Recently, Jinyao Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company") has received the "Approval Notice for the Marketing Application of Chemical Active Pharmaceutical Ingredient (API)" for Formoterol Fumarate, which was verified and issued by the National Medical Products Administration (hereinafter referred to as the "NMPA"). Relevant information is hereby announced as follows:
I. Basic Information of the Drug
Chemical API Name: Formoterol Fumarate
Registration Number: Y20230000656
Acceptance Number: CYHS2360607
Registration Standard Number of Chemical API: YBY75362024
Manufacturer Name: Jinyao Pharmaceutical Co., Ltd.
Manufacturer Address: No. 19 Xinyao 9th Street, West District, Tianjin Development Zone
Packaging Specifications: 100g/bag, 50g/bag, 20g/bag, 10g/bag
Application Item: Marketing application for domestically produced chemical API
Approval Conclusion: After review, this product meets the relevant requirements for drug registration and is approved for registration.
II. Drug-Related Information
Formoterol Fumarate is a β2 receptor agonist. It has the effects of relaxing bronchial smooth muscle, relieving bronchial smooth muscle spasm and anti-allergic reaction, with a long duration of action and high selectivity for the respiratory tract. Currently, the marketed dosage forms mainly include tablets, inhalation solutions, dry powder inhalers, etc. Among them, Formoterol Fumarate Inhalation Solution has been marketed both domestically and internationally. It is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), mainly for chronic bronchitis and emphysema, and can produce a strong and long-lasting anti-asthmatic effect.
According to the expanded national hospital data from MiNet (including urban public hospitals, county-level public hospitals, urban community hospitals, and township health centers), the domestic sales of formoterol single-ingredient preparations in 2022 and 2023 were RMB 7.56 million and RMB 80.49 million respectively.
The Company submitted the registration application for Formoterol Fumarate API to the NMPA in July 2023 and obtained acceptance. In June 2024, the supplementary data were submitted in accordance with the notification requirements, and the "Approval Notice for the Marketing Application of Chemical Active Pharmaceutical Ingredient (API)" for Formoterol Fumarate verified and issued by the NMPA was recently received. The status of this API on the Auxiliary Materials, Excipients and Packaging Materials Registration Information Platform of the Center for Drug Evaluation (CDE) of the NMPA is "A" (raw materials approved for use in marketed preparations).
Up to now, the Company has accumulated an investment of approximately RMB 3.52 million in the R&D project of Formoterol Fumarate API.
