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。 ...

值得关注的是，EGFR野生型非鳞状NSCLC患者(n=15)的经确认客观缓解率(cORR)为46.7%，DCR达 93.3%。接受2.5mg/kg剂量HLX43治疗的患者(n=5)cORR高达60.0%，DCR为80%，彰显HLX43在非鳞状 NSCLC患者人群中更为显著的疗效优势。安全性方面，最常见的≥3级治疗相关不良事件(TRAEs)为贫血 (19.6%)、白细胞计数减少(19.6%)、中性粒细胞计数减少(16.1%)及淋巴细胞计数减少(12.5%)，血小板计 数减少仅3.6%。与此前在2025ASCO上披露的安全性一致，HLX43血液学毒性较低，延续了良好的安全 性，支持未来扩展至一线疗法及联合治疗方案。 该行指，目前复宏汉霖正全力推进HLX43的临床开发进程，已在全球入组超过300例患者，并在中国、 美国、日本等多国顺利推进患者入组。同时公司正在积极探索HLX43在多种实体瘤中的治疗潜力，包 括宫颈癌、肝细胞癌、食管鳞癌、头颈鳞癌、鼻咽癌、结直肠癌、胃癌/胃食管交界部癌等，持续挖掘 治疗潜力。单药之外，HLX43联用其他产品的临床试验也正在进行中，进一步探索"ADC+IO"的协同抗 肿瘤疗效。 公司此 ...

Group 1 - The report highlights that the overall fund inflow into stock ETFs shows a reverse correlation with the market trend, indicating a lag in retail investor sentiment and behavior during market uptrends [2][24][25] - It notes that since the beginning of the year, net inflows have been particularly strong in technology growth, non-bank financials, and certain core assets [2][24] - The report suggests that while high levels of ETF fund inflows do not correlate with significant stock price increases, the pricing power of ETFs has been increasing from May to September, indicating a shift towards more informed investment behavior [2][24][26] Group 2 - The fixed income section discusses the current state of the bond market, indicating that without a strong configuration of buyers, the market remains in a state of fluctuation, particularly for long-term bonds [3][32] - It emphasizes that the lack of demand from banks and insurance companies for long-term bonds is a persistent issue, compounded by increased supply pressures [3][32][34] - The report projects that the yield on 10-year government bonds may face resistance in the range of 1.80%-1.90%, while the 30-year bonds do not show signs of reaching a peak yet [3][34] Group 3 - The report on the chemical industry indicates that the revenue and net profit of listed companies in the basic chemical sector showed slight year-on-year growth in the first half of 2025, with total revenue reaching 1.12 trillion yuan, up 3.1% [8] - It highlights that the second quarter of 2025 saw a slight increase in revenue but a decrease in profit margins, indicating a challenging environment for profitability [8] - The report notes a significant decline in the growth rate of construction projects, suggesting a potential bottoming out of profitability in the sector [8] Group 4 - The report on Tonghe Technology indicates that the company is positioned to be a leader in the charging module sector, with expectations of significant growth driven by the data center HVDC power module market [7][22] - It forecasts revenue growth from 13.3 billion yuan in 2025 to 21.9 billion yuan by 2027, with net profit expected to increase significantly during the same period [7][22] - The report assigns a price-to-earnings ratio of 43x for 2026, suggesting a target price of 43.7 yuan per share, reflecting a positive outlook for the company's future performance [7][22] Group 5 - The report on electric power companies indicates that the investment in the power grid is expected to exceed 825 billion yuan in 2025, reflecting a significant increase in infrastructure spending [20] - It highlights the establishment of settlement companies to address renewable energy subsidy gaps, indicating a proactive approach to financing renewable energy projects [20] - The report suggests that investors should focus on companies involved in renewable energy operations and those transitioning from coal to renewable sources [20]

在全球生物制药行业竞争日益激烈的大环境下，复宏汉霖始终坚守初心，凭借自身的专业优势与不懈努 力，积极推动业务发展，在行业内逐步崭露头角。 复宏汉霖自成立以来，便致力于为全球患者提供高质量、可负担的生物药。公司以创新为驱动，不断加 大在研发领域的投入，搭建起了完善的一体化生物制药平台。从生物类似药的深入钻研，到创新药的积 极探索，复宏汉霖的研发管线日益丰富。在研发过程中，公司注重与国际先进水平接轨，严格遵循相关 法规和标准，确保每一个研发项目都具备科学性与可靠性。 在产品布局方面，复宏汉霖取得了一系列重要进展。截至目前，已有多款产品在中国成功获批上市，为 国内患者带来了更多治疗选择。同时，部分产品也成功获得全球市场准入，其覆盖范围不断扩大，惠及 众多不同地区的患者群体。在拓展全球市场的进程中，复宏汉霖通过与全球合作伙伴紧密协作，充分发 挥各自优势，加速产品的上市与推广。目前，已与 20 余家全球企业建立起稳固的合作关系，依托合作 伙伴的渠道与资源，推动产品能够更快、更广泛地触达全球患者。 在创新研发层面，复宏汉霖从未停下脚步。近期，公司自主开发的帕博利珠单抗生物类似药 HLX17 取 得重大突破。2025 年 ...

Core Insights - The company, Fuhong Hanlin, is making significant strides in the competitive global biopharmaceutical industry by focusing on high-quality and affordable biological drugs for patients worldwide [1][2] - Fuhong Hanlin has developed a comprehensive integrated biopharmaceutical platform, emphasizing innovation and substantial investment in research and development [1] - The company has successfully launched multiple products in China and gained global market access, expanding its reach to various patient groups [1] Group 1: Business Development - Fuhong Hanlin has established over 20 solid partnerships with global enterprises to accelerate product launch and promotion [1] - The company is committed to aligning its research with international standards and regulations to ensure scientific reliability in its projects [1] Group 2: Innovation and R&D - The recent breakthrough of HLX17, a biosimilar of Pembrolizumab, received FDA approval for clinical trials, marking a significant step towards global market entry [2] - HLX17 has shown similarity to the original Pembrolizumab through rigorous preclinical studies, including pharmacology and immunogenicity assessments [2] Group 3: Future Outlook - Fuhong Hanlin aims to enhance its R&D capabilities and optimize its product pipeline while increasing market promotion efforts for existing products [2] - The company is focused on advancing its ongoing projects to achieve more innovative outcomes, contributing to the development of the biopharmaceutical industry [2]

Core Viewpoint - Tianfeng Securities maintains a "Buy" rating for Junshi Biosciences (02696), projecting total revenue for 2025-2027 to be 5.873 billion, 5.970 billion, and 7.125 billion yuan, with year-on-year growth rates of 2.60%, 1.64%, and 19.36% respectively, and net profit attributable to shareholders to be 827 million, 797 million, and 1.122 billion yuan, keeping previous forecasts unchanged [1] Group 1 - HLX43 demonstrates high efficacy and low toxicity, with outstanding data for EGFR wild-type NSCLC presented at the WCLC conference [1][2] - The overall objective response rate (ORR) for evaluable patients is 37.0%, with a disease control rate (DCR) of 87.0% [2] - In a subgroup analysis of EGFR wild-type non-squamous NSCLC patients, the confirmed ORR reaches 46.7%, indicating HLX43's anti-tumor activity is not dependent on PD-L1 expression levels [2][3] Group 2 - HLX07 shows impressive efficacy, potentially providing a new approach for first-line treatment of EGFR high-expressing squamous NSCLC [4] - In a phase II dose exploration study, the high-dose group achieved a median progression-free survival (mPFS) of 17.4 months, significantly higher than the standard therapy's mPFS of around 7 months [4] - Safety profiles for both HLX43 and HLX07 are reported to be manageable, with most treatment-emergent adverse events (TEAEs) being controllable [4]

Core Viewpoint - Tianfeng Securities maintains a "Buy" rating for Junshi Biosciences (02696), projecting total revenue for 2025-2027 to be 5.873 billion, 5.970 billion, and 7.125 billion yuan, representing year-on-year growth of 2.60%, 1.64%, and 19.36% respectively, with net profit attributable to shareholders forecasted at 827 million, 797 million, and 1.122 billion yuan [1] Group 1 - HLX43 demonstrates high efficacy and low toxicity, with outstanding data for EGFR wild-type NSCLC presented at the WCLC conference [1][3] - In a study involving 56 NSCLC patients, the overall objective response rate (ORR) was 37.0%, and the disease control rate (DCR) was 87.0% [2] - Among patients with prior multiple lines of treatment, HLX43 showed significant advantages, particularly in EGFR wild-type non-squamous NSCLC patients, achieving a cORR of 46.7% [2] Group 2 - 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% [2] - The incidence of grade ≥3 thrombocytopenia is low at 3.6%, indicating manageable hematological toxicity [2] - A total of 21.4% of patients experienced immune-related adverse events (irAEs), with most being manageable [2] Group 3 - HLX07 shows promising efficacy in first-line treatment for EGFR high-expressing squamous NSCLC, with a median progression-free survival (mPFS) of 17.4 months in the high-dose group [4] - The standard mPFS for first-line squamous NSCLC therapies is around 7 months, making HLX07's results noteworthy [4] - Safety during treatment was reported to be good, with manageable treatment-emergent adverse events (TEAEs) [4]

Group 1 - The core point of the article is that Fuhong Hanlin (02696) is in negotiations with multinational pharmaceutical companies such as Johnson & Johnson and Roche to sell rights related to the targeted PD-L1 antibody-drug conjugate HLX43, potentially receiving several hundred million dollars in upfront payments and milestone payments based on the drug's performance [1][1][1] Group 2 - Fuhong Hanlin's stock price increased by over 9% during the trading session, with a current price of 82.75 HKD and a trading volume of 114 million HKD [1][1][1] - Morgan Stanley recently upgraded the ratings for Fosun Pharma (600196) A-shares and H-shares to "Overweight," raising the A-share target price to 42 CNY and the H-share target price to 33 HKD [1][1][1] - Morgan Stanley values Fuhong Hanlin at 72 billion CNY, significantly higher than its current market value of approximately 44 billion CNY, translating to a per-share value of 143-145 HKD, with 73% of this valuation attributed to core candidate drugs HLX43, HLX22, and serplulimab [1][1][1]