Hutchmed (China) Limited Stock Price, News & Analysis

HUTCHMED has completed enrollment for a Phase II registration study of fanregratinib (HMPL-453) targeting intrahepatic cholangiocarcinoma (IHCC) patients with FGFR2 fusion/rearrangement in China. The single-arm, multi-center, open-label trial has enrolled 87 patients since March 2023.

The study's primary endpoint is objective response rate (ORR), with secondary endpoints including progression-free survival (PFS), disease control rate (DCR), duration of response (DoR), and overall survival (OS). Topline results are expected around the end of 2025, and favorable outcomes could lead to a New Drug Application submission to China's National Medical Products Administration (NMPA).

HUTCHMED (Nasdaq/AIM:HCM, HKEX:13) has announced the appointment of Mr Alvin Wong as an Independent Non-executive Director and Audit Committee member, effective March 6, 2025. Wong brings over 35 years of experience in accounting, auditing, and corporate finance, including significant expertise in stock exchange listings and mergers & acquisitions.

A former PricewaterhouseCoopers partner until 2017, Wong currently serves as a non-executive director of Melbourne Enterprises His distinguished career includes leadership roles as president of the Hong Kong Institute of Certified Public Accountants (HKICPA) and chairman of its auditing standards committee.

The appointment includes an annual compensation of US$76,000 for his director role and US$13,500 for Audit Committee membership. His initial term will end at the next annual general meeting, subject to re-election and regulatory requirements.

HUTCHMED (Nasdaq/AIM: HCM; SEHK:13) has scheduled the announcement of its 2024 final results for Wednesday, March 19, 2025, at 7:00 am EDT / 11:00 am GMT / 7:00 pm HKT. The company will host two conference calls with audio webcasts: an English presentation at 8:00 am EDT on March 19, and a Chinese (Putonghua) presentation at 8:30 pm EDT on the same day.

The presentation materials will be available for download before the conference calls on the company's website. Both webcasts can be accessed at www.hutch-med.com/event/, and a replay will be made available after the events.

HUTCHMED (HCM) announces full NMPA approval for ORPATHYS® (savolitinib) in China for treating adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET exon 14 skipping alteration. The approval expands to include treatment-naïve patients and converts the 2021 conditional approval for previously treated patients to full approval.

The approval is based on Phase IIIb trial results showing significant efficacy: In treatment-naïve patients, the objective response rate was 62.1%, disease control rate 92.0%, and median duration of response 12.5 months. For previously treated patients, these metrics were 39.2%, 92.4%, and 11.1 months respectively. The safety profile was tolerable with no new safety signals.

ORPATHYS®, marketed by AstraZeneca, is the first selective MET inhibitor approved in China for this indication.

HUTCHMED announces that its New Drug Application (NDA) for the combination of ORPATHYS® and TAGRISSO® has been accepted with priority review status by China's NMPA. The treatment targets patients with locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer with MET amplification after disease progression on first-line EGFR inhibitor therapy.

The NDA is supported by data from the Phase III SACHI trial, which evaluated the combination therapy against standard platinum-based doublet-chemotherapy. The study met its primary endpoint of progression-free survival in a planned interim analysis. The acceptance triggers a milestone payment from AstraZeneca.

The NMPA granted Breakthrough Therapy designation to this combination in December 2024, recognizing it as a potential new treatment showing substantial advantages over existing therapies.

HUTCHMED has agreed to sell its 45% stake in Shanghai Hutchison Pharmaceuticals (SHPL) for US$608 million in cash. The sale involves two transactions: GP Health Service Capital will acquire 35% for US$473 million, and Shanghai Pharma will acquire 10% for US$135 million. HUTCHMED will retain a 5% stake in SHPL.

The divestment aligns with HUTCHMED's November 2022 strategy to focus on its core business of developing novel cancer and immunological disease therapies. The company plans to use the proceeds to advance its pipeline, including its antibody-targeted therapy conjugate (ATTC) platform, with first candidates expected to enter clinical trials in H2 2025.

HUTCHMED expects to record a gain of approximately US$477 million before taxation. The deal includes a three-year transition period where HUTCHMED will guarantee SHPL's minimum net profit growth of 5% annually. The transaction is expected to close by Q1 2025, subject to shareholder and regulatory approvals.

HUTCHMED (HCM) will receive a $10 million milestone payment from Takeda following Spain's first national reimbursement recommendation for FRUZAQLA® (fruquintinib) in December 2024. This marks the first national reimbursement recommendation in Europe for the treatment of previously treated metastatic colorectal cancer (CRC).

FRUZAQLA® received European Commission approval in June 2024, representing the first novel oral targeted therapy in the EU for metastatic CRC regardless of biomarker status in over a decade. The drug has already secured approvals in multiple regions including the US, Switzerland, Canada, Japan, UK, Argentina, Australia, and Singapore. Takeda holds exclusive worldwide rights for fruquintinib outside mainland China, Hong Kong, and Macau.

HUTCHMED (HCM) announces that China's NMPA has granted Breakthrough Therapy Designation (BTD) to the combination of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) for treating advanced EGFR mutation-positive non-small cell lung cancer with MET amplification after disease progression on EGFR inhibitor therapy.

The treatment is being evaluated in the Phase III SACHI trial, comparing the combination therapy against standard platinum-based doublet-chemotherapy. The study's primary endpoint is progression-free survival, with additional endpoints including overall survival and objective response rate.

The BTD status may enable conditional approval and priority review for the NDA, potentially expediting the therapy's development and review process to address unmet patient needs.

Innovent Biologics and HUTCHMED announce that their combination therapy of TYVYT® (sintilimab injection) and ELUNATE® (fruquintinib) has received conditional approval from China's NMPA for treating advanced endometrial cancer patients with pMMR tumors who failed prior systemic therapy.

The approval is based on the FRUSICA-1 study results, which showed significant efficacy with an IRC-assessed ORR of 35.6% and DCR of 88.5%. The median PFS reached 9.5 months and OS 21.3 months, with a rapid median time to tumor response of 1.6 months. This marks TYVYT®'s eighth approved indication, following priority review status and breakthrough therapy designation.