2025年，我们实现了从单品授权出海向体系化价值出海的质变，我们新增4款产品登陆海外市场，我们自主研发的H药 汉斯状®、HLX11、HLX14在欧美主 流市场接连获批，多产品矩阵在欧美主流市场协同推进，标志着我们的多产品矩阵已具备在全球生物药主流市场协同作战的能力。在广阔的新兴市场，H药 汉斯状®成为印度唯一获批小细胞肺癌的PD-1抑制剂，上市12天即惠及150余位患者。这一系列成功不仅是产品的胜利，也是复宏汉霖质量体系、临床数据 和注册策略获得全球监管机构系统性认可的证明，更印证了中国药企在全球主流医药市场实现系统性突破的实力。 背景介绍： 当2025年的日历翻至末页，生物医药产业正站在一个特殊的历史节点——这既是"十四五"的收官沉淀之年，更是"十五五"宏伟蓝图的启航之时。这一年，技 术狂飙与商业理性的碰撞、全球化布局与本土化深耕的平衡、"创新驱动"向"价值驱动"的范式转型，共同勾勒出2025年的行业主线。2026年，产业如何跨越 技术周期与资本周期的双重考验，在"健康中国"战略与全球创新格局双轨并行中，探寻可持续增长路径？思享启发思想，"生物医药大健康2026思享汇：双 轨并行・破局生长"重磅上线，与核心 ...

格隆汇12月2日丨复星医药(02196.HK)近日，上海复星医药(集团)股份有限公司控股子公司上海复宏汉 霖生物技术股份有限公司及其控股子公司自主研发的地舒单抗生物类似药HLX14(即重组抗RANKL全人 单克隆抗体注射液，申请注册分类：治疗用生物制品3.3类；以下简称"HLX14")的药品注册申请获国家 药品监督管理局受理。本次申报适应症为其参照药普罗力®(英文商品名：Prolia®)于中国境内已获批上 市的所有适应症。 ...

Core Viewpoint - Fosun Pharma's subsidiary Shanghai Fuhong Hanlin Biotech has had its drug registration application for the biosimilar HLX14 accepted by the National Medical Products Administration of China, targeting all indications approved for the reference drug Prolia in mainland China [1] Group 1 - The drug HLX14 is a biosimilar to Prolia, which has already been approved for marketing in the US, EU, and UK [1] - The application for HLX14 covers all indications that Prolia has been approved for in China, excluding Hong Kong, Macau, and Taiwan [1] - Two products under HLX14, BILDYOS and BILPREVDA, have received approval in the aforementioned regions, aligning with the indications of their reference products Prolia and XGEVA [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]

Group 1 - The core point of the news is that Shanghai Fosun Pharmaceutical (Group) Co., Ltd. has received approval from the European Commission for the marketing authorization applications (MAAs) of two biosimilar products, BILDYOS® and BILPREVDA®, in the European Union and certain EEA countries [1][2] Group 2 - The biosimilar HLX14 is developed for the treatment of osteoporosis in postmenopausal women at high risk of fractures, along with other indications consistent with the reference drug label [2] - The product is expected to receive approval in the United States by August 2025 for eight indications related to osteoporosis treatment, covering all indications approved for the reference product in the U.S. [2] - As of July 2025, the cumulative R&D investment for HLX14 is approximately RMB 323 million (unaudited) [2]

Group 1 - The core point of the news is that Shanghai Fosun Pharmaceutical (Group) Co., Ltd. has received approval from the European Commission for the marketing authorization applications (MAAs) of two biosimilar products, BILDYOS® and BILPREVDA®, in the European Union and certain EEA countries [1][2] Group 2 - The biosimilar HLX14 is developed for the treatment of osteoporosis in postmenopausal women at high risk of fractures, along with other indications consistent with the reference drug label [2] - The product is expected to receive approval in the United States by August 2025 for eight indications related to osteoporosis treatment, covering all indications approved for the reference product in the U.S. [2] - As of July 2025, the cumulative R&D investment for HLX14 is approximately RMB 323 million (unaudited) [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 - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., has received approval from the European Commission for the marketing authorization applications (MAAs) of two biosimilar products, BILDYOS® and BILPREVDA® [1] Group 1 - The approved products, BILDYOS® (60 mg/mL) and BILPREVDA® (120 mg/1.7 mL), are biosimilars of denosumab, intended for the treatment of osteoporosis in postmenopausal women at high risk of fractures [1] - The marketing authorization allows for the sale of these products in all EU member states as well as in Iceland, Liechtenstein, and Norway [1] - HLX14, the project code for these biosimilars, is developed independently by the group [1]

Core Viewpoint - Fosun Pharma's subsidiary, Fuhong Hanlin, has received EU approval for two denosumab injection products, BILDYOS® and BILPREVDA®, targeting osteoporosis treatment in high-risk postmenopausal women and men [1] Group 1 - The approved products are indicated for the treatment of osteoporosis in high-risk populations [1] - HLX14 has also been approved in the US for specific osteoporosis indications and its registration application in Canada has been accepted [1] - The commercialization rights for HLX14 have been granted to Organon LLC, with Fosun Pharma set to enjoy related rights under the licensing agreement [1]

Core Viewpoint - The company Fuhong Hanlin faced criticism from the Hong Kong Stock Exchange due to internal control failures and misappropriation of IPO funds, leading to a significant drop in stock price, followed by a partial recovery the next day [1][2]. Group 1: Company Actions and Consequences - On September 2, the company disclosed that it was reprimanded by the Stock Exchange, and its former CEO Liu Shigao was criticized and required to complete training on regulatory and legal issues before being eligible for future directorships [1][4]. - The investment management agreement signed by the company with Shangcheng Global, which involved the misallocation of IPO funds, was not in line with the intended use disclosed during the IPO process [3][7]. - The company approved management fees totaling $3.5 million over two years based on the investment management agreement, which was deemed inappropriate as it did not undergo proper board review [4][5]. Group 2: Financial Implications - As of the end of 2024, the company had an outstanding receivable of $66.36 million (approximately 477 million RMB) from Shangcheng Global, which has been fully impaired [5][6]. - The company reported that it had recovered $30.64 million from Shangcheng Global by the end of 2022 and an additional $20 million in the 2023 fiscal year [5]. Group 3: Governance and Management Changes - The company has experienced significant management turnover since 2019, with three CEOs and four CFOs, indicating instability within its leadership [8]. - Liu Shigao and Zhang Zidong, both involved in the investment management agreement, have since left the company, with Liu resigning in September 2020 and Zhang in December 2020 [8].