000513SZSE
🚨 Material Event

Notice on the Acceptance of the Application for Marketing Authorization of Lakanqita Monoclonal Antibody Injection

Livzon Pharmaceutical Group Inc.··2 pages

✨ AI Summary

Lijun Pharmaceutical Group Co., Ltd. announces that its subsidiary, Zhuhai Lijun Monoclonal Antibody Biotechnology Co., Ltd., has received acceptance from the National Medical Products Administration for the marketing authorization application of Lakanqita Monoclonal Antibody Injection. This product is intended for the treatment of ankylosing spondylitis, with a significant patient population in China. The application is based on a pivotal Phase III clinical trial demonstrating robust efficacy and safety.

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Full Translation

AI Translation· azure_openai

Lijun Pharmaceutical Group Co., Ltd. (hereinafter referred to as "the Company") and all members of the Board of Directors guarantee that the information disclosed is true, accurate, and complete, with no false records, misleading statements, or significant omissions.

Recently, Zhuhai Lijun Monoclonal Antibody Biotechnology Co., Ltd. (hereinafter referred to as "Lijun Monoclonal Antibody"), a subsidiary of the Company, received the "Acceptance Notice" (Acceptance No.: CXSS2600087) issued by the National Medical Products Administration (hereinafter referred to as "NMPA"). The application for the domestic production marketing authorization of "Lakanqita Monoclonal Antibody Injection" (hereinafter referred to as "the Product"), jointly developed by Lijun Monoclonal Antibody and Beijing Xinkanghe Biomedical Technology Co., Ltd. (hereinafter referred to as "Beijing Xinkanghe"), has been accepted by the NMPA. The relevant information is announced as follows:

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