000661SZSE
🚨 Material Event

Announcement on Approval of GenSci164 Injection Domestic Production Drug Registration Clinical Trial Application by Subsidiary

✨ AI Summary

Changchun High-Tech Industries (Group) Inc. announces that its subsidiary, Jilin Changchun GeneScience Pharmaceutical Co., Ltd., has received approval from the NMPA for the domestic production drug registration clinical trial application of GenSci164 Injection. The drug is intended for the treatment of hypoparathyroidism. This approval marks a significant step in the development of a novel long-acting PTH analog.

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Full Translation

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Stock Code: 000661

Stock Abbreviation: Changchun High-Tech

Announcement No.: 2026-054

Changchun High-Tech Industries (Group) Co., Ltd.

Announcement on Approval of GenSci164 Injection Domestic Production Drug Registration Clinical Trial Application by Subsidiary

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, Changchun High-Tech Industries (Group) Co., Ltd. (hereinafter referred to as the "Company") and its subsidiary, Jilin Changchun GeneScience Pharmaceutical Co., Ltd. (hereinafter referred to as "GeneScience Pharmaceutical"), received a "Notice of Approval for Drug Clinical Trial" issued by the National Medical Products Administration. The clinical trial application for the domestic production drug registration of GeneScience Pharmaceutical's GenSci164 Injection has been approved. The relevant matters are hereby announced as follows:

I. Basic Information of the Drug

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