted priority review by the NMPA.
In addition, two clinical studies of sintilimab have met their primary endpoints:
Statement: Innovent does not recommend the use of any unapproved drug(s)/indication(s).
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 medicines marketed in China, the first of which is also marketed in the U.S. For more information, please visit: www.hutch‑med.com or follow us on LinkedIn.
Innovent is a leading biopharmaceutical company founded in 2011 with the mission to provide high-quality biologics that are affordable to all. The company discovers, develops, manufactures and commercializes innovative medicines that treat some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 10 products in the market, 3 new drug applications under NMPA review, 5 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare leaders, including Eli Lilly, Roche, Sanofi, Adimab, Incyte and MD Anderson Cancer Center.
Guided by the motto, “Start with Integrity, Succeed through Action,” Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including its expectations regarding the therapeutic potential of the fruquintinib and sintilimab combination for the treatment of patients with advanced endometrial cancer and the further clinical development of the fruquintinib and sintilimab combination in this and other indications. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the sufficiency of clinical data to support NDA approval of the fruquintinib and sintilimab combination for the treatment of patients with advanced endometrial cancer in China, or other jurisdictions, its potential to gain expeditious approvals from regulatory authorities, the safety profile of fruquintinib, HUTCHMED’s ability to fund, implement and complete its further clinical development and commercialization plans for the fruquintinib and sintilimab combination, and the timing of these events. In addition, as certain studies rely on the use of other drug products such as sintilimab as combination therapeutics with fruquintinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of these therapeutics. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission, on AIM and on The Stock Exchange of Hong Kong Limited. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
Medical Information
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.
REFERENCES
[1] pMMR = Mismatch Repair proficient.
[2] MSI-H = Microsatellite instability-high.
[3] The Global Cancer Observatory, World Fact Sheet. Accessed June 12, 2023.
[4] The Global Cancer Observatory, China Fact Sheet. Accessed June 12, 2023.
[5] Yi A, et al. Real-world characteristics and treatment pattern of patients with newly diagnosed endometrial cancer in China. J Clin Oncol. 2023;41, no. 16_suppl (June 01, 2023) e17613-e17613. DOI: 10.1200/JCO.2023.41.16_suppl.e17613.
[6] Koppikar S, et al. Pan-Asian adapted ESMO Clinical Practice Guidelines for the diagnosis, treatment and follow-up of patients with endometrial cancer. ESMO Open. 2023;8(1):100774. DOI: 10.1016/j.esmoop.2022.100774.
[7] Siegel RL, et al. Cancer statistics, 2023. CA Cancer J Clin. 2023;73(1):17-48. DOI:10.3322/caac.21763.
[8] Wang J, et al. Durable blockade of PD-1 signaling links preclinical efficacy of sintilimab to its clinical benefit. mAbs 2019;11(8): 1443-1451. DOI: 10.1080/19420862.2019.1654303.