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.

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.

HUTCHMED (HCM) announced on March 13, 2023, that it has no exposure to Silicon Valley Bank (SVB) or SVB UK Limited, confirming it holds no cash deposits or securities with these institutions. This statement assures investors regarding the company’s financial stability amid recent banking sector turmoil. HUTCHMED, a biopharmaceutical firm focused on cancer and immunological treatments, employs approximately 5,000 personnel, with a substantial portion dedicated to oncology and immunology. The company's drugs are now commercially available in China, further solidifying its market presence.

HUTCHMED announced a landmark licensing agreement with Takeda for fruquintinib, with potential proceeds of up to $1.13 billion plus royalties, reinforcing its global strategy. The company reported a 20% revenue increase to $426.4 million in 2022, driven by a 37% rise in oncology/immunology revenues, totaling $163.8 million. Notable product performances included ELUNATE® with a 32% increase in sales, and SULANDA® showing a 178% surge. The company aims for sustainable growth, maintaining a substantial cash balance of $631 million to support future developments and pioneering clinical trials.

HUTCHMED has completed patient enrollment for its Phase II trial of amdizalisib in relapsed or refractory follicular lymphoma (FL), enrolling 108 patients across 35 sites in China. The trial, which has primary and secondary endpoints focusing on response rates and survival metrics, aims to assess the safety and efficacy of amdizalisib. The last patient was enrolled on February 24, 2023, and topline results are expected in the second half of 2023. A positive outcome may lead to a marketing authorization application in China. HUTCHMED retains worldwide rights to amdizalisib, a selective PI3Kδ inhibitor.