LUYE PHARMA's innovative formulation ERZOFRI®, independently developed, has been approved by the FDA for the treatment of schizophrenia and schizoaffective disorder
LUYE PHARMA's self-developed innovative formulation ERZOFRI® has been approved by the FDA for the treatment of schizophrenia and schizoaffective disorder. This is the first long-acting injection of paliperidone palmitate developed by a Chinese company, administered once a month. The product is expected to provide patients with a new treatment option
According to the news from Zhitong Finance and Economics APP, LUYE PHARMA (02186) announced that its independently developed innovative formulation ERZOFRI® (Paliperidone Palmitate Extended-Release Suspension for Injection, also known as LY03010) has been approved by the U.S. Food and Drug Administration (FDA) for marketing. It is used for the treatment of adult patients with schizophrenia, as well as as monotherapy or adjunctive therapy for mood stabilizers or antidepressants in the treatment of adult patients with schizoaffective disorder.
ERZOFRI® is the first paliperidone palmitate long-acting injection with independent intellectual property rights developed by a Chinese company to be approved in the United States, with a once-monthly dosing regimen. The product was granted a U.S. invention patent in 2023 (U.S. Patent No.: 11,666,573), which will expire in 2039. ERZOFRI® obtained new drug approval in the U.S. through the 505(b)(2) pathway.
Public information indicates that the sales of existing paliperidone palmitate long-acting injections in the U.S. market in 2023 amounted to $2.897 billion. ERZOFRI® is expected to provide new treatment options for patients upon its market launch
