Core Viewpoint - The Alzheimer's treatment drug, Ganluo Sodium Capsule, is entering a new phase under Fosun Pharma after facing scientific scrutiny and market challenges, with plans for post-marketing confirmatory clinical trials approved by the National Medical Products Administration (NMPA) [1][2]. Group 1: Clinical Development and Market Position - Fosun Pharma has announced a post-marketing confirmatory clinical trial plan for Ganluo Sodium Capsule, with an increased sample size of 1,950 participants, aiming for completion by the end of 2027 and data release in early 2029 [1][2]. - The drug was conditionally approved for marketing in November 2019 and has since benefited hundreds of thousands of patients, with sales exceeding 1 billion yuan since its inclusion in the national medical insurance catalog in 2021 [1][2]. - The price of the drug decreased from 895 yuan to 296 yuan after being included in the national medical insurance catalog, with over 2 million boxes expected to be sold in 2024 alone [1]. Group 2: Scientific and Regulatory Challenges - The drug faced challenges due to the NMPA not approving the extension of its conditional marketing authorization, leading to a supply interruption and various criticisms [2]. - Prior to conditional approval, Ganluo Sodium Capsule completed phase III confirmatory clinical trials with 818 participants across 34 clinical research centers, and real-world studies involving 3,300 participants have been submitted to validate its long-term safety and efficacy [3]. Group 3: Market Demand and Strategic Response - Alzheimer's disease has become a significant public health challenge in China, with nearly 17 million patients reported in 2021, representing 29.8% of global cases [4]. - The existing treatment options are limited and primarily symptomatic, highlighting a substantial unmet clinical need for effective therapies [4][5]. - The Chinese government is encouraging innovation in drug development, aligning with Fosun Pharma's strategic focus on addressing unmet clinical needs in the Alzheimer's treatment space [5]. Group 4: Company Capabilities and Future Outlook - Fosun Pharma's confidence in taking over the Ganluo Sodium project stems from its proven integrated capabilities in research, clinical trials, and commercialization, with ongoing investments in CNS-related products [6]. - The company has successfully launched several innovative drugs in China and is expanding its clinical and commercial teams in the U.S. to support global market entry [6]. - If clinical results are positive, Ganluo Sodium could re-enter the market post-2029, enhancing Fosun Pharma's capabilities in CNS diseases and attracting further collaborations [7].

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 ...

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]

据了解，胃癌是全球高发恶性肿瘤，发病率和死亡率均居前列。当前，免疫治疗在晚期胃癌中已取得进 展，但在围手术期(手术前后)的应用仍属空白，中国尚无在该阶段获批的免疫疗法，临床需求迫切，亟 需能有效降低复发、提升治愈率的新方案。 12月12日，复宏汉霖(02696)宣布公司自研创新型抗PD-1单抗H药汉斯状(斯鲁利单抗，欧洲商品名： Hetronifly)联合含铂化疗新辅助治疗，在手术后辅助治疗，用于PD-L1阳性的、可手术切除的胃癌患者 的上市注册申请(NDA)获国家药品监督管理局(NMPA)受理，并被纳入优先审评审批程序。 此次被纳入优先审评意味着审评时限将大幅缩短至130个工作日，标志着H药胃癌围手术期治疗适应症 的上市进程全面提速，H药有望成为全球首个获批用于该领域的抗PD-1单抗。复宏汉霖执行董事、首席 执行官朱俊博士表示，此次获受理并被纳入优先审评，标志着H药胃癌围手术期适应症正式进入上 市"快车道"。 本次上市申请主要基于该项关键性研究ASTRUM-006的积极结果。期中分析结果显示：该研究达到预设 的优效性标准，与安慰剂联合化疗相比，汉斯状联合化疗显著改善无事件生存期(EFS)，病理完全缓解 (p ...

今日，复宏汉霖（2696.HK）宣布公司自研创新型抗PD-1单抗H药 汉斯状®（斯鲁利单抗，欧洲商品 名：Hetronifly®）联合含铂化疗新辅助治疗，在手术后辅助治疗，用于PD-L1阳性的、可手术切除的胃 癌患者的上市注册申请（NDA）获国家药品监督管理局（NMPA）受理，并被纳入优先审评审批程序。 此次被纳入优先审评意味着审评时限将大幅缩短至130个工作日，标志着H药胃癌围手术期治疗适应症 的上市进程全面提速，H药有望成为全球首个获批用于该领域的抗PD-1单抗。 复宏汉霖执行董事、首席执行官朱俊博士表示"此次获受理并被纳入优先审评，标志着H药胃癌围手术 期适应症正式进入上市'快车道'。作为全球首个在胃癌围手术期以免疫单药取代术后辅助化疗的创新方 案，该疗法将显著改善患者的生活质量与生存获益。期待这一创新治疗策略尽早惠及广大胃癌患者，为 他们带来治愈希望。 此前，H药已被CDE纳入突破性治疗品种名单，是首个在胃癌围手术期治疗领域获此认定的药物。因符 合优先审评范围，CDE同意将其纳入优先审评审批程序。 ...

Core Insights - The collaboration between Fosun Pharma and Pfizer marks a significant milestone in the competitive landscape of GLP-1 therapies, highlighting Fosun's innovative capabilities in small molecule drug development [3][8][10] Group 1: Transaction Details - On December 9, Fosun Pharma announced a licensing agreement with Pfizer for its orally administered small molecule GLP-1 receptor agonist YP05002, granting Pfizer global rights for development, production, and commercialization [4][5] - Fosun Pharma will receive an upfront payment of up to $150 million, with potential milestone payments totaling up to $1.935 billion, along with tiered royalties post-approval [4][5] Group 2: Market Context - The GLP-1 market is experiencing intense competition, with major pharmaceutical companies actively pursuing next-generation therapies. Sales of existing GLP-1 products like semaglutide and tirzepatide have reached $25.462 billion and $24.837 billion respectively in the first three quarters of the year, indicating a strong market demand [6][7] - The collaboration signifies Fosun Pharma's recognition in the global market, as it aligns with the trend of multinational corporations seeking innovative GLP-1 solutions [5][6] Group 3: Strategic Implications - Fosun Pharma's chairman emphasized that this partnership is a key step in the company's strategy for innovation and internationalization, aiming to address unmet clinical needs in obesity and metabolic diseases [5][8] - The deal is part of a broader trend where Fosun Pharma has secured multiple business development transactions in 2023, totaling approximately $4 billion, showcasing its diverse research capabilities [9][10]

摘要 HLX43（43P 六 1 ADC）在 PD-L1 阳性宫颈癌患者中显示出初步疗效， 尤其是在 3.0 毫克剂量组中，客观缓解率（ORR）达到 70%，但样本量 小（n=10），随访时间短（3.5 个月），需扩大样本验证。 HLX43 在不同剂量下安全性总体可控，主要毒性为血液学毒性，如贫血、 恶心呕吐，免疫相关不良事件（IAE）发生率为 23.3%，程度轻微，未 见严重级别不良反应，血液学毒性与剂量相关。 公司已停止 2.0 毫克剂量组的入组，后续研究将重点放在 2.5 毫克和 3.0 毫克两个高剂量组上，并密切监测长期毒性的累积效应，优化给药 方案。 8,201 药物（HLX43）在不同瘤种中的疗效存在差异，宫颈癌初步数据 显示 3 毫克剂量组的 ORR 达到 70%，但数据尚不完全可靠，需扩大样 本量并优化剂量方案。 公司计划继续扩大患者入组数量，优化给药方案，研究加载剂量，并进 行斯鲁利单抗与 8,201 联合用药的安全性研究，未来将根据适应症优先 级推进不同组合治疗策略。 Q&A 请介绍一下此次在 ESMO Asia 大会上披露的 HLX43 在宫颈癌二期临床试验 中的具体数据和结果。 在此次 ...

Core Viewpoint - Shanghai is emerging as a global hub for biopharmaceutical innovation, with local companies leveraging innovation, transformation, and internationalization to enhance their competitiveness on the world stage [4][6]. Group 1: Innovation - Junshi Bioscience has focused on unmet clinical needs, successfully launching its PD-1 monoclonal antibody, which has reshaped the landscape for domestic innovative drugs in international markets [4][5]. - Fosun Pharma has achieved significant milestones in innovation, including the development of China's first self-developed CAR-T cell therapy product and the first PD-1 monoclonal antibody approved for first-line treatment of small cell lung cancer [8][9]. - The company has established a comprehensive innovation system, with over 12 innovative drugs launched during the 14th Five-Year Plan period, focusing on oncology, immune inflammation, and chronic diseases [11][12]. Group 2: Transformation - First Pharmaceutical has adapted to the challenges posed by e-commerce in the pharmaceutical retail sector by integrating smart healthcare services, revitalizing its traditional pharmacy model [5][30]. - Fosun Pharma's transformation journey aligns with the rapid evolution of China's innovative drug industry, emphasizing a combination of generics and original innovations [5][11]. - Seer Bio has expanded its research into broader biotoxin treatments after mastering snake venom therapies, indicating a strategic shift towards a wider range of biological toxin therapies [5][26]. Group 3: Internationalization - Fosun Pharma has successfully penetrated international markets, with its anti-tumor innovative drug, Slulizumab, approved in approximately 40 countries, showcasing the company's global strategy [12][13]. - Junshi Bioscience has transitioned from a "single-point breakthrough" to "platform innovation," with its core product, Toripalimab, now available in major markets including the US and EU [16][17]. - The company is building a global commercialization network through partnerships and local teams, aiming to enhance its international presence [22][23]. Group 4: Market Challenges and Opportunities - First Pharmaceutical faces significant challenges in the pharmaceutical distribution industry, including regulatory changes, evolving sales models, and increased consumer expectations for professional services [32][33]. - Despite these challenges, First Pharmaceutical has reported substantial revenue growth, with sales increasing from 1.398 billion yuan in 2021 to 1.915 billion yuan in 2024 [32]. - The company is strategically focusing on the silver economy, aiming to develop integrated services for the elderly, aligning with national policies on aging [34][35].

Core Insights - The pharmaceutical MNC supply chain has extremely high entry barriers, requiring years for supplier certification through cross-departmental audits in technology, quality, EHS, and compliance. Once included in the qualified supplier list, a strong lock-in effect is formed, making it difficult for new entrants to disrupt the existing supply structure even if they meet technical standards, thus demonstrating a strong first-mover advantage [4][7]. - MNCs demand far more than conventional quality compliance, emphasizing full-process controllability and risk management capabilities. Compliance with guidelines such as EU GMP and ICHQ is required, along with the establishment of traceability systems and safety stock. Any process changes or relocation of production sites must undergo strict and time-consuming certification [4][7]. - In procurement decisions, MNCs are relatively insensitive to price factors, prioritizing the integrity of the supply chain over cost. For MNCs, API costs represent only a small portion of their terminal formulation sales, leading them to pay a premium for stable, traceable, and zero major quality incident supply capabilities, viewing supply chain resilience as a core competitive advantage rather than a cost item. Thus, entering the MNC supply chain often means effectively avoiding "price internalization" [4][7]. - Investment recommendations include innovative drug and device companies such as Furuya Co., Aonlikang, Shutaishen, Weichuang Bio, and others. From the perspective of CXO and raw materials, companies like WuXi AppTec, Jiuzhou Pharmaceutical, Chengda Pharmaceutical, and others are suggested for attention [4][7]. Market Performance Overview - As of November 21, 2025, the TTM-PE of the pharmaceutical and biotechnology industry is 48.84 times, which is 100% higher than the historical lowest PE valuation of 24.38 times on January 3, 2019. The premium rate relative to the CSI 300 is 252%, exceeding the historical lowest valuation premium of 124% on February 6, 2018, by 128 percentage points, and is 11 percentage points higher than the average valuation premium rate of 241% over the past decade [8][12]. - From November 17 to November 21, 2025, the pharmaceutical and biotechnology sector experienced a decline of 6.88%, ranking 22nd among 27 sub-industries. The chemical raw materials sector saw the largest decline at -8.60% [12][15]. Industry Dynamics - Pfizer's Class 1 new drug, Matacizumab, was approved for marketing on November 21, 2025, for the routine prevention and treatment of bleeding in patients with severe hemophilia A or B [20]. - Boehringer Ingelheim's Class 1 new drug, BI764198, was proposed for inclusion as a breakthrough therapy on November 18, 2025, targeting primary focal segmental glomerulosclerosis [21]. - The PD-1 inhibitor H drug, Surulutumab, developed by Fuhong Hanlin, was officially included as a breakthrough therapy on November 20, 2025, for gastric cancer treatment [22]. - On November 17, 2025, FDA approved the biosimilar of Tysabri, developed by Sandoz, for multiple sclerosis and Crohn's disease [23].

Core Insights - The article highlights the significant growth in the number of research papers published by Chinese scientists in Cell Press journals over the past decade, indicating advancements in originality, systematic approaches, and openness in Chinese research [2] - In 2024, the total number of research papers published by Chinese institutions in Cell Press journals reached 2,446, marking a 17.6% increase from the previous year and nearly quadrupling the publication volume from 2020 [2] Group 1: Research Output - The number of research papers published by Chinese institutions in Cell Press journals has shown a remarkable increase, with 2,446 papers published in 2024 [2] - This represents a 17.6% increase compared to the previous year and is nearly four times the publication volume from 2020 [2] Group 2: Awarded Papers - Cell Press has selected 50 papers for the "Cell Press 2024 China Annual Papers" across five fields: life sciences, material sciences, medicine, interdisciplinary studies, and sustainable development [2] - Each field includes 10 papers, showcasing the diversity and impact of Chinese research in various scientific domains [2]