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].

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） 內幕消息公告 歐盟委員會(EC)批准 HLX14（地舒單抗，歐洲商品名：BILDYOS®以及BILPREVDA®） 兩個產品用於特定人群骨質疏鬆症治療等適應症 B. 歐盟委員會(EC)批准依據 此次批准主要是基於對HLX14（地舒單抗）（「HLX14」）與其參照藥(Prolia®) 一系列比對研究數據的全面審查，包括分析相似性研究及臨床比對研究。 這些研究數據充分證明了HLX14與其參照藥在質量、安全性和有效性方面 的高度相似。歐洲藥品管理局人用醫藥產品委員會(CHMP)生物類似藥指南 (CHMP/437/04 Rev1)允許相關臨床安全及療效數據外推至參照藥的其他已 批准適應症。2025年6月，本集團收到比利時聯邦藥品和保健產品管理局 (Fe ...

Core Viewpoint - Fosun Pharma's subsidiary, Hanhui, received EU approval for its self-developed injection products BILDYOS and BILPREVDA, targeting osteoporosis and related conditions [1] Group 1: Product Approval - The European Commission approved the marketing authorization for BILDYOS (60mg/mL) and BILPREVDA (120mg/1.7mL) [1] - These products are indicated for the treatment of osteoporosis in high-risk postmenopausal women and men, as well as for prostate cancer-related bone loss and other severe bone conditions [1] Group 2: Financial Investment and Projections - As of July 2025, the cumulative R&D investment for HLX14 is approximately RMB 323 million [1] - The projected global sales for the injection products in 2024 are estimated to be around USD 7.463 billion [1]

Group 1 - Fuhong Hanlin's CDK4/6 inhibitor, citric acid voraselis, has received approval for a new indication in China for HR+/HER2- locally advanced or metastatic breast cancer in adults, in combination with aromatase inhibitors as initial endocrine therapy [1] - The approval expands the usage scenarios for HR+/HER2- breast cancer patients, enhancing market competitiveness and enriching treatment options for breast cancer [1] Group 2 - Xuan Zhu Bio has passed the Hong Kong Stock Exchange hearing and is set to go public, with CICC as the sole sponsor [2] - The company has established a comprehensive internal R&D platform supporting a diverse and balanced pipeline, including products in the fields of digestion, oncology, and NASH [2] - The upcoming IPO is expected to accelerate its R&D process and help capture opportunities in a competitive pharmaceutical market [2] Group 3 - Hongxing Xianghe has completed nearly 100 million RMB in Pre-A round financing, led by Northern Light Venture Capital [3] - The funds will be used to advance existing pipelines in preclinical and clinical POC research, as well as to develop AI and organ-like platforms for drug development and evaluation [3] - The successful financing indicates strong interest from international capital, industry funds, and local governments in the company's innovative R&D model and early-stage results [3]

Company News - China Pacific Insurance (02601.HK) reported original insurance premium income of 217.05 billion yuan for the first eight months, a year-on-year increase of 13.2%. The original insurance premium income for Taiping Property Insurance was 142.809 billion yuan, a year-on-year increase of 0.4%. The total original insurance premium income is approximately 360 billion yuan [2] - Datang Renewable (01798.HK) achieved a cumulative power generation of approximately 23.53 million megawatt-hours in the first eight months, an increase of 13.04% year-on-year. In August, the power generation was 2.169 million megawatt-hours, a year-on-year increase of 27.5% [2] - Green Energy Technology Group (00979.HK) issued a profit warning, expecting an annual net loss of approximately 15 to 18 million Hong Kong dollars [2] - Timekeeper (02033.HK) issued a profit warning, expecting a loss attributable to shareholders of approximately 17 million Hong Kong dollars for the fiscal year 2025 [2] - Fuhong Hanlin (02696.HK) completed the administration of the first patient in Australia for the international multi-center phase II clinical study of HLX43 for the treatment of advanced non-small cell lung cancer (NSCLC) [2] - IFBH (06603.HK) entered into a foreign exchange contract with Citibank [2] Buyback Activities - Tencent Holdings (00700.HK) repurchased 848,000 shares at a cost of 550 million Hong Kong dollars, with buyback prices ranging from 636 to 664 Hong Kong dollars [3] - HSBC Holdings (00005.HK) repurchased 1.48 million shares at a cost of approximately 158 million Hong Kong dollars, with buyback prices between 106.4 and 106.9 Hong Kong dollars [3] - Hang Seng Bank (00011.HK) repurchased 200,000 shares at a cost of approximately 23.8 million Hong Kong dollars, with buyback prices ranging from 118.5 to 119.6 Hong Kong dollars [3] - MGM China (02282.HK) repurchased 1.2 million shares at a cost of 18.758 million Hong Kong dollars, with buyback prices between 15.50 and 15.77 Hong Kong dollars [3]

本研究为一项评估HLX43在晚期非小细胞肺癌(NSCLC)患者的开放、国际多中心2期临床试验，旨在评 估HLX43在晚期非小细胞肺癌(NSCLC)患者中的有效性和安全性。研究分为两个阶段：第一阶段将进行 剂量探索，以选择合适的HLX43剂量进行第二阶段研究;第二阶段为单臂、多中心2期临床研究。本研究 的主要研究目的为评估HLX43在晚期非小细胞肺癌(NSCLC)中的临床疗效;主要研究终点为由盲态独立 中心审查委员会(BICR)根据RECIST v1.1标准评估的客观缓解率。 复宏汉霖(02696)发布公告，近日，一项注射用HLX43(靶向PD-L1抗体偶联药物)(HLX43)在晚期非小细 胞肺癌(NSCLC)患者中开展的国际多中心2期临床研究已完成澳大利亚首例患者给药。该2期临床研究亦 正同步于中国境内(不包括港澳台地区，下同)与美国开展。 2025年9月，HLX43的1期临床更新数据于2025年世界肺癌大会(WCLC)大会上发布。研究结果显示， HLX43在晚期实体瘤、尤其是绝大多数接受过检查点抑制剂(CPI)和化疗治疗并失败的后线耐药非小细 胞肺癌(NSCLC)患者中，持续表现出高应答率，同时在所有剂量水 ...

Core Viewpoint - The company has initiated a Phase 2 clinical trial for HLX43, a targeted PD-L1 antibody-drug conjugate, in patients with advanced non-small cell lung cancer (NSCLC) [1][2] Group 1: Clinical Trial Details - The Phase 2 clinical trial is an open-label, international, multicenter study aimed at evaluating the efficacy and safety of HLX43 in advanced NSCLC patients [1] - The study consists of two stages: the first stage focuses on dose exploration to select an appropriate dose for the second stage, which is a single-arm, multicenter Phase 2 clinical study [1] - The primary objective of the study is to assess the clinical efficacy of HLX43, with the main endpoint being the objective response rate (ORR) evaluated by a blinded independent central review committee (BICR) according to RECIST v1.1 criteria [1] Group 2: Clinical Data and Efficacy - Preliminary data from the Phase 1 clinical trial presented at the 2025 World Lung Cancer Conference (WCLC) showed HLX43 has a 37.0% ORR and an 87.0% disease control rate (DCR) in advanced solid tumors, particularly in NSCLC patients who have failed prior checkpoint inhibitors and chemotherapy [2] - In NSCLC patients who had previously received docetaxel as third-line or higher treatment, the ORR was 30.0% [2] - In the EGFR wild-type non-squamous NSCLC population, HLX43 demonstrated an ORR of 46.7%, with a confirmed ORR of 60.0% in patients receiving a 2.5 mg/kg dose [2] - Among patients with brain metastases, the confirmed ORR was 36.4% with a DCR of 100.0% [2] - The ORR for PD-L1 positive (TPS ≥ 1%) and PD-L1 negative (TPS < 1%) patients was 34.4% and 38.1%, respectively [2] Group 3: Market Context - As of the announcement date, there are no approved PD-L1 targeted antibody-drug conjugates available in the global market [3]