本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容 的真实性、准确性和完整性承担法律责任。 一、前期合作情况 2019年9月30日、2023年8月25日，本公司控股子公司复宏汉霖与KGbio先后签订《2019年独家许可协 议》《2023年独家许可协议》及《2019年独家许可协议之修正案》，复宏汉霖就许可产品（即斯鲁利单 抗注射液）授予KGbio于约定区域（即约定的东南亚、中东及北非国家）及约定领域内的独家商业化及 相关权利许可。 2024年12月31日，复宏汉霖与Abbott签订《2024年许可协议》，（其中包括）复宏汉霖就许可产品授予 Abbott于约定区域（即约定的拉丁美洲国家及加勒比海地区国家，以下简称"Abbott前次许可区域"）及 约定领域内的独家商业化许可。 二、本次进展 2026年2月24日，复宏汉霖与KGbio签订《修订及部分终止协议》，（其中包括）双方同意终止《2023 年独家许可协议》，并终止印度尼西亚以外的KGBio获许可区域（即"KGbio终止区域"）独家商业化许 可产品及相关权利的许可。 同日，复宏汉霖与Abbott签订《2024年许可协议之修 ...

格隆汇2月5日丨复宏汉霖(02696.HK)宣布，公司于2026年2月5日与Eisai Co., Ltd.("Eisai")订立一份许可 协议，据此，公司同意向Eisai授出一项许可，供其于日本("区域")及领域(定义如下文)内开发、生产和 商业化汉斯状®(斯鲁利单抗注射液)("许可产品")。 本次与Eisai就许可产品于区域内的商业化合作将有助于进一步拓展公司产品的海外市场，增强公司产品 在国际市场的可及性和认可度，从而为公司收入的持续提升创造条件。 汉斯状®在中国境内的销售推广由公司自建商业化团队主导。截至公告日期，公司已分别与多个国际知 名合作伙伴就汉斯状®于全球超100个国家和地区的商业化达成合作。 根据许可协议，公司将授予Eisai：(a) 一项独家许可，供其于区域及领域内商业化许可产品；及(b) 仅就 上文(a)项所述目的，于区域及领域内开发和生产许可产品的共同排他许可(即公司亦有权开发和生产)。 Eisai将向公司支付：(a) 首付款7500万美元，于许可协议订立后支付；(b) 监管里程碑款项合计至多8001 万美元，基于许可产品于区域内的各项监管里程碑达成情况支付；(c) 商业销售里程碑款项合 ...

Core Viewpoint - The company, Fuhong Hanlin, has received acceptance for its New Drug Application (NDA) for the innovative anti-PD-1 monoclonal antibody, Hanshuozhuang (Slulizumab), for use in combination with platinum-based chemotherapy in the neoadjuvant and postoperative adjuvant treatment of PD-L1 positive, resectable gastric cancer patients, which has been prioritized for review by the National Medical Products Administration (NMPA) [1][2] Group 1 - The acceptance of the NDA and its inclusion in the priority review process will significantly shorten the review timeline to 130 working days, accelerating the market entry of Hanshuozhuang for perioperative treatment of gastric cancer [1] - Gastric cancer is a highly prevalent malignancy globally, with high incidence and mortality rates, and there is an urgent clinical need for effective therapies in the perioperative setting, as no immunotherapy has been approved in China for this phase [1] Group 2 - The NDA is primarily based on the positive results from the key study ASTRUM-006, which showed that Hanshuozhuang combined with chemotherapy significantly improved event-free survival (EFS) and pathological complete response (pCR) rates compared to the control group, with a notable reduction in recurrence risk and manageable overall safety [2] - Hanshuozhuang, as a core anti-tumor drug for the company, demonstrates unique advantages in treating various solid tumors due to its differentiated mechanism, which enhances T cell activation and preserves CD28 signaling [2] - Currently, Hanshuozhuang has been approved for multiple indications, including squamous non-small cell lung cancer, and is available in over 40 countries, covering nearly half of the global population [2]

Core Viewpoint - The company, Junshi Biosciences (复宏汉霖), has announced that its self-developed innovative anti-PD-1 monoclonal antibody, Hanshu (斯鲁利单抗), has received acceptance for a New Drug Application (NDA) from the National Medical Products Administration (NMPA) for use in combination with platinum-based chemotherapy as neoadjuvant therapy and postoperative adjuvant therapy for PD-L1 positive, resectable gastric cancer patients. This application has been included in the priority review process, significantly shortening the review timeline to 130 working days, indicating a rapid advancement in the approval process for H drug in the perioperative treatment of gastric cancer. H drug is expected to become the first anti-PD-1 monoclonal antibody approved for this indication globally [1]. Group 1 - The company has received acceptance for its NDA for Hanshu in gastric cancer treatment [1] - The application is included in the priority review process, reducing the review timeline to 130 working days [1] - H drug is anticipated to be the first anti-PD-1 monoclonal antibody approved for this indication worldwide [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） （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/輔助治療的上市註冊申請(NDA) 獲國家藥品監督管理局(NMPA)受理，並已納入優先審評 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，本公司自主開發的漢斯狀® （斯魯 利單抗注射液）（「漢斯狀®」）聯合含鉑化療新輔助，在手術後輔助治療，用於 PD-L1陽性的、可手術切除的胃癌患者的上市註冊申請(NDA)獲國家藥品監 督管理局(NMPA)藥品審評中心受理，並已納入優先審評審批程序，將加速 其上市審評進程。 B. 申報背景及依據 本次漢斯狀®新適應症的上市註冊 ...

Major Announcements - EVE Energy signed a procurement framework agreement with Smoore International for the continuous supply of battery cells and other products as raw materials, with actual amounts to be determined by future orders [3] - ST Huami's stock is under "double risk" warning due to an audit report expressing inability to provide an opinion for the 2024 financial report, with a recovery of 1.567 billion yuan in occupied funds [4] - Wuzhou Transportation received a regulatory warning for accounting irregularities and failure to fulfill integrity checks for executives, leading to inaccurate financial disclosures [5] - Wenfeng Co. announced that its vice president is under investigation, but this will not significantly impact the company's operations [6] - Fosun Pharma's subsidiary has had its drug included in the breakthrough therapy designation program for gastric cancer treatment, marking a significant development in its product pipeline [7][8] - Shandong Steel's subsidiary is applying for bankruptcy liquidation, which is expected to increase the parent company's net profit by 15.88 million yuan [9] - Zhouming Technology established a new subsidiary, Shenzhen Zhixian Robotics Co., with a registered capital of 50 million yuan [10] Share Buybacks and Holdings - Spring Airlines conducted its first share buyback, acquiring 35,800 shares for a total of 1.9997 million yuan [11] - Donghua Software's controlling shareholder reduced his stake by 1%, selling 10.9832 million shares [12] - Changshu Bank's executives plan to increase their holdings by at least 550,000 shares over the next six months [13] Major Contracts - Nanfeng Co. won contracts worth 45.7 million yuan and 47.17 million yuan for HVAC systems, with delivery scheduled for 2027 [14] - Huakang Clean announced a pre-bid win for a purification system project at Keqiao Future Medical Center, with a bid price of 176 million yuan [15][16] - Qinglong Pipe Industry secured a contract worth 294 million yuan for a pipe procurement project, expected to impact its performance from 2026 to 2030 [17] - China Nuclear Engineering signed new contracts totaling 123.84 billion yuan as of October, with cumulative revenue of 81.334 billion yuan [18]

Core Viewpoint - Fosun Pharma's subsidiary Shanghai Fuhong Hanlin Biotech has received breakthrough therapy designation for its independently developed drug, Surulitinib injection, for use in combination with chemotherapy for gastric cancer treatment [1] Group 1: Drug Approval and Indications - Surulitinib injection has been approved for use in China, the EU, and the UK, with indications including first-line treatment for squamous non-small cell lung cancer, extensive small cell lung cancer, esophageal squamous cell carcinoma, and non-squamous non-small cell lung cancer [1] - The drug is an innovative anti-PD-1 monoclonal antibody developed by the company and its subsidiaries [1] Group 2: Market Position - As of the announcement date, there are no approved targeted PD-1 monoclonal antibody drugs for neoadjuvant/adjuvant treatment of gastric cancer globally [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） （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 ...

H药目前已在欧洲、东南亚和中国等30多个国家获批上市。 本文为IPO早知道原创 作者｜罗宾 微信公众号｜ipozaozhidao 据IPO早知道消息，复宏汉霖（2696.HK）于近日公布了产品最新进展。2月5日，公司宣布，H药汉 斯状（斯鲁利单抗，欧洲商品名：Hetronifly）获欧盟委员会（EC）批准上市，用于联合卡铂和依 托泊苷用于广泛期小细胞肺癌（ES-SCLC）成人患者的一线治疗，H药成为了首个且唯一在欧盟获 批上市用于ES-SCLC治疗的抗PD-1单抗。截至目前，H药已在欧洲、东南亚和中国等30多个国家 获批上市，惠及超过90,000位患者。 此外，公司在研的Perjeta（帕妥珠单抗）生物类似药HLX11的生物制品许可申请（BLA）也于近日 获FDA受理。目前Perjeta已在多个国家和地区获批，适应症包括联合曲妥珠单抗和化疗用于HER2 阳性、局部晚期、炎性或早期乳腺癌患者的新辅助治疗，以及部分HER2阳性早期乳腺癌患者的辅助 治疗等。 迄今为止，复宏汉霖已有已有6款产品在中国获批上市，4款产品在国际获批上市，4个上市申请分别 获中国药监局、美国FDA和欧盟EMA受理。 突破差异化临床需求，H ...