300357SZSE
🚨 Material Event

Announcement on Receiving Acceptance Notice for Cat Dander Allergen Oral Lyophilized Powder Clinical Trial Application

✨ AI Summary

Zhejiang I-Mab Biopharma Co., Ltd. has received an acceptance notice from the National Medical Products Administration for its cat dander allergen oral lyophilized powder clinical trial application. This product aims to treat allergic rhinitis related to cat dander. The company expects this to complement its existing desensitization products, enhancing its market position. The next steps involve technical review and clinical trials, with uncertain outcomes.

Summary generated by AI · Always verify with source document

Full Translation

AI Translation· gemini_document

Securities Code: 300357

Securities Abbreviation: I-Mab Biopharma

Announcement No.: 2026-02

Zhejiang I-Mab Biopharma Co., Ltd.

Announcement on Receiving Acceptance Notice for Cat Dander Allergen Oral Lyophilized Powder Clinical Trial Application

The Company and all members of the Board of Directors guarantee the content of the information disclosure is true, accurate, and complete, and that there are no false records, misleading statements, or major omissions.

Recently, Zhejiang I-Mab Biopharma Co., Ltd. (hereinafter referred to as the "Company") received an "Acceptance Notice" issued by the National Medical Products Administration. The clinical trial application for "Cat Dander Allergen Oral Lyophilized Powder" (hereinafter referred to as "this product") submitted by the Company has been formally accepted. The relevant content is hereby announced as follows:

I. Basic Information

Product Name: Cat Dander Allergen Oral Lyophilized Powder

Registration Category: Class 1 therapeutic biological product

Application Matter: Clinical trial for domestic production drug registration

Dosage Form: Lyophilized powder

Indication: As a specific immunotherapy, for adult patients with allergic rhinitis (with or without allergic conjunctivitis, allergic asthma) related to cat dander sensitization.

Drug Registration Applicant: Zhejiang I-Mab Biopharma Co., Ltd.

Sign in to read the full translation

Free accounts get 10 full releases per month. Pro subscribers get unlimited access.