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HutchMed’s Elunate Receives NMPA Review for Second-Line Gastric Cancer Treatment
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China-based HutchMed (HKG: 0013, NASDAQ: HCM) has announced that the National Medical Products Administration (NMPA) has accepted a market approval filing for the VEGFR inhibitor Elunate (fruquintinib) in China. The filing focuses on the use of Elunate in combination with paclitaxel as a second-line treatment for advanced gastric or gastroesophageal…
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HuidaGene Receives CDE IND Approval for Ophthalmology Gene Therapy HG004
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China-based HuidaGene (Shanghai) Biotechnology Co., Ltd has announced receiving Investigational New Drug (IND) approval from the Center for Drug Evaluation (CDE) in China for its ophthalmology gene therapy, HG004. This gene replacement therapy drug utilizes a recombinant non-adeno-associated virus serotype 2 (non-AAV2) vector to deliver a functional human RPE65 gene…
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CBMG’s C-CAR031 Shows Promising Results in Phase I Study for Hepatocellular Carcinoma
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China-based cell therapy specialist Cellular Biomedicine Group Inc. (CBMG) has published the results of the Phase I clinical study for its C-CAR031 at the American Association for Cancer Research (AACR) annual meeting 2023. The open Phase I study was designed to assess the safety and tolerability of C-CAR031, featuring a…
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CanSino Biologics Reports 2022 Revenue Drop and Increased Losses Amid COVID-19 Vaccine Market Shifts
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China-based vaccines specialist CanSino Biologics Inc., (HKG: 6185) has released its 2022 financial report, recording RMB 1.031 billion (USD 149.9 million) in revenue, marking a 76.02% year-on-year (YOY) decrease, and reporting RMB 187 million (USD 27.19 million) in losses compared to RMB 3 billion (USD 436 million) in gross profits…
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PackGene Secures Series C Financing to Boost AAV Innovation and Global Expansion
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China-based PackGene Biotech has announced the successful completion of a Series C financing round, securing hundreds of millions of renminbi. The round was led by a consortium of investors including GDD Industry Fund, Guangzhou Xinxing Industry Development Fund, Yuegang Capital, Sanmei Investment, and Guangzhou Guoju Venture Capital, along with an…
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Bioworkshops Secures RMB 100 Million in Series A Financing for Biologic Drug Development
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Bioworkshops, a Contract Development and Manufacturing Organization (CDMO) based in Suzhou and specializing in biologic drugs, has announced the completion of a Series A financing round worth RMB 100 million (USD 14.5 million). The investment was led by Jiangsu Tech Industry Investment Co., Ltd. Company Background and ServicesFounded in 2019,…
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Sinovation Medical’s SinoLITT System and Fiber Kit Gain NMPA Approval for Epilepsy Treatment
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Sinovation (Beijing) Medical Technology Co., Ltd has announced that its in-house developed magnetic resonance monitoring semiconductor laser therapy equipment, the SinoLITT System, and disposable laser fiber kit have been approved by the National Medical Products Administration (NMPA) for use in laser treatment of local lesions in patients with drug-resistant epilepsy,…
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Merck and XtalPi Leverage Molecular Dynamics to Enhance Small-Molecule Crystallization
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German pharmaceutical giant Merck (NYSE: MRK) and China-based drug discovery solutions specialist XtalPi have published a study demonstrating the application of molecular dynamics (MD) simulations to guide small-molecule crystallization experiments. This innovative approach aims to achieve crystal shapes that facilitate crystallography data collection throughout the drug development process. Case Study:…
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Neurophth Biotechnology Receives NMPA Approval for Phase I/II Gene Therapy Study
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Neurophth Biotechnology Ltd, a leading gene therapy specialist based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Sino-US multi-center Phase I/II study. The study will assess the safety, efficacy, and tolerability of its gene therapy NFS-02 (rAAV2-ND1) for ND1…
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Shenzhen Core Medical Technology Secures RMB 200 Million in Series C+ Financing for Artificial Heart Tech
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Shenzhen Core Medical Technology Co., Ltd, a leading Chinese manufacturer of artificial hearts, has reportedly raised nearly RMB 200 million (USD 29.1 million) in a Series C+ financing round. The round was led by Loyal Valley Capital, with participation from Greenwoods Asset, highlighting the strong investor confidence in Core Medtech’s…
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Hainan Poly Pharm Wins Health Canada Approval for Generic Cytovene-IV (Ganciclovir)
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Hainan Poly Pharm Co., Ltd (SHE: 300630), a China-based pharmaceutical company, has announced that it has received marketing approval from Health Canada for its generic version of Roche’s Cytovene-IV (ganciclovir). This development marks a significant step for the company as it expands its international footprint in the generic drugs market.…
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Zephyrm Bioscience Secures Over RMB 200 Million in Series B Financing for Stem-Cell Drug Development
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Zephyrm Bioscience, a prominent stem cell drug developer headquartered in Suzhou, has reportedly secured more than RMB 200 million (USD 29.1 million) in a Series B financing round. This significant investment, led by CCB Trust, will fuel the company’s efforts in advancing stem-cell drugs for a variety of diseases and…
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Legend Biotech and Janssen Partner with Novartis on Carvykti Manufacturing and Clinical Supply
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Legend Biotech Corporation (NASDAQ: LEGN), a China-based biotech firm, and its US partner Janssen Pharmaceutical have entered into a significant technology transfer, manufacturing, and clinical supply service agreement with Swiss pharmaceutical giant Novartis (NYSE: NVS). The agreement pertains to the co-developed CAR-T cell therapy, Carvykti (ciltacabtagene autoleucel; cilta-cel), and is…
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CanSino Biologics Receives NMPA Approval for Bivalent COVID-19 mRNA Vaccine
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CanSino Biologics Inc., a leading Chinese vaccines specialist, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its innovative bivalent COVID-19 mRNA vaccine. This development signifies a significant step forward in the company’s efforts to combat the evolving SARS-CoV-2 virus. Preclinical Study…
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JS InnoPharm Initiates Phase Ib Study of AURKA Inhibitor VIC-1911 for EGFR-TKI Resistant NSCLC
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JS InnoPharm Ltd, a Shanghai-based pharmaceutical company, announced that the first patient has been dosed in a Phase Ib clinical study for its small-molecule aurora A kinase (AURKA) inhibitor, VIC-1911. This trial marks a significant step in the development of the drug, which is being investigated for its potential in…
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Simcere Pharmaceutical Group Reports 26.4% YOY Revenue Growth in 2022 Financials
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Simcere Pharmaceutical Group (HKG: 2096), a China-based pharmaceutical company, has reported its financial results for the year 2022, showcasing a significant increase in revenues. The company recorded RMB 6.139 billion (USD 920 million) in revenues, marking a 26.4% year-on-year (YOY) growth. Revenue Breakdown and R&D InvestmentRevenues from the innovative medicine…
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Henlius Reports 97.2% YOY Revenue Growth in Q1 2023, Highlighted by Strong Sales of Hanquyou and HaiSiZhuang
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China-based biopharmaceutical company Henlius (HKG: 2696) has released its financial report for the first quarter of 2023, showing a robust increase in revenues. As of March 31, 2023, the company reported revenues of RMB 995.7 million (USD 144.9 million), marking a 97.2% year-on-year (YOY) growth. Sales Performance of Key ProductsHenlius’s…
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Minghui Pharmaceutical’s MH004 Cream Shows Positive Results in Atopic Dermatitis Phase II Trial
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China-based Minghui Pharmaceutical has unveiled positive top-line data from a Phase II trial of its MH004 cream, which is being evaluated as a treatment for adolescents and adults with mild-to-moderate atopic dermatitis (AD). The cream, a pan-JAK inhibitor, successfully met its primary endpoint and all key secondary endpoints, demonstrating its…
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AffaMed Therapeutics Gets NMPA Approval for Phase III Dextenza Study in Post-Ophthalmic Surgery
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China-based AffaMed Therapeutics has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase III regulatory study. The study will assess the efficacy and safety of Dextenza in subjects following ophthalmic surgery, marking a significant step forward for the company. Dextenza’s Development and…
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Harbour Biomed to Present Early Clinical Data for CTLA-4 Antibody Combo at AACR 2023
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China-based Harbour Biomed (HKG: 2142) is set to release early clinical data for its CTLA-4 antibody in combination with Junshi Biosciences’ (HKG: 1877, SHA: 688180) programmed death-1 (PD-1) inhibitor toripalimab as a treatment for neuroendocrine neoplasms (NENs). The findings will be presented via a poster at the upcoming American Association…
