Core Insights - The company reported a revenue of 2.8195 billion RMB for the first half of 2025, representing a year-on-year growth of 2.7% [1] - Gross profit reached approximately 2.1992 billion RMB, with a year-on-year increase of 10.5%, while net profit stood at 390.1 million RMB [1] - Operating cash flow exceeded 770.9 million RMB, showing a significant year-on-year growth of 206.8% [1] Group 1: Financial Performance - The company experienced a substantial increase in overseas product profits, exceeding 200%, with cash inflow from BD contracts surpassing 1 billion RMB, marking a 280% year-on-year growth [1] - Research and development expenditure for the first half of 2025 was 995.4 million RMB, with capitalized R&D expenses increasing by 21.3% [1] Group 2: Product Development and Market Expansion - The company has six products approved for sale in China and four internationally, reaching nearly 60 countries and regions, benefiting over 850,000 patients globally [1] - The core innovative product in the oncology field, H drug (斯鲁利单抗), achieved global sales revenue of 597.7 million RMB during the reporting period [1] Group 3: H Drug Market Expansion - H drug has accelerated its market expansion, receiving approvals in the EU, Singapore, Malaysia, the UK, and India for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) [2] - The product is now approved in nearly 40 countries and regions, covering almost half of the global population [2] - The company plans to submit a Biologics License Application (BLA) to the FDA in the first half of 2026 [2] Group 4: Other Product Developments - The company's biosimilar of pertuzumab, HLX11, has received acceptance for listing applications from regulatory agencies in China, the US, and Europe, with potential approval in the US expected in the second half of the year [3] - The company is developing a comprehensive innovative product matrix, including new endocrine therapy HLX78 and various targeted therapies [3]

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） 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） 自願公告 帕妥珠單抗生物類似藥HLX11 （抗HER2結構域II人源化單克隆抗體注射液）的 上市許可申請(MAA)獲歐洲藥品管理局(EMA)受理 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，本公司自主研發的Perjeta® （帕妥 珠單抗）生物類似藥候選藥HLX11（重組抗HER2結構域II人源化單克隆抗體 注射液）（「HLX11」）的上市許可申請（「MAA」）獲歐洲藥品管理局（「EMA」） 受理，本次申請涉及的適應症如下：(1)與曲妥珠單抗和化療聯合：用於 HER2陽性、局部晚期、炎性或早期乳腺癌且具有高復發風險成人患 ...