Hengrui Pharma(SH:600276) Zhong Guo Zheng Quan Bao - Zhong Zheng Wang·2026-01-09 23:14Group 1 - The core announcement is that Jiangsu Hengrui Medicine Co., Ltd. has received acceptance for the drug listing application of HRS-5965 capsules from the National Medical Products Administration (NMPA) [1] - The drug HRS-5965 is intended for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have not previously received complement inhibitor therapy [1][2] - The clinical trial for HRS-5965 demonstrated significant improvements in hemoglobin levels, reduced need for blood transfusions, and enhanced quality of life compared to the existing treatment, eculizumab [2] Group 2 - PNH is a rare acquired hemolytic disease characterized by the deficiency of CD55 and CD59, leading to complement-mediated intravascular hemolysis [3] - HRS-5965 is a complement factor B inhibitor that aims to improve hemoglobin levels in PNH patients [3] - Currently, the only approved drug for this indication is Novartis's eculizumab, which is projected to have global sales of approximately $129 million in 2024 [3] Group 3 - The company has also received clinical trial approval for several other drugs, including SHR-4394 for prostate cancer, HRS-5041 for prostate cancer, and Zemeituzumab for peripheral T-cell lymphoma [9][10][11] - SHR-4394 has a cumulative R&D investment of approximately 38.4 million yuan, while HRS-5041 has an investment of about 92.66 million yuan [9][10] - Zemeituzumab was approved in 2025 and has a cumulative R&D investment of around 216.82 million yuan, with a projected global sales of approximately $51 million in 2024 [10]