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Novo Nordisk Posts Strong 2022 Results; GLP-1 Therapies Drive Growth
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Denmark-based diabetes giant Novo Nordisk (NYSE: NVO) has reported financial results for the fourth quarter and full-year 2022. The company enjoyed a robust year with sales increasing 16% year-on-year (YOY) in constant currency terms to DKK 177.0 billion (USD 26.21 billion). The growth was primarily driven by strong sales of…
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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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NeuShen Therapeutics Partners with UMass Chan for ALS Gene Therapy Development
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Sino-US biotech firm NeuShen Therapeutics Inc., focused on central nervous system (CNS) disorders, has announced a three-year Sponsored Research Agreement with UMass Chan Medical School (UMass Chan) to develop gene therapy for amyotrophic lateral sclerosis (ALS), a rare and severe neurological disease. The collaboration aims to advance therapeutic solutions for…
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F-Star Therapeutics and Sino Biopharmaceutical Seek CFIUS Approval with Extended Deadline
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The acquisition of UK-based biologics firm F-Star Therapeutics (NASDAQ: FSTX) by China’s Sino Biopharmaceutical (HKG: 1177) may still secure approval from the Committee on Foreign Investment in the United States (CFIUS). According to a recent SEC filing, the companies have requested another extension to their deal deadline, now set for…
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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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Pfizer Reports Record Revenues as COVID-19 Sales Soar; 2023 Guidance Amid Market Shifts
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US-based Pfizer Inc. (NYSE: PFE) reported its Q4 2022 financial results, highlighting an all-time high in 12-month revenues of USD 100.3 billion, up 30% year-on-year (YOY) excluding foreign exchange impacts. The company’s COVID-19 portfolio, including the Comirnaty vaccine and Paxlovid treatment, drove significant growth, though Pfizer expects a substantial revenue…
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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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R&B Bio Raises RMB 200 Million in Series A+ Round to Advance Gene Therapy Pipeline
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Chengdu-based gene therapy firm R&B Biotech has reportedly secured over RMB 200 million (USD 29.64 million) in a Series A+ financing round. The round was led by SDIC Venture Capital, with participation from Panlin Capital, Essence Fund’s healthcare fund, and existing investor Loyal Valley Capital. The proceeds will be allocated…
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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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Daewoong Pharmaceutical Licenses Bersiporocin to CSP for Greater China Development
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South Korea-based Daewoong Pharmaceutical has entered into an exclusive licensing agreement with UK-based CS Pharmaceuticals (CSP) for its first-in-class PRS inhibitor, bersiporocin. Under the agreement, CSP will hold exclusive development and commercial rights to the drug in Greater China, including mainland China, Hong Kong, Taiwan, and Macau. The deal covers…
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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…
