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Dizal Pharmaceutical Presents Positive Trial Data for Golidocitinib at ASH Annual Meeting
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China-based Dizal Pharmaceutical Co., Ltd, (SHA: 688192), a spin-off from AstraZeneca (AZ, NASDAQ: AZN) China established in 2017, has presented robust pivotal trial data for its pipeline candidate golidocitinib at the American Society of Hematology (ASH) Annual Meeting. The data was presented in an oral presentation, showcasing the full analysis…
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China Medical System Gets NMPA Green Light for Phase III Vitiligo Study with Ruxolitinib Cream
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China Medical System Holdings (CMS; HKG: 0867) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase III clinical study for its Opzelura (ruxolitinib) cream for the treatment of non-segmental vitiligo. Opzelura, a topical Janus kinase (JAK) inhibitor, was approved in the…
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CARsgen Therapeutics Halts Clinical Studies for Three CAR-T Therapies in the US Following FDA Request
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China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced that the US Food and Drug Administration (FDA) has requested its US subsidiary, CARsgen Therapeutics Corporation, to place clinical studies for CT053, CT041, and CT071 on hold. These chimeric antigen receptor (CAR)-T therapies are on hold pending the FDA’s conclusion after…
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Shanghai Henlius Biotech Submits Another Application for Serplulimab in China
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Shanghai Henlius Biotech Inc., (HKG: 2696) has announced a new market filing for its anti-programmed death-1 (PD-1) drug, HanSiZhuang (serplulimab), seeking approval for use in combination with chemotherapy for first-line non-squamous non-small cell lung cancer (nsqNSCLC). The filing, accepted for review by the National Medical Products Administration (NMPA), marks the…
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Clover Biopharmaceuticals Commences Phase I Trial for RSV Vaccine in Australia
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China-based Clover Biopharmaceuticals Ltd., (HKG: 2197) has announced the successful enrollment of the first batch of subjects in a Phase I clinical study in Australia for its pipeline candidate, SCB-1019, a respiratory syncytial virus (RSV) PreF trimeric subunit candidate vaccine. The randomized, placebo-controlled Phase I study aims to assess the…
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HutchMed’s Elunate-Tyvyt Combination Study for Renal Cell Carcinoma Completes Enrollment
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China-based HutchMed (NASDAQ: HCM) has announced the completion of patient enrollment in its Phase II/III clinical study for Elunate (fruquintinib) in combination with Tyvyt (sintilimab) for the treatment of second-line locally advanced or metastatic renal cell carcinoma (RCC). The randomized, open-label controlled study aims to compare the efficacy and safety…
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Luye Pharma’s Lurbinectedin Receives Market Approval in Hong Kong for SCLC Treatment
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China-based Luye Pharma Group (HKG: 2186) has announced that Hong Kong’s pharmacy and poisons board has approved a market approval filing for the company’s lurbinectedin (LY01017), a drug indicated for metastatic small-cell lung cancer (SCLC) in patients with tumor progression during or after platinum-based chemotherapy. The approval, facilitated by the…
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Suzhou OSAI Biopharma’s L. crispatus Capsule Meets Phase III Endpoints in Bacterial Vaginosis Study
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China-based Suzhou OSAI Biopharma Inc., a specialist in live biotherapeutic products (LBPs), has announced that its vaginal L. crispatus live bacteria capsule (Lc262-1) has achieved both primary and secondary endpoints in a Phase III study. The multicenter, randomized, double-blind, placebo-controlled trial involved 320 patients with bacterial vaginosis (BV). Following a…
