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Legend Biotech’s Carvykti Earns FDA Committee’s Unanimous Recommendation for Expanded Use
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GenScript Biotech Corporation (HKG: 1548), a Contract Research Organization (CRO) based in China, has announced that its subsidiary Legend Biotech Corporation’s (NASDAQ: LEGN) BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel), has received a recommendation from the US FDA’s Oncologic Drugs Advisory Committee (ODAC). Following a review…
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Legend Biotech’s Carvykti Earns FDA Committee’s Unanimous Recommendation for Expanded Use
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GenScript Biotech Corporation (HKG: 1548), a Contract Research Organization (CRO) based in China, has announced that its subsidiary Legend Biotech Corporation’s (NASDAQ: LEGN) BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel), has received a recommendation from the US FDA’s Oncologic Drugs Advisory Committee (ODAC). Following a review…
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Microenergy Medical Technology Secures Pre-Series A Funding to Advance Medical Devices
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Microenergy Medical Technology Co., Ltd, a Hangzhou-based manufacturer of active intervention medical devices, has reportedly secured “tens of millions” of renminbi in a pre-Series A financing round. The funding was led by TigerYeah Capital, with contributions from TriWise Capital and HUAGAI Capital. Established in 2021, Microenergy Medtech has a presence…
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Getein Biotech Partners with Dymind Biotechnology to Advance IVD Market Presence
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Getein Biotech Inc., (SHA: 603387), a company based in China with a focus on in vitro diagnostic (IVD) solutions, has entered into a strategic partnership with Dymind Biotechnology Co., Ltd. Both firms are dedicated to the IVD sector, and this collaboration aims to enhance resource sharing and capitalize on their…
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CanSino Biologics Partners with Asymchem Laboratories to Innovate Biopharmaceutical Development
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CanSino Biologics Inc., (HKG: 6185), a leading vaccine specialist based in China, has entered into a strategic partnership with Asymchem Laboratories (Tianjin) Co., Ltd (SHE: 002821), a Contract Development and Manufacturing Organization (CDMO). This collaboration is designed to drive the development of cutting-edge technologies that align with market demands. The…
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Simcere Pharmaceutical’s Suvemcitug Files for Approval in China for Recurrent Ovarian Cancer
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Simcere Pharmaceutical Group (HKG: 2096), a biopharmaceutical company based in China, has announced that an approval filing for its drug candidate suvemcitug (also known as sevacizumab; APX-003; BD-0801) has been submitted in China and accepted for review by the National Medical Products Administration (NMPA). The filing seeks the first indication…
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Bristol Myers Squibb’s Breyanzi Receives FDA Accelerated Approval for CLL/SLL Treatment
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The US Food and Drug Administration (FDA) has granted accelerated approval to Bristol Myers Squibb’s (BMS; NYSE: BMY) CAR-T cell therapy Breyanzi (lisocabtagene maraleucel) for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults who have undergone at least two prior lines…
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Sino Biopharmaceutical Advances Lanifibranor and TQA2225 into Late-Stage Clinical Trials for MASH
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company based in China, has announced the commencement of Phase III and Phase II clinical studies for two of its drug candidates. Lanifibranor, a PPAR agonist, and TQA2225, an FGF21-Fc fusion protein, are both being evaluated as potential treatments for metabolic dysfunction-associated…
