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 ...