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Zhaoke Ophthalmology Ltd (HKG: 6622), a former subsidiary of Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), has announced that its cyclosporine A eye gel for dry eye treatment has passed the market filing review and clinical trial on-site inspection by the National Medical Products Administration (NMPA). This milestone brings the firm’s…
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Hangzhou-based Sciwind Biosciences Co., Ltd has announced the first subject dosing in a Phase III clinical study for its ecnoglutide (XW003), a novel, long-acting glucagon-like peptide-1 (GLP-1) analog, in adult patients with type 2 diabetes in China. The trial marks a significant milestone in the development of this innovative therapy,…
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Beijing’s municipal Healthcare Security Administration (HSA) bureau has released details of the initial quote and Chinese market price for Hainan Simcere Pharmaceutical Co., Ltd’s recently approved small-molecule COVID-19 therapy, SIM0417. The drug will be launched at RMB 750 (USD 111) per box, with an ex-factory price including tax (or CIF…
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China-based Qilu Pharmaceutical has announced that its market approval filing for a biosimilar version of Novartis’ (NYSE: NVS) Lucentis (ranibizumab) has been accepted for review by the Center for Drug Evaluation (CDE) in China. Qilu’s biosimilar is the most advanced version of Lucentis currently under development, positioning the company to…
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China-based RemeGen Co., Ltd (HKG: 9995, SHA: 688331) has announced receiving approval from the US Food and Drug Administration (FDA) to conduct a Phase III clinical study for its novel fusion protein telitacicept in myasthenia gravis (MG). The FDA has also awarded telitacicept fast-track status, highlighting the potential significance of…
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China-based Luye Pharma Group (HKG: 2186) has announced receiving approval from the Center for Drug Evaluation (CDE) to conduct a clinical study for its goserelin acetate sustained-release microspheres for injection (LY01022, three-month long-acting dosage form). The drug will be evaluated for treating prostate and breast cancers that are suitable for…
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China-based CAR-T cell specialist CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced a clinical cooperation agreement with Swiss pharmaceutical giant Roche. The partnership will focus on a clinical study assessing the combination of CARsgen’s Claudin18.2 (CLDN18.2)-targeted monoclonal antibody (mAb) AB011 with Roche’s PD-L1 therapy Tecentriq (atezolizumab) alongside standard chemotherapy for…
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Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced that the clinical trial filing for its Category 1 chemical drug HSK38008 oral preparation has been accepted for review by the National Medical Products Administration (NMPA). Additionally, the NMPA has accepted Haisco’s market filing for its Category 1 chemical HSK7653, according…
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Hangzhou-based HealZen Therapeutics has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 drug candidate HZ-A-018 in recurrent multiple sclerosis (RMS) and neuromyelitis optica spectrum disorders (NMOSD). This marks a significant step forward in exploring new treatment options for these…
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China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) has announced that another market approval filing for its third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) BPI-D0316 has been accepted for review by the Center for Drug Evaluation (CDE). The company is seeking approval for BPI-D0316 in first-line treatment of locally advanced…
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China-based Jiangsu Alpha Biopharma Ltd has announced that the New Drug Application (NDA) for its zorifertinib, an oral tyrosine kinase inhibitor targeting epidermal growth factor receptor (EGFR) mutations (L858R and Exon 19Del), has been accepted for review by the Center for Drug Evaluation (CDE). Zorifertinib is indicated for the treatment…
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced receiving official approval from the Guangdong provincial Medical Products Administration bureau for its Jext pre-filled adrenaline auto-injector pen. The product is now permitted to be imported into the Greater Bay Area (GBA) as a clinically urgently needed product. Product Details and…
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced receiving breakthrough therapy designation (BTD) status from the US FDA for its Category 1 drug ABSK021, also known as pimicotinib. The designation is for the treatment of inoperable tenosynovial giant cell tumor (TGCT) and is based on positive Phase Ib…
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The Center for Drug Evaluation (CDE) website indicates that Kechow Pharma’s HL-085 is set to obtain priority review status, with the drug in line for conditional approval. HL-085 is being developed to treat advanced melanoma with NRAS mutations in patients previously treated with immunotherapy. The investigational MEK inhibitor is undergoing…
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The National Medical Products Administration (NMPA) has issued conditional marketing approvals to two novel, China-discovered COVID-19 small-molecule therapies: SIM0417 from Hainan Simcere Pharmaceutical Co., Ltd, and VV116 from Shanghai JunTop Biosciences Co., Ltd. JunTop is a joint venture (JV) between Junshi Biosciences and Vigonvita Life Sciences Co., Ltd. SIM0417: Next-Generation…
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Shanghai-based JS InnoPharm Ltd has announced the initiation of a Phase I clinical study by its US subsidiary VITRAC Therapeutics, LLC for its small molecule aurora A kinase (AURKA) inhibitor VIC-1911. The molecule is being assessed both as a monotherapy and in combination with sotorasib for the treatment of KRAS…
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Beijing InnoCare Pharma Tech Co. (HKG: 9969), a China-based biotech specializing in cancer and autoimmune diseases, has announced the latest data for its pan-fibroblast growth factor receptor (FGFR) inhibitor gunagratinib (ICP-192) in cholangiocarcinoma at the ASCO-GI 2023 meeting. The findings highlight the drug’s potential in treating this challenging form of…
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Hangzhou-based clinical stage gene therapy firm Exegenesis Bio has announced receiving approval from the US FDA to conduct a Phase I clinical study for its EXG102-031. The study will assess the safety, tolerability, and vision improvement potential of this once-administered gene therapy in patients with wet age-related macular degeneration (wAMD).…
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China-based Simcere Pharmaceutical Group (HKG: 2096) has announced the issuance of the first prescription for its Cosela (trilaciclib) at the Jilin Cancer Hospital. This milestone marks the official clinical application of the first-in-class CDK4/6 inhibitor in China. Drug Background and DevelopmentTrilaciclib, discovered by US biotech G1 Therapeutics Inc., was in-licensed…
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its Kisqali (ribociclib), a cyclin-dependent kinase (CDK) 4/6 inhibitor. The drug is now approved for use as initial endocrine therapy in premenopausal or perimenopausal female patients with hormone receptor (HR) positive,…