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。 （股份代號：2696） 本公司董事會欣然宣佈，近日，本公司與Sandoz AG（「Sandoz」）訂立一份許 可協議（「許可協議」），據此，本公司向Sandoz授出獨家許可，供其於美國、 約定的歐洲地區（42個歐洲國家）、日本、澳大利亞及加拿大（「區域」）內及領 域（定義如下）內商業化HLX13（重組抗CTLA-4全人單克隆抗體注射液）（「許 可產品」或「HLX13」）。 內幕消息公告 就HLX13（重組抗CTLA-4全人單克隆抗體注射液） 與Sandoz訂立的許可協議 Shanghai Henlius Biotech, Inc. 上海復宏漢霖生物技術股份有限公司 A. 緒言 （於中華人民共和國註冊成立的股份有限公司） 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（ ...

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） HLX22（重組人源化抗HER2單克隆抗體注射液） 聯合曲妥珠單抗和化療(XELOX) 對比曲妥珠單抗和化療(XELOX)聯合或不聯合帕博利珠單抗 一線治療HER2陽性局部晚期或轉移性胃食管交界部和胃癌的 國際多中心3期臨床試驗申請於歐盟國家（德國）獲批 C. 市場情況 截至本公告日，於全球範圍內尚無同類聯合用藥治療方案獲批用於治療胃癌╱胃 食管交界部癌。 自願公告 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」）自願作出，以告知本公 司股東及潛在投資者本公司最新業務更新。 本公司董事會（「董事會」）欣然宣佈，近日，HLX22（重組人源化抗HER2單克隆 抗體注射液）（「HLX22」）聯合曲妥珠單抗和化療(XELOX)對比曲妥 ...

Investment Rating - The report does not explicitly state an investment rating for the industry, but it suggests a long-term focus on domestic innovative drugs in the oncology field and AI medical investment opportunities [3][4]. Core Insights - The pharmaceutical and biotechnology sector saw a weekly increase of 1.16%, outperforming the Wind All A index (1.15%) and the CSI 300 index (0.38%) [3][8]. - The upcoming ASCO conference is highlighted as a significant event for domestic innovative drug companies, with over 70 oral presentations and more than 10 major studies expected [3][4]. - The Ministry of Industry and Information Technology and six other departments issued a plan for the digital transformation of the pharmaceutical industry, aiming for significant advancements by 2027 and full coverage by 2030 [3][4]. Market Weekly Review - The pharmaceutical and biotechnology sector increased by 1.16% from April 21 to April 25, outperforming the Wind All A index and the CSI 300 index [3][8]. - Notable performers included medical research outsourcing (6.34%) and raw materials (4.72%), while blood products (-3.26%) and vaccines (-6.38%) continued to decline [3][9]. - Individual stock performances showed significant gains for Yong'an Pharmaceutical (31.4%), Shuyou Shen (28.4%), and Erkang Pharmaceutical (27.7%), while *ST Jiyuan (-43.2%), Nanhua Biological (-35.3%), and Shuangcheng Pharmaceutical (-27.7%) faced substantial losses [3][11]. Industry News and Key Company Announcements - On April 25, Kangfang Bio announced FDA approval for its drug Anike for the treatment of recurrent or metastatic nasopharyngeal carcinoma [12]. - The same day, Kangfang Bio also reported the approval of its PD-1/VEGF bispecific antibody for first-line treatment of specific lung cancer types [13]. - The digital transformation plan for the pharmaceutical industry aims to enhance competitiveness and quality management through AI and data integration by 2030 [3][4].

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]