Hutchmed (China) Limited Stock Price, News & Analysis

HUTCHMED (NASDAQ:HCM) has completed patient enrollment for the SANOVO Phase III trial, evaluating the combination of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) as a first-line treatment for non-small cell lung cancer (NSCLC) patients with EGFR mutation and MET overexpression in China.

The randomized, controlled study will compare the efficacy and safety of the combination therapy versus TAGRISSO® alone. The trial's primary endpoint is progression-free survival (PFS), with secondary endpoints including overall survival, objective response rate, and safety measures. Topline results are expected in the second half of 2026, potentially leading to a supplementary New Drug Application to China's NMPA.

HUTCHMED (NASDAQ/AIM:HCM) reported significant financial and operational achievements in H1 2025. The company achieved $455.0 million in net income (vs $25.8M in H1 2024), largely driven by a $416.3 million divestment gain from a non-core joint venture. Total revenue was $277.7 million, down 9% year-over-year.

Key highlights include ORPATHYS® securing China approval for its third lung cancer indication, triggering an $11.0 million milestone payment from AstraZeneca. FRUZAQLA® sales by Takeda grew 25% to $162.8 million, expanding to over 30 countries. The company's cash balance stood at $1.36 billion as of June 30, 2025.

HUTCHMED also announced progress with its new Antibody-Targeted Therapy Conjugates (ATTC) platform, with clinical development planned for late 2025. The company presented positive results from multiple clinical trials, including the SACHI and SAVANNAH lung cancer trials.

HUTCHMED (NASDAQ/AIM/HKEX: HCM) has scheduled the announcement of its 2025 half-year financial results for Thursday, August 7, 2025 at 7:00 am EDT. The company will host two separate webcasts for analysts and investors:

The English presentation will take place on August 7, 2025, at 8:00 am EDT, while the Chinese (Putonghua) presentation will be held on August 8, 2025, at 8:30 am HKT. Both webcasts will be accessible through the company's website, with presentation materials available for download before the events and replays available afterward.

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.