Group 1: Product Announcement - The product "Lai Kang Qi Ta" monoclonal antibody injection has been included in the priority review list by the National Medical Products Administration (NMPA) as of December 26, 2025, following its application on December 18, 2025 [1][2] - This drug is intended for adult patients with moderate to severe plaque psoriasis who are suitable for systemic therapy or phototherapy [1] Group 2: Clinical Trial Results - The drug is the first domestically developed and the second globally in progress IL-17A/F dual-target inhibitor, showing superior efficacy in clinical trials compared to the control group [3] - Key efficacy endpoints were met in a clinical trial, demonstrating faster onset and better short-term and long-term efficacy, with a comparable safety profile to the control group [3] Group 3: Financial Guarantees - The company has approved a maximum guarantee of RMB 14.15 billion for its subsidiaries to secure financing from banks [7] - A guarantee agreement was signed with Zhuhai China Resources Bank, providing a maximum guarantee of RMB 12 million for a specific loan [8] Group 4: Guarantee Overview - As of December 31, 2025, the total amount of guarantees provided by the company is RMB 1,325.83 million, with an external guarantee balance of RMB 162.15 million, representing 11.70% of the company's latest audited net assets [10]
丽珠医药集团股份有限公司关于莱康奇塔单抗注射液被纳入优先审评审批程序的公告