Hutchmed (China) Limited Stock Price, News & Analysis

HUTCHMED has completed patient enrollment for the registration phase of its Phase II trial evaluating savolitinib in gastric cancer patients with MET amplification. The single-arm, multi-center study enrolled 64 patients to assess the drug's efficacy in treating gastric or gastroesophageal junction adenocarcinoma.

Interim results showed promising outcomes with a 45% objective response rate (ORR) confirmed by Independent Review Committee, and 50% ORR in patients with high MET gene copy number. The 4-month duration of response rate was 85.7% with 5.5 months median follow-up.

The drug received Breakthrough Therapy Designation from China's NMPA for treating advanced gastric cancer patients who failed standard therapies. HUTCHMED plans to apply for marketing authorization in China by late 2025 if results remain positive.

HUTCHMED (HCM) has received conditional approval from China's NMPA for TAZVERIK® (tazemetostat), marking its first approval in hematological malignancies. The drug is approved for treating adult patients with relapsed or refractory follicular lymphoma with EZH2 mutation who have received at least two prior systemic therapies.

The approval is based on a multicenter, open-label, Phase II bridging study in China and clinical studies conducted by Epizyme outside China. TAZVERIK® is the first and only EZH2 inhibitor approved by the NMPA and represents HUTCHMED's fourth approved product.

The ongoing SYMPHONY-1 study will serve as the confirmatory trial, evaluating TAZVERIK® in combination with rituximab and lenalidomide in R/R FL patients. HUTCHMED is responsible for research, development, manufacturing, and commercialization in China Mainland, Hong Kong, Macau, and Taiwan, while Epizyme remains the Marketing Authorization Holder in China.

HUTCHMED (Nasdaq/AIM:HCM, HKEX:13) announced significant changes to its Board of Directors and committee compositions. Two Independent Non-executive Directors, Paul Rutherford Carter and Graeme Allan Jack, will retire at the annual general meeting on May 13, 2025, after serving more than eight years.

Following their retirement, several key appointments will take effect:

• Professor Mok Shu Kam, Tony will become Senior and Lead Independent Non-executive Director
• Mr Wong Tak Wai will chair the Audit Committee and join the Remuneration Committee
• Dr Chaohong Hu will join the Audit Committee
• Dr Renu Bhatia will chair the Remuneration Committee

The Chairman praised both retiring directors for their contributions, with Carter's role in shaping remuneration policies and Jack's oversight of financial reporting and audit processes.

HUTCHMED has presented promising results from multiple studies of savolitinib at ELCC 2025. The SAVANNAH Phase II trial showed that savolitinib plus TAGRISSO® achieved significant outcomes in MET-high lung cancer patients, with a confirmed ORR of 56% and 55% by investigator and BICR assessment respectively.

The combination therapy demonstrated median DoR of 7.1 and 9.9 months, with median PFS of 7.4 and 7.5 months. Safety profiles were consistent with established data, with Grade 3 or higher AEs occurring in 57% of patients.

Additionally, a Phase IIIb study in China revealed strong survival benefits for MET exon 14 skipping alteration NSCLC patients, with median OS of 28.3 months in treatment-naïve patients and 25.3 months in previously treated patients. The study also showed positive outcomes for patients with brain metastasis.

HUTCHMED reported strong financial results for 2024, achieving profitability with a net income of $37.7 million and a cash balance of $836.1 million. The company's oncology products saw significant growth, with total in-market sales up 134% to $501.0 million and consolidated revenue increasing 65% to $271.5 million.

FRUZAQLA® (fruquintinib) demonstrated impressive performance with ex-China in-market sales of $290.6 million in its first full year, driven by US patient uptake and launches in EU and Japan. The company reached a significant milestone by agreeing to a partial disposal of equity in SHPL joint venture for $608 million.

Key pipeline developments included positive results from multiple clinical trials: SACHI Phase III for savolitinib in NSCLC, SAVANNAH global pivotal Phase II for savolitinib with TAGRISSO®, and FRUSICA-2 Phase III for fruquintinib. The company also introduced its new ATTC platform for developing next-generation antibody drug conjugates.

Innovent Biologics (IVBIY) and HUTCHMED have announced positive results from their FRUSICA-2 Phase 2/3 clinical trial, evaluating sintilimab combined with fruquintinib as second-line treatment for advanced renal cell carcinoma (RCC) in China.

The study met its primary endpoint of progression-free survival (PFS) and showed improvements in secondary endpoints, including objective response rate (ORR) and duration of response (DoR). The trial compared the combination therapy against axitinib or everolimus monotherapy for second-line RCC treatment.

The combination has previously received conditional approval from China's NMPA for treating advanced endometrial cancer with pMMR tumors based on the FRUSICA-1 study. The companies plan to proceed with NDA filings in the coming months, aiming to make this treatment option available to patients who have progressed on previous therapy.

HUTCHMED and Innovent have announced positive results from their FRUSICA-2 Phase II/III clinical trial evaluating fruquintinib combined with sintilimab as second-line treatment for advanced renal cell carcinoma (RCC) in China. The study met its primary endpoint of progression-free survival (PFS) and showed improvements in secondary endpoints including objective response rate (ORR) and duration of response (DoR).

The combination therapy has already received conditional approval from China's NMPA for treating advanced endometrial cancer with pMMR tumors based on the FRUSICA-1 study. The FRUSICA-2 trial compared the combination against axitinib or everolimus monotherapy for second-line RCC treatment.

Full results will be presented at an upcoming scientific conference, and the companies plan to proceed with NDA filings in the coming months.

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.