HUTCHMED (China) Limited American Depositary Shares - HCM STOCK NEWS

HUTCHMED announced new data presentations at the 2024 ASH Annual Meeting and ESMO Asia Congress. The key highlight is the long-term safety and efficacy data from the ESLIM-01 Phase III study of sovleplenib in adult patients with chronic primary immune thrombocytopenia (ITP) in China. The study showed that 81% of patients achieved overall response, with durable response rates of 51.4% and long-term durable response of 59.8%. Among 179 treated patients, 55.3% remained on treatment with a median exposure of 56.6 weeks. The treatment demonstrated effectiveness in maintaining platelet counts and showed a favorable safety profile consistent with previous studies.

HUTCHMED will receive a US$20 million milestone payment from Takeda after FRUZAQLA® (fruquintinib) achieved over US$200 million in sales for metastatic colorectal cancer treatment. Takeda reported US$203 million in net sales of FRUZAQLA® in the nine months ended September 2024. This marks HUTCHMED's first commercial milestone payment. The drug has received approval in multiple regions including the US, EU, Switzerland, Canada, Japan, UK, Argentina, Australia, and Singapore, with more regulatory applications in progress.

HUTCHMED (Nasdaq/AIM:​HCM; HKEX:​13) announced positive results from the SAVANNAH Phase II trial, showing that TAGRISSO® (osimertinib) plus ORPATHYS® (savolitinib) demonstrated a high, clinically meaningful, and durable objective response rate (ORR) in patients with EGFR-mutated non-small cell lung cancer (NSCLC) with high levels of MET overexpression and/or amplification. The combination targets MET-driven resistance in EGFR-mutated lung cancer patients who progressed on TAGRISSO® treatment.

Key findings include:

• 62% of screened patients had tumors with MET overexpression and/or amplification
• 34% met the high MET level cut-off upon clinical progression
• The combination received Fast Track designation from the FDA in 2023
• Safety profile was consistent with known profiles of the combination and individual treatments

The global SAFFRON Phase III trial will further assess the combination versus chemotherapy in this patient population.

HUTCHMED announces that its partner Takeda has received approval from the Japanese Ministry of Health, Labour and Welfare to manufacture and market FRUZAQLA® (fruquintinib) for previously treated metastatic colorectal cancer (CRC). FRUZAQLA® is the first novel targeted therapy approved in Japan for metastatic CRC, regardless of biomarker status, in over a decade.

CRC is the most prevalent cancer in Japan, with an estimated 161,000 new cases and 54,000 deaths in 2023. The approval was based on results from the global Phase III FRESCO-2 trial. Fruquintinib is already approved in several regions including the United States, Europe, and China.

Takeda has the exclusive worldwide license to develop, commercialize, and manufacture fruquintinib outside of mainland China, Hong Kong, and Macau. FRUZAQLA® was approved in the US in November 2023 and in Europe in June 2024.

HUTCHMED (HCM) announces upcoming presentations at the 2024 World Conference on Lung Cancer (WCLC24) in San Diego and the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona. Key results include the FLOWERS study, a Phase II trial of osimertinib with or without savolitinib for first-line treatment in EGFRm, MET-aberrant advanced NSCLC patients. As of May 28, 2024, the median follow-up was 8.2 months. Cohort 2 (osimertinib + savolitinib) showed a 90.5% ORR and 95.2% DCR, compared to Cohort 1's (osimertinib) 60.9% ORR and 87% DCR. Median PFS was 9.3 months in Cohort 1 and 19.6 months in Cohort 2. Safety profiles were manageable. Additional presentations cover studies of surufatinib and fruquintinib in various cancers at ESMO 2024.

HUTCHMED has voluntarily withdrawn its supplemental New Drug Application (NDA) in China for fruquintinib in combination with paclitaxel for second-line advanced gastric cancer treatment. This decision follows discussions with the National Medical Products Administration of China (NMPA) and an internal review of the data package from the Phase III FRUTIGA study.

While the study showed statistically significant improvements in progression-free survival (PFS) and other endpoints, the overall survival (OS) improvement was not statistically significant. The high proportion of patients receiving subsequent therapies confounded the OS effect, although favorable trends were observed. HUTCHMED remains optimistic about fruquintinib's potential in gastric cancer treatment and will evaluate new paths forward.

HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) announces an expert call on immune thrombocytopenia (ITP) treatment on August 28, 2024, at 7:00 p.m. HKT. The webcast, featuring a professor and key opinion leader, will be in Chinese with an English transcript available later. This investor-focused event follows the successful Phase III ESLIM-01 trial of HUTCHMED's novel drug candidate sovleplenib for primary ITP in China.

The trial met all endpoints, with results published in The Lancet Haematology and presented at the European Hematology Association Congress. HUTCHMED filed a New Drug Application in China for sovleplenib in January 2024, marking a significant step in advancing ITP treatment options.

HUTCHMED reported financial results for the six months ending June 30, 2024, with significant updates on clinical and commercial developments.

Key Highlights:

• Revenue: $305.7 million, down from $532.9 million in H1 2023.
• Net Income: $25.8 million.
• Oncology Product Revenue: Increased by 59% to $127.8 million.

Key Product Updates:

• FRUZAQLA®: $130.5 million in US sales since its November 2023 launch.
• ELUNATE®: Revenue increased by 8% to $61 million in China.

Other Financial Metrics:

• Cash Balance: $802.5 million as of June 30, 2024.
• R&D Expenses: Reduced by 34% to $95.3 million.

Future Outlook:

• Potential US NDA filing for savolitinib by year-end.
• EU launch preparations for FRUZAQLA® post-European Commission approval in June 2024.

HUTCHMED (Nasdaq/AIM: HCM) has announced that its New Drug Application (NDA) for tazemetostat, aimed at treating adult patients with relapsed or refractory follicular lymphoma (R/R FL), has been accepted for review by the China National Medical Products Administration (NMPA) with Priority Review status. Tazemetostat, developed by Epizyme (an Ipsen company), is a first-in-class EZH2 methyltransferase inhibitor already approved by the FDA for specific patients with R/R FL and advanced epithelioid sarcoma (ES). The NDA acceptance in China is backed by a multicenter, open-label Phase II bridging study in China and global clinical studies by Epizyme. This drug was previously approved in the Hainan Pilot Zone, Macau, and Hong Kong. HUTCHMED has a strategic collaboration to develop, manufacture, and commercialize tazemetostat in Greater China.