Welcome to our dedicated page for Hutchmed (China) news (Ticker: HCM), a resource for investors and traders seeking the latest updates and insights on Hutchmed (China) stock.
HUTCHMED (China) Limited develops and commercializes targeted therapies and immunotherapies for cancer and immunological diseases through a China-based commercial organization and a global clinical pipeline. News for HCM centers on marketed oncology products such as FRUZAQLA and ELUNATE for fruquintinib, ORPATHYS for savolitinib, China regulatory actions, and partner-driven commercialization outside China.
Recurring updates also cover pipeline compounds including sovleplenib, HMPL-760 and HMPL-A580, clinical data presented at oncology meetings, and the company’s Antibody-Targeted Therapy Conjugate platform. Corporate items include annual results, product-license updates such as TAZVERIK in China, board and committee changes, and disclosures tied to HUTCHMED’s Nasdaq, AIM and HKEX listings and ADR structure.
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HUTCHMED has announced that its New Drug Application (NDA) for fruquintinib in combination with paclitaxel for treating second-line advanced gastric cancer has been accepted for review by the China National Medical Products Administration (NMPA). This is a significant move, considering gastric cancer's high prevalence in China, which accounts for over 40% of global cases. The NDA is backed by data from the Phase III FRUTIGA study, where fruquintinib showed a statistically significant improvement in progression-free survival (PFS). Although its overall survival (OS) results were not statistically significant, the drug's potential as a new treatment option is promising. Fruquintinib, already approved under the brand name ELUNATE® in China, has shown clinically meaningful benefits for patients and is being developed globally with Takeda Pharmaceutical Company.
HUTCHMED (Nasdaq/AIM: HCM) announced the presentation of new clinical data for five investigational drug candidates at the American Association for Cancer Research Annual Meeting 2023, scheduled from April 14-19 in Orlando, Florida. Key highlights include:
- Savolitinib: Phase II trial data presented for MET-amplified gastroesophageal junction adenocarcinoma and NSCLC.
- Surufatinib: Results from a Phase II study on NSCLC with PD-L1 positive expression showcased promising antitumor activity.
- HMPL-760: Preclinical data indicates strong potential against B-cell malignancies.
- HMPL-306: Demonstrated efficacy as a dual inhibitor for mutant IDH1 and IDH2.
- HMPL-453: Highly selective FGFR inhibitor showing potent activity in FGFR-altered tumor models.
HUTCHMED (HCM) announced the retirement of Dr. Karen Jean Ferrante as an Independent Non-executive Director, effective at the May 12, 2023 annual general meeting. Dr. Ferrante will cease her roles, including chair of the Technical Committee. Professor Mok Shu Kam will be appointed as chair of the Technical Committee, pending his re-election. Simon To, Chairman of HUTCHMED, highlighted Dr. Ferrante's significant contributions to the company's growth from early-stage drug development to a commercial entity with three approved oncology medicines. The company confirmed that Dr. Ferrante has no disagreements with the Board and no other matters to disclose. A future announcement regarding the Audit Committee will follow.
HUTCHMED has announced the initiation of the registration phase for two ongoing Phase II clinical trials: HMPL-453 for intrahepatic cholangiocarcinoma (IHCC) patients with FGFR2 fusion and savolitinib for gastric cancer patients with MET amplification. Both trials aim to assess the efficacy, safety, and pharmacokinetics of the treatments. The primary endpoint for HMPL-453 is the objective response rate, with an enrollment of approximately 90 patients. The savolitinib trial will enroll about 60 patients, focusing on its safety and tolerability. First doses for both treatments were administered in March 2023. Positive results may lead to future NDA filings.
HUTCHMED (HCM) has submitted a New Drug Application (NDA) to the FDA for fruquintinib, an oral VEGFR inhibitor for refractory metastatic colorectal cancer (CRC). Supported by Phase III FRESCO-2 data, the submission shows a 34% reduction in death risk. The NDA is part of global regulatory efforts, with submissions in Europe and Japan planned for 2023. Fruquintinib, launched in China since 2018, has proven effective in improving patient outcomes and is now positioned for commercialization outside China thanks to a partnership with Takeda.
HUTCHMED announced the closing of an exclusive license agreement with Takeda Pharmaceutical for the development and commercialization of fruquintinib outside of China. HUTCHMED will receive an upfront payment of US$400 million, with potential additional payments of up to US$730 million based on milestones and royalties. Fruquintinib targets refractory metastatic colorectal cancer and has shown a solid clinical profile, with plans for marketing authorization submissions in the U.S., Europe, and Japan in 2023. The agreement aims to enhance treatment options for cancer patients globally.