Core Viewpoint - Fuhong Hanlin's biosimilar drug POHERDY has received FDA approval, making it the first interchangeable biosimilar of PERJETA in the U.S. market, covering all indications approved for the original product [1] Group 1: Company Developments - Fuhong Hanlin's stock price increased by 4.58%, reaching HKD 67.40, with a trading volume of HKD 40.6885 million [1] - The FDA approval allows POHERDY to be used interchangeably with the original PERJETA, marking a significant milestone for the company [1] - POHERDY is the first biosimilar of pertuzumab approved in the U.S. and the first interchangeable biosimilar for cancer treatment [1] Group 2: Market Position - Fuhong Hanlin has submitted applications for HLX11 in China, Europe, and Canada, which have been accepted [1] - The company has a total of seven products approved for sale overseas, with four of those approved in the U.S. [1]

Core Viewpoint - Fuhong Hanlin (02696) shares rose over 4% following the FDA approval of its biosimilar drug POHERDY, making it the first interchangeable biosimilar of PERJETA in the U.S. market [1] Company Summary - Fuhong Hanlin's stock increased by 4.11%, reaching HKD 67.1, with a trading volume of HKD 31.4021 million [1] - The FDA approved POHERDY, a biosimilar of pertuzumab, allowing it to be used interchangeably with the original product PERJETA, covering all indications previously approved for the original drug in the U.S. [1] - POHERDY is noted as the first biosimilar of pertuzumab in the U.S. and the first interchangeable biosimilar approved for cancer treatment by the FDA [1] - Fuhong Hanlin has submitted applications for HLX11 in China, Europe, and Canada, which have been accepted for review [1] - The company has a total of seven products approved for sale overseas, with four of those approved in the U.S. [1]

Core Viewpoint - Fuhong Hanlin (02696) shares rose over 4% following the FDA approval of its biosimilar drug POHERDY, making it the first interchangeable biosimilar of PERJETA in the U.S. market [1] Group 1: Company Developments - Fuhong Hanlin's stock increased by 4.11%, reaching HKD 67.1, with a trading volume of HKD 31.4021 million [1] - The FDA approved the biosimilar injection of pertuzumab, POHERDY, which can be used interchangeably with the original product PERJETA, covering all indications approved for the original product in the U.S. [1] - POHERDY is noted as the first biosimilar of pertuzumab in the U.S. and the first interchangeable biosimilar approved for cancer treatment by the FDA [1] Group 2: Market Position - Fuhong Hanlin has submitted marketing applications for HLX11 in China, Europe, and Canada, which have been accepted [1] - The company has a total of seven products approved for sale overseas, with four of those products receiving approval in the U.S. [1]

Core Viewpoint - The company Fuhong Hanlin faced criticism from the Hong Kong Stock Exchange due to internal control failures and misappropriation of IPO funds, leading to a significant drop in stock price, followed by a partial recovery the next day [1][2]. Group 1: Company Actions and Consequences - On September 2, the company disclosed that it was reprimanded by the Stock Exchange, and its former CEO Liu Shigao was criticized and required to complete training on regulatory and legal issues before being eligible for future directorships [1][4]. - The investment management agreement signed by the company with Shangcheng Global, which involved the misallocation of IPO funds, was not in line with the intended use disclosed during the IPO process [3][7]. - The company approved management fees totaling $3.5 million over two years based on the investment management agreement, which was deemed inappropriate as it did not undergo proper board review [4][5]. Group 2: Financial Implications - As of the end of 2024, the company had an outstanding receivable of $66.36 million (approximately 477 million RMB) from Shangcheng Global, which has been fully impaired [5][6]. - The company reported that it had recovered $30.64 million from Shangcheng Global by the end of 2022 and an additional $20 million in the 2023 fiscal year [5]. Group 3: Governance and Management Changes - The company has experienced significant management turnover since 2019, with three CEOs and four CFOs, indicating instability within its leadership [8]. - Liu Shigao and Zhang Zidong, both involved in the investment management agreement, have since left the company, with Liu resigning in September 2020 and Zhang in December 2020 [8].

Core Viewpoint - The stock price of Fuhong Hanlin has surged over 250% year-to-date, reaching a new high of 85.95 HKD, reflecting strong market recognition of the company's long-term value driven by innovative product development and international expansion [1][2]. Financial Performance - In the first half of the year, Fuhong Hanlin achieved a total revenue of approximately 2.8195 billion CNY, a year-on-year increase of 2.7%, with six products generating global revenue of about 2.5568 billion CNY [2]. - The operating cash flow exceeded 770.9 million CNY, marking a significant year-on-year growth of 206.8% [2]. Product Development and Market Expansion - Fuhong Hanlin has six products approved in China and four globally, reaching nearly 60 countries and benefiting over 850,000 patients [2]. - The international sales of its products have seen a year-on-year increase of over 200%, with cash inflow from business development contracts exceeding 1 billion CNY, a growth of 280% [2]. - The company is actively expanding its product portfolio, with H drug (Hanshu) achieving global sales of 597.7 million CNY during the reporting period [2][3]. Clinical Trials and Regulatory Approvals - H drug has received approvals in multiple countries for treating extensive-stage small cell lung cancer (ES-SCLC) and is undergoing clinical trials for various cancers, including gastric and colorectal cancers [3][4]. - The company is advancing clinical trials for HLX43, a novel ADC targeting PD-L1, and HLX22, a new HER2-targeted monoclonal antibody, both showing promising therapeutic potential [7][9]. Strategic Collaborations and Market Positioning - Fuhong Hanlin has established partnerships with over 20 international pharmaceutical companies to enhance its global market presence [11]. - The company is focused on building a robust commercialization strategy for its core products, which is expected to strengthen its market position in oncology [5][12]. Future Outlook - The company is well-positioned to leverage its innovative pipeline, with expectations of significant revenue growth from new product launches and international market penetration [6][12]. - Analysts have updated their ratings on the company, with target prices being raised due to the strong performance and potential of its innovative drug pipeline [13].

Core Viewpoint - 招银国际 has raised the target price for复宏汉霖 from HKD 20.33 to HKD 61.98, indicating strong potential for growth in the innovative drug development sector [1] Company Summary - 复宏汉霖 is transitioning from a profitable biosimilar company to a leading player in the biopharmaceutical field, with several innovative drugs such as HLX43, HLX22, and Serplulimab showing promising clinical data [1] - The company is actively expanding its global biosimilar business through partnerships with pharmaceutical companies, with strong commercialization performance from 汉曲优 (Trastuzumab) and Serplulimab [1] - The FDA is currently reviewing the market approval applications for HLX14 and HLX11, which are expected to contribute to overseas revenue sources [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 HLX11是本公司自主研發的帕妥珠單抗生物類似藥，擬聯合曲妥珠單抗和化 療用於具有高復發風險HER2陽性早期乳腺癌患者的輔助治療；以及擬聯合 曲妥珠單抗和多西他賽用於HER2陽性、轉移性或不可切除的局部復發性乳 腺癌患者，患者既往未接受過針對轉移性乳腺癌的抗HER2治療或者化療。 2021年11月，HLX11成功完成於中國境內（不包括港澳台地區，下同）的1期 臨床研究。2024年9月，HLX11用於HER2陽性且HR陰性的早期或局部晚期 乳腺癌新輔助治療的國際多中心3期臨床研究達到了主要研究終點。 1 本次申報基於HLX11對比參照藥Perjeta®產生的數據，包括分析相似性研究及 臨床比對研究。這些數據都證明了HLX11與參照藥Perjeta®在質量、安全性和 有效性方面的高度相似。 （於中華人民共和國註冊成 ...