汉斯状®为公司自主开发的创新型抗PD-1单抗，其于中国境内(不包括中国港澳台地区，下同)已获批上 市的适应症包括联合化疗一线治疗鳞状非小细胞肺癌(sq-NSCLC)、广泛期小细胞肺癌(ES-SCLC)、食管 鳞状细胞癌(ESCC)及非鳞状非小细胞肺癌(nsq-NSCLC)。同时，汉斯状®亦已分别于欧盟、英国、印度 尼西亚、柬埔寨、泰国、马来西亚、新加坡、及印度等国家/地区获批上市，并分别获美国、欧盟、瑞 士及韩国等国家/地区的药品监督管理部门授予孤儿药资格认定。 此外，公司正有序推进汉斯状®及相关联合疗法在全球开展的多项临床试验，广泛覆盖肺癌、食管癌、 头颈鳞癌、结直肠癌和胃癌等适应症。 格隆汇12月12日丨复宏汉霖(02696.HK)宣布，近日，公司自主开发的汉斯状®(斯鲁利单抗注射液)("汉 斯状®")联合含铂化疗新辅助，在手术后辅助治疗，用于PD-L1阳性的、可手术切除的胃癌患者的上市 注册申请(NDA)获国家药品监督管理局(NMPA)药品审评中心受理，并已纳入优先审评审批程序，将加 速其上市审评进程。 本次汉斯状®新适应症的上市注册申请(NDA)主要基于一项比较汉斯状®联合化疗对比安慰剂联合化疗 新辅 ...

Core Viewpoint - The company, Junshi Biosciences (复宏汉霖), announced that its drug Hansizhuang® (sulunatuzumab injection) has been officially included in the breakthrough therapy designation process by the National Medical Products Administration (NMPA) for the neoadjuvant/adjuvant treatment of gastric cancer [1] Group 1 - Junshi Biosciences' drug Hansizhuang® has received recognition from the NMPA, indicating a significant step in its development for gastric cancer treatment [1] - The inclusion in the breakthrough therapy designation process suggests potential expedited review and approval, which could enhance the drug's market entry timeline [1]

Core Viewpoint - The company, Junshi Biosciences (复宏汉霖), announced that its drug Hansizhuang® (sulunatuzumab injection) has been officially included in the breakthrough therapy designation process by the National Medical Products Administration (NMPA) for the neoadjuvant/adjuvant treatment of gastric cancer [1] Group 1 - Junshi Biosciences' Hansizhuang® has received recognition from NMPA's Center for Drug Evaluation (CDE) [1]

Core Viewpoint - The article emphasizes the journey and vision of Fosun Pharma under the leadership of Chairman Chen Yuqing, focusing on innovation, global expansion, and the integration of AI in drug development and operations [3][10][20]. Group 1: Company Background and Leadership - Chen Yuqing transitioned from academia to the corporate world 26 years ago, eventually becoming the Chairman of Fosun Pharma in April 2025 [1][3]. - Under his leadership, Fosun Pharma has grown into a nearly 100 billion yuan global innovative pharmaceutical company, with a strong emphasis on corporate culture that fosters innovation and talent development [3][4]. Group 2: Innovation and Product Development - Fosun Pharma has consistently prioritized innovation, launching 12 innovative drugs since 2019, including the first CAR-T product in China and the first PD-1 monoclonal antibody approved for small cell lung cancer [4][6]. - The company’s innovative drug revenue exceeded 4.3 billion yuan in the first half of 2025, accounting for 31% of its pharmaceutical business revenue, with a year-on-year growth of 14.26% [8][10]. Group 3: Globalization Strategy - Fosun Pharma's globalization strategy focuses on building local capabilities rather than merely exporting products, with over 1,000 personnel in its overseas commercialization team and a marketing network covering over 110 countries [10][12]. - The company has established regional distribution centers in emerging markets and has supplied over 420 million doses of anti-malarial products globally, significantly impacting public health [13][20]. Group 4: AI Integration in Operations - Fosun Pharma is actively integrating AI into its operations, utilizing the PharmAID decision-making platform to enhance drug development efficiency, reducing target validation time by over 60% [14][15]. - The company emphasizes that while AI is a powerful tool for enhancing efficiency, it cannot replace the intrinsic value of human expertise and understanding of patient needs [16][17]. Group 5: Future Vision and Commitment - The company aims to become a global "Big Pharma" over the next decade, focusing on innovation, deep internationalization, and comprehensive AI adoption as its core strategies [19][20]. - Fosun Pharma's mission remains to ensure every family enjoys health, reflecting its commitment to addressing clinical needs through continuous innovation [20].

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） 自願公告 漢斯狀® （斯魯利單抗注射液）聯合化療一線治療廣泛期 小細胞肺癌(ES-SCLC)的日本橋接試驗完成首例患者給藥 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，一項在日本一線治療廣泛期小 細胞肺癌(ES-SCLC)患者中開展的漢斯狀® （斯魯利單抗注射液）（「漢斯狀®」） 聯合化療（卡鉑 － 依託泊苷）的橋接試驗已完成首例患者給藥。本次試驗系 本公司依據日本藥品醫療器械綜合機構(PMDA)的2期臨床試驗默示許可開 展的橋接試驗，用於支持未來漢斯狀®於日本的上市申報。此前，一項比較 漢斯狀®或安慰劑聯合化療（卡鉑 ...

Core Viewpoint - The company has entered into an exclusive licensing agreement with Alvogen Korea for the commercialization of its innovative anti-PD-1 monoclonal antibody, Hanshuo® (sulizumab injection), in South Korea [1][2]. Group 1: Product Information - Hanshuo® is an innovative anti-PD-1 monoclonal antibody developed by the company, approved for various indications in mainland China, including squamous non-small cell lung cancer (sqNSCLC), extensive small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsNSCLC) [2]. - The product has also received approvals in the European Union, Indonesia, Cambodia, and Thailand, and has been granted orphan drug designation by the FDA and the European Commission for small cell lung cancer [2]. Group 2: Market Potential - According to IQVIA MIDAS TM, the global sales of anti-PD-1 monoclonal antibodies are projected to reach approximately $45.55 billion in 2024 [3]. - The collaboration with Alvogen Korea is expected to enhance the company's product accessibility and recognition in international markets, contributing to sustained revenue growth [3]. Group 3: Commercialization Strategy - The company leads the sales and promotion of Hanshuo® in mainland China through its own commercialization team and has established partnerships for commercialization in Europe, India, Southeast Asia, the Middle East, North Africa, and the United States [3].

（股份代號：2696） 自願公告 注射用HLX43（靶向PD-L1抗體－新型DNA 拓撲異構酶I抑制劑偶聯藥物）聯合漢斯狀® （斯魯利單抗注射液） 治療晚期/轉移性實體瘤患者的1b/2期臨床 研究於中國境內完成首例患者給藥 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。 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） HLX43是由本公司利用於2022年11月自蘇州宜聯生物醫藥有限公司許可引進 的新型DNA拓撲異構酶I抑制劑小分子毒素－肽鏈連接子與本公司自主研發 的靶向PD-L1的抗體進行偶聯開發的靶向PD-L1的抗體偶聯藥物(ADC)，擬用 於晚期/轉移性實體瘤的治療。2023年10月，HLX43用於治療晚期/轉移性實 體瘤的1期臨床 ...

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） 自願公告 注射用HLX43（靶向PD-L1抗體－新型DNA拓撲異構酶I抑制劑 偶聯藥物）用於治療復發/轉移性食管鱗癌(ESCC)的 2期臨床研究於中國境內完成首例患者給藥 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。 本研究為評估不同劑量HLX43在經一線標準治療失敗或不可耐受毒性的復發/ 轉移性食管鱗癌患者中的有效性和安全性的2期臨床試驗。篩選合格的受試者 將接受每3周一次(Q3W)HLX43治療。本研究主要目的是評估HLX43在復發/ 轉移性食管鱗癌中的臨床療效。次要目的是評估安全性和耐受性、藥代動力 學特徵及免疫原性、和潛在預測性生物標誌物。 1 C. 關於HLX43 HLX43是由本公司利用於2022年11月自蘇州宜聯生物醫藥有限公司許可引進 的新型DNA拓撲異構酶I抑制劑小分子毒 ...