Luye Pharmaceutical Group (2186.HK) updated the latest progress of its new drug marketing review for its paliperidone palmitate sustained-release suspension injection (LY03010) in the US on February 1. Currently, the new drug marketing application (NDA) for this product has been accepted by the US Food and Drug Administration (FDA), and no patent infringement lawsuit has been filed within the time limit stipulated in the US Federal Food, Drug, and Cosmetics Act, which means that the LY03010 project's patent challenge in the FDA approval process has been successful.

LY03010 is an innovative formulation independently developed by Luye Pharmaceutical to treat schizophrenia and schizoaffective disorder. The product was granted an American invention patent in 2023, and the patent will expire in 2039. After submitting LY03010's new drug marketing application to the FDA through 505 (b) (2) in the US, Luye Pharmaceutical sent the fourth patent statement (Paragraph IV) to INVEGA SUSTENNA's new drug holders and patentees. According to the provisions of the US Federal Food, Drug, and Cosmetic Act, the new drug holder and patentee must sue Luye within 45 days of receiving the fourth patent statement before triggering a 30-month standstill period.

As of the announcement of Luye Pharmaceuticals, the lawsuit period that triggered the 30-month standstill had expired, and the company had not been sued, so LY03010 had no patent barriers in the US FDA approval process. According to the Prescription Drug Declarant Payment Act (PDUFA), the target date for the FDA to decide on LY03010's marketing application is July 26, 2024, US time. The company expects to commercialize the product in the US as soon as it is approved for marketing in the US. At the same time, LY03010 has also entered the marketing review stage in China and is carrying out key clinical trials in Europe.

LY03010 is a long-acting injection of paliperidone, administered once a month. Its application for the marketing of the new drug in the US is based on a randomized, multiple-dose, open, parallel clinical trial with INVEGA SUSTENNA. Test results showed that compared with INVEGA SUSTENNA's dosing regimen, LY03010 reduced the initial dosage frequency, eliminated the patient's administration on the eighth day after the first injection, and achieved an exposure equivalent to INVEGA SUSTENNA. Safety aspects: LY03010 has good safety and tolerability. The test suggests that through an optimized initial dosing regimen, LY03010 will further facilitate administration and improve compliance while ensuring efficacy and safety.

LY03010, which is administered once a month, is expected to form a product combination with Rykindo risperidone sustained-release microsphere injection that Luye Pharmaceutical has marketed every two weeks in the US). Currently, Luye Pharmaceutical is actively promoting the commercialization of this product in the US with potential multinational corporate partners.

Schizophrenia is a serious mental illness that affects around 24 million people worldwide. As a recurrent chronic protracted disease, the high recurrence rate and recurrence of symptoms due to poor patient adherence to treatment have become the main difficulties in treating schizophrenia for a long time. Long-acting dosage forms can further meet clinical needs, significantly improve patients' adherence to treatment, reduce recurrence, and have become an important antipsychotic treatment. LY03010 is expected to provide patients with new treatment options after launch. According to public information, sales of paliperidone palmitate long-acting injections in the global and US markets in 2023 were US$4.115 billion and US$2,897 million, respectively.

Mr. Yang Rongbing, President of Luye Pharmaceutical Group, said, “LY03010 is expected to be the first domestically produced paliperidone palmitate long-term injection with independent intellectual property rights approved in the US. The current progress of the product's launch review in the US is in line with expectations, and progress on related patent issues has further strengthened our confidence that it can be approved as scheduled. We will actively cooperate with the FDA's review requirements and fully prepare for the next Pre-Approval Inspection (PAI). We expect this product to benefit patients around the world as soon as possible and serve clinical treatment needs.”

The central nervous system (CNS) treatment field where schizophrenia is located is one of the core treatment areas of Luye Pharmaceutical's strategic layout. The company has formed a series of product portfolios with differentiated advantages around this treatment field: Rykindo (risperidone sustained-release microsphere injection), approved in the US, became the first new CNS drug independently developed by a Chinese pharmaceutical company and approved in the US; Ruoxinlin (toludivenlafaxine hydrochloride sustained-release tablets) was the first class 1 innovative chemical drug independently developed in China to treat depression. In addition, Sirecon (quetiapine fumarate) and its extended-release tablets, and Lisimin transdermal patches administered once a day are sold in Chinese and overseas markets, and Lisimin transdermal patches administered twice a week are marketed in China and major European countries.

Among the products under development, injectable rotigotin sustained-release microspheres (LY03003) are also being developed simultaneously in Chinese and overseas markets, and their new drug marketing applications in China are included in the priority review and approval process; in addition, many new drugs under development, such as the VMAT2 inhibitor LY03015, are in clinical stages in China and overseas. The company has established superior international R&D, clinical registration, supply chain and commercialization capabilities, laying a solid foundation for future global commercialization of new products.