HUTCHMED (China) Limited reports that the Phase III registration part of its ESLIM-02 trial of sovleplenib in adults with warm antibody autoimmune hemolytic anemia (wAIHA) in China met its primary endpoint. The study achieved a durable hemoglobin response rate between weeks 5 and 24, indicating rapid and sustained improvements in red blood cell levels for relapsed or refractory patients.
Earlier Phase II data showed hemoglobin benefits versus placebo with overall response rates of 43.8% vs 0% in the first 8 weeks, and 66.7% over 24 weeks of sovleplenib treatment with a favorable safety profile. HUTCHMED plans to submit a New Drug Application for sovleplenib in wAIHA to China’s NMPA in the first half of 2026 and is also developing the drug for immune thrombocytopenia, where a China Phase III trial has already reported positive results.
HUTCHMED (CHINA) LIMITED filed a Form 6-K to furnish two exhibits. One is an announcement related to a blocklisting six monthly return, which is a routine administrative update. The other is a press release stating that an NDA in China for fanregratinib in second-line intrahepatic cholangiocarcinoma has been accepted with priority review status, signaling a notable regulatory milestone for this cancer therapy candidate.
HUTCHMED (CHINA) LIMITED submitted a Form 6-K indicating it issued a press release about starting global clinical development of its ATTC candidate HMPL-A251 in patients with solid tumors. The report is signed by the Chief Financial Officer, Johnny Cheng, and dated December 17, 2025.
HUTCHMED (CHINA) LIMITED filed a Form 6-K furnishing Exhibit 99.1, a press release about completion of enrollment in the SAFFRON global phase III trial evaluating the combination of ORPATHYS and TAGRISSO for certain lung cancer patients with MET overexpression and/or amplification after progression on TAGRISSO.