Core Insights - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of Rivolumab tablets, a second-generation AR inhibitor, which is expected to enhance treatment for metastatic hormone-sensitive prostate cancer [1][2] - The company’s subsidiary, Chengdu Shengdi Pharmaceutical Co., has its HRS-5965 capsules listed for priority review, targeting adult patients with paroxysmal nocturnal hemoglobinuria (PNH) [1][2] Group 1: Rivolumab Tablets - Rivolumab tablets are a second-generation AR inhibitor with stronger AR suppression and no agonistic effects compared to first-generation inhibitors [1] - The global sales of similar products are projected to reach approximately $11.037 billion in 2024 [1] - Cumulative R&D investment for Rivolumab tablets has reached about 693 million yuan [1] Group 2: HRS-5965 Capsules - HRS-5965 capsules are a complement factor B inhibitor designed to treat PNH, a rare acquired hemolytic disease [2] - The global sales for HRS-5965 are estimated to be around $12.9 million in 2024 [2] - Cumulative R&D investment for HRS-5965 has reached approximately 210 million yuan [2] Group 3: Share Buyback Program - Heng Rui Medicine has repurchased 7.9188 million shares, accounting for 0.12% of the total share capital, with a total expenditure of 535 million yuan [2][3] - The buyback program was approved in August, with a maximum purchase price of 90.85 yuan per share and a total budget between 1 billion and 2 billion yuan [3] - The buyback period is set for 12 months from the board's approval date [3]

Core Insights - Chengdu Shengdi Pharmaceutical, a subsidiary of Heng Rui Medicine, has its HRS-5965 capsule proposed for inclusion in the priority review list by the National Medical Products Administration, with a public notice period of 7 days [1] Product Details - Indication: Treatment for adult patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who have not previously received complement inhibitors [2] - Reason for Priority Review: Classified as an innovative drug for rare diseases, meeting the criteria for urgently needed and scarce drugs [2] - Mechanism of Action: Complement factor B inhibitor, capable of inhibiting complement-mediated intravascular and extravascular hemolysis [2] Market Situation - Competitive Landscape: The only drug targeting the same mechanism is Novartis' Iptacopan capsule, which has been approved abroad [2] - Market Size: Novartis' product is projected to achieve global sales of approximately $129 million in 2024 [2] - R&D Investment: Cumulative R&D investment for this project is approximately 210 million yuan [2]