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

HUTCHMED announces that its New Drug Application (NDA) for the combination of ORPATHYS® and TAGRISSO® has been accepted with priority review status by China's NMPA. The treatment targets patients with locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer with MET amplification after disease progression on first-line EGFR inhibitor therapy.

The NDA is supported by data from the Phase III SACHI trial, which evaluated the combination therapy against standard platinum-based doublet-chemotherapy. The study met its primary endpoint of progression-free survival in a planned interim analysis. The acceptance triggers a milestone payment from AstraZeneca.

The NMPA granted Breakthrough Therapy designation to this combination in December 2024, recognizing it as a potential new treatment showing substantial advantages over existing therapies.

HUTCHMED has agreed to sell its 45% stake in Shanghai Hutchison Pharmaceuticals (SHPL) for US$608 million in cash. The sale involves two transactions: GP Health Service Capital will acquire 35% for US$473 million, and Shanghai Pharma will acquire 10% for US$135 million. HUTCHMED will retain a 5% stake in SHPL.

The divestment aligns with HUTCHMED's November 2022 strategy to focus on its core business of developing novel cancer and immunological disease therapies. The company plans to use the proceeds to advance its pipeline, including its antibody-targeted therapy conjugate (ATTC) platform, with first candidates expected to enter clinical trials in H2 2025.

HUTCHMED expects to record a gain of approximately US$477 million before taxation. The deal includes a three-year transition period where HUTCHMED will guarantee SHPL's minimum net profit growth of 5% annually. The transaction is expected to close by Q1 2025, subject to shareholder and regulatory approvals.

HUTCHMED (HCM) will receive a $10 million milestone payment from Takeda following Spain's first national reimbursement recommendation for FRUZAQLA® (fruquintinib) in December 2024. This marks the first national reimbursement recommendation in Europe for the treatment of previously treated metastatic colorectal cancer (CRC).

FRUZAQLA® received European Commission approval in June 2024, representing the first novel oral targeted therapy in the EU for metastatic CRC regardless of biomarker status in over a decade. The drug has already secured approvals in multiple regions including the US, Switzerland, Canada, Japan, UK, Argentina, Australia, and Singapore. Takeda holds exclusive worldwide rights for fruquintinib outside mainland China, Hong Kong, and Macau.

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.