Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., has received approval from the National Medical Products Administration to conduct clinical trials for HLX22 and HLX87 in China, targeting HER2-positive breast cancer [1] Group 1 - The approved clinical trials include a Phase II/III trial for HLX22 as a first-line treatment for HER2-positive breast cancer [1] - A second Phase II/III trial is approved for HLX22 in neoadjuvant therapy for HER2-positive breast cancer [1] - Fuhong Hanlin plans to initiate these clinical studies in China once conditions are met [1]

Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotech Co., Ltd., has received approval from the National Medical Products Administration to conduct clinical trials for HLX22 and HLX87 in China, targeting HER2-positive breast cancer [1] Group 1 - The approved clinical trials include a Phase II/III trial for HLX22 as a first-line treatment for HER2-positive breast cancer [1] - A second Phase II/III trial is approved for HLX87 as neoadjuvant therapy for HER2-positive breast cancer [1] - Fuhong Hanlin plans to initiate these clinical studies in China once conditions are met [1]

Core Viewpoint - The company, Junshi Biosciences (复宏汉霖), has received approval from the National Medical Products Administration for clinical trial applications of HLX22 and HLX87 for the treatment of HER2-positive breast cancer [1] Group 1 - HLX22, a humanized anti-HER2 monoclonal antibody injection, is approved for first-line treatment of HER2-positive breast cancer [1] - HLX87, a HER2-targeted antibody-drug conjugate, is approved for neoadjuvant treatment of HER2-positive breast cancer [1] - The company plans to conduct related clinical research in China once conditions are met [1]

自願公告 HLX22（重組人源化抗HER2單克隆抗體注射液）聯合 注射用HLX87（靶向HER2抗體偶聯藥物）分別用於 HER2陽性乳腺癌(BC)一線治療與HER2陽性乳腺癌新輔助治療 (BC neo)的2/3期臨床試驗申請獲國家藥品監督管理局批准 A. 緒言 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） 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」）欣然宣布，近日，HLX22（重組人源化抗HER2單 克隆抗體注射液）（「HLX22」）聯合注射用HLX87（靶向HER2抗體偶聯藥物） （「HLX87」）(1)用於HER2陽性乳腺癌(BC)一線治療，以及(2)用於HER2陽性 乳腺癌新輔助治療(B ...