Zhitong Financial APP News, Green Leaf Pharmaceutical (02186) announced that the Group has submitted a new drug marketing application (NDA) for palmitate sustained release suspension injection (LY03010) to the US Food and Drug Administration (FDA) through 505 (b) (2) for the treatment of schizophrenia and schizophrenic affective disorder. Based on the Group's long-acting and sustained-release technology platform, LY03010 is expected to become the first long-acting palmitate injection produced by a Chinese company in the United States. At present, LY03010 is in the stage of listing review in China.
Paliperidone is one of the first-line drugs for the treatment of schizophrenia, which can relieve the positive symptoms of psychosis and improve cognitive and emotional symptoms. There are two dosage forms of paliperidone: oral tablets and long-acting injection. Compared with oral dosage form, long-acting injection has the characteristics of less frequency of administration and maintaining a stable effective blood concentration for a long time, so as to improve patient compliance, reduce the risk of recurrence more significantly in long-term treatment, and improve long-term benefits of patients.
LY03010 is a long-acting injection of paliperidone and is given once a month. Its listing application in the United States is based on a random, multiple administration, open, and INVEGA SUSTENNAKey clinical trials of parallel controls. The test results show that LY03010 and INVEGA SUSTENNAIt is bioequivalent when multiple administration reaches steady state. And INVEGA SUSTENNACompared with the initial administration regimen, LY03010 reduces the frequency of initial administration, eliminates the administration on the eighth day after the first injection, and can be achieved with INVEGA SUSTENNA.A considerable amount of exposure. Safety: LY03010 has good safety and tolerance. The trial suggests that LY03010 can not only ensure the efficacy and safety of initial administration, but also improve the compliance of drug administration.
Schizophrenia is a serious mental illness that afflicts an estimated 24 million people worldwide. As a recurrent chronic persistent disease, patients with low treatment compliance lead to high recurrence rate and recurrent disease, which has become the main difficulty in the treatment of schizophrenia for a long time. Long-acting dosage forms can further meet clinical needs, significantly improve patients' treatment compliance and reduce recurrence, which has become an important means of antipsychotic therapy. The listing of LY03010 (if approved) is expected to provide patients with new treatment options. According to public information, the global sales of palmitate long-acting injection reached US $4.14 billion in 2022 and US $2.075 billion in the first half of 2023.
The central nervous system (CNS) treatment area where schizophrenia is located is one of the core treatment areas of the group's strategic layout. With the repeated breakthroughs in the development of new drugs, the Group's product matrix in the field of CNS has become increasingly rich.
Around this treatment area, the group has formed a series of differentiated product portfolios: Rykindo, which was approved in the United States in January 2023.(risperidone sustained release microsphere injection) is (to the best of the company's knowledge) the first new CNS drug independently developed by a Chinese pharmaceutical company and approved in the United States; Ruoxilin, a class 1 new drug approved in China in November 2022.(torudi venlafaxine hydrochloride sustained release tablets) is (to the best of the company's knowledge) the first class 1 innovative chemical drug independently developed in China for the treatment of depression. In addition, StrykerCNS products such as quetiapine fumarate (quetiapine fumarate) and its sustained-release tablets and Lish's clear skin patches (single-day patch and multi-day patch) are also sold in major markets in China and overseas.
In the research products, rotigotin sustained release microspheres (LY03003) for injection have been developed simultaneously in China and overseas markets, and have entered the NDA review stage and been included in the priority review and approval process in China. In addition, a number of new drugs under development, such as VMAT2 inhibitors (LY03015), are also in the clinical stage in China and overseas. The Group has established superior international R & D, registered clinical, supply chain and commercialization capabilities, laying a solid foundation for the global commercialization of new products in the future.