300683SZSE
🚨 Material Event

Announcement on the Acceptance of the Clinical Trial Application for Recombinant Human Tumor Necrosis Factor Receptor Superfamily Member 10a Fusion Protein for Injection

Haitai Biotechnology Co., Ltd.··2 pages

✨ AI Summary

Wuhan Hite Bio-pharmaceutical announced that its application for a clinical trial of its self-developed drug, recombinant human tumor necrosis factor receptor superfamily member 10a fusion protein for injection, for unresectable or metastatic classic chondrosarcoma has been accepted by the NMPA. This drug is a first-in-class biologic targeting DR4/DR5.

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Stock Code: 300683

Stock Abbreviation: Hite Bio-pharmaceutical

Announcement No.: 2026-033

Wuhan Hite Bio-pharmaceutical Co., Ltd.

Announcement on the Acceptance of the Clinical Trial Application for Recombinant Human Tumor Necrosis Factor Receptor Superfamily Member 10a Fusion Protein for Injection

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

Wuhan Hite Bio-pharmaceutical Co., Ltd. (hereinafter referred to as the "Company") recently received the "Acceptance Notice" issued by the National Medical Products Administration (hereinafter referred to as the "NMPA"). The Company's application for a clinical trial of recombinant human tumor necrosis factor receptor superfamily member 10a fusion protein for injection (Product Name: Shaait) for the indication of unresectable or metastatic classic chondrosarcoma has been accepted. The relevant information is hereby announced as follows:

I. Basic Information of the Clinical Trial Application

Product Name: Recombinant Human Tumor Necrosis Factor Receptor Superfamily Member 10a Fusion Protein for Injection

Application Matter: Domestic Production Drug Registration Clinical Trial

Acceptance Number: CXSL2600766

Indication: Unresectable or metastatic classic chondrosarcoma

Applicant: Wuhan Hite Bio-pharmaceutical Co., Ltd.

Conclusion: In accordance with the provisions of Article 32 of the "Administrative Licensing L

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