江苏恒瑞医药股份有限公司关于药物拟纳入优先审评程序的公告

Group 1 - Jiangsu Hengrui Medicine Co., Ltd. announced that its subsidiary Chengdu Shengdi Pharmaceutical Co., Ltd.'s HRS-5965 capsules have been proposed for inclusion in the priority review list by the National Medical Products Administration (NMPA) [1][2] - HRS-5965 capsules are intended for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have not previously received complement inhibitor therapy [1][2] - PNH is a rare acquired hemolytic disease characterized by the lack of CD55 and CD59, leading to complement-mediated intravascular hemolysis, and has been included in the national rare disease directory [2] Group 2 - The company has received approval from the NMPA for the clinical trial of Ruvelimab tablets, which are second-generation androgen receptor (AR) inhibitors, with a stronger AR inhibition effect compared to first-generation inhibitors [7][8] - Ruvelimab tablets were approved for the treatment of high-burden metastatic hormone-sensitive prostate cancer (mHSPC) in 2022, and similar products are projected to have a combined global sales of approximately $11.037 billion in 2024 [8] - The company has invested approximately 693.09 million yuan in the development of Ruvelimab tablets [8] Group 3 - The company has initiated a share repurchase program, with a total repurchase amount between 1 billion and 2 billion yuan, at a maximum price of 90.85 yuan per share [11][12] - As of October 31, 2025, the company has repurchased a total of 7.9188 million shares, accounting for 0.12% of the total share capital, with a total expenditure of approximately 535.43 million yuan [13] - The repurchase is in accordance with relevant laws and regulations and the company's established repurchase plan [14]