Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for the clinical trial of Ruvelimab tablets, which will soon commence phase III trials for prostate cancer treatment [1] Group 1: Clinical Trial Approval - The National Medical Products Administration approved the clinical trial application for Ruvelimab tablets on August 26, 2025, allowing the company to conduct phase III clinical trials for prostate cancer [1] - Ruvelimab tablets are classified as a second-generation AR inhibitor, offering stronger AR inhibition without androgenic effects compared to first-generation inhibitors [1] Group 2: Market Context - Ruvelimab tablets were approved for market release in 2022 for treating high tumor burden metastatic hormone-sensitive prostate cancer (mHSPC) patients [1] - Competing second-generation AR inhibitors currently available in the market include Enzalutamide, Apalutamide, and Darolutamide [1] - According to EvaluatePharma, the global sales of similar products are projected to reach approximately $11.037 billion in 2024 [1] Group 3: Research Investment - The total research and development investment for Ruvelimab tablets has reached approximately 693.09 million yuan [1]

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 Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of Rivoceranib tablets, a second-generation AR inhibitor, which is expected to enhance its market position in the treatment of metastatic hormone-sensitive prostate cancer [1] Group 1: Product Development - Rivoceranib tablets are a second-generation AR inhibitor that offers stronger AR inhibition without agonistic effects compared to first-generation inhibitors [1] - The product was approved for market launch in 2022 for treating patients with high tumor burden metastatic hormone-sensitive prostate cancer (mHSPC) [1] Group 2: Market Context - Rivoceranib tablets are entering a competitive market with other second-generation AR inhibitors such as Enzalutamide, Apalutamide, and Darolutamide already available [1] - According to EvaluatePharma, the global sales for similar products are projected to reach approximately $11.037 billion in 2024 [1] Group 3: Investment and R&D - The cumulative R&D investment for Rivoceranib tablets has reached approximately 693.09 million yuan [1]

Core Viewpoint - 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 its market position in the treatment of metastatic hormone-sensitive prostate cancer [1] Company Summary - Rivolumab tablets are a second-generation AR inhibitor that offers stronger AR inhibition without agonistic effects compared to first-generation inhibitors [1] - The product was approved for market launch in 2022 for treating patients with high tumor burden metastatic hormone-sensitive prostate cancer (mHSPC) [1] - Cumulative R&D investment in Rivolumab tablets has reached approximately 693 million yuan [1] Industry Summary - The global sales of similar second-generation AR inhibitors, including Enzalutamide, Apalutamide, and Darolutamide, are projected to total approximately 11.037 billion USD in 2024 [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of its drug, Ruvelimab tablets, in combination with HS-20093 for prostate cancer treatment [2] Group 1: Company Developments - Heng Rui Medicine announced the approval of clinical trials for Ruvelimab tablets, a second-generation AR inhibitor, which has a stronger AR inhibition effect compared to first-generation AR inhibitors and does not have agonistic effects [2] - Ruvelimab tablets were approved for market launch in 2022 for the treatment of high tumor burden metastatic hormone-sensitive prostate cancer (mHSPC) patients [2] Group 2: Industry Context - The market currently has several second-generation AR inhibitors available, including Enzalutamide, Apalutamide, and Darolutamide [2]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for the clinical trial of Rivolumab tablets, a second-generation AR inhibitor, which will be conducted shortly [1] Group 1: Product Development - Rivolumab tablets exhibit stronger AR inhibition compared to first-generation AR inhibitors and do not have agonistic effects [1] - The product was approved for market launch in 2022 for treating high tumor burden metastatic hormone-sensitive prostate cancer (mHSPC) patients [1] Group 2: Market Context - Competing second-generation AR inhibitors such as Enzalutamide, Apalutamide, and Darolutamide are already available in the market [1] - According to EvaluatePharma, the total global sales of similar products are projected to reach approximately $11.037 billion in 2024 [1] Group 3: Investment and R&D - The cumulative R&D investment related to Rivolumab tablets has reached approximately 693 million yuan [1]