港股生物医药股午后走强，荣昌生物(09995.HK)涨超8%，诺诚健华(09969.HK)涨超7%，百济神州 (06160.HK)涨超6%，科伦博泰生物(06990.HK)、复宏汉霖(02696.HK)均涨超5%。 ...

Core Insights - Henlius is a leading Chinese biopharmaceutical company focused on R&D with six products approved for marketing in China and four products successfully entering international markets [1][4] - The company's pipeline emphasizes oncology and autoimmune diseases, featuring innovative candidates like HLX43 (PD-L1 ADC) and HLX22 (anti-HER2 monoclonal antibody) [1][2] Product Development - HLX43 is the first PD-L1 ADC globally to enter Phase II clinical trials, showing promising efficacy with an objective response rate (ORR) of 75% in thymic squamous cell carcinoma (TSCC) patients and 40% in squamous non-small cell lung cancer (sqNSCLC) patients [1] - HLX22, a novel anti-HER2 monoclonal antibody, is expected to redefine the standard of care for first-line HER2-positive gastric cancer, with ongoing Phase III trials in combination with trastuzumab and chemotherapy [2] Market Performance - Hansizhuang (Serplulimab) has achieved rapid domestic sales growth, reaching Rmb1.31 billion in 2024, and has been approved in multiple international markets [3] - The company has successfully entered global markets with four products, including Hanlikang and Hanquyou, and has established collaborations for the commercialization of various biosimilars [4] Financial Projections - Revenue forecasts indicate growth to Rmb5.96 billion in 2025, Rmb6.36 billion in 2026, and Rmb7.02 billion in 2027, with net profits projected at Rmb790 million, Rmb900 million, and Rmb1.14 billion respectively [5]

港股生物医药概念今日大幅回升，荣昌生物(09995.HK)涨超7%，君实生物(01877.HK)涨超4%，泰格医 药(03347.HK)、再鼎医药(09688.HK)、复宏汉霖(02696.HK)等个股跟涨。 ...

Group 1 - The company has entered into a licensing agreement with FBD Biologics Limited, granting an exclusive license to develop, produce, commercialize, or otherwise utilize HCB101 and its derivative pharmaceutical products in specific fields and regions [1] - The licensing agreement is effective from the date of signing and will last until the expiration of the licensing product's patent rights, which is determined by the later of the following dates: (a) fifteen years from the first commercial sale of the licensed product; (b) the expiration date of the last valid claim of the patent covering the licensed product; and (c) the expiration of the market exclusivity period for the licensed product [1]

Group 1 - The core viewpoint is that Fuhong Hanlin (02696) has seen a significant stock price increase of over 6% following the announcement of a stock option plan and restricted share unit plan, which requires shareholder approval [1] - The board of directors approved the conditional grant of a total of 6.985 million stock options and 698.5 restricted share units to 279 participants, including 75,000 stock options and restricted share units to CEO Dr. Zhu Jun [1] - Fuhong Hanlin's PD-L1 ADC (HLX43) has entered the international multi-center Phase II clinical study for advanced non-small cell lung cancer patients, marking it as the first PD-L1 ADC to enter Phase II clinical trials globally [1] Group 2 - CMB International highlights Fuhong Hanlin's potential to evolve from a profitable biosimilar company to a leading player in the biopharmaceutical sector, with promising clinical data for several innovative drugs including HLX43 and Serplulimab [2] - The target price for Fuhong Hanlin has been raised from HKD 20.33 to HKD 61.98, maintaining a "Buy" rating due to the company's strong commercial performance of its products and ongoing FDA reviews for HLX14 and HLX11 [2] - The company is actively expanding its global biosimilar business through partnerships with pharmaceutical companies, which is expected to enhance overseas revenue sources [2]

Core Viewpoint - The company, a leading domestic biotechnology firm focused on research and development, has successfully launched six products in China and four products in international markets, with a strong pipeline in oncology and autoimmune diseases [1][4]. Product Pipeline - The company has six products approved for the domestic market, including four biosimilars and one innovative product [1]. - HLX43 is the first PD-L1 ADC to enter Phase II clinical trials globally, with promising efficacy and safety data reported at the 2025 ASCO annual meeting [2]. - HLX22, a novel anti-HER2 monoclonal antibody, shows potential to change the standard treatment for HER2-positive gastric cancer, with ongoing Phase III trials [3]. - The company’s product Hanshu (sruvulimab) has multiple approved indications and is the first PD-1 monoclonal antibody approved for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) [3]. International Market Expansion - The company has successfully launched four products in international markets, including Hanquyou and Hanlikang, across multiple countries [3]. - The company has established partnerships for global sales of its biosimilars, enhancing its international presence [3]. Financial Projections - Revenue projections for the company are estimated at 5.96 billion, 6.36 billion, and 7.02 billion yuan for 2025-2027, with net profits expected to reach 790 million, 900 million, and 1.14 billion yuan respectively [4]. - The target price for the company is set at 71.0 HKD, indicating a potential upside of 40% [4].

Investment Rating - The report maintains a "Buy" rating for the company with a target price of 78.01 HKD per share, indicating an expected return of over 20% within the next six months [4]. Core Insights - The company has approved a stock option plan and a restricted share unit plan, which will be subject to shareholder approval. A total of 6.985 million stock options and restricted share units have been conditionally granted to 279 participants, including 75,000 each to the CEO [1][2]. - The HLX43 PD-L1 ADC has completed dosing in an international Phase II clinical trial, marking it as the first PD-L1 ADC to enter this stage globally. Initial Phase I data showed promising safety and efficacy results in patients with advanced non-small cell lung cancer [3]. Financial Projections - The company is projected to achieve total revenues of 5.873 billion, 5.970 billion, and 7.125 billion HKD for the years 2025, 2026, and 2027, representing year-on-year growth rates of 2.60%, 1.64%, and 19.36% respectively. Net profits attributable to shareholders are expected to be 827 million, 797 million, and 1.122 billion HKD for the same years [4].

Investment Rating - The report initiates coverage with a "Buy" rating for the company [8][10]. Core Views - The company has a strong product pipeline with potential first-in-class (FIC) candidates, including HLX43 (PD-L1 ADC) and HLX22 (HER2 monoclonal antibody) [4][5][34]. - The company is expected to achieve significant revenue growth, with projected revenues of CNY 59.6 billion, CNY 63.6 billion, and CNY 70.2 billion from 2025 to 2027 [8][16]. - The target price is set at HKD 71.0, indicating a potential upside of 40% [8][14]. Summary by Sections Product Pipeline - The company has six products approved in China, including Hanshu (HLX10), four biosimilars, and one in-licensed product [4][25]. - HLX43 is the first PD-L1 ADC to enter Phase II clinical trials globally, with promising efficacy and safety data reported at the ASCO 2025 conference [4][39]. - HLX22 is expected to change the first-line treatment standard for HER2-positive gastric cancer, with ongoing Phase III trials [5]. Financial Projections - Revenue projections for 2025-2027 are CNY 59.6 billion, CNY 63.6 billion, and CNY 70.2 billion, with biosimilar sales contributing CNY 51.7 billion, CNY 55.7 billion, and CNY 58.1 billion respectively [9][16]. - The company is expected to achieve net profits of CNY 7.9 billion, CNY 9.0 billion, and CNY 11.4 billion during the same period [9][16]. Market Expansion - The company has successfully launched four products in international markets, including Hanshu in over 30 countries [7][25]. - The company has established multiple commercial partnerships for its biosimilars, enhancing its international market presence [30][31]. Clinical Development - The company is actively conducting multiple Phase II and III clinical trials for its innovative drugs, with HLX43 and HLX22 being key candidates [4][5][34]. - The company has a robust pipeline with over 10 innovative drugs and 10 biosimilars under development [26][28].

招银国际一举升复宏汉霖目标价至61.98港元 料创新药研发有庞大潜力 金十数据6月25日讯，招银国际发表研究报告指，复宏汉霖(02696.HK)有能力从一家正在盈利的生物类 似药公司，发展成为生物制剂领域的领先企业，包括HLX43、HLX22、斯鲁利单抗（Serplulimab）等多 款正在研发的创新药临床数据均表现良好，相信发展潜力庞大，因此目标价从20.33港元一举上调至 61.98港元，维持买入评级。招银国际认为，复宏汉霖正积极通过与药企合作，拓展全球生物类似药业 务，旗下汉曲优（曲妥珠单抗）及斯鲁利单抗商业化表现强劲，而HLX14和HLX11的上市许可申请目 前正获FDA审查当中，相信可开招海外收入来源。 ...

Core Viewpoint - The company has initiated a bridging trial in Japan for its drug Hanshuo® (sulunatuzumab injection) in combination with chemotherapy for the treatment of extensive-stage small cell lung cancer (ES-SCLC) patients, aiming to support future market approval in Japan [1][2] Group 1 - The bridging trial is a single-arm, open-label, phase 2 study conducted in Japan, where eligible patients will receive Hanshuo® combined with chemotherapy (carboplatin - etoposide) every three weeks [2] - The primary objective of the study is to evaluate the efficacy of Hanshuo® in combination with chemotherapy in first-line treatment of ES-SCLC patients, while secondary objectives include assessing safety, pharmacokinetics, and immunogenicity [2] - The main endpoint of the study is the response rate at 24 weeks, which includes complete response (CR) or partial response (PR), with secondary endpoints including overall survival (OS), progression-free survival (PFS), objective response rate (ORR), duration of response (DOR), quality of life, safety, pharmacokinetics, and immunogenicity metrics [2]