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BIO Reverses Support for WuXi AppTec Amid Security Concerns, Plans Legislative Shift
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The Biotech Innovation Organization (BIO), a US-based industry lobbying group, has reversed its stance on the Chinese Contract Development and Manufacturing Organization (CDMO) WuXi AppTec (SHA: 603259). In a press release from BIO CEO John Crowley, the organization announced it is taking steps to dissociate from WuXi AppTec regarding its…
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European Commission Approves Pfizer’s Prevenar 20 for Pediatric Use
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The European Commission (EC) has granted regulatory approval to Pfizer (NYSE: PFE) for its 20-valent pneumococcal vaccine, Prevenar 20, aimed at preventing invasive disease, pneumonia, and acute otitis media caused by Streptococcus pneumoniae in individuals aged 6 weeks to 18 years. This vaccine was previously approved for use in adults…
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Merck Plans Broader HPV Vaccine Development, Targeting African and Asian Populations
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has unveiled plans to develop a multi-valent human papillomavirus (HPV) vaccine aimed at providing broader protection than the currently approved 9-valent Gardasil 9. This new candidate will include additional virus-like particles (VLPs) targeting HPV types that disproportionately affect populations in Africa and Asia,…
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Shanghai BDgene Partners with SPH RD to Advance Gene Therapy Development
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Shanghai BDgene Technology Co., Ltd., a China-based specialist in gene therapy, has entered into a strategic partnership with SPH RD, a wholly owned subsidiary of Shanghai Pharmaceuticals Holding Co., Ltd (SHA: 601607, HKG: 2607). This collaboration aims to leverage BDgene’s advanced carrier technology and gene therapy R&D achievements alongside SPH…
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Allist Pharmaceuticals Secures NMPA Approval for Phase I Study of AST2169 Liposome in KRAS G12D Tumors
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Shanghai-based biotech Allist Pharmaceuticals Co., Ltd. (SHA: 688578) has received clearance from the National Medical Products Administration (NMPA) in China to commence a Phase I clinical study of its AST2169 liposome. This study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of AST2169 in patients with advanced solid tumors…
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BioGeometry and Sanyou Biopharmaceuticals Forge AI Partnership for Antibody Drug Discovery
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BioGeometry, an AI-driven pharmaceutical company based in Beijing, has formed a strategic partnership with Sanyou Biopharmaceuticals Co., Ltd. The collaboration aims to harness their combined expertise in generative AI technology for target discovery, with the goal of developing IND-stage drugs and creating an advanced AIGC-driven antibody drug discovery platform. The…
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Sichuan Biokin Gains NMPA Approval for Phase I Study of BL-M05D1 in Advanced Solid Tumors
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Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) has received approval from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its antibody drug conjugate (ADC) BL-M05D1, targeting locally advanced solid tumors. BL-M05D1 utilizes the same “linker+toxin” platform as BL-B01D1, an EGFR/HER3-targeted ADC that was the…
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Genor Biopharma Secures NMPA Review for Lerociclib in Advanced Breast Cancer Indication
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Genor Biopharma Co., Ltd. (HKG: 6998) has announced that the National Medical Products Administration (NMPA) has accepted its filing for another indication approval of lerociclib (GB491), a cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor. The new indication seeks to utilize lerociclib in combination with letrozole for patients with hormone receptor-positive…
