Core Viewpoint - Heng Rui Medicine (600276.SH) has received approval from the National Medical Products Administration for clinical trials of SHR-1905 injection, a monoclonal antibody targeting TSLP, aimed at improving inflammatory conditions and controlling disease progression [1] Group 1: Product Development - SHR-1905 injection is designed to block the release of inflammatory cytokines and inhibit downstream inflammatory signaling [1] - The company has invested approximately 20.962 million yuan in the research and development of SHR-1905 injection to date [1] Group 2: Market Context - Tezepelumab, a similar product developed by AstraZeneca/Amgen, has been approved and is projected to generate global sales of approximately 1.22 billion USD in 2024 [1]

Core Viewpoint - Heng Rui Medicine's subsidiary received approval from the National Medical Products Administration for clinical trials of SHR-1905 injection, a monoclonal antibody targeting TSLP, aimed at improving inflammation and controlling disease progression [1] Group 1: Product Development - SHR-1905 injection is designed to block the release of inflammatory cytokines and inhibit downstream inflammatory signaling [1] - The global market has a similar product, Tezepelumab, which is projected to generate approximately $1.22 billion in sales in 2024 [1] - The cumulative R&D investment for SHR-1905 injection has reached approximately 209.62 million yuan [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of its self-developed antibody-drug conjugate, SHR-A2102, targeting Nectin-4, which is associated with tumor progression and poor prognosis [1] Group 1: Company Developments - The company's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., and Shanghai Hengrui Medicine Co., Ltd. have been granted the clinical trial approval for SHR-A2102 [1] - SHR-A2102 is an antibody-drug conjugate (ADC) with a payload of topoisomerase I inhibitor (TOP1i) [1] Group 2: Industry Context - Nectin-4 is highly expressed in tumors, correlating with tumor development and adverse prognosis, highlighting the potential significance of SHR-A2102 in cancer treatment [1]

Core Viewpoint - Heng Rui Medicine (01276) has received approval from the National Medical Products Administration for clinical trials of SHR-A2102, a targeted antibody-drug conjugate (ADC) [1] Group 1: Product Development - SHR-A2102 is a self-developed ADC targeting Nectin-4, with a payload of topoisomerase I inhibitor (TOP1i) [1] - Nectin-4 is highly expressed in tumors, correlating with tumor progression and poor prognosis [1] Group 2: Market Context - Currently, there is one similar product approved globally, Enfortumab vedotin (brand name: Padcev), with projected global sales of approximately $1.949 billion in 2024 [1] - The cumulative R&D investment for SHR-A2102 has reached approximately 225 million yuan [1]

Core Insights - Jiangsu Hengrui Medicine Co., Ltd. has been recognized as a respected enterprise for the 2024-2025 period by Economic Observer, highlighting its excellent performance in quality operations, innovation breakthroughs, and social contributions [1] Financial Performance - The company has achieved positive growth in total assets for three consecutive years, according to the comprehensive value assessment system for listed companies by Economic Observer [1]

Core Viewpoint - Recently, the company announced that its subsidiaries received approval from the National Medical Products Administration for clinical trials of three drug candidates, indicating progress in its oncology pipeline [1][2][3] Group 1: Drug Candidates - SHR-A2102 is a targeted antibody-drug conjugate (ADC) developed by the company, which targets Nectin-4 and has a payload of a topoisomerase I inhibitor. It is noted that Nectin-4 is highly expressed in tumors, correlating with tumor progression and poor prognosis. Currently, there is one similar product approved globally, Enfortumab vedotin, with projected global sales of approximately $1.949 billion in 2024. The cumulative R&D investment for SHR-A2102 is about 225 million yuan [1] - SHR-1802 is a humanized monoclonal antibody developed by the company that activates and promotes anti-tumor T cell responses. There are currently no similar products approved in the domestic market. The cumulative R&D investment for SHR-1802 is approximately 62.09 million yuan [2] - Adebali monoclonal antibody injection is a humanized anti-PD-L1 monoclonal antibody that blocks the PD-1/PD-L1 pathway, reactivating the immune system's anti-tumor activity. It was approved for market in February 2023 for first-line treatment of extensive-stage small cell lung cancer. Similar products like Atezolizumab, Avelumab, and Durvalumab have been approved in the U.S., with combined global sales projected to be around $9.648 billion in 2024. The cumulative R&D investment for Adebali is approximately 939 million yuan [3]

Core Viewpoint - 恒瑞医药's subsidiary received approval for clinical trials of SHR-1905 injection, targeting atopic dermatitis, which may present a significant market opportunity given the success of similar products like Tezepelumab [1] Company Summary - 江苏恒瑞医药股份有限公司's subsidiary, 广东恒瑞医药有限公司, has been granted a clinical trial approval notice by the National Medical Products Administration for SHR-1905 injection [1] - The clinical trial application for SHR-1905 was accepted on July 17, 2025, and meets the requirements for drug registration [1] - SHR-1905 is a monoclonal antibody targeting thymic stromal lymphopoietin (TSLP), designed to block the release of inflammatory cytokines and inhibit downstream inflammatory signaling [1] Industry Summary - The global market for similar products, such as Tezepelumab (AstraZeneca/Amgen, marketed as Tezspire), is projected to generate approximately $1.22 billion in sales in 2024 [1] - The total research and development investment for SHR-1905 has reached approximately 209.62 million yuan [1]

Core Viewpoint - Heng Rui Medicine announced the approval of clinical trial notifications for three drug candidates, indicating a significant step in their oncology pipeline [1] Group 1: Clinical Trials - The company’s subsidiaries received approval from the National Medical Products Administration to conduct clinical trials for SHR-A2102, Abediteranib injection, and SHR-1802 [1] - The trials will focus on the safety, tolerability, and efficacy of SHR-A2102 in combination with Abediteranib and SHR-1802 in patients with advanced solid tumors [1] Group 2: Drug Candidates - SHR-A2102 is a company-developed antibody-drug conjugate (ADC) targeting Nectin-4, with a payload of topoisomerase I inhibitor [1] - SHR-1802 is a humanized monoclonal antibody designed to activate and promote anti-tumor T cell responses [1] - Abediteranib injection is a humanized anti-PD-L1 monoclonal antibody that blocks the PD-1/PD-L1 pathway, reactivating the immune system's anti-tumor activity [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of SHR-A2102, a targeted antibody-drug conjugate aimed at Nectin-4, indicating progress in its oncology pipeline [1][2] Group 1: Clinical Trial Approval - The company’s subsidiaries have been granted a clinical trial approval notice for SHR-A2102, which will soon commence trials [1] - The clinical trial is a multi-center, open-label Phase II study focusing on the safety, tolerability, and efficacy of SHR-A2102 in combination with other anti-tumor treatments for patients with advanced solid tumors [1] Group 2: Product Details - SHR-A2102 is a self-developed antibody-drug conjugate targeting Nectin-4, with a payload of topoisomerase I inhibitor [2] - Nectin-4 is highly expressed in tumors, correlating with tumor progression and poor prognosis [2] - Currently, there is one similar product approved globally, Enfortumab vedotin, projected to have global sales of approximately $1.949 billion in 2024 [2] - The cumulative R&D investment for SHR-A2102 has reached approximately 224.84 million yuan [2]

公告显示，SHR—1905注射液是胸腺基质淋巴细胞生成素（TSLP）单克隆抗体，可以阻断炎症细胞因 子的释放，抑制下游炎症信号的传导，最终改善炎症状态并控制疾病进展。 北京商报讯（记者 王寅浩 实习记者 宋雨盈）10月13日，恒瑞医药发布公告称，公司子公司广东恒瑞医 药有限公司收到国家药品监督管理局核准签发关于SHR—1905 注射液的《药物临床试验批准通知 书》，同意本品开展特应性皮炎的临床试验。 ...