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Junshi Biosciences’ PD-1 Inhibitor Tuoyi Faces FDA Review Delay
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Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced that they have not received an action letter from the US FDA regarding the Biologics License Application (BLA) for the programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab). The ongoing delay is attributed to the failure to inspect the manufacturing site. The…
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Huadong Medicine’s Lanluma V and X Approved for Use in Hainan
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced receiving approval from the Hainan Medical Products Administration for its poly-l-lactic collagen stimulators Lanluma V and X as clinically urgent medical devices for designated use in the Arsmo (Hainan) Aesthetic Hospital in the Boao Lecheng Medical Tourism Pilot Zone. The product…
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Antengene and MSD Collaborate on Global Clinical Study for ATG-037
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China-based Antengene Corporation Limited (HKG: 6996) has announced a global clinical collaboration with Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) to conduct a multicenter, open-label, Phase I dose-finding study for ATG-037 as a monotherapy and in combination with MSD’s anti-PD-1 therapy, Keytruda (pembrolizumab). The targeted indication is locally advanced…
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IASO Biotherapeutics Receives FDA Approval for CT103A IND Application
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China-based IASO Biotherapeutics has announced approval from the US FDA for an Investigational New Drug (IND) application for its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy CT103A (equecabtagene autoleucel). The therapy will be assessed in US-based clinical trials for relapsed/refractory multiple myeloma (r/r MM). Drug Profile and DevelopmentEquecabtagene autoleucel…
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Shenzhen Würzburg Dynamics Raises RMB 100 Million in Series A Financing Round
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China-based Shenzhen Würzburg Dynamics has reportedly raised RMB 100 million (USD 14.36 million) in a Series A financing round. The funding was led by 3E Bioventures Capital, with contributions from Tzitzit Asset and Fosun Health Capital. The proceeds will be used for research and development and market construction for multiple…
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AcornMed Raises RMB 200 Million in Series B Financing Led by Yikai Venture Capital
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AcornMed, a tumor precision medicine specialist based in Beijing, has reportedly raised RMB 200 million (USD 28.7 million) in a Series B financing round led by Yikai Venture Capital. Other investors included Lichen Investment, Qingdao Hongteng, and Wushi Capital. The proceeds will be used for research and development of tumor…
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CSPC’s NBL-020 Receives FDA IND Approval for Advanced Solid Tumors
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced receiving Investigational New Drug (IND) approval from the US FDA for its antibody-drug NBL-020. The targeted indication is advanced solid tumors, marking a significant step forward in the development of this innovative therapy. Drug Profile and Mechanism of ActionNBL-020 is an…
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Jiangsu Chia Tai Tianqing’s TQB2102m Gains NMPA Clinical Approval
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Jiangsu Chia Tai Tianqing Pharmaceutical Co., Ltd’s (CTTQ) Category 1 biologic product TQB2102m, an HER2 targeted antibody drug conjugate (ADC), has obtained clinical approval from the National Medical Products Administration (NMPA). The targeted indication is advanced malignant tumors, with no similar product currently approved for marketing anywhere in the world.…
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