消息面上，和誉公布，其附属和誉医药在结缔组织肿瘤学会(CTOS)2025年会上以壁报形式，展示匹米 替尼(pimicotinib/ABSK021)治疗腱鞘巨细胞瘤(TGCT)患者的全球III期MANEUVER研究的长期疗效、安 全性及患者报告结果数据。 和誉-B(02256)尾盘涨超4%，截至发稿，涨3.9%，报14.13港元，成交额4541万港元。 该长期分析显示，持续接受匹米替尼治疗可为TGCT患者在肿瘤缓解方面带来疗效持续提升与患者报告 结果(包括疼痛与功能)的进一步改善，同时维持可接受的安全性，强化匹米替尼在适合患者中的长期应 用潜力。 ...

Core Insights - Inhibrx Biosciences, Inc. announced positive primary results from the ChonDRAgon clinical trial (n=206) evaluating ozekibart (INBRX-109) in patients with advanced or metastatic, unresectable chondrosarcoma compared to placebo [1] - Based on these results, Inhibrx plans to submit a marketing application for ozekibart for chondrosarcoma to U.S. regulatory authorities by the end of June 2026 [1] - Ozekibart is the first investigational drug to significantly improve progression-free survival (PFS) in chondrosarcoma patients in a randomized controlled trial, addressing a significant unmet medical need [1] Company Developments - The company holds exclusive development and commercialization rights for ozekibart in mainland China, Hong Kong, Macau, and Taiwan through a licensing agreement with its wholly-owned subsidiary, HJB [1] - Inhibrx is also advancing an expanded cohort for ozekibart, assessing its combination with irinotecan for the treatment of Ewing sarcoma and colorectal cancer, with early results showing promising signals [2]

Group 1 - The core point of the news is that Inhibrx Biosciences, Inc. has reported positive primary results from the ChonDRAgon clinical study, which evaluated the efficacy of ozekibart (INBRX-109) in patients with advanced or metastatic, unresectable chondrosarcoma compared to a placebo [1] - Based on the positive results, Inhibrx plans to submit a marketing application for ozekibart for chondrosarcoma to U.S. regulatory authorities by the end of June 2026 [1] - Ozekibart is the first investigational drug to significantly improve progression-free survival (PFS) in chondrosarcoma patients in a randomized controlled trial, addressing a significant unmet medical need as there are currently no approved systemic treatment options for this disease [1] Group 2 - In addition to the registration clinical trial, Inhibrx is advancing an expanded cohort to evaluate ozekibart in combination with irinotecan for the treatment of Ewing sarcoma and colorectal cancer [2] - Early results from this expanded cohort show encouraging signals, supporting further exploration of ozekibart's potential in these difficult-to-treat tumors with unmet medical needs [2]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of four injectable drugs, indicating a significant advancement in its oncology pipeline [1][2]. Group 1: Drug Approvals and Clinical Trials - The company’s subsidiaries have been granted approval for clinical trials of SHR-7787, SHR-4849, Bevacizumab, and Adebali monoclonal antibody injections [1]. - SHR-7787 is a first-class therapeutic biological product aimed at activating T cells to target and kill tumor cells, with a cumulative R&D investment of approximately 48.93 million yuan [1]. - SHR-4849 is an antibody-drug conjugate targeting DLL3, designed to treat advanced malignant solid tumors, with a cumulative R&D investment of about 69.67 million yuan [1]. Group 2: Market Context and Competitors - Bevacizumab, a humanized anti-VEGF monoclonal antibody, has a global sales forecast of approximately 5.655 billion USD for 2024, with the company’s related R&D investment totaling around 348.89 million yuan [2]. - Adebali monoclonal antibody injection, a humanized anti-PD-L1 monoclonal antibody, was approved in February 2023 for first-line treatment of extensive-stage small cell lung cancer, with a cumulative R&D investment of about 939.08 million yuan [2]. - Competing products in the market include Atezolizumab, Avelumab, and Durvalumab, which collectively have a global sales forecast of approximately 9.648 billion USD for 2024 [2].

Core Insights - 恒瑞医药's subsidiaries have received approval from the National Medical Products Administration for clinical trials of four injectable drugs, including SHR-7787, SHR-4849, Bevacizumab, and Adebali monoclonal antibody [1][2] Group 1: SHR-7787 and SHR-4849 - SHR-7787 is a first-class therapeutic biological product that activates T cells to target and kill tumor cells, with no similar drugs approved in China to date. The total R&D investment for SHR-7787 is approximately 48.93 million yuan [1] - SHR-4849 is an antibody-drug conjugate targeting DLL3, designed to treat advanced malignant solid tumors, with no similar drugs approved in China or abroad. The total R&D investment for SHR-4849 is approximately 69.67 million yuan [1] Group 2: Bevacizumab and Adebali Monoclonal Antibody - Bevacizumab, a humanized anti-VEGF monoclonal antibody, was approved in the U.S. in 2004 and has generated global sales of approximately 5.655 billion USD in 2024. The total R&D investment for Bevacizumab by the company is approximately 348.89 million yuan [2] - Adebali monoclonal antibody is a humanized anti-PD-L1 monoclonal antibody approved in February 2023 for first-line treatment of extensive-stage small cell lung cancer. The total R&D investment for Adebali is approximately 939.08 million yuan, with similar products generating combined global sales of approximately 9.648 billion USD in 2024 [2]

Core Insights - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of four injectable drugs, including SHR-7787, SHR-4849, Bevacizumab, and Adebali monoclonal antibody [1][2] Group 1: Drug Approvals - The company’s subsidiaries have been granted clinical trial approval for SHR-7787, a first-class therapeutic biological product that activates T cells to target and kill tumor cells, with no similar drugs currently approved in China [1] - SHR-4849 is an antibody-drug conjugate targeting DLL3, designed to specifically bind to DLL3 antigens on tumor cells, leading to the release of cytotoxic agents to kill cancer cells, aimed at treating advanced malignant solid tumors [1] Group 2: Existing Products - Bevacizumab, a humanized anti-VEGF monoclonal antibody, was co-developed by Genentech and is currently marketed globally, including in China [2] - Adebali monoclonal antibody is a humanized anti-PD-L1 monoclonal antibody developed by the company, which aims to block the PD-1/PD-L1 pathway to reactivate the immune system against tumors [2]