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Aficamten Market Filing Accepted by China’s CDE for Hypertrophic Cardiomyopathy Treatment
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Ji Xing Pharmaceuticals (Jixing) and Cytokinetics Inc (CYTK, NASDAQ: CYTK) have achieved a significant milestone with the acceptance of their market filing for aficamten by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. Aficamten, a next-generation cardiac myosin inhibitor, is under development for…
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CDE Lists Five Drugs and One Companion Diagnostic for Priority Review Status
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The Center for Drug Evaluation (CDE) has indicated on its website that five investigational drugs and one companion diagnostic (CDx) are on track to receive priority review status. The drugs include: Novartis’ Fabhalta (iptacopan) for C3 glomerulopathy (C3G), a best-in-class specific complement factor B oral inhibitor that comprehensively controls intravascular…
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Ji Xing Pharmaceuticals Gets CDE Green Light for Phase III Aficamten Study in nHCM
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Ji Xing Pharmaceuticals, a China-based pharmaceutical company, has announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct the Phase III ACACIA-HCM study for its drug aficamten (CK-3773274) in symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM) in China. Aficamten, a next-generation cardiac myosin inhibitor, is under development…
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Ji Xing Pharmaceuticals Secures Licensing Rights for Biogen’s BIIB131 in Stroke Treatment
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Shanghai-based Ji Xing Pharmaceuticals, supported by RTW Investments, has secured a licensing agreement with Biogen (NASDAQ: BIIB) for the global clinical development rights to the US company’s pipeline candidate BIIB131. The terms of the deal include an undisclosed upfront payment, milestone payments, and royalties on future global sales. BIIB131 is…
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Ji Xing Pharmaceuticals Partners with WuXi STA for Sterile Nasal Spray Production
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Shanghai-based Ji Xing Pharmaceuticals, backed by RTW Investments, has formed a strategic partnership with WuXi STA, a subsidiary of WuXi AppTec (HKG: 2359, SHA: 603259), to establish a sterile nasal spray production line. This collaboration aims to leverage the strengths of both companies, with the new production facility set to…
