Yifan Pharmaceutical: Announcement on Obtaining Drug Registration Certificate
Securities code: 002019 Securities abbreviation: Yifan Pharmaceutical Announcement number: 2026-004
Yifan Pharmaceutical Co., Ltd.
Announcement on Obtaining Drug Registration Certificate
The company and all members of the board of directors guarantee that the information disclosed is true, accurate and complete, and contains no false records, misleading statements or major omissions.
Hefei Yifan Biopharmaceutical Co., Ltd., a wholly-owned subsidiary of Yifan Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company"), received the "Drug Registration Certificate" for vitamin K injection approved and issued by the State Food and Drug Administration on January 5, 2026. The relevant information is now announced as follows:
1. Main information of drug registration certificate
Drug name: Vitamin K injection
Dosage form: injection
Application matters: Drug registration (domestic production)
Registration classification: Class 3 chemicals
Specification: 0.2ml:2mg
Drug acceptance number: CYHS2401631
Certificate number: 2025S04086
Drug approval number: National Drug Approval Number H20256509
Drug approval number is valid until December 29, 2030
Marketing authorization holder: Hefei Yifan Biopharmaceutical Co., Ltd.
Manufacturer: Hefei Yifan Biopharmaceutical Co., Ltd.
Approval conclusion: According to the "Drug Administration Law of the People's Republic of China" and relevant regulations, after review, this product meets the relevant requirements for drug registration, the registration is approved, and a drug registration certificate is issued.
2. Product Introduction
Vitamin K injection is suitable for the prevention and treatment of vitamin K deficiency bleeding in infants.
The company submitted a drug marketing authorization application to the Drug Evaluation Center of the State Drug Administration in early May 2024 and it was accepted that month. In January 2026, it received the "Drug Registration Certificate" for vitamin K injection. This vitamin K injection was approved for marketing under the chemical drug registration classification Category 3, which means that this product is deemed to have passed the quality and efficacy consistency evaluation of generic chemical drug injections (hereinafter referred to as the "consistency evaluation").
As of the disclosure date of this report, many companies in China have approved vitamin K₁ injection for marketing. Only two companies, including the company, are micellar preparations and are deemed to have passed the generic drug consistency evaluation. There are also many companies in the process of submitting generic drugs for production review.
According to data from Minai.com, domestic sales of vitamin K₁ injection in 2023 will be 593 million yuan. As of the disclosure date of this report, the company has invested approximately RMB 20.6604 million in the research and development of vitamin K injection.
3. Impact on the company and risk warning
The acquisition of the "Drug Registration Certificate" this time has enriched the company's children's drug product line, and will form a synergistic effect with the company's other children's drug products on sale in terms of sales and brand building, further improving the company's comprehensive competitiveness in the field of children's drugs, and its listing and sales will have a positive impact on the company's performance. The specific operating conditions of the above products are affected by national policies, market competition environment and other factors, and are uncertain. Investors are advised to make prudent decisions and pay attention to investment risks.
4. Reporting documents
"Drug Registration Certificate"
Announcement is hereby made.
Board of Directors of Yifan Pharmaceutical Co., Ltd.
January 7, 2026