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Kangrui Health Partners with West China Second University Hospital for Pediatric Care Innovation
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Kangrui Health, a leading data and intelligence application company based in Beijing, has entered into a significant 10-year partnership with West China Second University Hospital. The collaboration focuses on the “Children’s Medical Counseling Game – Wonderful Hospital Series” technology translation project, which is set to revolutionize pediatric care approaches. West…
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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…
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Ascletis Pharma’s ASC40 Meets Acne Treatment Goals in Phase II Trial
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China-based Ascletis Pharma Inc. (HKG: 1672) has announced that its first-in-class, once-daily oral fatty acid synthase (FASN) inhibitor, ASC40 (senifanstat), has successfully met primary and key secondary endpoints in a Phase II clinical trial for acne vulgaris. ASC40’s Mechanism of Action and Trial DesignASC40 is an oral, selective small-molecule inhibitor…
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BDgene Technology’s BD111 Receives Tacit Approval for HSV-1 Keratitis Trial
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Shanghai BDgene Technology Co., Ltd has announced that it has received tacit clinical trial approval from the Center for Drug Evaluation (CDE) for its innovative therapy, BD111. This CRISPR-Cas9 in vivo-based therapy is designed for the treatment of recurrent type 1 herpes simplex virus (HSV-1)-related keratitis (HSK) and is being…
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SanReno Therapeutics Completes Dosing in Kidney Disease Trial for BION-1301
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SanReno Therapeutics, a China-based joint venture (JV) specializing in nephropathy treatments, has announced the completion of dosing in 36 patients for its new kidney disease drug, BION-1301, in a trial conducted in Shanghai. The JV is a collaboration between Chinook Therapeutics Inc., a US-based biopharmaceutical company listed on Nasdaq (KDNY),…
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Qilu Pharmaceutical Launches First Generic Iressa in the US Market
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China-based Qilu Pharmaceutical has announced the market launch of its generic version of AstraZeneca’s (AZ, NASDAQ: AZN) first-generation epidermal growth factor receptor (EGFR) inhibitor, Iressa (gefitinib), in the United States. This marks the debut of the first generic version of Iressa in the country, expanding access to this crucial medication…
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NeuExcell Therapeutics Secures Over $14.5 Million in Pre-Series A+ Funding for Neurological Treatments
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NeuExcell Therapeutics, a Sino-US biotech company specializing in treatments for neurological damage and degenerative diseases, has successfully raised over RMB 100 million (USD 14.5 million) in a pre-Series A+ financing round. The funding round saw participation from notable investors such as ZJ Leading VC, Jemincare, HX Pharma, Leader Venture Capital,…
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Transcenta’s Osemitamab Achieves Full Enrollment in Phase II Gastric Cancer Study
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Transcenta Holding Limited (HKG: 6628), a China-based biopharmaceutical company, has announced the completion of enrollment in two patient cohorts for its Phase II study of osemitamab (TST001), a CLDN18.2-targeted monoclonal antibody. The study, known as Transtar-102 (NCT04495296), focuses on patients with CLDN18.2 expressing gastric/gastro-esophageal junction (G/GEJ) adenocarcinoma in China. A…
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TYK Medicines’ TY-9591 Gains CDE Green Light for Pivotal Phase II Study in NSCLC with Brain Metastases
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Shanghai-based TYK Medicines has announced that it has received the green light from the Center for Drug Evaluation (CDE) to proceed with a pivotal Phase II clinical study for its drug candidate TY-9591, a novel therapy targeting lung cancer with brain metastases. This trial is strategically designed to support a…
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NMPA Transitions Desloratadine, Loratadine, Ambroxol, and Naproxen to OTC Status
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The National Medical Products Administration (NMPA) has indicated on its website that four products will be switched from prescription-only to over-the-counter (OTC) status. The medications in question are desloratadine, loratadine, ambroxol, and naproxen. This move is part of ongoing efforts to make certain medications more accessible to the public. Instructions…
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Skyline Therapeutics Reports Positive Preclinical Results for SKG0106 and SKG0201 Gene Therapies
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Skyline Therapeutics, a Shanghai-based cell and gene therapy (CGT) developer, has announced encouraging preclinical study results for its AAV gene therapies, SKG0106 and SKG0201, targeting neovascular age-related macular degeneration (nAMD) and spinal muscular atrophy (SMA), respectively. SKG0106: A Novel AAV Therapy for nAMDSKG0106 is a self-developed novel AAV vector carrying…
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Cellular Biomedicine Group Inc. and Janssen Biotech, Inc. Announce Global Collaboration for CAR-T Therapies
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China-based cell therapy specialist Cellular Biomedicine Group Inc. (CBMG), emerging from a merger deal in February 2021, has announced a significant global collaboration and license agreement with US firm Janssen Biotech, Inc. (Janssen). The partnership is centered on the development and commercialization of C-CAR039, an anti-CD19 and CD20 bi-specific chimeric…
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Chinese Authorities Launch Special Campaign to Combat Fraud in Medical Insurance
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The National Healthcare Security Administration, Supreme People’s Procurator, Ministry of Public Security, Ministry of Finance, and National Health Commission have collaboratively released a special rectification work plan aimed at combating fraud and deception in the medical insurance field in China. This initiative underscores the government’s commitment to safeguarding the integrity…
