HUTCHMED (China) Limited - HCM STOCK NEWS

HUTCHMED (China) Limited (HCM) announces that the New Drug Application (NDA) for sovleplenib for the treatment of adult patients with primary immune thrombocytopenia (ITP) has been accepted for review and granted priority review by the China National Medical Products Administration (NMPA). Sovleplenib is a novel, selective, oral inhibitor targeting spleen tyrosine kinase (Syk), being developed for the treatment of hematological malignancies and immune diseases. The NDA is supported by data from ESLIM-01, a randomized, double-blinded, placebo-controlled Phase III trial in China of sovleplenib in 188 adult patients with primary ITP who have received at least one prior line of standard therapy. In August 2023, the trial had met its primary endpoint of demonstrating a clinically meaningful and a statistically significant increase in durable response rate in patients treated with sovleplenib as compared to patients treated with placebo. Secondary endpoints including response rate and safety were also met. The NMPA granted Breakthrough Therapy designation (BTD) to sovleplenib for the indication studied in ESLIM-01 in January 2022.

HUTCHMED (China) Limited (HCM) announces that ELUNATE® and SULANDA® will continue to be included in the National Reimbursement Drug List (NRDL) under the 2023 simple renewal mechanism of the China National Healthcare Security Administration (NHSA). The updated NRDL will maintain the same terms as the current two-year agreement, allowing more patients in China to access these innovative medicines for the treatment of metastatic colorectal cancer and non-pancreatic and pancreatic neuroendocrine tumors.

HUTCHMED (China) Limited (HCM) has completed enrollment of its Phase II/III trial of fruquintinib in combination with sintilimab for treating advanced renal cell carcinoma in China. The study aims to evaluate the efficacy and safety of the combination versus axitinib or everolimus monotherapy, with topline results expected by the end of 2024.

HUTCHMED (China) Limited (HCM) released new clinical data from ongoing studies with their investigational drug candidates fruquintinib, surufatinib, and HMPL-295. The data will be presented at the upcoming European Society for Medical Oncology (ESMO) Asia Congress and ESMO Immuno-Oncology Congress in December 2023.

HUTCHMED (China) Limited (Nasdaq/AIM:​HCM, HKEX:​13) announced that its partner Takeda received U.S. FDA approval for FRUZAQLA™ (fruquintinib), an oral targeted therapy for metastatic colorectal cancer, triggering a US$35 million milestone payment and royalties on net sales. The approval is a landmark moment for metastatic colorectal cancer patients in the U.S., with FRUZAQLA being the first and only selective inhibitor of all three VEGF receptor kinases approved in the U.S. for previously treated metastatic CRC regardless of biomarker status. The approval is based on data from two large Phase III trials, with consistent benefits among patients treated with FRUZAQLA.

Takeda submits NDA for fruquintinib in Japan for metastatic colorectal cancer treatment, based on successful clinical trials

HUTCHMED announces positive results from Phase IIIb trial of savolitinib in NSCLC patients with MET exon 14 skipping alterations

HUTCHMED completes patient enrollment of tazemetostat bridging study in China for the treatment of relapsed/refractory follicular lymphoma (R/R FL).

HUTCHMED receives Breakthrough Therapy Designation for savolitinib in gastric cancer treatment