Announcement from Zhejiang Huahai Pharmaceutical Co., Ltd. on obtaining a drug registration certificate
Stock abbreviation: Huahai Pharmaceutical Stock code: 600521 Announcement number: Lin 2026-023 Bond abbreviation: Huahai convertible bonds Bond code: 110076
Zhejiang Huahai Pharmaceutical Co., Ltd.
Announcement on Obtaining Drug Registration Certificate
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.
Zhejiang Huahai Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company") recently received the "Drug Registration Certificate" for mesalazine enteric-coated tablets approved and issued by the State Food and Drug Administration (hereinafter referred to as the "NMPA"). The relevant information is now announced as follows:
1. Basic information about drugs
Drug name: mesalazine enteric-coated tablets
Dosage form: tablet
Specifications: 0.5g
Application matters: Drug registration (domestic production)
Registration classification: Chemicals Class 4
Applicant: Zhejiang Huahai Pharmaceutical Co., Ltd.
Drug approval number: National Drug Approval Number H20263759
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. Other related information about drugs
Mesalazine enteric-coated tablets are used for: 1. Treatment of ulcerative colitis, including treatment of acute attacks and maintenance treatment to prevent recurrence; 2. Treatment of acute attacks of Crohn's disease. Mesalazine enteric-coated tablets were first developed by Dr. Falk Pharma GmbH and were launched in Switzerland in December 1984. In China, they were approved for import in 2003. At present, the main domestic manufacturers that have obtained the drug registration certificate include Heilongjiang Tianhong Pharmaceutical Co., Ltd., Hengcheng Pharmaceutical Group Huainan Co., Ltd., etc. According to forecasts from Minai.com, the domestic market sales of mesalazine enteric-coated tablets in 2025 will be approximately RMB 787 million.
Up to now, the company has invested approximately RMB 12.43 million in research and development expenses on the research and development project of mesalazine enteric-coated tablets.
3. Impact on the company
According to relevant national policies, the company's mesalazine enteric-coated tablets approved for production under Category 4 chemical drugs can be regarded as passing the consistency evaluation. The approval of this product further enriches the company's product line and helps enhance the market competitiveness of the company's products.
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. Investors are advised to make prudent decisions and pay attention to preventing investment risks.
Announcement is hereby made.
Board of Directors of Zhejiang Huahai Pharmaceutical Co., Ltd.
April 3, 2026