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 ...

（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。 Shanghai Henlius Biotech, Inc. 上海復宏漢霖生物技術股份有限公司 HLX22（重組人源化抗HER2單克隆抗體注射液）用於胃癌(GC)治療 獲歐盟委員會(EC)孤兒藥資格認定 A. 緒言 HLX22為本公司許可引進並後續自主研發的新型靶向HER2的單克隆抗體， 潛在適應症包括胃癌和乳腺癌等實體瘤。HLX22用於治療胃癌(GC)已分別於 2025年3月及2025年5月獲美國食品藥品監督管理局(FDA)及歐盟委員會(EC) 授予孤兒藥資格認定(Orphan-drug Designation)。截至本公告日，HLX22相關 研發進展情況如下： 1 | 產品/聯合療法 | 適應症 | 最新進展 | | --- | --- | --- | | HLX22 | HER2 過表達的晚期 | 已於中國境內完成1期臨床 ...

Overview - Shanghai Fosun Pharmaceutical (Group) Co., Ltd. has initiated a Phase I/III clinical trial for HLX13, a biosimilar of ipilimumab, targeting unresectable advanced hepatocellular carcinoma (HCC) patients in China [2]. HLX13 Information and Research Status - HLX13 is a biosimilar of ipilimumab developed by the group, intended for treating multiple cancers including melanoma, renal cell carcinoma, colorectal cancer, HCC, non-small cell lung cancer, malignant pleural mesothelioma, and esophageal squamous cell carcinoma [3]. - As of April 2025, the group has invested approximately RMB 104 million (about $15 million) in the development of HLX13 [3]. - According to IQVIA MIDASTM data, global sales of ipilimumab formulations are projected to reach approximately $2.873 billion in 2024 [3].

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） 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，本公司自主研發的伊匹木單抗生 物類似藥HLX13（重組抗CTLA-4全人單克隆抗體注射液）（「HLX13」）一綫治 療不可切除的晚期肝細胞癌(HCC)患者的1/3期臨床研究於中國境內完成首例 患者給藥。 B. 臨床試驗設計及目的 本研究為一項多中心、隨機、雙盲、平行對照1/3期臨床研究，旨在評估 HLX13與其原研藥YERVOY® （美國市售和歐盟市售）在既往未經治療的不可 切除的晚期肝細胞癌(HCC)患者中的藥代動力學(PK)特徵、有效性、安全性 和免疫原性相似性。合格的受試者將按2:1:1的比例隨機分配至三組 ...

Major Events - Heng Rui Medicine (01276) plans to globally issue 224.5 million H-shares, expected to be listed on May 23 [1] - MIRXES-B (02629) will conduct an IPO from May 15 to May 20, aiming to globally issue 46.62 million shares [1] - Green Tea Group (06831) received 317.54 times subscription for its public offering in Hong Kong, with a final issue price of HKD 7.19 per share [1] - CSPC Pharmaceutical Group (01093) signed an exclusive licensing agreement with Cipla for the commercialization of Irinotecan Liposome Injection in the United States [1] - CanSino Biologics (06185) received clinical trial approval for its inhaled tuberculosis booster vaccine in Indonesia [1] - Fuhong Hanlin (02696) has been included in the MSCI Global Small Cap Index [1] - Financial One Account (06638) received a privatization offer from Ping An Group (02318) at a premium of approximately 23.10% [1] Financial Reports - Alibaba-W (09988) reported revenue and net profit growth for the fiscal year 2025, with net profit attributable to shareholders increasing by 62% to CNY 129.47 billion [1] - NetEase-S (09999) announced Q1 results with net profit attributable to shareholders at CNY 10.301 billion, a year-on-year increase of 34.94%, and a quarterly dividend of USD 0.135 per share [1] - Geely Automobile (00175) released Q1 results showing a significant increase in profit attributable to shareholders of CNY 5.672 billion, up 263.59% year-on-year [1] - Beike-W (02423) reported a total transaction volume growth of 34.0% year-on-year in Q1, with net revenue increasing by 42.4% [1] - Minhua Holdings (01999) announced annual results with profit attributable to shareholders of HKD 2.063 billion, a decrease of 10.41% year-on-year [1] - Shoucheng Holdings (00697) reported Q1 results with profit attributable to shareholders of HKD 213 million, an increase of 80.5% year-on-year [1] - Fourth Paradigm (06682) showed strong performance in core business with total revenue of CNY 1.077 billion in Q1, a year-on-year growth of 30.1% [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） 本公司股東及潛在投資者在買賣本公司股份時務請審慎行事。 代表董事會 上海復宏漢霖生物技術股份有限公司 主席 Wenjie Zhang 香港，二零二五年五月十五日 於本公告日期，本公司董事會包括主席及非執行董事Wenjie Zhang先生，執行董 事朱俊博士，非執行董事陳啟宇先生、吳以芳先生、關曉暉女士、文德鏞先生及 Xingli Wang博士以及獨立非執行董事蘇德揚先生、陳力元博士、趙國屏博士及宋 瑞霖博士。 （股份代號：2696） 自願公告 本公司獲納入MSCI全球小型股指數成分股 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」）欣然宣布，近日，本公司獲納入MSCI全球小型 ...

比亚迪股份(01211)再涨3.53%，前四月新能源销量同比46.98%，新加坡销量首超丰田登顶。 网易-S(09999)涨1.8%，今日盘后将发布一季报，下周将举行年度产品展。 微盟集团(02013)大涨20%，微信成立电商产品部，公司在AI开发和微信小商店业务具备潜力。 腾讯音乐-SW(01698)绩后涨超7%，ARPPU增长稳健，一季度纯利同比增长22.8%。 易鑫集团(02858)盘中涨超7%，一季度金融科技平台促成融资额同比劲增56.5%。 中烟香港(06055)再涨超7%，签约蒙昆助力免税卷烟业务增长，公司有望整合中烟系资源。 复宏汉霖(02696)再涨超6%，授予Sandoz AG许可产品HLX13开发、生产及商业化权利。 布鲁可(00325)早盘涨6.48%，公司近期密集上新，新品节奏加速高增可期。 德康农牧(02419)再涨超11%，4月生猪销售收入18.67亿，公司头均盈利行业领先。 心动公司(02400)涨超6%，《伊瑟》国际服6月正式上线，有望进一步驱动业绩增长。 贝壳-W(02423)跌4.14%，今日将披露一季报，机构称对其利润端仍保持谨慎。 微创机器人-B(02252)再跌3.6 ...

（於中華人民共和國註冊成立的股份有限公司） Shanghai Henlius Biotech, Inc. 上海復宏漢霖生物技術股份有限公司 （股份代號：2696） 於2025年5月8日（星期四）舉行的 股東周年大會 所提呈決議案之投票結果 上海復宏漢霖生物技術股份有限公司（「本公司」）董事（「董事」）會（「董事會」）欣 然宣佈於2025年5月8日（星期四）上午10時正假座中國上海市徐匯區宜州路188號 B8幢10樓會議室舉行的股東周年大會（「股東周年大會」）之投票結果。 茲提述本公司日期均為2025年4月15日之股東周年大會通告及通函（「通函」）。除 文義另有所指外，本公告所用詞彙與通函所界定者具有相同涵義。 股東周年大會 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。 於股東周年大會日期，本公司已發行股份（「股份」）總數為543,494,853股（包 含380,066,312股非上市股份及163,428,541股H股），該等股份持有人（或授權 代表） ...

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].