Welcome to our dedicated page for Hutchmed (China) news (Ticker: HCM), a resource for investors and traders seeking the latest updates and insights on Hutchmed (China) stock.
HUTCHMED (China) Limited develops and commercializes targeted therapies and immunotherapies for cancer and immunological diseases through a China-based commercial organization and a global clinical pipeline. News for HCM centers on marketed oncology products such as FRUZAQLA and ELUNATE for fruquintinib, ORPATHYS for savolitinib, China regulatory actions, and partner-driven commercialization outside China.
Recurring updates also cover pipeline compounds including sovleplenib, HMPL-760 and HMPL-A580, clinical data presented at oncology meetings, and the company’s Antibody-Targeted Therapy Conjugate platform. Corporate items include annual results, product-license updates such as TAZVERIK in China, board and committee changes, and disclosures tied to HUTCHMED’s Nasdaq, AIM and HKEX listings and ADR structure.
HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) announced that China’s NMPA has granted conditional approval for ATLED® (fanregratinib, HMPL-453), a novel oral FGFR 1/2/3 inhibitor, to treat adult patients in China with advanced, metastatic or unresectable intrahepatic cholangiocarcinoma harboring FGFR2 fusion or rearrangement after prior systemic therapy.
The approval is based on a pivotal Phase II registration cohort in China (NCT04353375), which showed an IRC-assessed objective response rate of 42.5%, median duration of response of 6.9 months, disease control rate of 83.9%, median progression-free survival of 6.9 months and median overall survival of 16.6 months. Median time to response was 1.4 months. Enrollment for a Phase IIIb confirmatory study began in January 2026, and HUTCHMED plans to commercialize ATLED® in China using its existing infrastructure while retaining worldwide rights to fanregratinib.
HUTCHMED (NASDAQ/AIM:HCM; HKEX:13) reported positive high-level results from the global Phase III SAFFRON trial, in which ORPATHYS® (savolitinib) plus TAGRISSO® (osimertinib) achieved statistically significant and clinically meaningful improvements in progression-free survival and overall survival versus doublet platinum-based chemotherapy in patients with MET-driven EGFR-mutated advanced NSCLC after progression on TAGRISSO®.
The safety profile of the combination was consistent with known profiles of each medicine, with no new safety findings. According to HUTCHMED, the data will be presented at an upcoming medical meeting and shared with global regulators to support potential registrations of the ORPATHYS® plus TAGRISSO® regimen.
HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) reported 2026 interim results for the six months ended June 30, 2026. According to HUTCHMED, total revenue was $278.3 million, broadly unchanged from $277.7 million in H1 2025, while net income attributable to HUTCHMED was $15.9 million (H1 2025: $455.0 million including a large one-off gain).
Oncology product in‑market sales rose to $279.8 million, with China in‑market oncology sales up 32% to $94.4 million. ELUNATE® sales increased 41% to $60.8 million and SULANDA® 45% to $18.4 million, while FRUZAQLA® global in‑market sales reached $185.4 million, supported by ~70% ex‑US growth and launches or approvals in 41 countries.
Total consolidated oncology product revenue grew 23% to $121.4 million. Other Oncology/Immunology revenue was $40.9 million, including an $18.1 million milestone from Eli Lilly, and Other Ventures revenue declined 14% to $116.0 million. HUTCHMED reported a cash balance of $1.37 billion and highlighted multiple new NDAs, approvals and advancing ATTC and late‑stage clinical programs.
HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) received conditional NMPA approval in China for ORPATHYS® (savolitinib) to treat locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with MET amplification after at least two prior systemic therapies.
Approval is based on a Phase II study showing IRC-assessed ORR of 32.3%, DCR 63.1%, median DoR 9.7 months and PFS 4.0 months.
HUTCHMED (Nasdaq/AIM: HCM; HKEX:13) will announce its 2026 half-year financial results for the six months ended June 30, 2026, on Thursday, July 30, 2026, at 7:00 am EDT / 12:00 noon BST / 7:00 pm HKT.
Management will host English and Chinese webcasts with Q&A for analysts and investors, accessible live and via replay on the company website.
HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) reported pivotal Phase II data for fanregratinib in pretreated advanced intrahepatic cholangiocarcinoma with FGFR2 fusions/rearrangements.
The single-arm trial (53 sites in China) showed IRC-assessed ORR 42.5%, DCR 83.9%, median DoR 6.9 months, PFS 6.9 months, and OS 16.6 months. An NDA received priority review in China.
HUTCHMED (Nasdaq:HCM) reported Phase III ESLIM-02 data for sovleplenib in warm antibody autoimmune hemolytic anemia (wAIHA). The 90-patient China study met its primary endpoint, with a 66% durable hemoglobin response vs 15% on placebo, and showed reduced rescue therapy, transfusions and steroid use, with a favorable safety profile.
An NDA for wAIHA has been accepted and granted priority review and Breakthrough Therapy Designation by China’s NMPA.
HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) will present new and updated clinical data at the 2026 ASCO Annual Meeting (May 29–June 2, Chicago). Key results include a pivotal Phase II savolitinib study in MET-amplified gastric/GEJ cancer that met its primary ORR endpoint.
The Independent Review Committee–assessed ORR was 32.3% (95% CI: 21.2–45.1), with DCR 63.1%, median TTR 1.4 months, DoR 9.7 months and PFS 4.0 months. These data supported a China NDA that received priority review in December 2025. Multiple fruquintinib and surufatinib studies will also be presented.
HUTCHMED (NASDAQ:HCM) and Innovent announced NMPA approval of ELUNATE (fruquintinib) plus TYVYT (sintilimab) for adults with locally advanced or metastatic renal cell carcinoma in China after VEGFR-TKI failure and without prior PD-1/PD-L1 first-line therapy.
FRUSICA-2 showed a 63% lower risk of progression or death and median PFS of 22.2 months.
HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) announced that the NDA for sovleplenib in adult warm antibody autoimmune hemolytic anemia (wAIHA) was accepted for review by the NMPA with Priority Review and Breakthrough Therapy Designation.
The submission is supported by ESLIM-02 Phase II/III data: the Phase III part met its primary durable hemoglobin response endpoint in January 2026; Phase II published in The Lancet Haematology showed ORR 43.8% vs 0% at eight weeks and 66.7% over 24 weeks. ClinicalTrials.gov ID: NCT05535933.