Core Viewpoint - The company has initiated the first patient dosing of its self-developed biosimilar HLX17 in a multi-center Phase 1 clinical study for various resected solid tumors in mainland China, with plans to expand trials to the US, Europe, and Australia once conditions permit [1]. Group 1: Clinical Study Overview - The Phase 1 clinical study is a multi-center, randomized, double-blind, parallel-controlled trial aimed at evaluating the pharmacokinetics (PK), efficacy, safety, and immunogenicity similarity of HLX17 compared to KEYTRUDA in patients with various resected solid tumors, including non-small cell lung cancer, melanoma, and renal cell carcinoma [2]. - Eligible participants will be randomly assigned in a 1:1 ratio to either Group A, receiving HLX17 every three weeks, or Group B, receiving KEYTRUDA for the first eight cycles before switching to HLX17 [2]. - The primary endpoint of the study is the area under the serum drug concentration-time curve from 0 to 21 days (AUC0-21d) after the first dose, along with the steady-state serum drug concentration-time curve area (AUCss) after the sixth dose [2]. Group 2: Product and Market Potential - HLX17 is a biosimilar of pembrolizumab with potential indications including melanoma, non-small cell lung cancer, esophageal cancer, head and neck squamous cell carcinoma, colorectal cancer, hepatocellular carcinoma, cholangiocarcinoma, triple-negative breast cancer, and other tumors with specific genetic defects [3]. - The mechanism of action involves blocking the interaction between PD-1 and its ligands PD-L1 and PD-L2, thereby enhancing the immune response against tumor cells [3]. - The clinical trial application for HLX17 was approved by the National Medical Products Administration (NMPA) in September 2024, and the Investigational New Drug (IND) application for the Phase 1 trial in the US was approved by the FDA in September 2025 [3].

Core Viewpoint - The company has completed the first patient dosing in an international multicenter Phase 1 clinical study of its self-developed biosimilar HLX17, aimed at evaluating its pharmacokinetics, efficacy, safety, and immunogenicity compared to KEYTRUDA in patients with various resected solid tumors [2] Group 1 - The clinical study is a multicenter, randomized, double-blind, parallel-controlled Phase 1 trial [2] - The study focuses on patients with multiple resected solid tumors [2] - HLX17 is a recombinant humanized monoclonal antibody targeting PD-1 [2]

Core Viewpoint - The company has announced the completion of the first patient dosing in an international multicenter Phase 1 clinical study of its self-developed biosimilar HLX17 for various resected solid tumors in mainland China, excluding Hong Kong, Macau, and Taiwan [1] Group 1 - The biosimilar HLX17 is a recombinant humanized monoclonal antibody targeting PD-1 [1] - The company plans to conduct the international multicenter clinical trial in other countries/regions such as the United States, Europe, and Australia once conditions are met [1]

（股份代號：2696） 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） 自願公告 帕博利珠單抗生物類似藥HLX17 （重組抗PD-1人源化克隆抗體注射液） 在多種已切除實體瘤患者中開展的國際多中心1期臨床研究 於中國境內完成首例患者給藥 A. 緒言 D. 市場情況 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，本公司自主研發的帕博利珠單抗 生物類似藥HLX17（重組抗PD-1人源化克隆抗體注射液）（「HLX17」）在多種 已切除實體瘤患者中開展的國際多中心1期臨床研究於中國境內（不包括中國 港澳台地區）完成首例患者給藥。本公司亦將於條件具備後於美國、歐洲及 澳大利亞等國家/地區開展該國際多中心臨床試驗。 ...

Core Viewpoint - Shanghai Fuhong Hanlin Biotechnology Co., Ltd. has received marketing authorization from the European Commission for its biosimilar drug, Duzallo, in two specifications, which covers all indications approved for the original product in the EU [2] Group 1 - The approved specifications for Duzallo are 60mg/mL and 120mg/1.7mL [2] - The approval is seen as a significant achievement for the company and its partners in meeting the needs of European patients and healthcare systems [2] - The company emphasizes its commitment to scientific excellence and product quality, building on its previous approval in the United States [2]

Core Viewpoint - The approval of BILDYOS and BILPREVDA by the European Commission marks a significant milestone for the company, enhancing its international presence and product influence in the market [1] Product Approval - BILDYOS (60mg/mL) is indicated for the treatment of osteoporosis in postmenopausal women and men at high risk of fractures, as well as for bone loss related to hormone ablation in prostate cancer patients and long-term systemic glucocorticoid treatment in adult patients at high risk of fractures [1] - BILPREVDA (120mg/1.7mL) is indicated for the prevention of skeletal-related events in adults with advanced bone malignancies and for the treatment of patients with giant cell tumors of bone that are unresectable or may lead to severe functional impairment post-surgery, including adults and skeletally mature adolescents [1] International Market Recognition - The approval in the EU follows the previous approval in the United States, representing further recognition of the company's products in major international markets, which will facilitate the company's internationalization efforts and enhance the global influence of its products [1]

Company News - SF Holding (06936.HK) reported a total revenue of 24.787 billion yuan from its express logistics business in August, representing a year-on-year growth of 7.86% [2] - Guohao Group (00053.HK) announced its annual results for the year ending June 30, 2025, with revenue of 24.4 billion HKD, a year-on-year increase of 9%, and a net profit of 4.03 billion HKD, up 13% year-on-year [2] - Jieli Trading Treasure (08017.HK) launched the Deep Trade AI Agent, an intelligent trading system [2] - Innovent Biologics (01801.HK) received approval from the National Medical Products Administration for Masitinib to be used for blood sugar control in adult patients with type 2 diabetes [2] - Datang New Energy Group (00559.HK) issued a profit warning, expecting an annual net profit of 30 to 35 million HKD [2] - Zhonghuan New Energy (01735.HK) plans to collaborate with Ant Blockchain Technology (Shanghai) in the fields of new energy digital assets and new energy artificial intelligence ecosystem [2] - Fuhong Hanlin (02696.HK) received approval from the European Commission for the HLX14 product for the treatment of osteoporosis in specific populations [2] - Zhaoyan New Drug (06127.HK) subscribed to a financial product from Industrial and Commercial Bank of China worth 40 million yuan [2] Buyback Activities - Tencent Holdings (00700.HK) repurchased 857,000 shares at a cost of 551 million HKD, with repurchase prices ranging from 638.5 to 647 HKD [2] - HSBC Holdings (00005.HK) spent approximately 160 million HKD to buy back about 1.49 million shares, with repurchase prices between 106.9 and 107.6 HKD [3] - Shango Holdings (00412.HK) repurchased 3.7 million shares at a cost of approximately 22.623 million HKD, with repurchase prices ranging from 6.08 to 6.2 HKD [3]

Core Viewpoint - The European Commission has approved two biosimilars of denosumab, BILDYOS and BILPREVDA, developed by Fuhong Hanlin and Organon, marking a significant milestone in expanding treatment options for osteoporosis and related conditions in Europe [1] Group 1: Product Approval - The approval includes BILDYOS (60 mg/mL) and BILPREVDA (120 mg/1.7 mL), which are biosimilars to PROLIA and XGEVA, respectively, covering all indications approved for the original products in the EU [1] - With this approval, Fuhong Hanlin now has a total of four products approved in the EU [1] Group 2: Market Impact - The approval is expected to enhance accessibility to critical bone health treatments for millions of European patients, particularly women who are more affected by osteoporosis [1] - The launch of these biosimilars supports the sustainability of the European healthcare system by providing more treatment options for conditions related to bone loss [1] Group 3: Strategic Partnership - The approval is a result of the collaboration between Fuhong Hanlin and Organon, which signed a licensing and supply agreement in 2022, granting Organon exclusive commercialization rights for these biosimilars outside of China [2]

Core Viewpoint - The European Commission has approved the marketing authorization for two biosimilars of denosumab, BILDYOS® and BILPREVDA®, developed by Fuhong Hanlin in collaboration with Organon, marking a significant milestone in expanding treatment options for osteoporosis and related conditions in Europe [1][2]. Group 1: Product Approval - The approval includes BILDYOS® (60 mg/mL) and BILPREVDA® (120 mg/1.7 mL), which are biosimilars to PROLIA® and XGEVA®, respectively, covering all indications approved for the original products in the EU [1]. - With this approval, Fuhong Hanlin now has a total of four products approved in the EU [1]. Group 2: Market Impact - The approval of BILDYOS and BILPREVDA is expected to enhance accessibility to critical bone health treatments for millions of European patients, particularly women who are more affected by osteoporosis [1]. - The launch of these biosimilars supports the sustainability of the European healthcare system by providing more treatment options for conditions related to bone loss [1]. Group 3: Strategic Partnership - The collaboration between Fuhong Hanlin and Organon, established through a licensing and supply agreement in 2022, grants Organon exclusive commercialization rights for these biosimilars outside of China [2]. - This partnership is seen as a significant achievement in meeting the needs of European patients and healthcare systems [1].

Core Viewpoint - The European Commission has approved the marketing authorization for two biosimilars of denosumab, BILDYOS® and BILPREVDA®, developed by Fuhong Hanlin in collaboration with Organon, covering all indications of the original products in the EU [1] Group 1: Company Developments - Fuhong Hanlin's Chief Business Development Officer, Cao Ping, emphasized that this approval represents a significant achievement in meeting the needs of European patients and healthcare systems [1] - The approval of BILDYOS and BILPREVDA is based on a comprehensive review of data, including structural and functional analysis, clinical pharmacokinetics, and a clinical comparative study [1] Group 2: Product Characteristics - The clinical study demonstrated that BILDYOS and BILPREVDA are highly similar to the approved original product in terms of structure, biological activity, efficacy, safety, and immunogenicity characteristics [1]