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Junshi Biosciences’ JS401 Accepted for Review by China’s NMPA for Hyperlipidemia
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China-based Junshi Biosciences (HKG: 1877, SHA: 688180) has announced that the National Medical Products Administration (NMPA) has accepted a clinical trial filing for JS401, an injectable co-developed with partner Risen Pharma. The product is an ANGPTL3 mRNA-targeted small interfering RNA (siRNA) designed to treat hyperlipidemia. JS401: Mechanism and DevelopmentJS401 targets…
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Junshi Biosciences Partners with Huahai for Production of COVID-19 Drug VV116
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China-based Junshi Biosciences (HKG: 1877, SHA: 688180) has announced a production and supply agreement between its subsidiary, Shanghai JunTop Biosciences Co., Ltd, and Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521). Under the deal, Huahai will provide manufacturing and supply services for Junshi’s oral nucleoside analog drug JT001 (VV116), which is…
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Ocumension Completes Enrollment for Global Phase III Study of Myopia Treatment OT-101
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Chinese ophthalmology specialist Ocumension Therapeutics (HKG: 1477) has announced the completion of enrollment for a global Phase III study of its pipeline candidate OT-101. The randomized, double-blind, placebo-controlled, multi-center trial aims to assess the efficacy and safety of OT-101 in treating myopia in children. The study has enrolled 170 subjects,…
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Hengrui’s HER2-Targeted ADC SHR-A1811 Gains NMPA Clearance for Clinical Trial
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China’s Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced receiving clearance from the National Medical Products Administration (NMPA) to conduct an open, multi-center Phase Ib/II clinical study for its investigational HER2-targeted antibody-drug conjugate (ADC), SHR-A1811. The study will evaluate the drug in patients with unresectable or metastatic breast cancer with low…
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Hengrui’s Lutetium [177Lu] Oxy-Octreotide Gains Clinical Clearance in China
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China’s Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced receiving clinical clearance from the National Medical Products Administration (NMPA) for its lutetium [177Lu] oxy-octreotide. The drug is being developed to treat unresectable or metastatic, progressive, well-differentiated (G1 and G2) neuroendocrine tumors that are somatostatin receptor-positive, specifically targeting gastrointestinal and pancreatic neuroendocrine…
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Changchun BCHT Gains NMPA Approval for Herpes Zoster Vaccine
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China-based Changchun BCHT Biotechnology Co., Ltd (SHA: 688276) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its live attenuated herpes zoster vaccine. The vaccine is indicated for the prevention of herpes zoster in adults aged 40 and above, addressing a significant unmet medical need in…
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Jemincare’s Avatrombopag Market Filing Accepted for Review by China’s CDE
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China-based Jiangxi Jemincare Group has announced that its market filing for avatrombopag maleate (20mg) has been accepted for review by the Center for Drug Evaluation (CDE). The company is seeking approval for the Category 4 chemical drug to treat chronic liver disease-associated thrombocytopenia (CLDT) in patients undergoing elective diagnostic procedures…
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Ascletis Receives FDA Approval for Phase IIa Trial of ASC10 in RSV Infection
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China-based Ascletis Pharma Inc. (HKG: 1672) has announced receiving approval from the US FDA to conduct a Phase IIa clinical study for its investigational drug ASC10 in patients with respiratory syncytial virus (RSV) infection. ASC10 is an oral double prodrug designed to be rapidly and completely converted in vivo into…
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Sirnaomics Accelerates STP705 Development After Positive Skin Cancer Trial Results
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Sirnaomics Ltd (HKG: 2257) is advancing the clinical development of STP705 following positive results from a Phase IIb study in cutaneous squamous cell carcinoma in situ (isSCC) and a Phase II study in basal cell carcinoma (BCC). The company is actively engaging with the US FDA to finalize the protocol,…
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Betta Pharmaceuticals Gains FDA Approval for Clinical Trial of BPI-460372
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China’s Betta Pharmaceuticals (SHE: 300558) has announced receiving clinical trial approval from the US FDA for its Category 1 drug candidate BPI-460372. The trial will evaluate the drug as a potential treatment for advanced solid tumors, marking a significant milestone in the company’s oncology pipeline. BPI-460372: Targeting the Hippo Signaling…
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Kelun’s SKB264 Receives Breakthrough Therapy Designation for Lung Cancer
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Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) has announced that its antibody-drug conjugate (ADC) SKB264, targeting trophoblast cell-surface antigen 2 (TROP2), has obtained breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE). The designation is for the treatment of locally advanced or metastatic EGFR mutant non-small cell lung…
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Hengrui’s Camrelizumab-Apatinib Combo Approved for Liver Cancer in China
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China-based Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its programmed death-1 (PD-1) monoclonal antibody (mAb) camrelizumab, in combination with the small-molecule targeted cancer therapy apatinib, as a first-line treatment for unresectable or metastatic hepatocellular carcinoma (HCC). This marks the…
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Yiling Pharmaceutical’s G201-Na Accepted for Review by China’s NMPA for Prostate Cancer
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China-based Yiling Pharmaceutical Co., Ltd (SHE: 002603) has announced that its clinical trial filing for G201-Na, a Category 1 chemical being developed to treat prostate cancer requiring androgen castration, has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step forward in the development…
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Zhaoke Ophthalmology’s Cyclosporine A Eye Gel Nears Market Approval in China
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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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Sciwind Biosciences Initiates Phase III Trial for Ecnoglutide in Type 2 Diabetes
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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 HSA Sets Price for Hainan Simcere’s COVID-19 Therapy SIM0417
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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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Qilu Pharmaceutical’s Biosimilar Lucentis Accepted for Review by China’s CDE
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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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RemeGen’s Telitacicept Gains FDA Approval for Phase III Study in Myasthenia Gravis
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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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Luye Pharma Gains CDE Approval for Goserelin Acetate Microspheres Clinical Study
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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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CARsgen and Roche Partner on Clinical Study for Gastric Cancer Treatment
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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…
