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

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.

HUTCHMED and Innovent announce that China's NMPA has granted conditional approval for ELUNATE® (fruquintinib) in combination with TYVYT® (sintilimab) for treating advanced endometrial cancer. This marks the first regulatory approval for fruquintinib combination with an immune checkpoint inhibitor.

The approval is based on the FRUSICA-1 study results, which showed an objective response rate of 35.6% and disease control rate of 88.5%. The median progression-free survival was 9.5 months, with overall survival reaching 21.3 months. The combination demonstrated rapid onset efficacy with a median time to response of 1.6 months.

HUTCHMED announces that ORPATHYS® (savolitinib) will maintain its inclusion in China's National Reimbursement Drug List (NRDL) under the same terms, effective January 1, 2025. ORPATHYS®, an oral MET tyrosine kinase inhibitor, received conditional approval in China in 2021 for treating specific non-small cell lung cancer patients with MET exon 14 skipping alterations. The drug has been part of the NRDL since March 1, 2023. This continuation is significant as China represents over one-third of global lung cancer patients, with 2-3% of NSCLC cases showing MET exon 14 skipping alterations. The NRDL coverage extends to approximately 1.33 billion people in China, representing 95% of the population.

HUTCHMED announces the launch of FRUZAQLA® (fruquintinib) in Japan by Takeda following approval from the Japanese Ministry of Health, Labour and Welfare. The drug is indicated for treating advanced or recurrent colorectal cancer (CRC) that has progressed after chemotherapy. This marks the first novel oral targeted therapy approval for metastatic CRC in Japan in over a decade. CRC is Japan's most prevalent cancer, with an estimated 161,000 new cases and 54,000 deaths in 2023. The launch triggers a milestone payment to HUTCHMED from Takeda, who holds exclusive worldwide rights outside mainland China, Hong Kong, and Macau.

HUTCHMED (Nasdaq/AIM:HCM, HKEX:13) has appointed Dr Chaohong Hu (Dr Mary Hu) as an Independent Non-executive Director and member of the Technical Committee, effective November 21, 2024. Dr Hu brings over 20 years of experience in therapeutic antibodies, antibody-drug conjugates, and vaccines development. She is currently Chief Operating Officer of D Biotherapeutics and principal consultant of Lakebio Consulting. Her annual compensation includes US$76,000 as Director and US$8,000 as Technical Committee member. Dr Hu's expertise spans from early-stage discovery to clinical development, commercialization, and strategic partnerships.

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.