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Biocytogen and Merck KGaA Ink Global Deal for RenMice Platform Licensing
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Sino-US contract research organization (CRO) Biocytogen Pharmaceuticals (Beijing) Co., Ltd has entered into a global licensing agreement with Germany-based Merck KGaA, granting Merck exclusive rights to its RenMice platform. The platform will be used to discover and develop human antibodies against unlimited drug targets, with Merck holding full rights to…
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3SBio Inc. Reports H1 2020 Revenue of RMB 3.091B, Net Profit Up 6.19%
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China-based 3SBio Inc. (HKG: 1530) reported its H1 2020 financial results, with revenue of RMB 3.091 billion (USD 451.5 million), a 0.51% decrease year-on-year (YOY). Net profits rose 6.19% YOY to RMB 955 million (USD 145.3 million). R&D investment increased 14.7% to RMB 294 million (USD 42.9 million). Core Products3SBio’s…
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Betta Pharmaceuticals’ H1 2022 Revenues Rise 8.5% on Drug Sales Growth
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China’s Betta Pharmaceuticals (SHE: 300558) reported RMB 1.25 billion (USD 182.5 million) in revenue for H1 2022, up 8.5% year-on-year (YOY). The growth was driven by strong sales of key drugs, including icotinib and ensartinib, despite a 55.96% drop in net profits to RMB 95 million (USD 13.8 million). Drug…
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Ranok Therapeutics Doses First Patient in RNK05047 Study for BRD4-Targeted Cancers
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Ranok Therapeutics Co., Ltd, a Hangzhou-based biotech firm, announced that the first patient has been dosed in the Phase I/II CHAMP-1 study (NCT05487170) of its lead drug candidate RNK05047 in the United States. The trial will evaluate the safety and optimal dosage of the potential first-in-class small-molecule degrader targeting BRD4…
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CSPC Pharmaceutical’s SYS6006 mRNA Vaccine Shows Strong Safety and Efficacy in Trials
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has provided updates on its in-house COVID-19 mRNA vaccine SYS6006, which has completed six clinical trials demonstrating safety and efficacy across different age groups and vaccination scenarios. Trial Highlights Vaccine ProfileSYS6006 is designed with antigenic mutations targeting prevalent strains. Preclinical data show efficacy…
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China’s Health Commission Promotes Medical-Elderly Care Integration
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China’s National Health Commission (NHC), National Development and Reform Commission (NDRC), and National Healthcare Security Administration (NHSA) jointly released the “Guiding Opinions on Further Promoting the Development of the Combination of Medical and Elderly Care.” The initiative aims to enhance elderly care services by integrating medical resources with elderly care…
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China Passes WHO NRA Evaluation for Vaccine Regulatory System
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The World Health Organization (WHO) announced that China has successfully passed the evaluation of its vaccine National Regulatory Authority (NMPA), following the WHO’s upgrade of evaluation standards in July 2023. This marks the third time China’s vaccine regulatory system has met WHO criteria, following previous assessments in 2011 and 2014.…
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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,…
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Ascletis Pharma’s H1 2022 Revenue Rises 4.8% on R&D and Product Sales Growth
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Ascletis Pharma Inc. (HKG: 1672) reported RMB 38.2 million (USD 5.96 million) in revenue for the six months ending June 30, 2022, a 4.8% year-on-year (YOY) increase. The firm’s research and development (R&D) expenditure surged 60.5% YOY to RMB 118.8 million (USD 18.54 million), while cash reserves stood at RMB…
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Viatris Pharmaceuticals’ HIV/AIDS Drug Prioritized for CDE Review
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The Center for Drug Evaluation (CDE) has indicated that Viatris Pharmaceuticals Co., Ltd’s efavirenz/lamivudine/tenofovir is set for prioritized review. The drug is used to treat HIV/AIDS, combining three active ingredients to target viral replication. Drug Profile Global ApprovalsThe compound is marketed abroad under two single-dose regimes:
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Hansoh Pharma Licenses GHDDI’s GDI-4405 for Global Development in COVID-19
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced a licensing agreement with the Global Health Drug Discovery Institute (GHDDI) to develop the COVID-19 therapy GDI-4405. Hansoh will gain exclusive global rights to the drug’s clinical development, manufacturing, and commercialization. Agreement DetailsHansoh will pay GHDDI an upfront fee of RMB…
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Anhui Anke’s HK010 Bispecific Antibody Receives NMPA Review for Cancer Trials
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Anhui Anke Biotechnology (Group) Co., Ltd (SHE: 300009) announced that the National Medical Products Administration (NMPA) has accepted a clinical trial filing for HK010, a bispecific antibody (BsAb) targeting PD-L1 and 4-1BB, for the treatment of advanced malignant tumors. Drug ProfileHK010 is designed to block the PD-L1/PD-1 pathway while conditionally…
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China-Based Firms Form Partnership to Advance Cell and Gene Therapy Ecosystem
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Six China-based companies—Porton Advanced Solutions Ltd, Shanghai Sequanta Biological Technology Co., Ltd, QuaCell Biotechnology Co., Ltd, EurekaBio Technology Co., Ltd, SAFE Pharmaceutical Technology Co., Ltd, and SanQ (Beijing) Biotechnology Co., Ltd—have formed a strategic partnership in the cell and gene therapy (CGT) sector. The collaboration aims to create a comprehensive…
