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China’s CDE Releases 69th Batch of Generic Chemical Reference Preparations for Public Review
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The Center for Drug Evaluation (CDE) in China has released the 69th batch of chemical generic reference preparations, which includes 10 new specifications and updates to 31 previously published specifications. This release is a significant step in the ongoing effort to standardize and improve the quality of generic drugs available…
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Innovent Biologics’ GFH925 Earns Breakthrough Therapy Designation for KRASG12C CRC Treatment
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The Center for Drug Evaluation (CDE) website indicates that China-based Innovent Biologics’ (HKG: 1801) Category 1 chemical drug GFH925 has been awarded a breakthrough therapy designation (BTD) for the treatment of KRASG12C mutant advanced colorectal cancer (CRC). This designation highlights the potential of GFH925 in addressing a significant unmet medical…
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CARsgen Therapeutics’ AB011 and Tecentriq Combo Gets NMPA Approval for Gastric Cancer Treatment
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China-based chimeric antigen receptor (CAR)-T cell specialist CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its Claudin18.2 (CLDN18.2)-targeted monoclonal antibody (mAb) AB011 combined with Roche’s programmed death-ligand 1 (PD-L1) therapy Tecentriq (atezolizumab) alongside standard chemotherapy. This treatment is…
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Fujian Cosunter Pharmaceutical Completes Enrollment in Phase II/III Trial for GST-HG171/Ritonavir
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China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) has announced the completion of 1,200 patient enrollment in a Phase II/III clinical study for its Category 1 product, GST-HG171/ritonavir. This multi-center, randomized, double-blind, controlled trial is designed to assess the efficacy and safety of the drug in mild/common COVID-19 adult patients.…
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BeiGene Reports Q1 2023 Financial Growth, Advances Pipeline with Global Expansion Plans
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China-based BeiGene, Ltd. (NASDAQ: BGNE, HKG: 6160, SHA: 688235) has reported financial results for the first quarter of 2023, highlighting recent business achievements and upcoming milestones. The company’s revenue for the three months ended March 31, 2023, was USD 447.8 million, marking a robust 46.05% increase year-on-year (YOY). Product revenue…
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China’s Regulatory Bodies Unveil Guidelines to Strengthen Supervision of Medical Aesthetic Industry
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The State Administration for Market Regulation, National Health Commission, National Administration of Traditional Chinese Medicine, National Medical Products Administration, and Supreme People’s Court, among a total of 11 bureaus, have released the “Guidelines on Further Strengthening the Supervision of the Medical Aesthetic Industry.” These guidelines are designed to bring clarity…
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Medisan Pharmaceutical Secures PPAR Agonist Technology from China Pharmaceutical University
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Harbin Medisan Pharmaceutical Co., Ltd (SHE: 002900) has announced a significant patent and technology transfer agreement with China Pharmaceutical University (CPU) for the development rights of a peroxisome proliferator-activated receptor (PPAR) agonist. This agreement involves an upfront payment of RMB 11 million (USD 1.6 million) and potential milestone payments totaling…
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Meihua International Medical Expands with New Healthcare Industrial Park in Hainan
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Meihua International Medical Technologies Co., Ltd (NASDAQ: MHUA), has announced the acquisition of a land plot in the Boao Lecheng Medical Tourism Pilot Zone of Hainan Province for RMB 24.06 million (USD 3.5 million), with a 50-year land usage right. The company plans to develop a comprehensive healthcare industrial park…
