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Bristol-Myers Squibb’s Ozanimod Approved in China for Multiple Sclerosis
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Bristol-Myers Squibb (BMS, NYSE: BMY) has announced receiving marketing approval from China’s National Medical Products Administration (NMPA) for its ozanimod, a novel selective sphingosine-1-phosphate (S1P) receptor modulator. The drug is now approved to treat recurrent multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting multiple sclerosis, and active secondary progressive multiple…
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GenScript’s CAR-T Therapy Carvykti Achieves $55M in Sales, Awaits China Approval
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China-based Contract Research Organization (CRO) GenScript Biotech Corporation (HKG: 1548) has announced that sales of its subsidiary company Legend Biotech Corporation’s (NASDAQ: LEGN) BCMA-directed chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel), reached USD 55 million as of December 31, 2022. This figure, yet to be independently audited,…
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OcuMension’s Phase I Study for Dry Eye Treatment OT-202 Concludes
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Chinese ophthalmology specialist OcuMension Therapeutics (HKG: 1477) has announced the conclusion of a Phase I clinical study for its OT-202, a tyrosine kinase inhibitor (TKI) being developed to treat dry eye. This marks a significant step in the development of innovative treatments for this common condition. Study Design and ResultsThe…
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Antengene Launches Phase I CLINCH Study for ATG-022 in Australia
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China-based Antengene Corporation Ltd (HKG: 6996) has received approval from Australia’s Therapeutic Goods Administration (TGA) to commence the Phase I CLINCH study for its antibody-drug conjugate (ADC) ATG-022. The study targets advanced or metastatic solid tumors, with a focus on gastric cancer patients expressing Claudin 18.2. ATG-022: Mechanism and Preclinical…
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Henlius Begins Phase I Trial for Biosimilar HLX15 Targeting Multiple Myeloma
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Shanghai Henlius Biotech (HKG: 2696) has announced the dosing of the first subject in a Phase I clinical study for its biosimilar candidate HLX15, targeting Johnson & Johnson’s (J&J, NYSE: JNJ) blockbuster drug Darzalex (daratumumab). The study aims to evaluate the pharmacokinetics, safety, and immunogenicity of HLX15 in healthy male…
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Jiangsu Hengrui’s SHR8058 Accepted for Review by China’s NMPA for Dry Eye Disease
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China-based Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced that its market filing for the drug candidate SHR8058 has been accepted for review by the National Medical Products Administration (NMPA). The targeted indication is dry eye disease associated with meibomian gland dysfunction. SHR8058: Mechanism and DevelopmentSHR8058 is NOV03 (perfluorohexyl octane), a…
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Nanjing-Based Frontier Biotechnologies Secures Full Approval for Albuvirtide in China
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Nanjing-based Frontier Biotechnologies Inc. has announced that its supplementary approval filing for albuvirtide, China’s first domestically developed innovative HIV therapy, has been fully approved by regulators. The approval upgrades the drug’s status from “conditionally” approved to fully approved for marketing. Albuvirtide: A First-of-Its-Kind HIV TherapyAlbuvirtide is described as the world’s…
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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…
