Jianyou Co., Ltd.’s announcement that the company’s product Propofol Emulsion Injection has been approved by the U.S. FDA
Securities code: 603707 Securities abbreviation: Jianyou Shares Announcement number: 2025-089 Bond code: 113579 Bond abbreviation: Jianyou Convertible Bonds
Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd.
About the product Propofol Emulsion Injection obtained US FDA
Announcement of approval
The company's board of directors and all directors guarantee that the contents of this announcement do not contain any false records, misleading statements or major omissions, and bear individual and joint liability for the authenticity, accuracy and completeness of its contents.
Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd. (hereinafter referred to as "Jianyou" or the "Company") recently received the ANDA approval notice (ANDA) for propofol emulsion injection, 200 mg/20 mL (10 mg/mL), 500 mg/50 mL (10 mg/mL), 1,000 mg/100 mL (10 mg/mL) issued by the United States Food and Drug Administration (hereinafter referred to as the "U.S. FDA") No.: 217945). The relevant information is now announced as follows:
1. Basic information about drugs
(1) Drug name: Propofol emulsion injection
(2) Indications: General anesthesia and sedation
(3) Dosage form: injection
(4) Specifications: 200 mg/20 mL (10 mg/mL), 500 mg/50 mL (10 mg/mL), 1,000 mg/100 mL (10 mg/mL)
(5) ANDA number: 217945
(6) Applicant: Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd.
2. Other related information about drugs
The company received notification from the U.S. FDA on December 2, 2025 that the ANDA applications submitted by the company to the U.S. FDA for propofol emulsion injection, 200 mg/20 mL (10 mg/mL), 500 mg/50 mL (10 mg/mL), and 1,000 mg/100 mL (10 mg/mL) were approved.
The reference preparations of Propofol Emulsion Injection, 200 mg/20 mL (10 mg/mL), 500 mg/50 mL (10 mg/mL), and 1,000 mg/100 mL (10 mg/mL) are owned by FRESENIUS KABI USALC and were approved for marketing by the US FDA on June 11, 1996, under the trade name DIPRIVAN.
After inquiries, there are currently 8 other generic propofol emulsion injection manufacturers in the United States (HOSPIRA INC, HIKMA PHARMACEUTICALS USA INC, SAGENT PHARMACEUTICALS INC and other 8 manufacturers) approved for marketing.
Up to now, the company has invested approximately RMB 73.6637 million in research and development expenses on the propofol emulsion injection project.
3. Impact on the company
The newly approved products will be available for sale in the United States in the near future, which is expected to have a positive impact on the company's operating performance.
4. Risk warning
The company attaches great importance to drug research and development and strictly controls the quality and safety of drug research and development, production and sales. However, the production and sales of products are easily affected by uncertain factors such as national policies and market environment, and sales may not meet expectations. Investors are kindly requested to make prudent decisions and pay attention to preventing investment risks.
Announcement is hereby made.
Board of Directors of Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd.
December 04, 2025