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Luye Pharma’s Long-Acting Schizophrenia Drug Meets Endpoints in US Trial

publication date: Nov 22, 2022

Luye Pharma, a Yantai biopharma, announced its extended-release therapy for schizophrenia and schizoaffective disorders met its endpoints in a US pivotal trial. LY03010 is a Paliperidone Palmitate Extended-release Injectable suspension drug that is dosed monthly. Luye said the once-monthly dosing addresses compliance issues associated with oral schizophrenia drugs. The trial compared the pharmacokinetic profile and bioavailability of LY03010 to Invega Sustenna®. In a pre-IND meeting, the US FDA agreed to review an NDA for the therapy via the 505(b)(2) pathway. More details....

Stock Symbol: (HK: 2186)

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