Hutchmed (China) Limited Stock Price, News & Analysis

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.