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BGI Genomics Receives ANVISA Approval for Colorectal Cancer Detection Kit
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China-based genomics giant BGI Genomics Co., Ltd (SHE: 300676) has reported receiving product approval from Brazil’s National Health Surveillance Agency (ANVISA) for its colorectal cancer (CRC) early detection real-time PCR product. The diagnostic kit, used for the auxiliary diagnosis of CRC, is a non-invasive product that detects human genes SDC2,…
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InflaRx and Staidson Amend Deal to Advance Vilobelimab Regulatory Filing in China
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Germany-based biopharma InflaRx N.V. (Nasdaq: IFRX) has revealed an amendment to its underlying deal with China-based Staidson BioPharma Inc. (STS) to push forward a regulatory filing in China for the anti-C5a antibody vilobelimab (BDB-001). InflaRx will supply Staidson with an exclusive license to access the German firm’s clinical, manufacturing, and…
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Elpiscience Receives IND Approval for ES014 in China
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Shanghai-based Elpiscience Biopharmaceuticals Inc. has announced receiving Investigational New Drug (IND) approval in China to initiate a Phase I clinical trial for its bispecific antibody (BsAb) ES014 in patients with advanced solid tumors. ES014 is a potential first-in-class anti-CD39 x TGF-beta immunotherapeutic designed to activate T cells and overcome resistance…
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Ablaze Pharma and Yonghe Partner for Targeted Radiotherapy Development
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China-based Ablaze Pharma and Yonghe Pharmaceutical have struck a partnership agreement for the research and development (R&D) and commissioned manufacturing of targeted radiotherapy (TRT). Yonghe, Ablaze’s Contract Development and Manufacturing Organization (CDMO) partner, will provide R&D and cGMP-compliant manufacturing services from the pre-clinical to clinical stages. Company Background and Partnership…
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InnoCare Pharma’s Orelabrutinib Placed on Partial Clinical Hold by FDA
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China-based InnoCare Pharma (HKG: 9969, SHA: 688428) has announced that the US FDA has placed orelabrutinib for use in multiple sclerosis (MS) on partial clinical hold. As a result, new enrollment of the Phase II study in the United States will not be initiated. Participants in the US who have…
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Hainan Poly Pharm Receives FDA Approval for Generic Lincomycin
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China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced receiving marketing approval from the US FDA for its generic version of US-based Upjohn’s lincomycin. This approval marks a significant milestone for Poly Pharm in expanding its presence in the US market. Drug Profile and IndicationsLincomycin, first approved in the…
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Innovent Biologics’ GFH925 Receives Breakthrough Therapy Designation
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China’s Center for Drug Evaluation (CDE) website indicates that China-based Innovent Biologics (HKG: 1801) has received a breakthrough therapy designation (BTD) for its Category 1 chemical drug GFH925. The drug is intended for the treatment of KRASG12C mutant advanced non-small cell lung cancer (NSCLC) in patients who have previously received…
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Sichuan Healthcare Security Administration Announces VBP for Oral Implant Systems
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The Sichuan Provincial Healthcare Security Administration has released a notification regarding the inter-provincial alliance volume-based procurement (VBP) of oral implant systems, set to begin on January 11, 2023. This initiative aims to streamline the procurement process and ensure the availability of high-quality dental implant systems. Details of the ProcurementDental implant…
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