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Hutchmed
NEWS

HUTCHMED Initiates P-III Trial of Surufatinib + Camrelizumab + CT for Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

Shots:HUTCHMED has initiated P-III portion of P-II/III trial of the combination of surufatinib, camrelizumab, nab-paclitaxel & gemcitabine (S+C+AG) as the 1L treatment of metastatic PDAC in China, with the first patient receiving the dose on Dec 30, 2025Trial will evaluate the combination against nab-paclitaxel + gemcitabine in ~400 PDAC adults who have not…
January 5, 2026

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Mabwell Doses First Patient in P-II Trial of 9MW3811 for Pathological Scarring

Shots:Mabwell has dosed the first patient with 9MW3811 in its P-II (CTR20254857) trial in China for pathological scarringThe trial will assess safety, tolerability, PK, & preliminary efficacy of 9MW3811 in pts with pathological scarring following P-I completion in healthy subjects across Australia & China9MW3811 has shown significant preclinical efficacy in pulmonary fibrosis…
December 31, 2025

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NEWS

HUTCHMED Reports NMPA’s NDA Acceptance with Priority Review of Savolitinib for Gastric Cancer Patients with MET Amplification

Shots:The Chinese NMPA has accepted NDA & granted priority review to savolitinib for the treatment of LA/M gastric cancer or gastroesophageal junction (GC/GEJ) adenocarcinoma pts with MET amplification who have failed ≥2 prior systemic treatmentsNDA was supported by the P-II trial of savolitinib in gastric cancer pts with MET amplification in China, which met its 1EP of improved ORR by…
December 30, 2025

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HUTCHMED Reports NMPA’s NDA Acceptance with Priority Review of Fanregratinib for Intrahepatic Cholangiocarcinoma (ICC)

Shots:The Chinese NMPA has accepted NDA & granted priority review to fanregratinib (HMPL-453) for the treatment of adults with advanced, metastatic, or unresectable ICC with FGFR 2 fusion/rearrangement who have previously received systemic therapyNDA was supported by the P-II trial in China, which met its 1EP of improved ORR, with 2EPs findings, …
December 29, 2025

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Kyverna Therapeutics Reports Topline P-II (KYSA-8) Trial Data of Miv-cel in Stiff Person Syndrome (SPS)

Shots:Kyverna has reported P-II (KYSA-8) trial data assessing a single dose of mivocabtagene autoleucel (miv-cel; KYV-101) in 26 SPS pts having an inadequate response with non-approved treatment optionsTrial met its 1EP with 46% median improvement in T25FW & 81% pts achieving a clinically meaningful ≥20% gain, plus significant benefits were seen across all…
December 17, 2025

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Hope Medicine’s HMI-115 Receives the US FDA Fast Track Designation for Endometriosis-Associated Pain Relief

Shots:The US FDA has granted FTD to HMI-115 for the treatment of mod. to sev. pain associated with endometriosisDesignation was based on the global P-II dose-finding study assessing HMI-115 vs PBO for 12wks. in 108 females with surgically diagnosed endometriosis across the US, Poland & China, showing significant improvementTrial showed that HMI-115…
December 5, 2025

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