Peking University Medicine: Announcement on Obtaining the "Drug Registration Certificate"
Securities code: 000788 Securities abbreviation: Peking University Medicine Announcement number: 2026-035
Peking University Pharmaceutical Co., Ltd.
Announcement on Obtaining the "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.
Recently, Peking University Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company") received the "Drug Registration Certificate" approved and issued by the State Food and Drug Administration. The relevant information is now announced as follows:
1. Basic information on drugs
- Generic name of the drug: paliperidone extended-release tablets
English name/Latin name: Paliperidone Extended-Release Tablets Dosage form: Tablets
Specifications: 3mg
Registration classification: Chemicals Class 4
Drug approval number: National Drug Approval Number H20264823
Marketing authorization holder: Peking University Pharmaceutical Co., Ltd.
Pharmaceutical manufacturer: Peking University Pharmaceutical Co., Ltd.
Main conclusion of the review and approval: 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.
- Generic name of the drug: paliperidone extended-release tablets
English name/Latin name: Paliperidone Extended-Release Tablets Dosage form: Tablets
Specifications: 6mg
Registration classification: Chemicals Class 4
Drug approval number: National Drug Approval Number H20264822
Marketing authorization holder: Peking University Pharmaceutical Co., Ltd.
Pharmaceutical manufacturer: Peking University Pharmaceutical Co., Ltd.
Main conclusion of the review and approval: 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
Paliperidone is the main active metabolite of risperidone and a second-generation antipsychotic drug with strong control effect, high affinity, tolerance and efficacy. It is mainly suitable for the treatment of schizophrenia in adults and adolescents aged 12-17 years old (weight ≥ 29Kg).
3. Impact on the company
The approval of paliperidone extended-release tablets further enriches the company's existing product layout, is conducive to enhancing the company's competitiveness in the mental product market, and has a positive effect on improving the company's future performance.
4. Risk warning
Affected by uncertain factors such as changes in the market environment, the production and operation of the company's drugs may have certain uncertainties. Investors are advised to make prudent decisions and pay attention to investment risks.
5. Documents for reference
"Drug Registration Certificate"
Announcement is hereby made.
Board of Directors of Peking University Pharmaceutical Co., Ltd.
June 24, 2026