Group 1 - Health元药业's subsidiary, Zhuhai Lizhu Monoclonal Antibody Biotechnology Co., Ltd., has received priority review status for its drug, Laikangqita Monoclonal Antibody Injection, which is intended for adult patients with moderate to severe plaque psoriasis [1][2] - The drug is the first domestically developed and the second globally IL-17A/F dual-target inhibitor, showing superior efficacy in clinical trials compared to the control group [3] - The drug's application for marketing authorization was accepted in December 2025, indicating progress towards potential market entry [4] Group 2 - The priority review was granted based on compliance with the relevant regulations and guidelines set by the National Medical Products Administration [2] - Clinical trials demonstrated that Laikangqita Injection achieved primary and secondary efficacy endpoints, with faster onset and better long-term efficacy compared to the control [3] - The safety profile of the drug was comparable to that of the control group, indicating a favorable risk-benefit ratio [3] Group 3 - Health元药业 has announced a change in the audit project partner for its 2025 financial report, appointing Tang Hanlin as the new project partner due to the previous partner's work adjustment [8][9] - The change in audit personnel is not expected to impact the financial reporting and internal control audit for 2025 [12] Group 4 - In December 2025, Health元药业 provided a guarantee of RMB 120 million for its subsidiary, Lizhu Pharmaceutical Group, to support its operational needs [15] - The company has a total guarantee balance of RMB 2,111.52 million as of December 31, 2025, with no overdue guarantees reported [19][20]
健康元药业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