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]

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 就漢斯狀®與Alvogen Korea訂立的許可協議 A. 緒言 本公告由上海復宏漢霖生物技術股份有限公司（「本公司」）根據香港聯合交易 所有限公司證券上市規則（「上市規則」）第13.09條及香港法例第571章證券及 期貨條例第XIVA部之內幕消息條文（定義見上市規則）而作出。 本公司董事會欣然宣佈，本公司於2025年4月25日與Alvogen Korea Co., Ltd.（「Alvogen Korea」）訂立一份許可協議（「許可協議」），據此，本公司向 Alvogen Korea授出獨家許可，供其於韓國（「區域」）於領域（定義見下文）內 商業化漢斯狀® （斯魯利單抗注射液）（「許可產品」或「漢斯狀®」）。 B. 許可協議的主要 ...

近日，复星医药披露公告称，在2025年4月11日至17日期间，公司控股子公司复星医药产业与上海善 梧、无锡通善、舟山果运及Henlink分别签订转让协议，受让卖方合计持有的2103.43万股复宏汉霖非上 市股份，转让价款共计5.17亿港元。 本次增持完成后，集团持有复宏汉霖的股权比例将从59.56%增至63.43%。其中，复星医药产业受让的 无锡通善持有的466.67万股复宏汉霖非上市股份构成关联交易。 这是继私有化复宏汉霖未果后，复星医药再次对其出手。 2024年6月24日，复星医药抛出了一则关于拟以不超过54.07亿港元私有化复宏汉霖计划。彼时复宏汉霖 H股价格为18.84港元/股，私有化溢价达30.57%。不过，在今年1月复宏汉霖股东大会投票中，因独立H 股股东反对票占比超10%，导致私有化方案告终。 资料显示，复星汉霖是复星医药旗下专注于生物制药的重要子公司，公司业务涉及创新生物药，涵盖肿 瘤、自身免疫性疾病等多个领域。 值得一提的是，在增持复宏汉霖的同时，复星系正在抛售其它医药资产。今年2月，山河药辅发布公告 称，股东复星医药因经营需要拟减持公司不超过697.8万股股份。3月份，通过复星实业以1.2 ...

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]

Core Insights - The company Fuhong Hanlin has announced the completion of the first patient dosing in the Phase II clinical trial of its innovative anti-HER2 monoclonal antibody HLX22, in combination with Trastuzumab, for the treatment of HER2 low-expressing HR-positive locally advanced or metastatic breast cancer [1] Group 1 - The Phase II clinical study (HLX22-BC201) has been completed for the first patient in China [1] - The treatment area for HLX22 has expanded to include breast cancer, following its application in HER2-positive gastric cancer [1]

Core Insights - The article highlights the growth and global ambitions of Fuhong Hanlin, showcasing its achievements in providing affordable biopharmaceuticals to 750,000 patients globally and generating over 20 billion yuan in sales over the past four years [2] - Fuhong Hanlin is transitioning from a "follower" to a "definer" in the biopharmaceutical industry, with a focus on innovative drugs and breaking the monopoly of multinational pharmaceutical companies [4][5] - The company is leveraging strategic partnerships and advanced technology platforms to enhance its research and development capabilities, aiming to create a comprehensive "R&D-production-commercialization" loop [3][9] Company Growth and Market Strategy - Fuhong Hanlin has successfully launched six drugs, with four approved overseas, and is expanding its market presence in over 50 countries [2] - The company’s revenue from overseas markets is on the rise, supported by its "wall-breaking strategy" in regions like the EU and Japan [2][3] - The PD-1 monoclonal antibody, Hanshuang, has become the first approved treatment for extensive-stage small cell lung cancer globally, showcasing the company's innovative capabilities [4][5] Product Development and Innovation - The company has developed a diverse pipeline of approximately 50 molecules, including monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates (ADCs) [9] - Fuhong Hanlin's HLX22, targeting HER2-positive gastric cancer, demonstrates promising results in clinical trials, indicating its potential as a new first-line treatment option [12] - The company is also advancing its next-generation product, HLX43, a PD-L1 ADC drug, which shows significant efficacy in early trials for pancreatic and colorectal cancers [6] Technological Advancements - Fuhong Hanlin has established three major technology platforms to enhance its drug development process, including the Hinova TCE platform for T cell activation and the Hanjugator™ ADC platform to overcome traditional drug resistance [9][10] - The integration of AI in the drug development process has significantly reduced the research cycle for hyaluronidase from 18 months to 5 months, showcasing the company's commitment to innovation [12] Globalization and Strategic Partnerships - The company is strategically targeting six major global markets, with a focus on the U.S., EU, and Japan, while also establishing local partnerships in Southeast Asia, the Middle East, and Latin America [13][14] - Fuhong Hanlin has formed collaborations with notable entities, including Nobel laureate Carolyn Bertozzi, to develop dual-function antibodies and enhance its ADC product pipeline [14]

Transaction Overview - The company plans to acquire a total of 21,034,313 non-listed shares of Fuhong Hanlin at a price of HKD 24.60 per share, representing approximately 3.87% of the total shares outstanding as of the announcement date [2][7] - The total transaction value amounts to HKD 517,444,099.80, which is equivalent to approximately RMB [2][7] - Following the completion of this acquisition, the company's ownership in Fuhong Hanlin will increase from 59.56% to 63.43% [3][9] Related Party Transactions - The acquisition includes a related party transaction as the company’s executive director, Ms. Guan Xiaohui, is also a director of Wuxi Tongshan, which is a related party [3][9] - The shares acquired from Wuxi Tongshan amount to 4,666,667, constituting part of the related party transaction [3][9] Regulatory Compliance - The acquisition does not constitute a major asset restructuring as defined by the relevant regulations [4][10] - No approval from the board of directors or shareholders is required for this transaction [5][11] Company Background - Fuhong Hanlin, established in February 2010 and listed on the Hong Kong Stock Exchange in September 2019, focuses on the research, production, and sales of monoclonal antibody drugs [12] - As of the announcement date, Fuhong Hanlin has a total of 543,494,853 shares, including 163,428,541 H-shares and 380,066,312 non-listed shares [12] Financial Performance - As of December 31, 2024, Fuhong Hanlin reported total assets of RMB 1,059,752,000, equity attributable to shareholders of RMB 301,362,000, and total liabilities of RMB 758,390,000 [13] - For the year 2024, Fuhong Hanlin achieved revenue of RMB 572,445,000 and a net profit of RMB 82,047,000 [13] Seller Information - Wuxi Tongshan, one of the sellers, was established in May 2016 and has total assets of RMB 9,519,000 as of December 31, 2024 [14] - Other sellers include Shanghai Shanwu, Zhoushan Guoyun, and Henlink, each with varying business focuses and financial standings [15][16][17] Impact on the Company - The acquisition reflects the company's confidence in Fuhong Hanlin's growth and value, enhancing its stake in a key antibody technology platform [19]