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Sperogenix Therapeutics’ Agamree Receives NMPA Approval for Duchenne Muscular Dystrophy Treatment
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China-based rare disease specialist Sperogenix Therapeutics Limited has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its drug Agamree (vamorolone), which is used to treat patients with Duchenne muscular dystrophy (DMD). This marks a significant milestone as Agamree becomes the first DMD drug approved in China,…
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CDE Indicates BTD Status for Visirna’s VSA001, Sperogenix’s Vamorolone, and Zai Lab’s Efgartigimod
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The Center for Drug Evaluation (CDE) website has indicated that Visirna Therapeutics’ novel siRNA therapy VSA001, Sperogenix Therapeutics’ vamorolone, and Zai Lab’s (HKG: 9688) efgartigimod are on track for breakthrough therapy designation (BTD) status awards in China. VSA001 for Familial Chylomicronemia Syndrome (FCS)VSA001 is designed to reduce triglyceride levels in…
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Sperogenix Therapeutics and LUCA Healthcare Join Forces to Advance Digital Therapy for Myasthenia Gravis
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China-based rare disease specialist Sperogenix Therapeutics Limited has entered into a partnership with compatriot firm LUCA Healthcare Limited Co., a company specializing in digital targeting and healthcare solutions, to bolster the application of digital therapy in myasthenia gravis. The collaboration aims to enhance the use of digital therapy in treating…
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Santhera and ReveraGen Submit NDA for Vamorolone in Duchenne Muscular Dystrophy
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Swiss firm Santhera Pharmaceuticals and US-based ReveraGen BioPharma, Inc have announced the rolling submission of a New Drug Application (NDA) for vamorolone in Duchenne Muscular Dystrophy (DMD) with the US FDA. The drug, with China rights owned by China-based Sperogenix Therapeutics, is expected to enter the US market during the…
