深圳市卫光生物制品股份有限公司关于收到药品注册临床试验受理通知书的公告

Group 1 - The company, Shenzhen Weiguang Biological Products Co., Ltd., has received a clinical trial acceptance notice for subcutaneous immunoglobulin from the National Medical Products Administration [1][2] - The drug is classified as a Class 3.2 therapeutic biological product, with a specification of 2g/bottle (20%, 10ml), aimed at treating primary immunodeficiency diseases (PID) [1][3] - Currently, there are no approved subcutaneous immunoglobulin products in the domestic market, while several have been approved overseas, including CSL Behring's HIZENTRA, Takeda's CUVITRU, and Grifols' XEMBIFY [1][4] Group 2 - The company will actively promote the subsequent progress of the clinical trial and fulfill its information disclosure obligations in a timely manner [1][5] - The approval timeline and outcome for the clinical trial remain uncertain, and the company advises investors to make cautious decisions [1][5]