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]

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 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。 | 產品/聯合療法 | 適應症 | 最新進展 | | --- | --- | --- | | HLX43 | 晚期/轉移性 | 於中國境內處於1期臨床試驗中 | | | 實體瘤 | （其中胸腺癌(TC)隊列為國際多 | | | | 中心試驗） | | | | 於美國、日本獲許可開展1期臨 | | | | 床試驗 | | HLX43 | 晚期非小細胞肺癌 | 於中國境內、美國、澳大利亞處 | | | (NSCLC) | 於2期臨床試驗中（國際多中心 | | | | 試驗） | | | | 於日本獲許可開展2期臨床試驗 | | HLX43單藥或 | 晚期/轉移性 | 轉移性結直腸癌(mCRC)、宮頸 | | 聯合治療 | 實體瘤 | 癌( ...

Core Viewpoint - The updates presented at WCLC regarding HLX43 and HLX07 indicate promising efficacy and safety profiles for these novel therapies in treating NSCLC, suggesting potential for significant market impact and investment opportunities [1][2][4]. Group 1: HLX43 Data Summary - HLX43 demonstrated high efficacy with an overall response rate (ORR) of 37.0% and a disease control rate (DCR) of 87.0% among evaluable patients [2] - In a subgroup analysis of EGFR wild-type non-squamous NSCLC patients, the confirmed ORR reached 46.7%, indicating HLX43's effectiveness is not reliant on PD-L1 expression levels [2][3] - The safety profile of HLX43 is favorable, with the most common grade ≥3 treatment-related adverse events (TRAEs) being anemia and leukopenia, both at 19.6%, and a low incidence of grade ≥3 thrombocytopenia at 3.6% [3] Group 2: HLX07 Data Summary - HLX07 combined with PD-1 inhibitor showed a median progression-free survival (mPFS) of 17.4 months in the high-dose group, significantly exceeding the standard therapy's mPFS of around 7 months [4] - The study involved patients with high EGFR expression (H score ≥150) and no prior systemic treatment, indicating a targeted approach to therapy [4] - Safety data indicated manageable treatment-emergent adverse events (TEAEs), suggesting a good tolerability profile for HLX07 in combination therapy [4] Group 3: Financial Projections - The company forecasts total revenues of 58.73 billion, 59.70 billion, and 71.25 billion for 2025-2027, reflecting year-on-year growth rates of 2.60%, 1.64%, and 19.36% respectively [4] - Net profits attributable to shareholders are projected at 8.27 billion, 7.97 billion, and 11.22 billion for the same period, maintaining previous estimates [4] - The target price for the company's stock has been raised from 78.01 HKD to 120.87 HKD per share, reflecting an adjustment based on the expanded product advantages of HLX43 [4]

公司此次更新的HLX43患者数据来自于Ia期与Ib期2.0 mg/kg剂量组及2.5 mg/kg剂量组。共计56例NSCLC 患者入组Ia期及Ib期2.0和2.5 mg/kg剂量组，其中29例(51.8%)为鳞状，27例(48.2%)为非鳞状。其中，非 鳞状NSCLC患者中位既往治疗线数为2，鳞状NSCLC患者中位既往治疗线数为3。在四线及以后的鳞状 NSCLC患者(n=28)中，HLX43的ORR为28.6%，DCR为82.1%，较标准治疗药物多西他赛(ORR=12.8%) 展现出显著的临床获益。值得关注的是，既往接受过多西他赛治疗的三线及后线NSCLC患者 (n=10)ORR达30.0%，DCR为80%;接受2 mg/kg剂量HLX43治疗患者(n=15)ORR达40.0%，DCR为73.3%， 提示HLX43在肺鳞癌后线治疗中的重要潜力。在三线及以后的非鳞状NSCLC人群中(n=26)，ORR达 46.2%，DCR为96.2%。 （原标题：招商证券：维持复宏汉霖(02696)"强烈推荐"评级 看好HLX43的成药潜力） 智通财经APP获悉，招商证券发布研报称，维持复宏汉霖(02696)"强烈推荐"评级。 ...