Hutchmed (China) Limited Stock Price, News & Analysis

HUTCHMED (NASDAQ/AIM/HKEX: HCM) has received approval from China's NMPA for ORPATHYS® (savolitinib) in combination with TAGRISSO® (osimertinib) for treating lung cancer patients with MET amplification after progression on first-line EGFR inhibitor therapy.

The approval is based on the Phase III SACHI trial results, which demonstrated that the combination reduced the risk of disease progression by 66% compared to chemotherapy. The median progression-free survival was 8.2 months for the combination therapy versus 4.5 months for chemotherapy in the ITT population.

This milestone triggers an $11 million payment from AstraZeneca to HUTCHMED. The treatment represents the first all-oral combination option for these patients, with a tolerable safety profile showing Grade 3 or above adverse events in 57% of patients in both treatment groups.

HUTCHMED (HCM) and Innovent Biologics announce that China's NMPA has accepted their New Drug Application for the combination of fruquintinib and sintilimab to treat advanced renal cell carcinoma in patients who failed prior TKI treatment. The application is supported by the FRUSICA-2 study, which met its primary endpoint of progression-free survival and showed improvements in secondary endpoints including objective response rate and duration of response. The safety profile was tolerable with no new safety signals. This marks sintilimab's 10th indication as a PD-1 inhibitor. The combination therapy previously received conditional approval in China for treating advanced pMMR endometrial cancer in December 2024.

HUTCHMED announced positive interim results from the SACHI Phase III study evaluating savolitinib plus osimertinib combination for EGFR mutation-positive NSCLC with MET amplification. The study demonstrated significant progression-free survival benefit, with median PFS of 8.2 months for the combination therapy versus 4.5 months for chemotherapy (HR 0.34, p<0.0001). The combination showed higher objective response rate (58% vs 34%) and disease control rate (89% vs 67%) compared to chemotherapy. Safety profile was favorable with Grade 3+ adverse events at 57% in both groups. Based on these results, the combination therapy has been granted priority review by China's NMPA. The study met its primary endpoint early, leading to concluded enrollment.

HUTCHMED (HCM) will present clinical data for several compounds at the 2025 ASCO Annual Meeting in Chicago. Key highlights include: 1. SACHI Phase III study of savolitinib + osimertinib in NSCLC patients met its primary PFS endpoint, supporting NDA with priority review in China. 2. SAVANNAH Phase II study showed savolitinib + osimertinib combination demonstrated improved efficacy and promising CNS activity compared to savolitinib + placebo. 3. Phase I study of ranosidenib (HMPL-306) showed good tolerability and efficacy in solid tumors with IDH mutations, achieving 7.1% ORR and 100% DCR in lower-grade glioma patients. 4. FRUSICA-1 study of fruquintinib + sintilimab showed meaningful results in endometrial cancer, with 37% ORR in serous carcinoma patients. 5. Phase IV study of fruquintinib in 2,798 colorectal cancer patients demonstrated manageable safety profiles in both monotherapy and combination therapy groups.

HUTCHMED (HCM) has announced upcoming presentations of new and updated data from several studies at the American Association of Cancer Research (AACR) Annual Meeting 2025 in Chicago. The presentations will feature research on compounds discovered by HUTCHMED, including savolitinib, fruquintinib, and surufatinib.

The presentations include both sponsored and investigator-initiated studies, covering various aspects of cancer treatment. Key highlights include the SAVANNAH study examining plasma clearance in NSCLC patients, multiple studies on fruquintinib in colorectal cancer treatment, and several investigations of surufatinib in different cancer types. The research spans clinical trials, mechanism studies, and combination therapies with other treatments.

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.