Group 1 - The core announcement is about the acceptance of the marketing authorization application for "Lai Kang Qi Ta" monoclonal antibody injection by the National Medical Products Administration [1][2] - The drug is a first-in-class, self-developed innovative IL-17A/F dual-target inhibitor for moderate to severe plaque psoriasis in adults [3][4] - The clinical trials showed that the drug achieved superior efficacy compared to the control group, with faster onset and better long-term effects [3] Group 2 - The total research and development expenses incurred for the drug amount to approximately RMB 204.03 million [5] - Currently, there are no approved products for psoriasis indications targeting IL-17A/F dual targets in China, while there are five products targeting IL-17A and IL-17RA [7] - The estimated domestic terminal sales for IL-17A and IL-17RA single-target drugs in 2024 is RMB 2.833 billion [7] Group 3 - The company has completed a share repurchase program, acquiring 16,193,259 A-shares, which is 1.79% of the total share capital [9][10] - The repurchase was conducted at a total cost of approximately RMB 600.22 million, with a maximum price of RMB 41.99 per share and a minimum price of RMB 33.21 per share [9][10] - All repurchased shares will be canceled, leading to a reduction in registered capital [11][13]
丽珠医药集团股份有限公司关于莱康奇塔单抗注射液上市许可申请获受理的提示性公告