2025年9月2日，复宏汉霖（02696.HK）收到了港交所的谴责，同时其联合创始人、前执行董事、前CEO刘世高收到批评，港交所要求刘世高接受26小时的 合规培训，才能继续做港交所（待）上市公司董事。 本次受处罚，是因刘世高在2019年未尽勤勉义务，没有过目一份重要的投资管理协议——这份协议让复宏汉霖29%的IPO所得款被用于投资，金额为1.17亿 美元（约8.4亿元人民币）。 港交所称，这笔款项被尚乘环球全数用于认购债券，再购买由若干私人实体发行的承兑票据。 复宏汉霖迟迟未公布这笔投资，但自2020年起便一直尝试收回投资款。直到安永会计师事务所在2022年财报中出具了保留意见，这笔投资管理协议才被公之 于众。 截至2024年底，复宏汉霖仍有6636万美元的投资款（约4.7亿元人民币）未成功追回。 执行董事未尽勤勉义务 6年前的2019年9月25日，复宏汉霖在港交所上市，集资净额31.47亿港元（约4.03亿美元）。 港交所指出，有1.17亿美元是由尚乘环球市场有限公司（下称"尚乘环球"，该公司现名为奥翱骜集团[香港]证券有限公司）配售集资得来，占总金额的 29%。尚乘环球是复宏汉霖IPO的联席账簿管理人、联 ...

Core Viewpoint - The Hong Kong Stock Exchange has issued a disciplinary action against Shanghai Henlius Biotech, Inc. and its former CEO, Dr. Liu Shigao, for compliance failures related to the company's IPO in 2019 [2][4]. Group 1: Disciplinary Action - The Hong Kong Stock Exchange criticized Henlius and Dr. Liu for failing to adhere to compliance standards, mandating Dr. Liu to complete 26 hours of training on regulatory and listing rule compliance before being eligible for reappointment as a director [4]. - The disciplinary action stems from a management agreement signed by the former CFO on the company's IPO day, which involved a $117 million investment from IPO proceeds that did not align with the stated use of funds in the prospectus [4]. Group 2: Company Performance - Henlius reported a revenue of 2.82 billion yuan for the first half of the year, a 2.7% increase year-on-year, with a net profit of 390 million yuan [8]. - For 2024, the company achieved a revenue of 5.724 billion yuan, reflecting a 6.1% year-on-year growth, and a net profit of 821 million yuan, marking a 50.3% increase [9]. Group 3: Product Portfolio and Market Presence - Henlius has six products approved for sale, covering 25 indications, including major monoclonal antibodies, with four products approved in various overseas markets [9]. - The company has a robust pipeline with 50 molecules and 10 research platforms, encompassing a diverse range of drug formats [9]. Group 4: Corporate History and Relationships - Dr. Liu co-founded Henlius in partnership with Dr. Jiang Weidong after returning to China in 2008, and he maintained a close relationship with the company even after his departure [6]. - In June 2023, Henlius and Dr. Liu's new venture, HanchorBio, announced a collaboration that includes a $10 million upfront payment and potential milestone payments totaling $192 million [6]. Group 5: Privatization Attempt - In June 2024, Fosun Pharma announced plans to privatize Henlius at specific share prices, citing underperformance in stock price and trading volume since the IPO [10]. - However, the privatization attempt was declared unsuccessful in January 2023 [11].

Core Viewpoint - Henlius has received FDA approval for two biosimilar products, BILDYOS® and BILPREVDA®, which are biosimilars to PROLIA® and XGEVA®, respectively, covering all indications approved for the original products in the U.S. [1] Group 1 - The FDA approved BILDYOS® (60mg/mL) for five indications, including osteoporosis [3] - The FDA approved BILPREVDA® (120mg/1.7mL) for three indications, including bone-related events [3] - This marks Henlius's third product approved in the U.S. [3] Group 2 - The approval reflects Henlius's commitment to scientific excellence and product quality [1] - The collaboration with Organon aims to enhance the accessibility of high-quality biologics for U.S. patients [1]

致：香港交易及結算所有限公司 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年8月31日 狀態: 新提交 公司名稱: 上海復宏漢霖生物技術股份有限公司 呈交日期: 2025年9月2日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02696 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 163,428,541 | RMB | | 1 RMB | | 163,428,541 | | 增加 / 減少 (-) | | | | | | RMB | | | | 本月底結存 | | | 163,428,541 | RMB | | 1 RMB | | 163,428,541 | | 2. 股份分類 | 普通股 | 股份類別 | 其他類別 (請 ...

Core Viewpoint - The approval of BILDYOS and BILPREVDA by the FDA marks a significant advancement in improving accessibility to critical bone care treatments for millions of Americans, particularly the aging population [1][2] Company Summary - Fuhong Hanlin has successfully developed and produced biosimilars BILDYOS and BILPREVDA, which have received FDA approval, demonstrating the company's commitment to scientific excellence and product quality [1] - The collaboration with Organon aims to expand the accessibility of high-quality biologics, providing patients with treatment options that are equivalent in efficacy and safety to the original drugs [1] Industry Summary - The approval of BILDYOS and BILPREVDA is based on a comprehensive review of data, including structural and functional analyses, pharmacokinetic data, and a clinical comparative study, showing high similarity in safety, purity, and efficacy to the original drugs PROLIA and XGEVA [2] - The approval enhances Organon's portfolio of biosimilars in the U.S., which has been developed over eight years and covers five major therapeutic areas [2]

Core Viewpoint - The approval of two products of Dazhu Single Antibody Injection by the FDA marks a significant milestone for the company, being the first domestically produced Dazhu Single Antibody to be approved overseas [2] Company Summary - The company, Fuhong Hanlin, has announced that its Dazhu Single Antibody Injection products (60mg/mL and 120mg/1.7mL) have received FDA approval for eight indications, including osteoporosis and bone-related events [2] - With this approval, the company now has three products approved in the United States [2]

Core Viewpoint - The approval of BILDYOS and BILPREVDA by the FDA marks a significant advancement in improving accessibility to critical bone care treatments for millions of Americans, particularly the aging population [1][2] Group 1: Product Approval - The FDA has approved two biosimilar products, BILDYOS (denosumab-nxxp) and BILPREVDA (denosumab-nxxp), which are biosimilars to PROLIA and XGEVA, covering all indications previously approved for the original products in the U.S. [1] - The approval is based on a comprehensive review of data, including structural and functional analyses, clinical pharmacokinetics, and a clinical comparative study demonstrating high similarity in safety, purity, and efficacy to the original drugs [2] Group 2: Strategic Partnerships - In 2022, the company entered into a licensing and supply agreement with Organon, granting Organon exclusive commercialization rights for several biosimilars, including BILDYOS and BILPREVDA, outside of China [2] - The approval of these biosimilars enhances Organon's portfolio in the U.S., which has been developed over eight years and covers five major therapeutic areas [2] Group 3: Company Commitment - The approval signifies the company's commitment to scientific excellence and product quality, as stated by the CEO, highlighting the goal of providing affordable treatment options that are equivalent in efficacy and safety to the original drugs [1]

Core Viewpoint - The approval of BILDYOS and BILPREVDA by the FDA marks a significant advancement in improving accessibility to critical bone care treatments for millions of Americans, particularly the aging population [1][2] Company Summary - Fuhong Hanlin has successfully developed and produced biosimilars BILDYOS and BILPREVDA, which have received FDA approval, demonstrating the company's commitment to scientific excellence and product quality [1] - The partnership with Organon aims to expand the accessibility of high-quality biologics, providing patients with treatment options that are equivalent in efficacy and safety to the original drugs [1] Industry Summary - The approval of BILDYOS and BILPREVDA is based on a comprehensive review of data, including structural and functional analyses, pharmacokinetic data, and a clinical comparative study, showing high similarity in safety, purity, and efficacy to the original drugs PROLIA and XGEVA [2] - The approval enhances Organon's portfolio of biosimilars in the U.S., which has been developed over eight years and covers five major therapeutic areas [2]

Core Viewpoint - The first domestically developed Dazhu single antibody from China has successfully received approval from the US FDA for market entry, marking a significant milestone for the company and the industry [1] Company Summary - The company, Fuhong Hanlin, announced that its Dazhu single antibody injection products (60mg/mL and 120mg/1.7mL) have been approved by the US FDA for the treatment of osteoporosis and eight other indications [1] - This approval represents the first instance of a domestically produced Dazhu single antibody being approved for sale overseas [1] - Currently, Fuhong Hanlin has three products approved in the United States [1] Industry Summary - The approval of a Chinese-developed drug by the US FDA highlights the growing capabilities and competitiveness of the Chinese biopharmaceutical industry in the global market [1] - The successful entry of this product into the US market may pave the way for further international approvals of Chinese-developed drugs, enhancing the industry's reputation and potential for growth [1]

香港聯合交易所有限公司 (香港交易及結算所有限公司全資附屬公司) THE STOCK EXCHANGE OF HONG KONG LIMITED (A wholly-owned subsidiary of Hong Kong Exchanges and Clearing Limited) 紀律行動聲明 聯交所對上海復宏漢霖生物技術股份有限公司（股份代號：2696）及一 名前董事的紀律行動 制裁及指令 香港聯合交易所有限公司（聯交所） (1) 上海復宏漢霖生物技術股份有限公司（該公司）；及 批評： (2) 該公司前執行董事兼首席執行官劉世高博士（劉博士）， 及進一步指令： 劉博士必須完成 26 小時有關監管和法律議題以及《上市規則》合規事宜的培訓，當中包 括: (i)董事職責；(ii)《企業管治守則》；及(iii)《上市規則》第 2.13 條以及第三 A、十一 及十四章的規定，三項內容各佔最少三小時，方可再獲委任為任何已於或將於聯交所上 市的公司董事。 實況概要 該公司於 2019 年 9 月 25 日上市，集資淨額 31.47 億港元（約 4.03 億美元）。尚乘環球 市場有限公司（尚乘環球，現已更名為奧翱驁 ...