Lee’s Pharmaceutical Wins NMPA Approval for ALS Drug Teglutik

China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) has announced receiving market approval from the National Medical Products Administration (NMPA) for its drug Teglutik (riluzole), intended to prolong the life of patients with amyotrophic lateral sclerosis (ALS) or delay the need for mechanical ventilation.

Drug Background and Mechanism
Teglutik, a neuroprotective agent for ALS treatment, works by inhibiting glutamate synaptic conduction and neuronal hyperexcitability through various receptors and ion channels. It increases neurotrophic factor expression, protects neurons from excitotoxicity, and supports neuronal survival, thereby improving the quality of life for ALS patients.

Market and Competition
Riluzole was first approved in the US in 1996 by Sanofi as the world’s first ALS therapy, marketed under the name Rilutek. Lee’s Pharma secured development and commercialization rights for the drug in mainland China, Hong Kong, Macau, and Taiwan through a licensing deal with Italfarmaco S.A. in November 2019. The drug now faces competition from domestic manufacturers, including Lunan Beite Pharmaceutical Co. Ltd and VenturePharm (Hainan) Co. Ltd.-Fineline Info & Tech

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