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SinoMab Bioscience’s SN1011 Gets NMPA Nod for NMOSD Trial
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Hong Kong-based SinoMab Bioscience Ltd (HKG: 3681) has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II/III study of its tyrosine kinase (BTK) inhibitor SN1011 for neuromyelitis optica spectrum disorders (NMOSD). The trial is expected to enroll its first patient in Q1 2023. Drug ProfileSN1011…
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Mabwell Bioscience Receives NMPA Approval for 6MW3511 Clinical Trial in Solid Tumors
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) announced that the National Medical Products Administration (NMPA) has approved a clinical trial for its drug candidate 6MW3511, targeting advanced solid tumors. The trial will evaluate the drug’s efficacy and safety in patients with advanced solid tumors. Drug Profile6MW3511 is a bifunctional…
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Bio-Thera Solutions Receives NMPA Approval for BAT8008 Clinical Trial in Solid Tumors
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Bio-Thera Solutions (SHA: 688177), a Guangzhou-based biotech firm, has received approval from the National Medical Products Administration (NMPA) to conduct a clinical trial for BAT8008, its antibody-drug conjugate (ADC) targeting solid tumors. This marks the fourth product from Bio-Thera’s pipeline to advance into clinical trials. Drug ProfileBAT8008 combines a recombinant…
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BeiGene’s Tislelizumab Receives 11th NMPA Filing for First-Line Esophageal Cancer
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BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) announced that the National Medical Products Administration (NMPA) has accepted a supplementary Biologic License Application (sBLA) for its PD-1 inhibitor tislelizumab, seeking approval for first-line treatment of unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC). This marks the 11th market…
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Innovent Biologics Doses First Patient in Australia Trial for PD-1/IL-2 Bispecific Antibody IBI363
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China-based Innovent Biologics, Inc. (HKG: 1801) announced that the first patient has been dosed in a Phase I clinical trial of IBI363, an in-house developed PD-1/IL-2 bispecific antibody (BsAb) fusion protein, in Australia. The trial will evaluate the safety, tolerability, and preliminary efficacy of IBI363 in patients with advanced solid…
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Lee’s Pharma Expands Global Rights to Windtree’s KL4 Surfactant Products
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China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) has expanded its licensing agreement with US-based Windtree Therapeutics, Inc. (NASDAQ: WINT), securing global exclusive rights to develop, manufacture, and commercialize KL4 surfactant products, including Surfaxin, Surfaxin LS, and Aerosurf. The revised deal, effective August 9, 2022, builds on the initial agreement signed…
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Genetron Holdings Receives Buyout Offer from CEO Wang Sizhen at USD 1.36 per ADS
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Beijing-based precision oncology firm Genetron Holdings Ltd announced receipt of a buyout and take-private offer from CEO, co-founder, and chairman Wang Sizhen. The proposal values the company at USD 0.272 per ordinary share, or USD 1.36 per American depositary share (ADS). Company BackgroundGenetron specializes in molecular profiling tests, early cancer…
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Supreme People’s Court Rules Against Chugai in China’s First Patent Linkage Case
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China’s Supreme People’s Court has delivered its verdict in the nation’s first patent linkage dispute, ruling against Japan’s Chugai Pharmaceutical Co., Ltd and in favor of generic drugmaker Wenzhou Haihe Pharmaceutical Co., Ltd. The case, involving osteoporosis drug eldecalcitol, marks a milestone under China’s Drug Patent Early Dispute Resolution Mechanism,…
