该IND申请获批后，公司已完成或正在进行的健康志愿者1期临床试验数据可直接用于支持IBD适应症推 进至2期临床开发。该IND申请代表着SM17治疗范围从特应性皮炎(「AD」)拓展至IBD的重要里程碑， 涵盖克罗恩病(「CD」)及溃疡性结肠炎(「UC」)等慢性、衰竭性疾病，这些疾病存在显着未满足的医 疗需求。 SM17是一种全新、全球首创的人源化IgG4-k单克隆抗体，旨在通过靶向II型免疫核心「警戒素 (Alarmin)」分子白细胞介素25(IL-25)受体，调节II型炎症反应。与II型固有淋巴样细胞(ILC2s)和Th2细 胞表面的IL-25受体(IL-17RB)结合，SM17可阻断IL-25诱导的信号级联反应，从而对下游细胞因子IL- 4、IL-5和IL-13产生抑制效果。该机制使SM17成为治疗UC(IL-25发挥促炎作用)有前景的候选药物。此 外，SM17在CD中具有双重潜在获益：一方面调控Th17驱动的炎症，另一方面发挥抗纤维化作用，有助 改善肠狭窄和瘘管等并发症。这种多机制特性使SM17区别于现有单通路疗法，为难治性或复杂表型患 者提供全新的治疗选择。 格隆汇12月11日丨中国抗体-B(03681 ...

Core Viewpoint - The company Zhixiang Jintai (688443.SH) is gaining attention as it progresses towards commercializing its core product, the Sairiqi monoclonal antibody injection, despite its initial poor stock performance and ongoing losses. Investors are keen to understand when the company will achieve profitability as it moves into a phase of revenue realization [1][4]. Financial Performance - In the third quarter, Zhixiang Jintai reported a revenue of 162.16 million yuan, a year-on-year increase of 1199.88%, while the net profit attributable to shareholders was a loss of 53.28 million yuan, significantly narrowing from a loss of 187 million yuan in the same period last year [3][4]. - For the first three quarters, the company achieved a total revenue of 208 million yuan, reflecting a year-on-year increase of 1562.05%, with the net loss narrowing from 550 million yuan to 370 million yuan, a reduction of 32.73% [4]. Product Development and Market Position - Zhixiang Jintai focuses on the development of monoclonal and bispecific antibodies for autoimmune, infectious diseases, and oncology. Currently, only one product has been approved for sale, and the company has incurred a cumulative net loss of 2.869 billion yuan from 2020 to 2024 [5][7]. - The Sairiqi monoclonal antibody injection has been approved for two indications and is expected to contribute significantly to revenue, having generated 45.38 million yuan in sales in the first half of the year [7][8]. - The company is facing competition from multiple IL-17A targeted drugs, including Novartis's Secukinumab, which has established a strong market presence with sales reaching 2.08 billion yuan in 2022 and increasing to 2.75 billion yuan in 2023 [8][9]. Research and Development - Zhixiang Jintai has over ten products in its research pipeline, with three currently under review for approval. The company has invested heavily in R&D, with expenditures of 4.54 billion yuan, 6.20 billion yuan, and 6.10 billion yuan over the last three years, totaling 16.85 billion yuan [10][11]. - Recent collaborations have provided short-term financial relief, including a partnership with Cullinan Therapeutics that brought in a $20 million upfront payment and potential milestone payments totaling $692 million [12][13]. Future Outlook - The company aims to enhance its product pipeline and market presence through innovative drug discovery technologies and expanding its therapeutic targets. However, long-term sustainability will depend on the success of its proprietary products in generating consistent revenue [13].

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 - 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] Group 1: Clinical Trial Approval - The company announced that its subsidiary, Guangdong Heng Rui Pharmaceutical Co., Ltd., received the clinical trial approval notice from 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] Group 2: Product Information - SHR-1905 injection is a monoclonal antibody targeting thymic stromal lymphopoietin (TSLP), which can block the release of inflammatory cytokines and inhibit downstream inflammatory signaling [1] - The product aims to improve inflammatory conditions and control disease progression [1] Group 3: Market Context - Tezepelumab, a similar product developed by AstraZeneca/Amgen, has been approved and is projected to generate approximately $1.22 billion in global sales in 2024 [1] - The cumulative R&D investment for SHR-1905 injection has reached approximately 209.62 million yuan [1]

Core Viewpoint - 恒瑞医药's subsidiary, Guangdong Heng Rui Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of SHR-1905 injection, targeting atopic dermatitis [1] Group 1: Clinical Trial Approval - The clinical trial application for SHR-1905 injection was accepted on July 17, 2025, and meets the requirements for drug registration [1] - The approval allows the company to conduct clinical trials for atopic dermatitis [1] Group 2: Product Information - SHR-1905 injection is a monoclonal antibody targeting thymic stromal lymphopoietin (TSLP), which can block the release of inflammatory cytokines and inhibit downstream inflammatory signaling [1] - The product aims to improve inflammatory conditions and control disease progression [1] Group 3: Market Context - A similar product, Tezepelumab (AstraZeneca/Amgen, marketed as Tezspire), has been approved and is projected to generate global sales of approximately $1.22 billion in 2024 [1] - The cumulative R&D investment for SHR-1905 injection has reached approximately 209.62 million yuan [1]

Core Viewpoint - Heng Rui Medicine's subsidiary has received approval for clinical trials of SHR-1905 injection, a monoclonal antibody targeting TSLP, which aims to improve inflammation and control disease progression [1] Group 1: Company Developments - Heng Rui Medicine (600276.SH) announced that its subsidiary, Guangdong Heng Rui Medicine Co., Ltd., has received the clinical trial approval notice from the National Medical Products Administration for SHR-1905 injection [1] - The SHR-1905 injection is designed to block the release of inflammatory cytokines and inhibit downstream inflammatory signaling [1] Group 2: Market Context - There is a similar product, Tezepelumab (AstraZeneca/Amgen, marketed as Tezspire), which has been approved and is projected to generate approximately $1.22 billion in global sales in 2024 according to EvaluatePharma database [1]

Core Viewpoint - Shenzhou Cell's subsidiary has received approval for clinical trials of SCT640C injection for adult rheumatoid arthritis, indicating progress in the development of treatments for autoimmune diseases [1] Group 1 - Shenzhou Cell announced that its subsidiary, Shenzhou Cell Engineering Co., Ltd., has received the Drug Clinical Trial Approval Notice from the National Medical Products Administration [1] - SCT640C is a monoclonal antibody injection independently developed by the company for the treatment of autoimmune diseases [1]

Summary of Kiniksa Pharmaceuticals International (KNSA) FY Conference Call Company Overview - Kiniksa Pharmaceuticals is a growth-oriented, well-capitalized organization focused on addressing unmet needs in the cardiovascular space, particularly recurrent pericarditis [5][6] - The company has a commercial stage product, Arclis, which was approved in 2021 and has shown significant revenue growth [5][6] Financial Performance - Kiniksa increased its revenue guidance for 2025 to between $590 million and $605 million [5] - The company reported significant growth in Q1 2025 compared to Q4 2024, driven by three key factors: an increase in prescriber base, longer durations of therapy, and the impact of the Medicare Part D redesign [10][11] Product Performance - Arclis has seen an increase in the prescriber base, with approximately 3,150 prescribers, including around 300 new prescribers in Q1 2025 [11][24] - The average duration of therapy for Arclis has increased from 27 months to 30 months [11] - The Medicare Part D redesign has improved affordability for patients, contributing to a transition of patients from free goods to commercial drugs [12][10] Clinical Development - Kiniksa is advancing its clinical portfolio, including KPL 387, a monoclonal antibody for recurrent pericarditis, which is set to enter a phase 2/3 clinical study in mid-2025 [6][46] - KPL 1161, another monoclonal antibody, is in IND enabling studies with undisclosed indications [6] Market Dynamics - The company is targeting a prescriber base of approximately 25,000 cardiologists and rheumatologists, indicating significant room for growth [24][26] - The treatment landscape for recurrent pericarditis is evolving, with more centers of excellence focusing on the disease [24] Manufacturing Strategy - Kiniksa is transitioning the manufacturing of Arclis to Samsung Biologics in South Korea, which is part of a planned technology transfer [40][41] - The company anticipates that potential tariffs on imported drug substances will have an immaterial impact on gross margins [42][43] Future Outlook - Kiniksa aims to continue innovating and providing treatment options for recurrent pericarditis, with a focus on expanding the use of Arclis and advancing its pipeline products [71][72] - The company reported a cash balance of approximately $268 million, indicating strong financial health and capacity for future growth [72] Key Takeaways - Kiniksa Pharmaceuticals is well-positioned in the recurrent pericarditis market with a strong product pipeline and financial backing - The company is actively expanding its prescriber base and improving patient access through strategic initiatives like the Medicare Part D redesign - Future clinical developments, including KPL 387, are expected to enhance treatment options for patients suffering from recurrent pericarditis [6][71]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容而產生或因倚賴 該等內容而引致的任何損失承擔任何責任。 Shanghai Henlius Biotech, Inc. 上海復宏漢霖生物技術股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2696） HLX22（重組人源化抗HER2單克隆抗體注射液） 聯合曲妥珠單抗和化療(XELOX) 對比曲妥珠單抗和化療(XELOX)聯合或不聯合帕博利珠單抗 一線治療HER2陽性局部晚期或轉移性胃食管交界部和胃癌的 國際多中心3期臨床試驗申請於歐盟國家（德國）獲批 C. 市場情況 截至本公告日，於全球範圍內尚無同類聯合用藥治療方案獲批用於治療胃癌╱胃 食管交界部癌。 自願公告 A. 緒言 本公告由上海復宏漢霖生物技術股份有限公司（「本公司」）自願作出，以告知本公 司股東及潛在投資者本公司最新業務更新。 本公司董事會（「董事會」）欣然宣佈，近日，HLX22（重組人源化抗HER2單克隆 抗體注射液）（「HLX22」）聯合曲妥珠單抗和化療(XELOX)對比曲妥 ...