According to the announcement made by Luye Pharma (02186), its self-developed second-generation long-acting injection for antipsychotic drugs, Mebir (Paliperidone Palmitate Injection), has obtained approval from the National Medical Products Administration of the People's Republic of China for use in the treatment of acute and maintenance phases of schizophrenia.

Schizophrenia is a chronic, highly recurrent, and highly disabling disease that affects approximately 24 million patients globally and around 8 million patients in China, accounting for one-third of the total number of patients worldwide. The recurrence of the disease due to patient treatment interruption or self-reduction of medication to the extent of developing treatment-resistant schizophrenia is a major challenge in the treatment of this disease. Long-acting injections for antipsychotic drugs can significantly improve patient compliance compared to oral formulations and are an important therapeutic strategy for preventing the recurrence of schizophrenia. Mebir is a long-acting injection of Paliperidone Palmitate given once a month, and its active ingredient Paliperidone is a first-line drug for the treatment of this disease, with a good effect on improving positive symptoms, negative symptoms, emotional symptoms, and cognitive function of schizophrenia.

Long-acting injections for antipsychotic drugs are an important treatment strategy for preventing the recurrence of schizophrenia compared to oral formulations. Mebir is a long-acting injection of Paliperidone Palmitate given once a month, and its active ingredient Paliperidone is a first-line drug for the treatment of this disease, with a good effect on improving positive symptoms, negative symptoms, emotional symptoms, and cognitive function of schizophrenia.

Under the huge demand of patients, Long-acting injections for antipsychotic drugs present a broad market space. According to IQVIA data, the global market size for long-acting antipsychotic injections is around $8 billion in 2023. Among them, the global sales of Paliperidone Palmitate long-acting injection are around $5 billion.

The central nervous system treatment field where schizophrenia is located is one of the core treatment fields in the group's global strategy. Around this treatment field, the group has formed a series of product combinations with differentiated advantages: Rykindo, approved in the US, is the first CNS drug developed by a Chinese pharmaceutical company that has received US approval; Ralotulin, a 1-class innovative drug approved in China for depression treatment, is the first self-developed innovative drug for this indication in China. In addition, CNS products such as Suricordine (Quetiapine Fumarate), its sustained-release tablets, and Risperidone Transdermal Patches (single-day and multi-day patches) are also sold in major markets in China and overseas.

In the pipeline, LY03003, a long-acting injectable sustained-release microsphere of rotigotine, is being simultaneously developed in the Chinese and overseas markets, with its NDA in China included in the priority review and approval process; there are also several new drugs in clinical development stages, such as VMAT2 inhibitors LY03015, etc. The group has established relatively advantageous international R&D, registration, clinical, supply chain, and commercial capabilities, laying a solid foundation for the global commercialization of new products in the future.