$HCM

HUTCHMED (HCM) announced the FDA granted Orphan Drug Designation to sovleplenib for treating autoimmune hemolytic anemia (AIHA). This is the second such designation for the drug, following a previous one for primary ITP. If approved, sovleplenib could receive 7 years of US market exclusivity and other development incentives. The company is also seeking approval for the drug in China for ITP and warm AIHA.

HUTCHMED (HCM) announced that regulatory filings for ORPATHYS combined with TAGRISSO have been accepted for review in Europe and Japan. The combination showed improved progression-free and overall survival in a Phase 3 trial for NSCLC patients. HCM stock closed at $13.15 on 30/10/2026, down 0.08% in after-hours trading.

HUTCHMED's drug sovleplenib received Orphan Drug Designation from the FDA for treating primary immune thrombocytopenia (ITP), a rare autoimmune disorder. If approved, the drug could gain 7 years of U.S. market exclusivity. Sovleplenib is currently under regulatory review in China for ITP and another indication, supported by positive trial data.

HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) will host a webcast on November 5, 2026, to discuss Phase III clinical data for savolitinib in MET-driven non-small cell lung cancer, presented at ESMO Congress 2026. The event will feature insights from Professor Yi-Long Wu and Dr. Weiguo Su. Savolitinib, co-developed with AstraZeneca, is approved in China for NSCLC and other cancers. The SANOVO and SAFFRON trials showed positive results, including improved progression-free and overall survival.

HUTCHMED and AstraZeneca announced positive Phase III trial results for ORPATHYS® (savolitinib) plus TAGRISSO® (osimertinib) in EGFR-mutated NSCLC with MET overexpression. The combo extended median overall survival by 4.9 months and reduced disease progression risk. Results were presented at ESMO and published in NEJM. NDAs have been submitted in the US, with submissions in Europe and Japan planned. ORPATHYS® is jointly developed by both companies and commercialized by AstraZeneca.

HUTCHMED (HCM) completed a licensing deal with GSK for its KRAS-EGFR antibody conjugate therapy, HMPL-A830, outside China. The agreement includes a $110M upfront payment and potential milestone payments up to $1.185B. HUTCHMED will lead Phase I trials, while GSK handles further development and commercialization in its territory.

HUTCHMED and AstraZeneca submitted a US NDA for ORPATHYS® (savolitinib) plus TAGRISSO® (osimertinib) to treat MET-driven EGFR-mutated lung cancer, supported by the SAFFRON Phase III trial showing improved PFS and OS. The application seeks approval for a biomarker-directed treatment option for patients who progressed on EGFR-TKI therapy. HUTCHMED's Johnny Cheng highlighted the significance of this filing for US patients, building on the drug's approval in China.

HUTCHMED and AstraZeneca submitted a US NDA for ORPATHYS plus TAGRISSO in MET-driven EGFR-mutated lung cancer. The Phase III SAFFRON trial showed significant improvements in progression-free and overall survival over chemotherapy. FDA approval is pending. (HCM, AZN)

HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) has started a Phase Ia global clinical trial of HMPL-A830, an ATTC drug candidate, in patients with advanced solid tumors. The trial aims to assess the safety, tolerability, and preliminary efficacy of HMPL-A830. HUTCHMED also announced a licensing agreement with GSK for the development and commercialization of HMPL-A830 outside of Mainland China, Hong Kong, Macau, and Taiwan.

HUTCHMED (HCM) began a global Phase Ia trial of HMPL-A830, a cancer drug targeting KRAS and EGFR, in patients with advanced solid tumors. The first patient was dosed in China on September 24, 2026. The study aims to assess safety, tolerability, and dosage. GSK obtained rights outside Greater China under an agreement signed September 3, 2026.