Guobang Pharmaceutical Group Co., Ltd. (hereinafter referred to as the "Company") announces that its wholly-owned subsidiary, Zhejiang Guobang Pharmaceutical Co., Ltd. (hereinafter referred to as "Zhejiang Guobang"), received the Approval Notice for the Marketing Application of Blonanserin Active Pharmaceutical Ingredient (API) issued upon official approval by the National Medical Products Administration (NMPA) on March 22, 2024.
Relevant details are hereby announced as follows:
I. Basic Information of the Drug
Notice No.: 2024YS00232
Acceptance No.: CYHS2260366
Name of Active Pharmaceutical Ingredient (API): Blonanserin
Registration Standard No. of API: YBY62762024
Validity Period: 18 months
Packaging Specifications: 1 kg/drum, 5 kg/drum, 10 kg/drum
Application Item: Marketing application for domestically-manufactured chemical API
Approval Conclusion: In accordance with the Drug Administration Law of the People's Republic of China, upon review, this product complies with the relevant provisions governing the approval of generic drugs, and the production of this product is hereby approved. The quality standard, packaging labels and production process shall be implemented in accordance with the attached documents.
Manufacturer: Zhejiang Guobang Pharmaceutical Co., Ltd.
Manufacturing Address: No. 6 Weiwu Road, Shangyu Economic & Technological Development Zone, Hangzhou Bay, Zhejiang Province
Validity Period of the Approval Notice: Expiring on March 21, 2029
II. Other Relevant Information of the Drug
Blonanserin is a novel atypical antipsychotic drug, exerting antagonistic effects on both dopamine receptors and 5-hydroxytryptamine (5-HT) receptors. It is indicated for the treatment of schizophrenia. According to the inquiry, the major domestic manufacturers of Blonanserin API currently include Zhuhai Free Trade Zone Livzon Synthetic Pharmaceutical Co., Ltd. and Hebei Guolong Pharmaceutical Co., Ltd., among others. Data from PharmaCloud shows that the global consumption volume of Blonanserin API increased by 26.68% in 2021 and 17.23% in 2022.
