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中国银河证券:首次覆盖复宏汉霖予“推荐”评级 国内外业务稳步推进
Zhi Tong Cai Jing· 2025-12-16 07:40
1)HLX43是全球潜在BICPD-L1ADC,肺癌、胃癌、胸腺癌等多适应症临床在研。继2025年9月WCLC大 会更新1期数据后(共计56例),2025年11月2日公司公布了HLX43治疗NSCLC的关键更新数据,首次合并 了国际多中心II期临床结果,总人群疗效显著:鳞状NSCLC患者(2mg/kg,n=33)ORR为33.3%,非鳞状 NSCLC患者(2.5mg/kg,n=35)ORR为48.6%。同时,HLX43不依赖生物标志物筛选:PD-L1阴性(TPS< 1%,n=43)患者ORR为39.5%,提示疗效不受PD-L1表达限制,有望覆盖更广泛群体。此外,HLX43安 全性良好:血小板计数减少仅1.7%,血液学毒性较低。9.8%患者报告了irAE,2.9%患者出现免疫相关 性肺病,但观察到显著治疗获益:40%的cORR及100%的肿瘤缩小率,提示其疗效经由小分子毒素以及 免疫机制共同介导。同时,2025ESMOAsia披露:HLX43在晚期宫颈癌II期临床研究中展现了优异的初 步临床疗效,ORR为37.9%,DCR为72.4%,且安全性可控。2)HLX22:与曲妥珠单抗联用更优效、安 全,HLX22联合 ...
中国银河证券:首次覆盖复宏汉霖(02696)予“推荐”评级 国内外业务稳步推进
智通财经网· 2025-12-16 07:37
Core Viewpoint - Fuhong Hanlin (复宏汉霖) is positioned as a leading player in the biosimilar drug market in China, focusing on hematological malignancies, solid tumors, and autoimmune diseases, with a strong emphasis on international collaboration and product commercialization [1][2] Group 1: Business Performance - In 2023, the company achieved profitability with projected revenue of 5.724 billion yuan in 2024, representing a 6% year-on-year growth, and a net profit of 815 million yuan, reflecting a 50% increase compared to the previous year [2] - The company is expected to enter a high-growth phase in overseas business by 2025, with overseas product profits projected to grow over 200% in the first half of 2025 [2] Group 2: Product Pipeline and R&D - HLX43, a potential BICPD-L1ADC, is under clinical development for multiple indications including lung cancer and gastric cancer, showing significant efficacy in clinical trials with an overall response rate (ORR) of 33.3% for squamous NSCLC and 48.6% for non-squamous NSCLC [3] - HLX22, in combination with trastuzumab, has shown improved efficacy and safety in treating HER2-positive gastric/gastroesophageal junction cancer, with ongoing global Phase III trials [3] - The company is also advancing the development of Surulitinib, which aims to replace postoperative chemotherapy in gastric cancer with immunotherapy, having met primary clinical endpoints [3] Group 3: Market Strategy and Valuation - The company has established a global presence with its biosimilar products, which are key drivers of revenue growth, and is considering implementing full circulation of H-shares to enhance liquidity [4] - The projected net profits for 2025-2027 are estimated at 823 million, 744 million, and 1.129 billion yuan respectively, with corresponding price-to-earnings ratios of 39, 43, and 28, suggesting a total market valuation between 52.1 billion and 67.9 billion yuan [4]
复星医药子公司药品临床试验获批
Bei Jing Shang Bao· 2025-12-09 12:04
Core Viewpoint - Fosun Pharma's subsidiary Shanghai Fuhong Hanlin Biotechnology Co., Ltd. has received approval from the National Medical Products Administration to conduct clinical trials for HLX22 in combination with HLX87 for HER2-positive breast cancer treatment in mainland China [1] Group 1 - The approved clinical trials will focus on the use of HLX22 as a novel targeted monoclonal antibody for first-line treatment and neoadjuvant therapy in HER2-positive breast cancer [1] - HLX87 is an innovative antibody-drug conjugate (ADC) that links a topoisomerase I inhibitor with an anti-HER2 monoclonal antibody through a stable cleavable linker [1]
复宏汉霖:HLX22联合注射用HLX87分别用于BC一线治疗与BC neo的2/3期临床试验申请获国家药监局批准
Zhi Tong Cai Jing· 2025-12-09 09:28
HLX87是靶向HER2的创新抗体偶联药物(ADC),通过稳定可裂解的开环连接子将拓扑异构酶I抑制剂与 抗HER2单抗偶联而成,目前正处于3期临床研究阶段,拟用于HER2阳性乳腺癌治疗等。该药物采用高 透膜性拓扑异构酶抑制剂作为有效载荷,具有强效旁观者杀伤作用,同时结合独特、稳定的连接子设计 降低全身毒性,实现疗效与安全性的平衡。临床前研究显示,HLX87在多个肿瘤细胞系异种移植模型 中展现出与德曲妥珠单抗相当的抗肿瘤活性,且安全性优势明显。根据2024年美国癌症研究协会年会 (AACR2024)公布的HLX87治疗HER2表达或突变晚期实体瘤的1期临床数据,结果显示,HLX87在 2.0mg/kg~8.4mg/kg剂量范围内均表现出良好的耐受性和安全性,同时在乳腺癌、胃癌、肺癌等多种实 体肿瘤患者中表现出优异的治疗效果。目前,一项HLX87用于HER2阳性乳腺癌二线治疗的3期临床试 验正于中国境内开展。此前,本公司与外部合作伙伴就本公司引进HLX87达成战略合作,具体合作安 排及执行将以双方后续拟签订的正式许可协议中的交易安排为准。 HLX22为本公司许可引进并后续自主研发的新型靶向HER2的单克隆抗体,潜 ...
复宏汉霖(02696):HLX22联合注射用HLX87分别用于BC一线治疗与BC neo的2/3期临床试验申请获国家药监局批准
智通财经网· 2025-12-09 09:23
智通财经APP讯,复宏汉霖(02696)发布公告,近日,HLX22(重组人源化抗HER2单克隆抗体注射液) (HLX22)联合注射用HLX87(靶向HER2抗体偶联药物)(HLX87)用于HER2阳性乳腺癌(BC)一线治疗,以 及用于HER2阳性乳腺癌新辅助治疗(BC neo)的2/3期临床试验申请,分别获国家药品监督管理局批准。 本公司拟于条件具备后于中国境内开展相关临床研究。 HLX22为本公司许可引进并后续自主研发的新型靶向HER2的单克隆抗体,潜在适应症包括胃癌和乳腺 癌等实体瘤。HLX22用于治疗胃癌已分别于2025 年3月及2025年5月获美国食品药品监督管理局(FDA)及 欧盟委员会(EC)授予孤儿药资格认定(Orphan-drug Designation)。 HLX87是靶向HER2的创新抗体偶联药物(ADC),通过稳定可裂解的开环连接子将拓扑异构酶I抑制剂与 抗HER2单抗偶联而成,目前正处于3期临床研究阶段,拟用于HER2阳性乳腺癌治疗等。该药物采用高 透膜性拓扑异构酶抑制剂作为有效载荷,具有强效旁观者杀伤作用,同时结合独特、稳定的连接子设计 降低全身毒性,实现疗效与安全性的平衡。临床前研 ...
复宏汉霖CEO朱俊:创新药出海忌迷信经验、“倚老卖老”|36氪专访
3 6 Ke· 2025-10-31 08:22
Core Viewpoint - The recent downturn in the Hong Kong innovative drug market has shifted investor focus towards the core value of pharmaceutical companies, with Fuhong Hanlin being a notable beneficiary of this trend, experiencing significant stock price increases and financial returns [1][2][3]. Group 1: Company Overview - Fuhong Hanlin, established in 2010, initially focused on developing biosimilars targeting blockbuster original drugs, covering areas such as oncology and autoimmune diseases [2]. - The company has achieved substantial financial returns early on, with total revenue of 2.8 billion yuan and a net profit of 390 million yuan in the first half of this year [3]. Group 2: Product Pipeline and Strategy - Fuhong Hanlin is shifting its focus towards innovative drugs as its biosimilar business matures, which is seen as a crucial path for overcoming growth ceilings [5]. - The company’s core innovative drug pipeline includes the PD-1 drug, H drug, which has shown promising results in clinical trials for gastric cancer and is expected to generate significant global sales [7][8]. Group 3: Market Expansion and Clinical Development - H drug is projected to reach global sales of 5 billion USD, with a focus on expanding into the U.S. market after initial approvals in Southeast Asia and the EU [8][9]. - The company aims to establish a clinical development capability that spans from clinical trials to product registration and GMP production, enhancing its competitiveness in the U.S. market [9]. Group 4: Innovative Approaches and Future Directions - Fuhong Hanlin is exploring differentiated indications based on clinical needs, particularly in areas where competitors have failed, such as perioperative treatment for gastric cancer [10][11]. - The company emphasizes the importance of addressing unmet clinical needs and adapting to regulatory environments to successfully penetrate local markets [12]. Group 5: Research and Development Investments - Fuhong Hanlin is investing heavily in its research pipeline, including a PD-L1 ADC drug, HLX43, which aims to address limitations of existing therapies and has shown promising early clinical results [14][15]. - The company is also developing HLX22 for HER2-positive advanced gastric cancer, with significant investment aimed at improving patient outcomes and expanding market potential [16].
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
Core Insights - Shanghai Junshi Biosciences Co., Ltd. announced that its self-developed PD-1 inhibitor, Hanshu (sulunlimab), achieved predefined efficacy standards in a Phase III clinical study for perioperative treatment of gastric cancer, marking a significant breakthrough in the field [1] - The company plans to expedite the application for market approval for this indication, emphasizing its commitment to transforming research results into patient benefits [1] - Gastric cancer poses a major public health challenge globally, with approximately 969,000 new cases and 660,000 deaths reported in 2022, ranking fifth in incidence and mortality among all cancers [2] Company Focus - The company is strategically focused on gastrointestinal tumors, with recent approvals and ongoing clinical studies in various cancer types, including esophageal squamous cell carcinoma and HER2-positive advanced gastric cancer [2] - The company is advancing multiple clinical trials, including a Phase III study for Hanshu in metastatic colorectal cancer and exploring new therapies such as PD-L1 antibody-drug conjugate HLX43 for advanced gastric and gastroesophageal junction adenocarcinoma [2][3] Future Plans - The company aims to leverage its innovative therapy matrix and extensive global clinical trial data to maintain its leading position in the gastrointestinal oncology field, with a commitment to delivering high-quality treatment options to a broader patient population [3]
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]