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Reistone Biopharma’s Edralbrutinib Earns Orphan Drug Designation for NMOSD from US FDA
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Reistone Biopharma Co., Ltd, a company incubated by Hengrui Medicine with an investment of USD 100 million in 2018, has announced the receipt of orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its Bruton’s tyrosine kinase (BTK) inhibitor, edralbrutinib. The designation is awarded for the…
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Lingyi Biotechnology Secures RMB 100 Million in Series A Funding for Gene Therapy Pipeline
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China-based gene therapy developer Lingyi Biotechnology Co., Ltd has reportedly raised close to RMB 100 million (USD 14.5 million) in a Series A finance round. This significant investment was co-led by Efung Capital and Huafang Asset Management, with additional participation from Transfar Science City, Sequoia China, and Huaiji Capital. The…
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Henlius Biotech’s HLX26 and HaiSiZhuang Combo for NSCLC Gets NMPA Phase II Approval
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Shanghai Henlius Biotech (HKG: 2696) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase II clinical study. The study will evaluate the combination of HLX26, an in-house developed lymphocyte activation gene 3 (LAG-3, aka CD233) inhibitor, with Henlius’s programmed-death 1…
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Shanghai Junshi Biosciences Inks Exclusive License Deal with Dr. Reddy’s Laboratories for Tuoyi
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Shanghai Junshi Biosciences Co., Ltd (SHA: 688180), a China-based biotechnology firm, has announced an exclusive license and commercialization agreement with India-based Dr. Reddy’s Laboratories (BOM: 500124). The agreement focuses on the programmed death-1 (PD-1) inhibitor, Tuoyi (toripalimab), marking a significant step in the global expansion of this therapeutic agent. Territorial…
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Sinopharm Partners with Shenzhen to Boost High-End Medical Device and Pharmaceutical Innovation
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China National Pharmaceutical Group Corporation (Sinopharm, HKG: 1099) has announced a strategic partnership with Shenzhen municipality, with the aim of intensifying collaboration on high-end medical devices, innovative drugs, pharmaceutical business, and medical wellness, among other sectors. The financial details of this agreement have not been disclosed, but the partnership signals…
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XtalPi Inc. and China Pharmaceutical University Launch Joint AI Research Center in China
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Sino-US artificial intelligence (AI) firm XtalPi Inc. has joined forces with China Pharmaceutical University (CPU) to establish a joint research center in China. This collaboration aims to leverage the strengths of both institutions in the field of AI and pharmaceutical research. Innovative Laboratory Automation and Intelligent SystemsThe project features an…
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Omega Medical Imaging’s Soteria.AI Receives FDA Approval for Interventional Cardiology
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US-based medical technology firm Omega Medical Imaging has received marketing approval from the US Food and Drug Administration (FDA) for its Soteria.AI, an image-guided X-ray system specifically designed for interventional cardiology labs. This marks a significant milestone as Soteria.AI is hailed as the first artificial intelligence (AI)-enabled X-ray system approved…
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NMPA Extends Public Feedback Period for ‘Drug Standardization Management Measures’ in China
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The National Medical Products Administration (NMPA) in China has announced an extension to the public feedback period for its draft proposal titled “Drug Standardization Management Measures.” Initially open for feedback from December 14, 2022, to January 13, 2023, the window has been extended to June 5, 2023. This initiative reflects…
