Luye Pharma’s Manufacturing Facility for Paliperidone Palmitate Extended-release Injectable Suspension (LY03010) Passes FDA’s PAI ...

Shanghai, June 27, 2024 - Luye Pharma Group today announced that it has recently received an Establishment Inspection Report from the U.S. Food and Drug Administration (FDA) indicating that the manufacturing facility of Paliperidone Palmitate Extended-release Injectable Suspension (LY03010) has successfully passed a Pre-Approval Inspection (PAI) with No Action Indicated (NAI or no FDA-483 issued).

Developed by Luye Pharma, LY03010 is a long-acting injectable formulation of paliperidone palmitate for the treatment of schizophrenia and schizoaffective disorder. The company submitted a New Drug Application (NDA) for LY03010 to the FDA through the 505(b)(2) pathway. As a crucial step in the review process of the NDA, the FDA needed to conduct a PAI of the drug's manufacturing facility.

This was the second time for Luye Pharma to pass a PAI of the FDA with no FDA-483 issued. The first time was in 2019 when the company's manufacturing facility for Rykindo® (risperidone) for extended-release injectable suspension passed a PAI of the FDA with no FDA-483 issued. Passing another PAI of the FDA with no FDA-483 issued again demonstrated the strong capability of Luye Pharma in maintaining a quality management system following the highest international standards, including the FDA's cGMP requirements. This system provides strong quality assurance for the company to launch more innovative products overseas and enhance its international competitiveness.

Yang Rongbing, President of Luye Pharma Group, said: "Passing the PAI was a major milestone in the review process of LY03010 in the U.S. and was very important to its future approval in the U.S. as well. LY03010 is expected to become the first proprietary long-acting injection of paliperidone palmitate from China to get approved in the U.S. We look forward to serving patients and addressing their unmet needs with this product as soon as possible."

According to the Prescription Drug User Fee Act (PDUFA), the target date for the FDA to make a decision on the NDA of LY03010 is 26 July 2024. Luye Pharma is currently in communication with potential partners about the commercialization of LY03010 in the U.S. The company expects to start the commercialization of this product as soon as it is approved for marketing in the U.S.

Schizophrenia is a severe mental disorder that affects about 24 million people worldwide . It is a chronic, relapsing, and progressive disease characterized by poor patient compliance, resulting in a high rate of relapses. This has long been a major challenge in treating the disease. Long-acting injections of antipsychotics are important in treating schizophrenia, as they can better address clinical needs such as significantly improving patient compliance and reducing relapses. Publicly available information shows that Paliperidone Palmitate Long-acting Injection generated sales of US$4.115 billion in the worldwide market and US$2.897 billion in the U.S. market in 2023.

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About Luye Pharma Group

Luye Pharma Group is an international pharmaceutical company dedicated to the R&D, manufacturing and sale of innovative medications. The company has established R&D centers in China, the U.S. and Europe, with a robust pipeline of over 30 drug candidates in China and more than 10 drug candidates in other international markets. Luye Pharma maintains high-level international standards in novel drug delivery technologies including microspheres, liposomes, and transdermal drug delivery systems. The company has also achieved multiple innovations in new chemical entities and antibodies, and is actively making strategic developments in the fields of cell therapies and gene therapies.

Luye Pharma is developing a global supply chain of 8 manufacturing sites built up around the world, with GMP quality management and control systems established in line with international standards. With more than 30 products covering the central nervous system, oncology, cardiovascular, metabolism and other therapeutic areas, business is conducted in over 80 countries and regions around the world, including the largest pharmaceutical markets - China, the U.S., Europe and Japan, as well as in fast growing emerging markets.