Core Viewpoint - The announcement indicates that the new drug application for Tienogratinib tablets has been accepted by the National Medical Products Administration of China, aimed at treating adult patients with advanced, metastatic, or unresectable cholangiocarcinoma who have previously received at least one systemic therapy and FGFR inhibitor treatment [1] Group 1 - The drug Tienogratinib is intended for patients with advanced cholangiocarcinoma [1] - The application has been prioritized and included in the breakthrough therapy list [1]

Group 1 - The National Medical Products Administration (NMPA) has announced a reward system for internal whistleblowers reporting major violations in drug and medical device quality safety, reflecting a commitment to strengthen regulatory oversight in the industry [1] - The introduction of an internal whistleblower incentive mechanism is expected to enhance compliance management among pharmaceutical and medical device manufacturers, promoting long-term healthy development in the industry [1] Group 2 - Sanofi's new drug application for a recombinant anti-IL-1β humanized monoclonal antibody injection for acute gouty arthritis has been accepted by the NMPA, following successful Phase III clinical trials [2] - With over 80 million gout patients in China and a rapid annual growth rate of 9.7%, the market potential for this treatment is significant, and targeting IL-1β is a valuable therapeutic option [2] - The differentiated binding site of the new drug compared to existing products may provide a competitive edge, although its clinical efficacy needs to translate into market competitiveness [2] Group 3 - Zai Lab has signed an exclusive marketing service agreement with Merck's Swiss subsidiary for a recombinant human thyroid-stimulating hormone injection, with a potential maximum authorization fee of RMB 250 million [3] - The agreement includes an initial payment of RMB 50 million and a subsequent payment of RMB 200 million upon approval of the first indication for the product, which is currently in the registration phase [3] - The introduction of this product is expected to fill a gap in the market for post-operative diagnosis of thyroid cancer, leveraging the synergy with Merck's other recommended thyroid medications [3] Group 4 - Maipu Medical has announced plans to acquire 100% equity of Yijie Medical through a combination of share issuance and cash payment, aiming to expand its product offerings into the interventional field [4] - The acquisition is expected to enhance the company's competitive advantage in the research and development of interventional biomaterials and improve marketing efficiency in neurology departments [4] - The company's stock will resume trading on June 6 following the announcement of this acquisition [4]