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Staidson’s Anti-C5a Monoclonal Antibody STSA-1002 Accepted for NMPA Review
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China-based Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204) has announced that the clinical trial filing for its injectable STSA-1002, an anti-human complement protein C5a (hC5a) monoclonal antibody (mAb) for use in acute respiratory distress syndrome (ARDS), has been accepted for review by the National Medical Products Administration (NMPA). About ARDS…
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Guangdong Raynovent Biotech Secures RMB 370 Million in Series C Financing
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Guangdong Raynovent Biotech Co., Ltd, a controlling subsidiary of China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317), has reportedly raised RMB 370 million (USD 53.72 million) in a Series C financing round. The round was co-led by Yide Private Equity Investment Fund Management (Guangzhou) Co., Ltd and Efung Capital, with…
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Hengrui Pharmaceuticals Appoints Dr. Jiang Ningjun as Deputy General Manager and CSO
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China-based Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced the appointment of Dr. “Frank” Jiang Ningjun as its deputy general manager and chief strategy officer (CSO). Dr. Jiang will be tasked with overseeing clinical studies and driving business expansion. Moving forward, Sun Piaoyang, Zhang Lianshan, and Dr. Jiang Ningjun will form…
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Junshi Biosciences’ CGRP Monoclonal Antibody JS010 Accepted for NMPA Review
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China-based Junshi Biosciences (HKG: 1877, SHA: 688180) has announced that the clinical trial filing for JS010, its in-house developed CGRP monoclonal antibody drug candidate for treating migraine, has been accepted for review by the National Medical Products Administration (NMPA) in China. About CGRP and JS010CGRP is a neuropeptide composed of…
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BeiGene’s Tislelizumab Receives NMPA Review for First-Line HCC Indication
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BeiGene (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has revealed that a supplementary Biologic License Application (sBLA) for its programmed death-1 (PD-1) inhibitor tislelizumab has been accepted for review by the National Medical Products Administration (NMPA). The latest prospective indication is for the drug’s use in first-line unresectable or metastatic hepatocellular…
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Immunohead Biotech Raises RMB 200 Million in Series A+ Financing Round
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Immunohead Biotechnology Co., Ltd, a cell therapy developer based in Suzhou, has reportedly raised close to RMB 200 million (USD 28.89 million) in a Series A+ financing round. The round was led by SDIC Venture Capital, with participation from the Bio-Town Equity Investment Fund. The proceeds will be used to…
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Biocytogen and Hansoh Enter Antibody Collaboration and Licensing Agreement
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China-based Biocytogen Pharmaceuticals (Beijing) Co., Ltd has announced an antibody collaboration, assignment, and exclusive license agreement with compatriot firm Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692). Under the agreement, Biocytogen will provide a license to Hansoh to use selected fully human antibody molecules against a designated target for global development,…
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CStone Pharmaceuticals Achieves Primary Endpoint in GEMSTONE-304 Study for Sugemalimab
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China-based CStone Pharmaceuticals (HKG: 2616) has announced the achievement of the primary endpoint in the regulatory GEMSTONE-304 study for its sugemalimab in first-line unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC). This makes sugemalimab the first PD-1 inhibitor to generate positive data in this indication globally. Study…
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3D Medicines Gains FDA Approval for Phase II Study of Envafolimab in dMMR Tumors
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China-based oncology specialist 3D Medicines (HKG: 1244) has announced receiving approval from the US FDA to conduct a single-arm, multi-center Phase II study assessing the safety and efficacy of envafolimab (KN035) in treating deficient mismatch repair (dMMR) advanced solid tumors. The study will involve one subcutaneous injection every three weeks.…
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Changzhou Qianhong Completes Phase I Study of QHRD107 for Acute Myeloid Leukemia
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China-based Changzhou Qianhong Bio-pharma Co., Ltd (SHE: 002550) has announced the completion of enrollment and clinical observation in a Phase I clinical study for its Category 1 drug QHRD107, targeting acute myeloid leukemia (AML). Preliminary findings indicate that the QHRD107 capsule is safe for AML patients, with controllable overall risk…
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Guangdong Zhongsheng Completes Enrollment for RAY1216 Phase III Study in COVID-19
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China – based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) has announced the completion of enrollment for its Phase III study of RAY1216, a drug candidate for the treatment of mild SARS – CoV – 2 infection. The randomized, double – blind, placebo – controlled study has enrolled 1,360 subjects…
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CDE Releases 65th Batch of Chemical Generic Reference Preparations
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The Center for Drug Evaluation (CDE) has released the 65th batch of chemical generic reference preparations, adding 35 new specifications to the list and updating information on 44 previously published specifications. This batch reflects the CDE’s ongoing efforts to expand and refine the availability of generic drugs in the market.…
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Viking Therapeutics Sues Ascletis Pharma Over Alleged Trade Secret Theft
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US – based Viking Therapeutics (NASDAQ: VKTX) is set to take China’s Ascletis Pharma Inc. (HKG: 1672) to court in the United States over alleged theft of trade secrets and breach of contract. Viking has filed separate complaints with the US District Court of Southern California and the US International…
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Shuwen Biotech Partners with Nottingham University Hospitals for MammaTyper
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China – based diagnostic specialist Shuwen Biotech Co., Ltd and its German wholly – owned subsidiary Cerca Biotech GmbH have entered into a collaboration agreement with Nottingham University Hospitals (NUH). The agreement is designed to bolster the clinical study, application, and promotion of Shuwen’s core product, MammaTyper. Financial details of…
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Chinagene Tech’s ZVS101e Receives FDA IND Approval for Bietti’s Crystalline Dystrophy
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Beijing – based Chinagene Tech, a specialist in hereditary ophthalmopathy diagnosis and gene therapy, has announced obtaining Investigational New Drug (IND) approval from the US FDA for its ophthalmology gene therapy ZVS101e. The therapy is designed to treat Bietti’s crystalline dystrophy (BCD), a rare genetic eye disease. ZVS101e, a Category…
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Jiangxi Leads 16-Province VBP Alliance with Winning Bids Announced
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The Jiangxi Province Healthcare Security Administration has released a notification regarding the winning bids of the 16 – province (municipalities, regions) alliance volume – based procurement (VBP). The event, initiated on November 18, 2022, and led by Jiangxi, included Inner Mongolia, Jilin, Heilongjiang, Zhejiang, Henan, Hunan, Guangxi, Hainan, Chongqing, Guizhou,…
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NMPA Approves 172 Medical Devices for Marketing in November 2022
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The National Medical Products Administration (NMPA) approved 172 medical devices for marketing in November 2022. This approval marks a significant step in expanding the availability of medical devices in the market, addressing various healthcare needs. Breakdown of Approved DevicesAmong the approved devices, there were 121 domestic Category III products, 22…
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Merck’s Lagevrio Receives Emergency Conditional Approval from China’s NMPA
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US-based Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK) has announced receiving emergency conditional approval from the National Medical Products Administration (NMPA) for its oral COVID-19 therapy Lagevrio (molnupiravir). The drug is approved for the treatment of adult patients with mild to moderate COVID-19 who have high-risk factors for severe…
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NHSA and CNIPA Issue Opinions on Strengthening IP Protection in Drug Procurement
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The National Healthcare Security Administration (NHSA) and the China National Intellectual Property Administration (CNIPA) have issued an Opinions paper titled “Strengthening the Protection of Intellectual Property Rights within Centralized Pharmaceutical Procurement.” The focus is on enhancing the protection of intellectual property (IP) rights during the drug procurement process. Coordination and…
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Legend Biotech’s Carvykti Accepted for Review by China’s CDE
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The Center for Drug Evaluation (CDE) website indicates that a market approval filing from Legend Biotech Corporation (NASDAQ: LEGN) for its BCMA-directed chimeric antigen receptor (CAR) T cell therapy Carvykti (ciltacabtagene autoleucel) has been accepted for review. This makes Carvykti the third BCMA CAR-T therapy to be filed for marketing…
