Group 1 - The core point of the article is that 恒瑞医药 has received approval from the National Medical Products Administration for clinical trials of SHR-3045 injection, a self-developed biological product aimed at treating rheumatoid arthritis [1] - SHR-3045 injection is expected to suppress immune cell function, reduce inflammation, and improve clinical symptoms during rheumatoid arthritis treatment [1] - Currently, there are no similar drugs approved for market in both domestic and international markets [1] Group 2 - The total research and development investment for the SHR-3045 injection project has reached approximately 35.54 million yuan [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of SHR-3045 injection, a self-developed biological product aimed at treating rheumatoid arthritis [1] Company Summary - The company’s subsidiary, Guangdong Heng Rui Medicine Co., Ltd. and Shanghai Heng Rui Medicine Co., Ltd. are involved in the clinical trial process for SHR-3045 injection [1] - SHR-3045 injection is expected to suppress immune cell function, reduce inflammation, and improve clinical symptoms in rheumatoid arthritis treatment [1] - The total research and development investment for SHR-3045 injection has reached approximately 35.54 million yuan [1] Industry Summary - Currently, there are no similar drugs approved for market use domestically or internationally, indicating a potential market opportunity for SHR-3045 injection [1]

SHR-1139注射液是公司自主研发的一种治疗用生物制品，预期可在溃疡性结肠炎治疗过程中,通过抑制 炎症反应和维持上皮屏障等机制协同增效。经查询，目前国内外尚无同类药物获批上市。截至目前， SHR-1139注射液相关项目累计研发投入约7,128万元。 智通财经APP讯，恒瑞医药(600276.SH)发布公告，近日，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(以下简称"国家药监局")核准签发关于SHR-1139注射液的《药物临床试验批准通知 书》，将于近期开展临床试验。 ...

Core Viewpoint - Heng Rui Medicine (600276.SH) has received approval from the National Medical Products Administration for clinical trials of SHR-1139 injection, a self-developed biological product aimed at treating ulcerative colitis [1] Group 1: Product Development - SHR-1139 injection is designed to inhibit inflammatory responses and maintain epithelial barriers, potentially enhancing treatment efficacy for ulcerative colitis [1] - Currently, there are no similar drugs approved for market in both domestic and international markets [1] - The total research and development investment for the SHR-1139 injection project has reached approximately 71.28 million yuan [1]

Core Viewpoint - Heng Rui Medicine's subsidiary, Shanghai Heng Rui Medicine Co., Ltd., has announced that its injectable SHR-1501 has been included in the list of proposed breakthrough therapeutic products by the National Medical Products Administration, with a public announcement period of 7 days [1] Group 1: Product Development - SHR-1501 is a self-developed interleukin-15 (IL-15) fusion protein that stimulates the proliferation of T cells, B cells, and NK cells, enhancing the immune response to eliminate foreign substances such as tumors [1] - The proposed indication for SHR-1501 is in combination with Bacillus Calmette-Guérin (BCG) for patients with non-muscle invasive carcinoma in situ (CIS) who do not respond to BCG [1] - The combination of SHR-1501 with BCG is expected to significantly enhance the immune response in the bladder, achieving a synergistic anti-tumor effect [1] Group 2: Market Context - Currently, there are no approved products in China targeting the same mechanism as SHR-1501, while a similar product, Nogapendekin Alfa Inbakicept (marketed as Anktiva), has been approved for sale in the United States [1] - The cumulative research and development investment for SHR-1501 has reached approximately 10.218 million yuan [1]

【恒瑞医药：子公司收到SHR-1139注射液临床试验批准通知书】智通财经9月18日电，恒瑞医药 (600276.SH)公告称，公司子公司广东恒瑞医药有限公司收到国家药监局核准签发关于SHR-1139注射液 的《药物临床试验批准通知书》，将于近期开展临床试验。SHR-1139注射液是公司自主研发的一种治 疗用生物制品，预期可在溃疡性结肠炎治疗过程中,通过抑制炎症反应和维持上皮屏障等机制协同增 效。经查询，目前国内外尚无同类药物获批上市。 转自：智通财经 ...

Core Insights - Company subsidiary Guangdong Hengrui Medicine Co., Ltd. and Shanghai Hengrui Medicine Co., Ltd. received approval from the National Medical Products Administration for the clinical trial of SHR-3045 injection [1] - SHR-3045 injection is a self-developed biological product aimed at treating rheumatoid arthritis, expected to suppress immune cell function, reduce inflammation, and improve clinical symptoms [1] Company Developments - The clinical trial for SHR-3045 injection will commence shortly following the approval [1] - This development highlights the company's ongoing commitment to advancing its pipeline of innovative treatments in the biopharmaceutical sector [1]

Core Viewpoint - Heng Rui Medicine's subsidiary, Shanghai Heng Rui Medicine Co., Ltd., has announced that its injectable SHR-1501 has been included in the list of proposed breakthrough therapeutic varieties by the National Medical Products Administration, with a public announcement period of 7 days [1] Group 1: Product Development - SHR-1501 is a self-developed interleukin-15 (IL-15) fusion protein that stimulates the proliferation of T cells, B cells, and NK cells, enhancing the immune system's ability to eliminate foreign substances such as tumors [1] - The proposed indication for SHR-1501 is in combination with Bacillus Calmette-Guérin (BCG) for patients with non-muscle invasive carcinoma in situ (CIS) who do not respond to BCG [1] - The combination of SHR-1501 with BCG is expected to significantly enhance the immune response within the bladder, achieving a synergistic anti-tumor effect [1] Group 2: Market Context - Currently, there are no approved products in China targeting the same mechanism as SHR-1501, while a similar product, Nogapendekin Alfa Inbakicept (marketed as Anktiva), has been approved for sale in the United States [1] - The cumulative research and development investment for SHR-1501 has reached approximately 10.218 million yuan [1]

南财智讯9月18日电，恒瑞医药公告，广东恒瑞医药有限公司收到国家药品监督管理局关于SHR-1139注 射液的《药物临床试验批准通知书》，同意开展溃疡性结肠炎的临床试验。该药物是公司自主研发的治 疗用生物制品，预期可通过抑制炎症反应和维持上皮屏障等机制协同增效。目前国内外尚无同类药物获 批上市。截至目前，该项目累计研发投入约7,128万元。公司提醒投资者注意药品研发过程中的不确定 性风险，并将按国家有关规定积极推进研发项目，及时披露项目后续进展。 ...

Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of SHR-1139 injection, a self-developed biological product aimed at treating ulcerative colitis through mechanisms that inhibit inflammation and maintain epithelial barrier [1] Group 1 - The company’s subsidiary, Guangdong Hengrui Medicine Co., Ltd., is responsible for the clinical trial of SHR-1139 injection [1] - SHR-1139 injection is expected to enhance treatment efficacy for ulcerative colitis by targeting inflammation and epithelial barrier maintenance [1]