Workflow
HLX43
icon
Search documents
胃癌术后不用再化疗?复宏汉霖汉斯状临床试验成功 为全球首个
Zheng Quan Ri Bao Wang· 2025-10-10 10:42
消化道肿瘤是复宏汉霖战略聚焦和深度布局的核心治疗领域之一。在食管癌领域,汉斯状已于2023年9 月在中国获批用于一线治疗食管鳞状细胞癌(ESCC);针对胃癌,除汉斯状在胃癌新辅助/辅助治疗方面 取得的积极结果外,公司自主研发的差异化新表位HER2单抗HLX22正通过国际多中心三期头对头临床 研究,挑战HER2阳性晚期胃癌的一线治疗标准;在结直肠癌领域,公司正积极推进汉斯状联合方案一 线治疗转移性结直肠癌(mCRC)的国际多中心三期临床研究。此外,复宏汉霖还通过布局PD-L1抗体偶 联药物(ADC)HLX43等新一代疗法,针对晚期胃/胃食管交界部腺癌等开展临床研究。 鉴于这一数据结果,复宏汉霖拟提前申报该适应症的上市。复宏汉霖执行董事、首席执行官朱俊博士表 示,消化道肿瘤是复宏汉霖深耕的核心领域,我们将积极推动成果转化,早日惠及患者,并持续加快更 多创新疗法的深度探索与广泛应用。 据悉,手术是胃癌治疗的核心环节,而在胃癌手术前及术后(即胃癌围术期),通过药物及放化疗等辅助 方式治疗也会直接影响患者的长期治疗效果。北京大学肿瘤医院季加孚教授表示,本期的临床研究首次 证实了胃癌手术后以免疫单药替代辅助化疗的可行性, ...
中国ADC“出海”潮迭起:下一个百亿重磅交易在哪?
而这仅仅是今年上半年中国抗体药物偶联物(ADC)出海浪潮的一朵浪花。医药魔方数据显示,2025年上半年,中国创新药License-out交易持续 升温,仅ADC领域就贡献了巨大比例。截至2025年5月底,中国企业License-out的ADC重磅交易(总交易金额≥10亿美元)数量已达到24笔。 近日也有市场消息指出,复宏汉霖就PD-L1 ADC在研管线HLX43的权益,正与包括强生、罗氏在内的跨国药企洽谈。据悉,此项协议可能带来至 少数亿美元的预付款,以及未来根据该药物的表现,获得更多的里程碑付款。 (原标题:中国ADC"出海"潮迭起:下一个百亿重磅交易在哪?) 21世纪经济报道记者 季媛媛 2025年,手里缺钱但有管线的中国创新药企,和手里有钱但缺管线的跨国药企,刚好对上了。 2025年5月,中国生物医药行业迎来历史性时刻。三生制药宣布与辉瑞达成一笔交易:首付款12.5亿美元,总金额超60亿美元,创下中国创新药出 海新纪录。 目前,复宏汉霖正全力推进HLX43的临床开发进程,已在全球入组超过300例患者,并在中国、美国、日本等多国顺利推进患者入组。 中国ADC领域正在经历从"快速跟随"到"同类最优"乃至"同 ...
西部证券晨会纪要-20250923
Western Securities· 2025-09-23 02:30
Group 1: Real Estate Industry - The core conclusion indicates that differentiation is an effective way to address industry challenges, with optimism for core quality new homes and related beneficiaries, while rationally viewing the pressure on the second-hand housing market [2][10] - The report highlights structural opportunities in the real estate sector, emphasizing that despite overall market pressure, several stocks have achieved over 40% gains, indicating a potential turning point for structural differentiation and total improvement [7][8] - Key investment logic includes focusing on quality real estate companies like Yuexiu Property, which is expected to see improved operational performance and profit expectations, and recommending companies like Binjiang Group and Longfor Group for their potential in core urban areas [10][9] Group 2: Biopharmaceutical Industry - The report on Fuhong Hanlin (2696.HK) predicts revenue growth from 60.34 billion to 70.13 billion from 2025 to 2027, with a notable increase in 2027 of 17.8%, reflecting significant potential due to innovative drug layouts and clinical data catalysts [3][14] - WuXi XDC (2268.HK) is projected to see substantial revenue growth from 60.01 billion to 107.36 billion from 2025 to 2027, with a compound annual growth rate (CAGR) of 102% from 2022 to 2024, driven by strong industry demand and capacity expansion [4][17] - The reports emphasize the importance of innovative drug development and the potential for biopharmaceutical companies to benefit from global market expansion and increasing demand for biosimilars [12][15] Group 3: Basic Chemicals Industry - The report on Shengquan Group (605589.SH) forecasts net profit growth from 12.63 billion to 18.99 billion from 2025 to 2027, highlighting the company's leadership in phenolic resin and casting resin, with expectations for steady growth due to industry changes [5][18] - The company is positioned as a "platform-type" enterprise in electronic and battery materials, with significant potential in traditional resin business as market conditions improve [18][19] - Shengquan Group's strategic expansion into electronic materials and new energy materials is expected to capture more potential products, supported by its strong R&D capabilities [19]
复宏汉霖(02696.HK):HLX43延续优异表现 HLX07MPFS数据惊艳
Ge Long Hui· 2025-09-18 08:30
Core Viewpoint - The updates presented at WCLC regarding HLX43 and HLX07 indicate promising efficacy and safety profiles for these novel therapies in treating NSCLC, suggesting potential for significant market impact and investment opportunities [1][2][4]. Group 1: HLX43 Data Summary - HLX43 demonstrated high efficacy with an overall response rate (ORR) of 37.0% and a disease control rate (DCR) of 87.0% among evaluable patients [2] - In a subgroup analysis of EGFR wild-type non-squamous NSCLC patients, the confirmed ORR reached 46.7%, indicating HLX43's effectiveness is not reliant on PD-L1 expression levels [2][3] - The safety profile of HLX43 is favorable, with the most common grade ≥3 treatment-related adverse events (TRAEs) being anemia and leukopenia, both at 19.6%, and a low incidence of grade ≥3 thrombocytopenia at 3.6% [3] Group 2: HLX07 Data Summary - HLX07 combined with PD-1 inhibitor showed a median progression-free survival (mPFS) of 17.4 months in the high-dose group, significantly exceeding the standard therapy's mPFS of around 7 months [4] - The study involved patients with high EGFR expression (H score ≥150) and no prior systemic treatment, indicating a targeted approach to therapy [4] - Safety data indicated manageable treatment-emergent adverse events (TEAEs), suggesting a good tolerability profile for HLX07 in combination therapy [4] Group 3: Financial Projections - The company forecasts total revenues of 58.73 billion, 59.70 billion, and 71.25 billion for 2025-2027, reflecting year-on-year growth rates of 2.60%, 1.64%, and 19.36% respectively [4] - Net profits attributable to shareholders are projected at 8.27 billion, 7.97 billion, and 11.22 billion for the same period, maintaining previous estimates [4] - The target price for the company's stock has been raised from 78.01 HKD to 120.87 HKD per share, reflecting an adjustment based on the expanded product advantages of HLX43 [4]
招商证券:维持复宏汉霖(02696)“强烈推荐”评级 看好HLX43的成药潜力
Zhi Tong Cai Jing· 2025-09-18 07:39
公司此次更新的HLX43患者数据来自于Ia期与Ib期2.0 mg/kg剂量组及2.5 mg/kg剂量组。共计56例NSCLC 患者入组Ia期及Ib期2.0和2.5 mg/kg剂量组,其中29例(51.8%)为鳞状,27例(48.2%)为非鳞状。其中,非 鳞状NSCLC患者中位既往治疗线数为2,鳞状NSCLC患者中位既往治疗线数为3。在四线及以后的鳞状 NSCLC患者(n=28)中,HLX43的ORR为28.6%,DCR为82.1%,较标准治疗药物多西他赛(ORR=12.8%) 展现出显著的临床获益。值得关注的是,既往接受过多西他赛治疗的三线及后线NSCLC患者 (n=10)ORR达30.0%,DCR为80%;接受2 mg/kg剂量HLX43治疗患者(n=15)ORR达40.0%,DCR为73.3%, 提示HLX43在肺鳞癌后线治疗中的重要潜力。在三线及以后的非鳞状NSCLC人群中(n=26),ORR达 46.2%,DCR为96.2%。 (原标题:招商证券:维持复宏汉霖(02696)"强烈推荐"评级 看好HLX43的成药潜力) 智通财经APP获悉,招商证券发布研报称,维持复宏汉霖(02696)"强烈推荐"评级。 ...
招商证券:维持复宏汉霖“强烈推荐”评级 看好HLX43的成药潜力
Zhi Tong Cai Jing· 2025-09-18 07:38
值得关注的是,EGFR野生型非鳞状NSCLC患者(n=15)的经确认客观缓解率(cORR)为46.7%,DCR达 93.3%。接受2.5mg/kg剂量HLX43治疗的患者(n=5)cORR高达60.0%,DCR为80%,彰显HLX43在非鳞状 NSCLC患者人群中更为显著的疗效优势。安全性方面,最常见的≥3级治疗相关不良事件(TRAEs)为贫血 (19.6%)、白细胞计数减少(19.6%)、中性粒细胞计数减少(16.1%)及淋巴细胞计数减少(12.5%),血小板计 数减少仅3.6%。与此前在2025ASCO上披露的安全性一致,HLX43血液学毒性较低,延续了良好的安全 性,支持未来扩展至一线疗法及联合治疗方案。 该行指,目前复宏汉霖正全力推进HLX43的临床开发进程,已在全球入组超过300例患者,并在中国、 美国、日本等多国顺利推进患者入组。同时公司正在积极探索HLX43在多种实体瘤中的治疗潜力,包 括宫颈癌、肝细胞癌、食管鳞癌、头颈鳞癌、鼻咽癌、结直肠癌、胃癌/胃食管交界部癌等,持续挖掘 治疗潜力。单药之外,HLX43联用其他产品的临床试验也正在进行中,进一步探索"ADC+IO"的协同抗 肿瘤疗效。 公司此 ...
天风证券:维持复宏汉霖“买入”评级 目标价上调至120.87港元
Zhi Tong Cai Jing· 2025-09-16 08:49
Core Viewpoint - Tianfeng Securities maintains a "Buy" rating for Junshi Biosciences (02696), projecting total revenue for 2025-2027 to be 5.873 billion, 5.970 billion, and 7.125 billion yuan, with year-on-year growth rates of 2.60%, 1.64%, and 19.36% respectively, and net profit attributable to shareholders to be 827 million, 797 million, and 1.122 billion yuan, keeping previous forecasts unchanged [1] Group 1 - HLX43 demonstrates high efficacy and low toxicity, with outstanding data for EGFR wild-type NSCLC presented at the WCLC conference [1][2] - The overall objective response rate (ORR) for evaluable patients is 37.0%, with a disease control rate (DCR) of 87.0% [2] - In a subgroup analysis of EGFR wild-type non-squamous NSCLC patients, the confirmed ORR reaches 46.7%, indicating HLX43's anti-tumor activity is not dependent on PD-L1 expression levels [2][3] Group 2 - HLX07 shows impressive efficacy, potentially providing a new approach for first-line treatment of EGFR high-expressing squamous NSCLC [4] - In a phase II dose exploration study, the high-dose group achieved a median progression-free survival (mPFS) of 17.4 months, significantly higher than the standard therapy's mPFS of around 7 months [4] - Safety profiles for both HLX43 and HLX07 are reported to be manageable, with most treatment-emergent adverse events (TEAEs) being controllable [4]
天风证券:维持复宏汉霖(02696)“买入”评级 目标价上调至120.87港元
智通财经网· 2025-09-16 08:48
Core Viewpoint - Tianfeng Securities maintains a "Buy" rating for Junshi Biosciences (02696), projecting total revenue for 2025-2027 to be 5.873 billion, 5.970 billion, and 7.125 billion yuan, representing year-on-year growth of 2.60%, 1.64%, and 19.36% respectively, with net profit attributable to shareholders forecasted at 827 million, 797 million, and 1.122 billion yuan [1] Group 1 - HLX43 demonstrates high efficacy and low toxicity, with outstanding data for EGFR wild-type NSCLC presented at the WCLC conference [1][3] - In a study involving 56 NSCLC patients, the overall objective response rate (ORR) was 37.0%, and the disease control rate (DCR) was 87.0% [2] - Among patients with prior multiple lines of treatment, HLX43 showed significant advantages, particularly in EGFR wild-type non-squamous NSCLC patients, achieving a cORR of 46.7% [2] Group 2 - Safety profile of HLX43 is favorable, with the most common grade ≥3 treatment-related adverse events (TRAEs) being anemia and leukopenia, both at 19.6% [2] - The incidence of grade ≥3 thrombocytopenia is low at 3.6%, indicating manageable hematological toxicity [2] - A total of 21.4% of patients experienced immune-related adverse events (irAEs), with most being manageable [2] Group 3 - HLX07 shows promising efficacy in first-line treatment for EGFR high-expressing squamous NSCLC, with a median progression-free survival (mPFS) of 17.4 months in the high-dose group [4] - The standard mPFS for first-line squamous NSCLC therapies is around 7 months, making HLX07's results noteworthy [4] - Safety during treatment was reported to be good, with manageable treatment-emergent adverse events (TEAEs) [4]
复宏汉霖盘中涨超9% 传公司正与强生、罗氏就HLX43相关授权进行谈判
Zhi Tong Cai Jing· 2025-09-16 06:46
Group 1 - The core point of the article is that Fuhong Hanlin (02696) is in negotiations with multinational pharmaceutical companies such as Johnson & Johnson and Roche to sell rights related to the targeted PD-L1 antibody-drug conjugate HLX43, potentially receiving several hundred million dollars in upfront payments and milestone payments based on the drug's performance [1][1][1] Group 2 - Fuhong Hanlin's stock price increased by over 9% during the trading session, with a current price of 82.75 HKD and a trading volume of 114 million HKD [1][1][1] - Morgan Stanley recently upgraded the ratings for Fosun Pharma (600196) A-shares and H-shares to "Overweight," raising the A-share target price to 42 CNY and the H-share target price to 33 HKD [1][1][1] - Morgan Stanley values Fuhong Hanlin at 72 billion CNY, significantly higher than its current market value of approximately 44 billion CNY, translating to a per-share value of 143-145 HKD, with 73% of this valuation attributed to core candidate drugs HLX43, HLX22, and serplulimab [1][1][1]
港股异动 | 复宏汉霖(02696)盘中涨超9% 传公司正与强生、罗氏就HLX43相关授权进行谈判
智通财经网· 2025-09-16 06:45
Group 1 - The core point of the article is that Fuhong Hanlin (02696) is in negotiations with multinational pharmaceutical companies such as Johnson & Johnson and Roche to sell rights related to the PD-L1 antibody-drug conjugate HLX43, potentially receiving several hundred million dollars in upfront payments and milestone payments based on the drug's performance [1][1][1] Group 2 - Fuhong Hanlin's stock price increased by over 9% during trading, with a current price of 82.75 HKD and a trading volume of 114 million HKD [1][1][1] - Morgan Stanley recently upgraded the ratings for Fosun Pharma's A-shares and H-shares to "Overweight," raising the A-share target price to 42 HKD and the H-share target price to 33 HKD [1][1][1] - Morgan Stanley assigned a valuation of 720 billion HKD to Fuhong Hanlin, which is significantly higher than its current market value of approximately 440 billion HKD, translating to a per-share value of 143-145 HKD, with 73% of the valuation attributed to core candidate drugs including HLX43, HLX22, and serplulimab [1][1][1]