本文源自：金融界 上海复宏汉霖生物技术股份有限公司(2696.HK)是一家国际化的创新生物制药公司,致力于为全球患者提 供可负担的高品质生物药,产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域,已在中国上市5款产品,在国 际上市2款产品,19项适应症获批,7个上市申请分别获中国药监局、美国FDA和欧盟EMA受理。自2010年 成立以来,复宏汉霖已建成一体化生物制药平台,高效及创新的自主核心能力贯穿研发、生产及商业运营 全产业链。公司已建立完善高效的全球创新中心,按照国际药品生产质量管理规范(GMP)标准进行生产 和质量管控,不断夯实一体化综合生产平台,其中,上海徐汇基地和松江基地(一)均已获得中国和欧盟GMP 认证。复宏汉霖前瞻性布局了一个多元化、高质量的产品管线,涵盖50多个分子,并全面推进基于自有抗 PD-1单抗H药汉斯状的肿瘤免疫联合疗法。继国内首个生物类似药汉利康(利妥昔单抗)、中国首个自主 研发的中欧双批单抗药物汉曲优(曲妥珠单抗,欧洲商品名:Zercepac)、汉达远(阿达木单抗)和汉贝泰(贝伐 珠单抗)相继获批上市,创新产品汉斯状(斯鲁利单抗)已获批用于治疗微卫星高度不稳定(MSI-H)实体瘤、 鳞状 ...

Core Insights - Shanghai Junshi Biosciences Co., Ltd. (复宏汉霖) has successfully transitioned from a pre-profit biotech firm to a profitable entity, achieving a net profit of 546 million yuan in 2023 and a 50.3% year-on-year growth to 820 million yuan in 2024, marking it as the first company to achieve full profitability under the Hong Kong Stock Exchange's Chapter 18A for pre-profit biotech firms [1][3][6] Group 1: Business Strategy - The company has adopted a differentiated and global strategy, rapidly commercializing its innovative products and establishing a significant presence in the global market [1][3] - Junshi's innovative drug, Hanshu, has become the first and only product in the EU to potentially secure a market exclusivity period of up to 10 years [1][6] - The company has successfully launched four products in over 50 countries, reaching 750,000 patients by the end of 2024 [1][8] Group 2: R&D and Innovation - Junshi has focused on high-risk, differentiated indications for drug development, targeting less crowded markets such as small cell lung cancer and gastric cancer [5][6] - The company is advancing its PD-L1 targeted antibody-drug conjugate (ADC) project, HLX43, which is the second globally to enter clinical trials, exploring efficacy against five solid tumors [4][5] - AI technology is being utilized to shorten R&D timelines and reduce costs, with successful projects including the development of a second-generation hyaluronidase [7][8] Group 3: Global Expansion - Junshi has submitted 25 registration applications globally in 2024, receiving 17 approvals across various regions including China and the US [6][8] - The company has established a strong international presence, with a focus on markets in the US, EU, Japan, Southeast Asia, the Middle East, and Latin America [6][8] - Collaborations with global partners such as Abbott and Dr. Reddy's are being pursued to enhance early pipeline development and create a collaborative ecosystem [7][8]

Investment Rating - The report maintains a "Buy" rating for the company, with a target price not specified [5]. Core Insights - The company has signed a collaboration and licensing agreement with Sandoz AG for the development and commercialization of its product HLX13, a recombinant anti-CTLA-4 monoclonal antibody, in several regions including the US and Europe, with potential payments up to $191 million [1]. - Sandoz, a leader in biosimilars, is expected to enhance the commercialization of HLX13, which is the first CTLA-4 monoclonal antibody biosimilar to enter Phase III clinical trials globally [2]. - The company has established a strong global presence through multiple licensing agreements for its biosimilars, generating significant upfront payments totaling $64 million in 2025 alone [3]. - The company plans to present clinical data for its innovative drugs HLX43 and HLX22 at the 2025 ASCO conference, with HLX43 expected to become a key product and HLX22 potentially changing the standard treatment for HER2-positive gastric cancer [4]. Financial Projections - The company is projected to achieve total revenues of 5.873 billion, 5.970 billion, and 7.125 billion yuan for the years 2025, 2026, and 2027, respectively, with year-on-year growth rates of 2.60%, 1.64%, and 19.36% [5]. - The net profit attributable to shareholders is expected to be 827 million, 797 million, and 1.122 billion yuan for the same years [5].

Investment Rating - The report maintains a "Buy" rating for the company, with a target price not specified [5]. Core Insights - The company has signed a collaboration and licensing agreement with Sandoz AG for the development and commercialization of its product HLX13, a recombinant anti-CTLA-4 monoclonal antibody, in several regions including the US and Europe, with potential payments up to $191 million [1]. - Sandoz, a leader in biosimilars, is expected to enhance the commercialization of HLX13, which is the first CTLA-4 monoclonal antibody biosimilar to enter Phase III clinical trials globally [2]. - The company has established a strong global presence through multiple licensing agreements for its biosimilars, generating significant upfront payments, showcasing its capabilities in overseas markets [3]. - The company plans to present clinical data for its innovative drugs HLX43 and HLX22 at the 2025 ASCO conference, with HLX43 expected to become a key product and HLX22 potentially changing the standard treatment for HER2-positive gastric cancer [4]. Financial Projections - The company is projected to achieve revenues of 5.873 billion, 5.970 billion, and 7.125 billion yuan for the years 2025, 2026, and 2027, respectively, with year-on-year growth rates of 2.60%, 1.64%, and 19.36% [5]. - The net profit attributable to shareholders is expected to be 827 million, 797 million, and 1.122 billion yuan for the same years [5].

Core Viewpoint - The company has entered into a collaboration and licensing agreement with Sandoz AG for the development, production, and commercialization of its investigational product HLX13 in specified regions [1] Group 1: Agreement Details - The agreement grants Sandoz AG rights to develop, produce, and commercialize HLX13 in the United States, 42 European countries, Japan, Australia, and Canada [1] - Sandoz AG will pay up to $191 million to the company, which includes an upfront payment of $31 million and milestone payments related to development [1]

Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 61.59 per share, compared to the current price of HKD 37.85 [6]. Core Insights - The company is entering a harvest period for its innovation and internationalization efforts, following significant progress in its pipeline and global expansion after privatization [1]. - The company has achieved historical profitability in the first half of 2023, with a revenue of HKD 25.01 billion, marking a year-on-year increase of 93.9% [6][25]. - The innovative drug segment, particularly the differentiated PD-1 drug, is expected to drive significant revenue growth in the medium term [4][6]. Summary by Sections 1. Commercialization and Innovation - The company has established itself as a pioneer in biosimilars, with its first product, Rituximab, approved in 2019, and is now focusing on expanding its innovative drug portfolio [14][15]. - The revenue from biosimilars reached HKD 36.3 billion in 2024, while the innovative drug segment generated HKD 13.1 billion, accounting for 22.86% of total sales [29]. 2. HLX43: Potential in PD-L1 ADC - HLX43 is the second PD-L1 ADC drug to enter clinical trials globally, showing significant potential as a future pillar in the company's pipeline [2]. - The drug is currently in clinical phase II and has demonstrated promising data, indicating a strong confidence from the company in its development [2]. 3. HLX22: Potential to Change HER2 Positive Gastric Cancer Treatment - HLX22 has shown superior clinical benefits compared to standard treatments in HER2 positive gastric cancer, with ongoing international phase III trials [3]. - The drug has received orphan drug designation in the US, highlighting its potential in the gastric cancer treatment landscape [3]. 4. Differentiated PD-1 Drug: Surulitinib - Surulitinib is positioned to address unmet clinical needs in small cell lung cancer, with expected rapid market uptake upon approval [4]. - The drug has shown optimal data in clinical trials, indicating a strong commercial potential in various indications [4]. 5. Internationalization and Market Expansion - The company has a strong track record in internationalization, with significant licensing agreements and expected revenue growth from overseas markets starting in 2025 [5]. - The company aims to leverage its first-mover advantage in biosimilars and innovative drugs to maximize market value domestically and internationally [5]. 6. Profit Forecast - Revenue projections for 2025-2027 are estimated at HKD 58.73 billion, HKD 59.70 billion, and HKD 71.25 billion, with corresponding net profits of HKD 8.27 billion, HKD 7.97 billion, and HKD 11.22 billion [6]. - The company is expected to continue its upward trajectory in profitability, driven by its innovative pipeline and effective cost management strategies [6][32].

Investment Rating - The investment rating for the company is "Buy" with a target price of HKD 61.59 per share, maintaining the rating from previous assessments [6]. Core Views - The report emphasizes that the company is entering a harvest period for its innovation and internationalization efforts, following significant progress in its pipeline and global expansion after privatization [1]. - The company has achieved historical profitability in the first half of 2023, with a notable increase in revenue and net profit, indicating strong growth potential [6][25]. Summary by Sections 1. Commercialization and Innovation - The company has established itself as a pioneer in biosimilars, with its first product, Rituximab, being the first biosimilar approved in China [14]. - The company is focusing on innovative drugs and has seen significant sales growth, with projected revenues of HKD 57.24 billion in 2024, reflecting a year-on-year increase of 6.06% [25][29]. 2. HLX43: PD-L1 ADC Development - HLX43 is the second PD-L1 ADC to enter clinical trials globally, showing promising potential for treating patients who do not respond to PD-1/PD-L1 therapies [2]. - The report highlights the urgent clinical need for effective treatments in EGFR wild-type NSCLC, where current therapies primarily rely on chemotherapy [37]. 3. HLX22: HER2 Positive Gastric Cancer - HLX22 has demonstrated significant clinical benefits in treating HER2 positive gastric cancer, with ongoing international trials expected to enhance its market position [3]. - The drug has received orphan drug designation in the US, indicating its potential as a key revenue driver for the company [3]. 4. Differentiated PD-1 SruLi monoclonal antibody - The company is advancing its differentiated PD-1 monoclonal antibody, SruLi, targeting unmet clinical needs in small cell lung cancer, with expected revenue of HKD 13.13 billion in 2024 [4]. - The report notes that SruLi has shown superior efficacy in clinical trials compared to existing treatments, positioning it for rapid market uptake [4]. 5. Internationalization and Market Expansion - The company has a strong track record in internationalization, with successful licensing agreements and product approvals in various global markets [5]. - The anticipated approval of SruLi in Europe and the US is expected to drive overseas revenue growth starting in 2025 [5]. 6. Financial Forecast - The company is projected to achieve revenues of HKD 58.73 billion, HKD 59.70 billion, and HKD 71.25 billion for the years 2025 to 2027, with corresponding net profits of HKD 8.27 billion, HKD 7.97 billion, and HKD 11.22 billion [6]. - The report indicates a significant improvement in the company's financial health, with a historical achievement of breakeven in 2023 [6][25].

Core Viewpoint - The company has entered into an exclusive licensing agreement with Alvogen Korea for the commercialization of its innovative anti-PD-1 monoclonal antibody, Hanshuo® (sulizumab injection), in South Korea [1][2]. Group 1: Product Information - Hanshuo® is an innovative anti-PD-1 monoclonal antibody developed by the company, approved for various indications in mainland China, including squamous non-small cell lung cancer (sqNSCLC), extensive small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsNSCLC) [2]. - The product has also received approvals in the European Union, Indonesia, Cambodia, and Thailand, and has been granted orphan drug designation by the FDA and the European Commission for small cell lung cancer [2]. Group 2: Market Potential - According to IQVIA MIDAS TM, the global sales of anti-PD-1 monoclonal antibodies are projected to reach approximately $45.55 billion in 2024 [3]. - The collaboration with Alvogen Korea is expected to enhance the company's product accessibility and recognition in international markets, contributing to sustained revenue growth [3]. Group 3: Commercialization Strategy - The company leads the sales and promotion of Hanshuo® in mainland China through its own commercialization team and has established partnerships for commercialization in Europe, India, Southeast Asia, the Middle East, North Africa, and the United States [3].

Core Viewpoint - The company has entered into a licensing agreement with Alvogen Korea Co., Ltd. for the exclusive commercialization of Hansizhuang (Sruvul monoclonal antibody injection) in South Korea [1] Financial Terms - Alvogen Korea will pay an upfront fee of $5 million [1] - Regulatory milestone payments will not exceed $9.5 million [1] - Commercial sales milestone payments will not exceed $97.5 million [1] - Tiered royalties based on annual net sales will range from 18% to 25% [1] Agreement Duration - The licensing agreement is effective from the date of signing and will remain valid for 10 years from the date of the first commercial sale of the licensed product [1]

Summary of Conference Call Records Company: 复宏汉霖 (Fuhong Hanlin) Key Points Industry Overview - The company is navigating potential drug tariff increases by lowering supply prices and patent licensing fees to maintain product competitiveness and reduce cost burdens, ensuring effective overseas market operations [1][2][3] - The company is considering transferring production rights to overseas partners to utilize manufacturing bases in low-tax countries or establishing an antibody company in Saudi Arabia to mitigate tariff impacts on profits [1][4] Clinical Trials and Regulatory Environment - Despite strict U.S. data protection policies, the impact on the company's clinical trials in the U.S. is limited due to the small sample sizes typically involved, which do not require large-scale genetic testing [1][8] - The new U.S. regulations on cross-border data transmission, effective April 8, 2025, may affect Chinese companies conducting clinical trials in the U.S., but the specific impacts are still to be observed [7] Product Development and Market Strategy - The company plans to launch eight biopharmaceuticals in the U.S. market over the next four years, including already marketed products and those expected to be approved soon [1][14] - The company aims to drive global first-to-market strategies for biosimilars while maintaining a dual strategy of innovative drugs and biosimilars [28] Revenue and Royalty Structure - The company's royalty range typically falls between 25% and 35% of net sales, with a future inclination towards profit-sharing models that could reach up to one-third of net profits [1][12] - The overseas revenue expectations are tied to accounting standards that require revenue to be recognized over multiple years, indicating that cash income from business development deals is expected to increase compared to the previous year [13] Market Position and Competitive Landscape - The company has established criteria for selecting overseas partners, focusing on global capabilities and strong performance in both mainstream and emerging markets [1][11] - The pricing of Chinese biosimilars is generally comparable to overseas markets, with specific examples showing stable pricing in China due to inclusion in medical insurance [18] Future Outlook - The company is not currently considering entering the medical insurance market for its product, thinking it has unique indications that warrant exclusivity [16] - The potential for collective procurement of biosimilars is anticipated to be low this year, with a possibility for next year, depending on whether it is led by individual provinces or at the national level [15] Challenges and Opportunities - The high cost of production in the U.S. is a significant barrier, leading most companies to avoid full production transfers to the U.S. despite some multinational companies announcing investments [5][6] - The company is actively expanding its international partnerships and plans to build its commercialization capabilities, particularly in Japan and the U.S. [28][29] Additional Insights - The company maintains a 100% success rate in delivering products, which enhances its credibility and attractiveness to potential partners [29] - The U.S. market remains a critical target for innovative drugs, with ongoing discussions about high drug prices and their implications for market access and innovation [25][24]