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Shanghai Leadingtac Pharmaceutical Secures $13.81 Million in Series A Financing
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Shanghai Leadingtac Pharmaceutical Co., Ltd., a China-based small molecule drug developer, has announced the successful completion of its Series A financing round, raising RMB100 million (USD 13.81 million). The round was led by Beijing Longpan Venture Capital Centre, with additional support from Tian Rui Feng Nian Investment and Shanghai Zhangke…
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Huadong Medicine’s DR10624 Receives NMPA Approval for MAFLD and MASH Clinical Trials
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with clinical trials for its protein drug DR10624 in metabolic related fatty liver disease (MAFLD) and metabolic associated steatohepatitis (MASH). DR10624’s Mechanism and Pre-Clinical PerformanceDR10624 is a…
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NMPA’s CDE Issues Guidelines for Leveraging Real-World Data in Drug Regulation
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The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has released the “Guidelines for Disease Registry-based Real-World Data Application (trial)”. These guidelines are designed to steer the utilization of real-world evidence (RWE) in supporting regulatory decisions related to drugs. Disease Registry and Data QualityThe document highlights…
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Biosion Secures Licensing Deal with Aclaris Therapeutics for Global Rights to BSI-045B and BSI-502
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Biosion, a clinical stage biotech company with operations in Delaware, US, and China, has entered into a licensing agreement with US based Acraris Therapeutics, Inc. (NASDAQ: ACRS). The deal grants Acraris exclusive global rights, excluding Greater China, to Biosion’s BSI-045B and BSI-502, further strengthening the two companies’ layout in the…
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Ratio Therapeutics Partners with Novartis on SSTR2 Radiotherapeutic for Cancer
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US-based Ratio Therapeutics Inc. has entered into a global exclusive licensing and cooperation agreement with Swiss pharmaceutical giant Novartis AG (NYSE: NVS) to develop a Somatostatin Receptor 2 (SSTR2) radiotherapeutic candidate for cancer treatment. Details of the AgreementRatio will apply its radioligand therapy discovery and development expertise, along with its…
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Huadong Medicine’s HDM1005 Receives FDA Approval for MASH Clinical Study
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Huadong Medicine Co., Ltd (SHE: 000963), a China-based pharmaceutical company, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its Category 1 chemical drug, HDM1005, in metabolic associated steatohepatitis (MASH). This development marks a significant step forward for…
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TenNor Therapeutics’ Rifasutenizol Shows High Eradication Rate in H. pylori Phase III Study
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China-based TenNor Therapeutics has announced positive results from its Phase III clinical study for rifasutenizol (TNP-2198) in treating Helicobacter pylori (H. pylori) infection. The study successfully met its primary endpoints, showing significant advantages of the rifasutenizol regimen over the bismuth-containing quadruple therapy (BQT), which is the current standard of care.…
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Beijing Wantai Receives NMPA Clearance for Nine-Valent HPV Vaccine Targeting Male Population
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Beijing Wantai Biological Pharmacy Enterprise Co., Ltd (SHA: 603392), a leading Chinese pharmaceutical company, has announced that it has received clinical clearance from the National Medical Products Administration (NMPA) for its nine-valent human papillomavirus (HPV) vaccine (Escherichia coli), specifically designed for the male population. Global Impact and Vaccine RelevanceGlobally, approximately…
