Core Viewpoint - Fosun Pharma's subsidiary Shanghai Fuhong Hanlin Biotech has received approval for its PD-1 monoclonal antibody, Surulitinib injection, to be included in the breakthrough therapy program for gastric cancer treatment, marking a significant advancement in the field [1] Group 1: Company Developments - The drug Surulitinib, marketed as Hanshuang in China, is an innovative anti-PD-1 monoclonal antibody developed by the company [1] - The inclusion of Surulitinib in the breakthrough therapy program indicates its potential as a new treatment option for gastric cancer [1] Group 2: Industry Context - Currently, there are no approved PD-1 targeted monoclonal antibody drugs for neoadjuvant/adjuvant treatment of gastric cancer globally [1] - According to IQVIA MIDAS data, the global sales of PD-1 targeted monoclonal antibody drugs are projected to reach approximately $45.704 billion in 2024 [1]

Core Viewpoint - Fosun Pharma's subsidiary Shanghai Fuhong Hanlin Biotech has received inclusion of its independently developed drug, Surulitinib Injection, in the breakthrough therapy designation for the treatment of gastric cancer, marking a significant advancement in the field of PD-1 monoclonal antibodies [1] Group 1: Company Developments - The drug Surulitinib Injection, marketed in China as Hanshuanzhuang®, is an innovative anti-PD-1 monoclonal antibody developed by the company [1] - The inclusion in the breakthrough therapy program indicates a potential expedited development and review process for the drug [1] Group 2: Industry Context - As of the announcement date, there are no approved PD-1 targeted monoclonal antibody drugs for neoadjuvant/adjuvant treatment of gastric cancer globally [1] - According to IQVIA MIDAS™ data, the global sales of PD-1 targeted monoclonal antibody drugs are projected to reach approximately $45.704 billion in 2024 [1]

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） C. 關於漢斯狀® 漢斯狀®為本公司自主開發的創新型抗PD-1單抗，其於中國境內（不包括中國 港澳台地區，下同）已獲批上市的適應症包括聯合化療一線治療鱗狀非小細 胞肺癌(sq-NSCLC)，廣泛期小細胞肺癌(ES-SCLC)、食管鱗狀細胞癌(ESCC) 及非鱗狀非小細胞肺癌(nsq-NSCLC)。同時，漢斯狀®亦已分別於歐盟、英 國、印度尼西亞、柬埔寨、泰國、馬來西亞、新加坡、及印度等國家/地區獲 批上市，並分別獲美國、歐盟、瑞士及韓國等國家/地區的藥品監督管理部門 授予孤兒藥資格認定(Orphan-drug Designation)。 （股份代號：2696） 自願公告 漢斯狀® （斯魯利單抗注射液）聯合化療用於 胃癌新輔助/輔助治療的3期臨床研究達到主要研究終點 A ...