本报讯 （记者金婉霞）9月19日，上海复宏汉霖生物技术股份有限公司（以下简称"复宏汉霖"）的微信 公众号显示，公司60mg/mL和120mg/1.7mL两规格的地舒单抗注射液已获得欧盟委员会（EC）的上市许 可，适应症覆盖了原研产品在欧盟已获批的所有适应症。 复宏汉霖首席商务发展官兼高级副总裁曹平表示，此次获批是复宏汉霖与合作伙伴强强联合、共同满足 欧洲患者和医疗系统需求的又一重要成果。"凭借对科学卓越与产品质量的始终坚守，我们在美国获批 的基础上不断前行，将这些生物类似药治疗方案带给全球更多有需要的患者。"曹平称。 （文章来源：证券日报） ...

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].

复宏汉霖(2696.HK)与Organon(OGN.US)今日联合宣布，欧盟委员会已批准地舒单抗注射液(60 复宏汉霖首席商务发展官兼高级副总裁曹平表示："此次获批是复宏汉霖与Organon强强联合、共同满足 欧洲患者和医疗系统需求的又一重要成果。凭借对科学卓越与产品质量的始终坚守，我们在美国获批的 基础上不断前行，将这些生物类似药治疗方案带给全球更多有需要的患者。" BILDYOS和BILPREVDA的获批是基于一整套全面数据的审查，其中包括结构与功能分析数据、临床药 代动力学数据，以及一项临床对比研究。研究表明，BILDYOS和BILPREVDA在结构、生物活性以及疗 效、安全性和免疫原性特征(蛋白和其他生物药物诱发免疫应答或免疫相关事件的能力)方面与欧盟已批 准的另一种生物药(即"原研产品")高度相似。 mg/mL)BILDYOS®(denosumab)和地舒单抗注射液(120mg/1.7mL)BILPREVDA®(denosumab)的上市许 可，两款产品分别为PROLIA®(地舒单抗)和XGEVA®(地舒单抗)的生物类似药，覆盖原研产品在欧盟已 获批的所有适应症。 ...

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][2] Group 1: Product Approval - BILDYOS and BILPREVDA have received centralized marketing authorization in all EU member states and EEA countries, which includes Iceland, Liechtenstein, and Norway [1] - BILDYOS is indicated for the treatment of osteoporosis in high-risk postmenopausal women and men, as well as for bone loss related to prostate cancer and long-term systemic glucocorticoid therapy [1] - BILPREVDA is indicated for the prevention of skeletal-related events in adults with advanced bone malignancies and for the treatment of giant cell tumors of bone in adults and skeletally mature adolescents [1] Group 2: Regulatory and Clinical Background - The approval was based on a comprehensive review of comparative studies demonstrating the high similarity of HLX14 (the active ingredient in BILDYOS and BILPREVDA) to its reference drug, Prolia, in terms of quality, safety, and efficacy [2] - The company received two GMP certificates from the Belgian Federal Agency for Medicines and Health Products in June 2025, confirming compliance with EU GMP standards for the production line of HLX14 [2] - In July 2025, HLX14 received a positive opinion from the EMA's Committee for Medicinal Products for Human Use, recommending the approval of the marketing authorization applications for BILDYOS and BILPREVDA [2]

Core Insights - The company, Fuhong Hanlin (复宏汉霖), has received approval from the European Commission for the marketing authorization applications (MAAs) of two products, BILDYOS and BILPREVDA, which are now authorized for sale in all EU member states and EEA countries [1][2] - BILDYOS is indicated for the treatment of osteoporosis in high-risk postmenopausal women and men, as well as for bone loss related to prostate cancer and long-term systemic glucocorticoid therapy [1] - BILPREVDA is indicated for the prevention of bone-related events in adults with advanced bone malignancies and for the treatment of giant cell tumors of bone in adults and skeletally mature adolescents [1] Product Details - BILDYOS (60mg/mL) is approved for three specific indications: 1. Treatment of osteoporosis in high-risk postmenopausal women and men 2. Treatment of bone loss in high-risk prostate cancer men related to hormone ablation 3. Treatment of bone loss in high-risk adult patients associated with long-term systemic glucocorticoid therapy [1] - BILPREVDA (120mg/1.7mL) is approved for two specific indications: 1. Prevention of bone-related events in adults with advanced bone malignancies 2. Treatment of giant cell tumors of bone in adults and skeletally mature adolescents [1] Market Context - The company’s biosimilar HLX14, a denosumab product, has also received approval in the U.S. for specific osteoporosis indications, covering all indications of the original product [2] - The global sales of denosumab are projected to be approximately $7.463 billion in 2024, indicating a significant market opportunity for the company’s products [2] - The approval of BILDYOS and BILPREVDA in the EU represents a further step in the company's international expansion and enhances the global influence of its product portfolio [2]

Core Viewpoint - The European Commission has approved Henlius and Organon's biosimilars BILDYOS® and BILPREVDA®, both of which are denosumab products, indicating a significant advancement in the biosimilars market [1] Group 1 - The approval of BILDYOS® and BILPREVDA® represents a strategic move for Henlius and Organon in expanding their product offerings in the biosimilars sector [1] - This approval is expected to enhance competition in the market for denosumab, which is used for conditions such as osteoporosis and certain cancers [1] - The introduction of these biosimilars may lead to cost savings for healthcare systems and patients, promoting greater access to treatment options [1]

Core Viewpoint - The approval of BILDYOS and BILPREVDA by the European Commission marks a significant milestone for the company, enhancing its international market presence and product influence [1][2]. Product Approval - BILDYOS (60 mg/mL) is approved for treating osteoporosis in high-risk postmenopausal women and men, bone loss in prostate cancer patients undergoing hormone ablation, and bone loss related to long-term systemic glucocorticoid treatment in high-risk adult patients [1]. - BILPREVDA (120 mg/1.7 mL) is approved for preventing bone-related events in adults with advanced bone malignancies and treating patients with giant cell tumors of bone that cannot be surgically removed or may lead to severe functional impairment [1]. Regulatory Basis - The approval is based on comprehensive reviews of comparative studies between HLX14 (the biosimilar) and its reference drug Prolia, demonstrating high similarity in quality, safety, and efficacy [2]. - The European Medicines Agency's guidelines allow extrapolation of clinical safety and efficacy data to other approved indications of the reference drug [2]. International Recognition - Following the approval in the United States, the EU approval of BILDYOS and BILPREVDA represents further recognition of the company's products in major international markets, supporting its globalization strategy [2].