Core Viewpoint - Fuhong Hanlin (02696) experienced a nearly 6% increase in stock price following the announcement of successful Phase III clinical trial results for its self-developed PD-1 inhibitor, Hanshu (Surulitinib), in combination with chemotherapy for gastric cancer treatment [1] Group 1: Clinical Trial Results - The Phase III clinical study achieved predefined efficacy standards and demonstrated good safety for the treatment regimen [1] - This treatment represents a significant breakthrough as it is the first global perioperative (preoperative/postoperative) therapy for gastric cancer to replace postoperative adjuvant chemotherapy with a single-agent immunotherapy [1] Group 2: Future Plans - In light of the positive trial results, the company plans to expedite the application for market approval for this indication [1] - The CEO, Dr. Zhu Jun, emphasized that gastrointestinal tumors are a core area of focus for the company, and they will actively promote the translation of results to benefit patients while accelerating the exploration and application of more innovative therapies [1]

Core Viewpoint - Fuhong Hanlin (02696) announced a significant breakthrough in the treatment of gastric cancer with its self-developed PD-1 inhibitor, Hanshu (Surulimumab), achieving predefined efficacy standards in a Phase III clinical trial, leading to a nearly 6% increase in stock price [1] Company Summary - Fuhong Hanlin's PD-1 inhibitor, Hanshu, combined with chemotherapy, has become the first treatment globally to replace postoperative adjuvant chemotherapy with immunotherapy in the perioperative setting for gastric cancer [1] - The company plans to expedite the application for market approval for this indication following the positive trial results [1] - CEO Dr. Zhu Jun emphasized the company's commitment to gastrointestinal tumors as a core area and the intention to accelerate the translation of research results to benefit patients [1]

炒股就看金麒麟分析师研报，权威，专业，及时，全面，助您挖掘潜力主题机会！ 10月9日，复宏汉霖宣布其自主研发的PD-1抑制剂H药（斯鲁利单抗）胃癌围手术期III期临床研究 （ASTRUM-006）达到主要终点，成为全球首个胃癌围术期以免疫单药取代术后辅助化疗的治疗方案。 这项研究在辅助治疗阶段创新性地采用"去化疗"的H药单药治疗策略，显著改善无事件生存期 （EFS），病理完全缓解（pCR）率是对照组的3倍多，同时复发风险显著降低。在K药（帕博利珠单 抗）、O药（纳武利尤单抗）相继在胃癌围手术期领域折戟的背景下，H药的成功尤为引人注目，标志 着胃癌治疗从"单纯强化治疗"到"高效低毒"精准模式的关键性跨越。 突破性设计引领治疗模式变革 H药成为复发与化疗耐受问题新答案 胃癌是全球重大公共卫生挑战，2022年全球新发病例约96.9万例，死亡病例约66万例，其发病率和死亡 率在所有癌症中均高居第五位。目前，根治性手术是治愈胃癌的唯一手段。然而，局部进展期胃癌术后 复发率高达40%-70%，两次术后的5年生存率不足25%。 胃癌围手术期治疗当前以化疗为标准方案，但复发率仍然较高，5年总生存率仍不足50%。在临床实践 中 ...

卢力媛 科技日报记者 王春 从领跑全国的创新药械数量，到占全国35%的创新药海外授权数量；从支持生物医药产业全链条创新发展的政策法规，到支撑全生命周期的产业 基金；从规上企业数量稳步扩张到跨国企业在沪布局不断深化……上海生物正形成全球生物医药全链条创新"强磁场"。 10月13日，2025上海国际生物医药产业周（以下简称产业周）拉开帷幕。作为汇聚生物医药产业全链条相关方的高能级平台，产业周不仅是一场 展示前沿医药技术与创新成果的盛会，更是观察上海生物医药产业动态的窗口。 生物医药产业发展离不开基础研究强大的策源功能和转化支撑。"十四五"期间，上海生物医药领域有6项研究登上三大全球顶尖学术期刊《细胞》 《自然》《科学》封面。同时，在全球医学领域四大顶尖期刊《新英格兰医学杂志》《柳叶刀》《美国医学会杂志》《英国医学杂志》中，来自 上海的研究成果近年快速增长，从2021年的24篇跃升至2024年的52篇，总数达127篇。上海市生物医药科技产业促进中心高级工程师唐军介 绍："《细胞》期刊发布的'Best of Cell 2024'榜单12篇研究论文中，有3篇出自上海。" "今年，复宏汉霖的汉斯状在欧盟获批上市，有幸成为 ...

Core Insights - Shanghai is leading the nation in the innovation of pharmaceuticals and medical devices, with 30 approved domestic Class I innovative drugs from 2021 to September 2025, accounting for 17% of the national total [1] - The biopharmaceutical industry in Shanghai reached a scale of 500.57 billion yuan in the first half of this year, with expectations to surpass 1 trillion yuan for the full year [2] - Shanghai's License-out transactions for innovative drugs reached 38 in 2024, representing 35% of the national total, with a transaction value of 30.7 billion USD, accounting for 47% of the national total [3] Industry Growth - The biopharmaceutical industry in Shanghai has shown consistent growth, increasing from 761.71 billion yuan in 2021 to an estimated 984.70 billion yuan in 2024, with a compound annual growth rate of 8.94% [2] - By the end of 2024, Shanghai is expected to have 2,183 biopharmaceutical enterprises, covering manufacturing, services, and wholesale [2] - Shanghai has seen 46 companies go public from 2021 to 2024, with 4 new listings in 2023 alone [2] International Recognition - Since 2021, 9 drugs have been approved in international markets such as the US and Japan, indicating the global recognition of Shanghai's innovative capabilities [3] - Major international pharmaceutical and medical device companies have established headquarters or R&D centers in Shanghai, with 19 out of the top 20 in each category present [2] Policy Support - Shanghai has implemented various policies to support the biopharmaceutical industry, including regulations and action plans focused on synthetic biology, cell and gene therapy, and AI in medicine [4] - A biopharmaceutical industry mother fund with a total scale of 22.5 billion yuan has been established, along with a 10 billion yuan merger fund targeting strategic acquisitions in traditional Chinese medicine, vaccines, and high-end medical devices [4] - From 2021 to 2024, Shanghai's biopharmaceutical sector has secured 238.37 billion yuan in financing, ranking among the top in the country [4] Innovation Ecosystem - Shanghai has built a comprehensive innovation ecosystem that spans from research to clinical application, providing new momentum for high-quality development in the biopharmaceutical industry [5]

Core Insights - Shanghai's biopharmaceutical industry is experiencing rapid growth, with 38 license-out transactions expected to reach $30.7 billion in 2024, accounting for nearly one-third of the national total [1] - The industry has a compound annual growth rate of 8.94%, with a projected market size exceeding 1 trillion yuan this year [1] - Shanghai is building a world-class innovation ecosystem to enhance its role as a leading biopharmaceutical hub [1] Industry Development - Since 1993, biopharmaceuticals have been a key focus in Shanghai, with industrial output surpassing 200 billion yuan by 2024 [2] - Recent regulations and action plans have been implemented to support innovation across the entire biopharmaceutical value chain [2] - The establishment of the Shanghai Clinical Innovation Transformation Research Institute aims to facilitate the commercialization of clinical results from hospitals [2][3] Clinical Innovation - The clinical results commercialization model allows hospitals to transfer patent rights to the institute, which then partners with investors to form companies [3] - This model addresses challenges hospitals face in managing clinical results and enhances the efficiency of technology transfer [3] Foreign Investment and Local Innovation - Shanghai has attracted major international pharmaceutical companies, with 19 out of the top 20 global firms establishing headquarters or R&D centers in the city [5] - The city is fostering collaboration between multinational and local companies, enhancing innovation capabilities [5][6] Policy Support - Shanghai has introduced comprehensive policies covering the entire biopharmaceutical industry chain, promoting R&D and manufacturing [8] - The city has recognized significant achievements in biopharmaceutical innovation, such as the development of the first domestically produced targeted drug for colorectal cancer [8][9] Financial Investment - The biopharmaceutical sector relies heavily on patient capital due to its high-risk and long-cycle nature [12] - Shanghai has established a 22.5 billion yuan biopharmaceutical industry fund to support strategic mergers and acquisitions [13][14] - From 2021 to 2024, the sector has seen cumulative financing of 238.37 billion yuan, with 1,494 financing events [13]

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， ...

Market Performance - The Hong Kong stock market continued its decline, with notable drops in several biotech companies [1] - Innovent Biologics (09969) fell by 11.19%, closing at 14.760, with a market capitalization of 26.021 billion and a year-to-date increase of 141.18% [2] - Rongchang Biologics (09995) decreased by 10.22%, with a latest price of 95.350 and a total market value of 53.74 billion, reflecting a year-to-date increase of 562.15% [2] - WuXi AppTec (02268) and WuXi Biologics (02269) experienced declines of 5.68% and 5.32%, respectively, with market caps of 89.818 billion and 1585.28 billion [2] - Other companies such as Fuhong Hanlin (02696) and Kelun-Biotech (06990) also saw declines of over 4% [1][2] Company Highlights - Innovent Biologics has shown a significant year-to-date performance increase of 141.18% despite the recent drop [2] - Rongchang Biologics has the highest year-to-date increase among the listed companies at 562.15% [2] - WuXi Biologics and WuXi AppTec have maintained strong year-to-date increases of 120.84% and 138.50%, respectively [2] - Fuhong Hanlin and Kelun-Biotech also reported substantial year-to-date increases of 205.49% and 199.33% [2]

Core Viewpoint - The Hong Kong biopharmaceutical stocks continued to decline, with significant drops in several key companies, indicating a bearish trend in the sector [1]. Group 1: Stock Performance - Innovent Biologics (09969) experienced a decline of 11.19%, with a latest price of 14.760 and a total market capitalization of 26.021 billion, despite a year-to-date increase of 141.18% [2]. - Rongchang Biologics (09995) fell by 10.22%, with a latest price of 95.350 and a market cap of 53.747 billion, showing a remarkable year-to-date increase of 562.15% [2]. - WuXi AppTec (02268) saw a decrease of 5.68%, with a latest price of 73.100 and a market cap of 89.818 billion, maintaining a year-to-date increase of 138.50% [2]. - WuXi Biologics (02269) dropped by 5.32%, with a latest price of 38.780 and a market cap of 158.528 billion, reflecting a year-to-date increase of 120.84% [2]. - Fuhong Hanlin (02696) declined by 4.42%, with a latest price of 72.400 and a market cap of 39.349 billion, showing a year-to-date increase of 205.49% [2]. - Kelun-Biotech (06990) decreased by 4.25%, with a latest price of 488.800 and a market cap of 113.981 billion, with a year-to-date increase of 199.33% [2]. - WuXi AppTec (02359) fell by 4.19%, with a latest price of 114.400 and a market cap of 339.275 billion, reflecting a year-to-date increase of 109.21% [2]. - Gendicine (09688) saw a decrease of 2.83%, with a latest price of 25.440 and a market cap of 28.432 billion, with a year-to-date increase of 21.72% [2]. - CanSino Biologics (09926) declined by 2.05%, with a latest price of 128.800 and a market cap of 118.643 billion, reflecting a year-to-date increase of 112.19% [2]. - Junshi Biosciences (01877) fell by 2.02%, with a latest price of 29.100 and a market cap of 29.877 billion, showing a year-to-date increase of 151.30% [2].

Core Insights - The company, Fuhong Hanlin (2696.HK), announced a significant breakthrough in gastric cancer treatment with its self-developed PD-1 inhibitor, H drug (sulfuril monoclonal antibody), achieving the primary endpoint of event-free survival in the phase III clinical study (ASTRUM-006) [1] Group 1 - The ASTRUM-006 study represents the first global instance of using an immune monotherapy to replace postoperative adjuvant chemotherapy in perioperative gastric cancer treatment [1] - The mid-term analysis of the clinical study was reported on October 9, indicating a successful outcome [1] - This development marks a major advancement in the field of gastric cancer therapy [1]