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Brii Biosciences Exercises Option for VIR-3434 in Greater China
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China-based Brii Biosciences Limited (HKG: 2137) announced the exercise of its option to acquire exclusive development and commercialization rights for VIR-3434 (BRII-877) in Greater China as part of its broader collaboration with Vir Biotechnology, Inc. (NASDAQ: VIR). Drug ProfileVIR-3434, an investigational subcutaneously administered HBV-neutralizing monoclonal antibody, is designed to block…
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Innovent Biologics Doses First Patient in IBI112 Phase II Study for Ulcerative Colitis
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China-based Innovent Biologics, Inc. (HKG: 1801) announced the successful first patient dosing in a Phase II clinical study (clinicaltrials.gov: NCT05377580) for its IBI112, a recombinant anti-interleukin 23p19 subunit antibody, in moderate-to-severe active ulcerative colitis (UC). The multi-center, randomized, double-blind, parallel, placebo-controlled Phase II clinical study aims to evaluate the efficacy,…
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VivaVision Biotech and Dragon Sail Pharmaceutical Partner on Ophthalmology R & D
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China’s VivaVision Biotech Inc. has entered into a partnership with compatriot firm Dragon Sail Pharmaceutical. Under the agreement, Dragon Sail will support VivaVision’s preclinical pharmaceutical research, ranging from sequence to IND filing, with a focus on eye diseases. Financial details of the deal were not disclosed. Company ProfilesVivaVision is dedicated…
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Junshi Biosciences Receives FDA Approval for PI3K-α Inhibitor RP903 in Breast Cancer Study
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China’s Junshi Biosciences (HKG: 1877, SHA: 688180) announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study of its PI3K-α inhibitor RP903 (JS105) in combination with fulvestrant for hormone receptor (HR)-positive, human epidermal growth factor receptor-2 (HER-2)-negative, PIK3CA-mutated advanced or metastatic…
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InnoCare Pharma’s Guangzhou Plant Approved for Orelabrutinib Commercial Production
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Beijing InnoCare Pharma (HKG: 9969) announced that as of June 30, its manufacturing plant in Guangzhou has been approved for the commercial manufacturing of its Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib. The plant, located in Sino-Singapore Guangzhou Knowledge City, is compliant with Good Manufacturing Practice (GMP) standards in China, Japan,…
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Hengrui Medicine’s Generic Tacrolimus Wins NMPA Approval for Transplant Rejection Prevention
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) announced that it has received market approval from the National Medical Products Administration (NMPA) for its generic version of Astellas’s tacrolimus. The drug is approved for use in the prevention of graft rejection after kidney transplantation, prevention of graft rejection in the…
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Medtronic Kanghui and Changzhou High-Tech Zone Partner on Science Park
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Medtronic Kanghui and Changzhou National High-Tech Industrial Development Zone have agreed to collaborate on the establishment of the “Medtronic Kanghui Changzhou Science and Technology Park.” The initiative aims to enhance regional advanced medical manufacturing capabilities, particularly in the orthopedic industry. Background and Strategic RoleKanghui became a wholly-owned subsidiary of Medtronic…
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NHC Releases Technical Guidelines for Drug Clinical Evaluation
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The National Health Commission (NHC) has released the “Technical Guidelines for Comprehensive Clinical Evaluation of Cardiovascular Drugs,” “Technical Guidelines for Comprehensive Clinical Evaluation of Antineoplastic Drugs,” and “Technical Guidelines for Comprehensive Clinical Evaluation of Children’s Drugs” (all 2022 trial versions), effective as of July 1, 2022. BackgroundThe NHC released the…
