Group 1 - The company has reached agreements with KGBio and Abbott regarding exclusive commercialization rights for the product Hansuz® (Sruilumab injection) in specified regions [1][2] - The original KGBio licensing agreement has been partially terminated, specifically for regions outside of Indonesia, allowing for a shift in commercialization rights [1] - The revised agreement with Abbott expands the licensing area and milestone payment terms, enhancing the product's market reach in Latin America and the Caribbean [1][2] Group 2 - The termination of the KGBio agreement allows the company to grant exclusive commercialization rights to Abbott in newly added regions, which includes the previously terminated areas [2] - The collaboration with Abbott is expected to strengthen the company's international market presence and product accessibility [2]

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 注射用HLX43（靶向PD-L1抗體偶聯藥物） 聯合HLX07（重組抗EGFR人源化單克隆抗體注射液） 或漢斯狀® （斯魯利單抗注射液） 在晚期或轉移性結直腸癌患者中開展的1b/2期臨床研究 於中國境內完成首例患者給藥 A. 緒言 1 料，暫定HLX43的劑量水準為2.5 mg/kg和3.0 mg/kg，該階段主要目的是研究不 同劑量HLX43聯合固定劑量HLX07在轉移性結直腸癌(mCRC)患者中的有效性， 次要目的包括評價其安全性和耐受性、HLX43的PK特徵和免疫原性、並研究潛在 預測性或耐藥性生物標誌物。第二部分為一項隨機、多中心、開放標籤研究，評 估HLX43 2.0 mg/kg或2.5 mg/kg聯合固定劑量漢斯狀®(30 ...

Core Viewpoint - The company has entered into a licensing agreement with Eisai Co., Ltd., granting Eisai exclusive rights to commercialize the product Hansizhuang® (sulrurolizumab injection) in a specified region and field [1] Group 1: Financial Terms - Eisai will pay an upfront fee of $75 million to the company [1] - Regulatory milestone payments could total up to $80.01 million, contingent on the achievement of various regulatory milestones for the licensed product in the region [1] - Commercial sales milestone payments could reach up to $233.33 million, based on the annual net sales levels of the licensed product in the region [1] - The company will receive royalties calculated as a double-digit percentage of the annual net sales of the licensed product in the region [1]

Core Viewpoint - The company has entered into a licensing agreement with Eisai Co., Ltd. for the development, production, and commercialization of Hanshuo® (sulunab injection) in Japan, which is aimed at treating tumor indications [1][2]. Group 1: Licensing Agreement Details - The company will receive an upfront payment of $75 million upon signing the licensing agreement [1]. - Regulatory milestone payments could total up to $80.01 million based on the achievement of various regulatory milestones for the licensed product in the region [1]. - Commercial sales milestone payments could reach approximately $233 million, contingent on the annual net sales levels of the licensed product in the region [1]. - The company will also receive royalties calculated as a double-digit percentage of the annual net sales of the licensed product in the region [1]. Group 2: Product Information and Market Expansion - Hanshuo® (sulunab injection) is an innovative anti-PD-1 monoclonal antibody developed by the company, already approved for multiple indications in mainland China, including treatments for various types of lung cancer and esophageal squamous cell carcinoma [2]. - The product has also received approvals in several countries/regions, including the EU, UK, and India, and has been granted orphan drug designation by regulatory authorities in the US, EU, Switzerland, and South Korea [2]. - The company is advancing multiple clinical trials for Hanshuo® and related combination therapies globally, covering a wide range of cancers [2]. - The collaboration with Eisai is expected to enhance the company's product accessibility and recognition in international markets, thereby creating conditions for sustained revenue growth [2].

Core Viewpoint - The company has entered into a licensing agreement with Eisai Co., Ltd. for the development, production, and commercialization of its innovative anti-PD-1 monoclonal antibody, Hanshuo® (sulunlimab injection), in Japan, which is expected to enhance the product's international market accessibility and recognition, thereby creating conditions for sustained revenue growth [1][3]. Group 1: Licensing Agreement Details - The company will grant Eisai an exclusive license to commercialize the licensed product in the specified region and field [1] - Eisai will pay the company a total of $75 million as an upfront payment, up to $80.01 million in regulatory milestone payments, up to $233.33 million in commercial sales milestone payments based on annual net sales, and a royalty fee calculated as a double-digit percentage of annual net sales [1] Group 2: Product Information and Market Potential - Hanshuo® has been approved for various indications in China, including first-line treatment for squamous non-small cell lung cancer (sq-NSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsq-NSCLC) [2] - The product has also received approvals in multiple countries and regions, including the EU, UK, and several Southeast Asian countries, and has been granted orphan drug designation in the US and other regions [2] - The global sales of PD-1 targeted monoclonal antibody drugs are projected to reach approximately $45.7 billion in 2024, indicating significant market potential for the licensed product [3]

Core Viewpoint - The company has received approval from the National Medical Products Administration (NMPA) for clinical trial applications of HLX43 in combination with HLX07 and Hanshuo® for the treatment of advanced solid tumors [1][2] Group 1: Clinical Trial Approvals - The clinical trial application for HLX43, a PD-L1 targeted antibody-drug conjugate, in combination with HLX07 and Hanshuo® has been approved by NMPA [1] - The company plans to conduct the relevant clinical trials within China once conditions are met [1] Group 2: Clinical Data and Product Development - Phase 1 clinical data for HLX43 will be presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting and the 2025 World Lung Cancer Conference (WCLC), showing promising safety and preliminary efficacy in non-small cell lung cancer (NSCLC) and other solid tumors [2] - HLX07, an innovative biopharmaceutical targeting EGFR, has shown good safety and tolerability in a 1b/2 phase clinical study for advanced solid tumors conducted in February 2023 [2] - Hanshuo®, an innovative anti-PD-1 monoclonal antibody developed by the company, has been approved for multiple indications in mainland China, including first-line treatment for squamous NSCLC and extensive-stage small cell lung cancer [2] - The New Drug Application (NDA) for Hanshuo® in combination with chemotherapy for neoadjuvant/adjuvant treatment of gastric cancer has been accepted by NMPA and is under priority review [2]

Core Viewpoint - The company has received acceptance for the New Drug Application (NDA) of its self-developed drug Hanshuan® (sulizumab injection) for a new indication in the treatment of PD-L1 positive, resectable gastric cancer patients, which is now prioritized for review by the National Medical Products Administration (NMPA) [1][2] Group 1 - The NDA acceptance is based on a Phase 3 clinical study that demonstrated the efficacy and safety of Hanshuan® combined with chemotherapy compared to placebo combined with chemotherapy, significantly extending the event-free survival (EFS) of patients [1] - The study met the predefined superiority criteria and showed better safety and tolerability compared to standard chemotherapy [1] Group 2 - Hanshuan® is an innovative anti-PD-1 monoclonal antibody that has already been approved for various indications in mainland China, including first-line treatment for squamous non-small cell lung cancer (sq-NSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsq-NSCLC) [2] - The drug has also received orphan drug designation in several regions, including the US, EU, Switzerland, and South Korea, and is approved in multiple countries such as the EU, UK, Indonesia, Cambodia, Thailand, Malaysia, Singapore, and India [2] - The company is actively advancing multiple clinical trials for Hanshuan® and related combination therapies globally, covering a wide range of indications including lung cancer, esophageal cancer, head and neck squamous cell carcinoma, colorectal cancer, and gastric cancer [2]

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].