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Ambrx Biopharma Halts Development of HER2 ADC ARX788, Cuts Workforce
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US-based, China-owned biotech Ambrx Biopharma Inc. (NYSE: AMAM) has announced plans to end the development of its HER2-targeted antibody drug conjugate (ADC) pipeline candidate ARX788. The decision follows a strategic assessment of factors including cash runway, pipeline near-term value creation opportunities, and other considerations. As a result, the company also…
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Sinopharm’s Wuhan Institute Isolates Monkeypox Strains, Begins Vaccine Research
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China’s Wuhan Institute of Biological Products, a research affiliate of Sinopharm’s China National Biotech Group (CNBG), has announced that it has successfully isolated monkeypox strains from clinical samples. This development marks a significant step in the global effort to combat the infectious disease. Research has now begun on developing vaccines…
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CATUG Biotechnology Partners with Duoning to Advance mRNA Industrialization
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China-based CATUG Biotechnology (Suzhou) Co., Ltd has entered into a partnership with compatriot firm Shanghai Duoning Biotechnology Co., Ltd, with the goal of strengthening the development of its mRNA industrialization platform. The collaboration aims to enhance the production capabilities and regulatory compliance of mRNA vaccines and drugs. No financial details…
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Fujian Procurement Center Announces VBP for Cardiac and Laparoscopic Medical Consumables
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The Fujian drug and device joint procurement center has released two separate notifications regarding the inter-provincial alliance volume-based procurement (VBP) of medical consumables. The initiatives target cardiac intervention electrophysiology and endoscopic cutting stapler/suture products. The documents outline the specific procurement modes, selection rules, and other details. The time for enterprise…
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NMPA Releases 61st Batch of Reference Drugs for Generic Quality Consistency Evaluation
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The National Medical Products Administration (NMPA) has released the 61st batch of reference drugs for generic quality consistency evaluation (GQCE) work. This batch includes 57 new specifications and 18 specifications with modifications, highlighting the ongoing efforts to ensure the quality and consistency of generic drugs in China. Inclusion of Biogen’s…
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Betta Pharmaceuticals’ BPI-460372 Accepted for Clinical Trial Review by NMPA
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China’s Betta Pharmaceuticals (SHE: 300558) has announced that its clinical trial filing for the Category 1 drug candidate BPI-460372 has been accepted for review by the National Medical Products Administration (NMPA). The targeted indication for the drug is advanced solid tumors, marking a significant step forward in the development of…
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Frontier Biotechnologies Secures Approval for HIV Therapy Alfusid
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Nanjing-based Frontier Biotechnologies Inc. has announced that its supplementary market filing for Alfusid (albuvirtide), China’s first homegrown innovative HIV therapy, has been approved. The approval allows the drug to be administered via intravenous bolus, significantly reducing the administration time. Alfusid: World’s First Long-Acting HIV DrugAlfusid is described as the world’s…
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Hengrui’s Camrelizumab and Akeso’s AK112 Set to Receive Breakthrough Designation in China
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The Center for Drug Evaluation (CDE) website indicates that China-based Jiangsu Hengrui Medicine Co., Ltd’s (SHA: 600276) new indication filing for its programmed death-1 (PD-1) monoclonal antibody (mAb) camrelizumab, combined with the multi-kinase inhibitor famitinib, is set to receive Breakthrough Therapy Designation (BTD) status. The combination is intended as a…
