Livzon Pharmaceutical Group Inc. (000513.SZ): Application for market approval of Lepikacumab injection received.
Lizhu Group (000513.SZ) announced that its controlling subsidiary, Lizhu Monoclonal Antibody Biotechnology Co., Ltd. in Zhuhai (hereinafter referred to as "Lizhu Monoclonal Antibody"), recently received the "Acceptance Notice" (Acceptance No.: CXSS2500144) issued by the National Medical Products Administration (hereinafter referred to as the "NMPA"). The application for the domestic production and marketing approval of the "Lai Kang Qita Monoclonal Antibody Injection" jointly developed by Lizhu Monoclonal Antibody and Beijing Xinkanghe Biomedical Technology Co., Ltd. has been accepted by the NMPA.
Livzon Pharmaceutical Group Inc. (000513.SZ) announced that its holding subsidiary, Zhuhai Livzon Monoclonal Antibody Biotechnology Co., Ltd. (hereinafter referred to as "Livzon Monoclonal Antibody"), has received the "Acceptance Notice" (Acceptance No.: CXSS2500144) issued by the National Medical Products Administration (hereinafter referred to as "NMPA") recently. The domestic production drug registration and listing application for "Lekang Qita Monoclonal Antibody Injection" jointly developed by Livzon Monoclonal Antibody and Beijing Xinkanghe Biopharmaceutical Technology Co., Ltd. has been accepted by the NMPA.
According to the NMPA and the Drug Evaluation Center website database, as of the disclosure date of this announcement, there are currently no approved products for psoriasis indication targeting the IL-17A/F dual targets in China. There are a total of 3 imported products and 2 domestic products approved for listing targeting the IL-17A and IL-17RA single targets in China.
According to IQVIA sampled statistical estimation data, the domestic terminal sales amount for drugs targeting IL-17A and IL-17RA single targets in 2024 is estimated to be RMB 2.833 billion.
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