格隆汇9月8日丨复宏汉霖(02696.HK)发布公告，近日，公司自主研发的帕博利珠单抗生物类似药 HLX17(重组抗PD-1人源化单克隆抗体注射液)("HLX17")在多种已切除实体瘤患者中的1期临床试验申请 (IND)获美国食品药品管理局(FDA)批准。公司拟于条件具备后于美国开展该国际多中心临床试验。 ...

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） 自願公告 HLX17是本公司自主研發的帕博利珠單抗生物類似藥，潛在適應症包括黑色 素瘤、非小細胞肺癌、食管癌、頭頸部鱗狀細胞癌、結直腸癌、肝細胞癌、 膽道癌、三陰性乳腺癌、微衛星高度不穩定型或錯配修復基因缺陷型腫瘤、 胃癌等原研藥已獲批的適應症。T細胞表達的PD-1受體與其配體PD-L1、 1 PD-L2結合，可以抑制T細胞增殖和細胞因子生成。部分腫瘤細胞的PD-1配 體上調，通過這個通路信號傳導可抑制激活的T細胞對腫瘤的免疫監視。帕 博利珠單抗是一種可與PD-1受體結合的單克隆抗體，可阻斷PD-1與PD-L1、 PD-L2的相互作用，解除PD-1通路介導的免疫抑制，包括抗腫瘤免疫應答， 提高免疫系統對腫瘤細胞的殺傷能力。2024年9月，HLX ...

Core Viewpoint - Fuhong Hanlin's stock price surged over 8%, reaching a historical high of 89 HKD, and currently stands at 85.55 HKD with a trading volume of 99.13 million HKD, following the announcement of the first prescription for its innovative small molecule CDK4/6 inhibitor, Fuzhoning [1] Group 1 - Fuhong Hanlin announced that its small molecule CDK4/6 inhibitor, Fuzhoning (Citrus Acid Vovisil Capsules), has received its first prescription from over ten hospitals across China, including Fudan University Shanghai Cancer Center and Zhejiang University School of Medicine First Affiliated Hospital [1] - Fuzhoning, in combination with Fulvestrant, is indicated for hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) recurrent or metastatic breast cancer patients who have experienced disease progression after prior endocrine therapy [1] - The drug is owned by Jinjou Aohong Pharmaceutical, a subsidiary of Fosun Pharma, while Fuhong Hanlin is responsible for its commercialization in China [1]

Core Viewpoint - Fuhong Hanlin (02696) shares have risen over 8%, reaching a historical high of 89 HKD, with a current price of 86.2 HKD and a trading volume of 73.65 million HKD, following the announcement of the first prescription for its innovative small molecule CDK4/6 inhibitor, Fuzhoning (Citrus Acid Vemurafenib Capsules) [1] Group 1 - Fuhong Hanlin announced that Fuzhoning has received its first prescription from over ten hospitals across China, including Fudan University Shanghai Cancer Center and Chinese Academy of Medical Sciences Cancer Hospital [1] - Fuzhoning, in combination with Fulvestrant, is indicated for adult patients with hormone receptor (HR) positive and HER2 negative recurrent or metastatic breast cancer who have previously experienced disease progression after endocrine therapy [1] - The drug is owned by Jincheng Aohong Pharmaceutical, a subsidiary of Fosun Pharma, while Fuhong Hanlin is responsible for its commercialization in China [1]

Core Viewpoint - The stock prices of several biotechnology companies have experienced significant increases, indicating positive market sentiment towards these firms [1]. Group 1: Company Performance - Junshi Biosciences (复宏汉霖) saw a stock price increase of 7.76% [1] - WuXi AppTec (药明康德) experienced a rise of 4.40% in its stock price [1] - WuXi Biologics (药明生物) reported a stock price increase of 4.11% [1] - Zai Lab (再鼎医药) had a stock price increase of 3.64% [1]

Core Viewpoint - Fuhong Hanlin (02696) shares rose over 8%, reaching a historical high of 89 HKD, and currently trading at 86.2 HKD with a transaction volume of 73.65 million HKD, following the announcement of the first prescription for its innovative small molecule CDK4/6 inhibitor, Fuzhoning (Citrus Acid Vemurafenib Capsules) [1] Group 1 - Fuhong Hanlin announced that Fuzhoning has been prescribed in over ten hospitals across China, including Fudan University Shanghai Cancer Center and Zhejiang University School of Medicine First Affiliated Hospital [1] - Fuzhoning, in combination with Fulvestrant, is indicated for adult patients with hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) recurrent or metastatic breast cancer who have previously experienced disease progression after endocrine therapy [1] - The drug is owned by Jinjou Aohong Pharmaceutical, a subsidiary of Fosun Pharma (600196), with Fuhong Hanlin responsible for its commercialization in China [1]

Summary of the Conference Call Company and Industry Overview - The conference call focused on **Fuhong Hanlin** and its developments in the **oncology** sector, specifically targeting **non-small cell lung cancer (NSCLC)** treatments. Key Points and Arguments 1. **HLX43p ADC Efficacy**: - HLX43p ADC demonstrated an **objective response rate (ORR)** of **28.6%** in patients with four or more lines of treatment and chemotherapy failure in NSCLC. In patients who failed docetaxel, the ORR reached **30%**. In EGFR wild-type patients, the confirmed ORR for third-line and above treatment was **46.7%**, with the **2.5 mg dose group** achieving an ORR of **60%** [2][3][13]. 2. **Safety Profile**: - The safety data for HLX43p ADC was consistent with previous ASCO reports, showing low hematological toxicity. The incidence of anemia was **19.6%**, neutropenia **16.1%**, and thrombocytopenia only **3.6%**. Immune-related adverse events were well controlled, supporting larger clinical trials for first-line and combination therapies [2][6][19]. 3. **HLX07 EGFR Monoclonal Antibody**: - The HLX07 EGFR monoclonal antibody, when combined with **SruLi monoclonal antibody** and chemotherapy, showed significant efficacy in second-line treatment for EGFR wild-type adenocarcinoma patients, achieving a PFS of **17.4 months** and an ORR of **69%-74%** [4][21][22]. 4. **Clinical Trial Plans**: - Fuhong Hanlin plans to advance HLX43p ADC and other candidates into further clinical trials, exploring combinations with other molecules like PD-1 or EGFR monoclonal antibodies. Discussions with the FDA regarding registration trials for HLX43 are anticipated by the end of the year, focusing on lung cancer [4][9][41]. 5. **Biomarker Independence**: - HLX43p ADC does not require biomarker screening, showing efficacy in both PD-L1 positive and negative patients. In a cohort of 11 patients with brain metastases, the ORR was **36.4%**, with a disease control rate (DCR) of **100%** [5][14]. 6. **Overall Efficacy Data**: - In a total of **54 tumor assessment cases**, the ORR was **37%**, with a DCR of **87%** and a median PFS of **5.4 months**, indicating significant tumor shrinkage signals in both squamous and non-squamous patients [4][15][19]. 7. **Future Development Directions**: - HLX43 is expected to be used not only in later lines of treatment but also in first-line settings, particularly in combination with other therapies. The potential for application in other cancers like esophageal and cervical cancer is also being explored [39][42]. 8. **Competitive Landscape**: - In the competitive landscape for NSCLC, HLX43's response rate of **46.7%** in EGFR wild-type patients significantly outperforms other ADCs, which generally do not exceed **30%** response rates. This advantage is attributed to its immune modulation capabilities [40][41]. Other Important but Possibly Overlooked Content - The conference highlighted the importance of maintaining a low incidence of hematological toxicity in ADC products, which is crucial for patient safety and treatment adherence [45][46]. - The potential for HLX43 to achieve **Breakthrough Therapy Designation (BTD)** from the FDA is contingent on maintaining a **30%** ORR in specific patient populations, particularly in third-line squamous cell carcinoma [44]. - The innovative design of HLX07, with a longer half-life compared to existing therapies, enhances its clinical applicability and safety profile [21][47][48]. This summary encapsulates the critical insights from the conference call, emphasizing the advancements and future directions of Fuhong Hanlin in the oncology sector, particularly in NSCLC treatment.

Investment Rating - The report maintains an investment rating of "Outperform the Market" [4] Core Insights - The report highlights the promising data disclosure of PD-L1 ADC HLX43 by Fuhong Hanlin at WCLC 2025, indicating its potential as a superior treatment option for patients with advanced non-small cell lung cancer (NSCLC) who have failed standard therapies [2][3][18] - The report suggests that there are multiple upcoming catalysts in the sector, including academic conferences, business development (BD) opportunities, and negotiations for medical insurance and innovative drug directories [2][18] Summary by Sections Weekly New Drug Market Review - From September 1 to September 7, 2025, the top five gainers in the new drug sector were: - Saintno Pharmaceutical (+62.01%) - Chuangsheng Group (+47.26%) - Jakes Pharmaceuticals (+40.69%) - Hualing Pharmaceutical (+30.90%) - Yiming Oncology (+28.26%) - The top five decliners were: - Frontier Biopharmaceuticals (-10.47%) - Kemia (-9.09%) - Zai Lab (-5.62%) - Ascentage Pharma (-4.57%) - Yundin New Medicine (-4.56%) [1][14] Weekly Focused Stocks - The report recommends focusing on several companies with upcoming data disclosures, including Fuhong Hanlin, Baillie Tenheng, and Kangfang Biopharmaceuticals, which are expected to provide significant updates [2][18] - Potential heavyweights for overseas licensing include differentiated GLP-1 assets from companies like Zhongsheng Pharmaceutical and Gilead Sciences, as well as upgraded PD-1 products from Kangfang Biopharmaceuticals [2][18] Weekly New Drug Industry Analysis - Fuhong Hanlin's PD-L1 ADC HLX43 has shown excellent efficacy in treating NSCLC, with an overall objective response rate (ORR) of 37.0% and a disease control rate (DCR) of 87.0% in the overall NSCLC population [19][20] - The data indicates that HLX43 has the potential to expand into frontline treatment and combination therapy [2][18] New Drug Approval and Acceptance Status - This week, three new drug applications were approved, including: - Fuhong Hanlin's new drug for NSCLC - Merck's Letermovir tablets - Sanofi's Tislelizumab injection - Eleven new drug applications were accepted for review [24][25] Weekly New Drug Clinical Application Status - Twenty new drug clinical applications were approved this week, with fifty-eight applications accepted for review [27]

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].

刘晓诺 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 ...