002653SZSE
🚨 Material Event

Announcement on the Approval and Listing of the Innovative Drug Compound Bosutinib Tablets

✨ AI Summary

Hansoh Pharmaceutical Group Company announces the approval and listing of its innovative drug Compound Bosutinib Tablets by the National Medical Products Administration. This oral small molecule inhibitor targets complement factor B (CFB) and is indicated for treating paroxysmal nocturnal hemoglobinuria (PNH) in adult patients. The drug offers advantages over existing treatments, with further clinical trials underway for other complement-mediated diseases.

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Securities Code: 002653

Securities Abbreviation: Hansoh Pharma

Announcement No.: 2026-080

Hansoh Pharmaceutical Group Co., Ltd.

Announcement on the Approval and Listing of the Innovative Drug Compound Bosutinib Tablets

The Company and all members of the Board of Directors guarantee the truthfulness, accuracy, and completeness of the information disclosed, and that there are no false records, misleading statements, or material omissions.

Hansoh Pharmaceutical Group Co., Ltd. (hereinafter referred to as the "Company") learned through an inquiry on the official website of the National Medical Products Administration (hereinafter referred to as the "NMPA") on July 23, 2026, that the NMPA has approved the listing of the Class 1 innovative drug Compound Bosutinib Tablets applied for by the Company. The relevant situation is hereby announced as follows:

I. Basic Information on the Drug and Application

Drug Name: Compound Bosutinib Tablets

Acceptance Number: CXHS2600002

Application Matter: Drug Registration (Domestic Production)

Registration Category: Class 1 Chemical Drug

Dosage Form: Tablets

Specification: 100mg (calculated as C26H27D3N2O3)

Indication: This product is indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have not previously received complement inhibitor therapy.

II. Introduction to the R&D Project

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