Lisheng Pharmaceutical: Announcement from Tianjin Lisheng Pharmaceutical Co., Ltd. on the approval of the marketing authorization application for its subsidiary Central Pharmaceutical’s drug Apremilast Tablets
Securities code: 002393 Securities abbreviation: Lisheng Pharmaceutical Announcement number: 2025-084
Tianjin Lisheng Pharmaceutical Co., Ltd.
About the subsidiary Central Pharmaceutical Pharmaceuticals Apremilast Tablets
Announcement of application for marketing authorization
The company and all members of the board of directors guarantee that the information disclosed is true, accurate and complete, and there are no false records, misleading statements or major omissions.
1. Overview
Recently, Tianjin Central Pharmaceutical Co., Ltd. (hereinafter referred to as "Central Pharmaceutical"), a subsidiary of Tianjin Lisheng Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company" or the "Company"), received the "Drug Registration Certificate" (approval number: 20) issued by the State Food and Drug Administration for the 10 mg specification of apremilast tablets. 25S03538); the "Drug Registration Certificate" for 20 mg apremilast tablets (approval number: 2025S03539); the "Drug Registration Certificate" for 30 mg apremilast tablets (approval number: 2025S03540). The above-mentioned drugs have passed the drug marketing authorization application.
2. Basic information about the drug
Drug name Apremilast tablets
Dosage form tablet
Specifications 10mg 20mg 30mg Registration Classification Chemical Drug Class 4
Pharmaceutical manufacturer Tianjin Central Pharmaceutical Co., Ltd.
Original drug approval number None
Application content Marketing authorization application
Acceptance number CYHS2401628 CYHS2401629 CYHS2401630 Approval conclusion Approval of marketing authorization application
3. Relevant information about the drug
Apremilast tablets are indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are eligible for phototherapy or systemic therapy.
4. Impact on the Company and Risk Warning
Central Pharmaceutical's drug application for marketing authorization will further enrich the company's psoriasis drug product line and improve the company's market competitiveness. According to relevant national policies, the company's product Apremilast tablets are approved for production as Class 4 chemicals and can be regarded as passing the consistency evaluation. This will help expand the market sales of the company's products and have a positive impact on the company's future operating performance. Due to the industry characteristics of pharmaceutical products, the specific sales of various products/drugs may be affected by changes in the market environment and other factors, and are highly uncertain. Investors are advised to pay attention to investment risks.
Announcement is hereby made.
Tianjin Lisheng Pharmaceutical Co., Ltd.
board of directors
December 13, 2025