根据IQVIA MIDASTM的资料(IQVIA是全球医药健康产业专业信息和战略谘询服务提供商)，2024年 度，伊匹木单抗于全球范围内的销售额约为28.73亿美元。 HLX13是公司自主研发的伊匹木单抗生物类似药，拟用于黑色素瘤、肾细胞癌、结直肠癌、肝细胞 癌、非小细胞肺癌、恶性胸膜间皮瘤及食管鳞状细胞癌等原研药已获批的适应症。伊匹木单抗是全人、 具有κ轻链的抗CTLA-4(细胞毒T淋巴细胞相关抗原4，又称CD152)的IgG1型单克隆抗体，通过阻断 CTLA-4与配体的结合，增强免疫反应进而达到杀伤肿瘤的目的。2023年6月，HLX13用于肝癌(HCC)治 疗的临床试验申请获国家药品监督管理局批准。2023年11月，HLX13用于黑色素瘤、肾细胞癌、结直 肠癌、肝细胞癌、非小细胞肺癌、恶性胸膜间皮瘤及食管鳞状细胞癌治疗的临床试验申请获国家药品监 督管理局批准。2025年9月，HLX13一线治疗不可切除的肝细胞癌(HCC)患者的1期临床试验申请(IND) 获美国食品药品管理局(FDA)批准。2025年4月，公司与Sandoz AG签订许可协议，据此，公司向Sandoz AG授出独家许可，供其于美国、约定的欧 ...

孙淑玉烟台报道 会上,由烟台毓璜顶医院肿瘤内二科主任刘爱娜和宫文静指导的青岛大学医学院研究生李菲,研究成果成 功入选大会电子海报,向国际同行展示了医院在晚期胃癌免疫再挑战治疗领域的重要探索与突破性进 展。该成果核心聚焦一线免疫联合化疗进展后患者的二线治疗策略优化,系统回顾分析了49例接受免疫 再挑战治疗的晚期胃癌患者临床数据,重点评估了客观缓解率(ORR)、疾病控制率(DCR)、无进展生存期 (PFS)、总生存期(OS)及≥3级免疫相关不良事件(irAEs)等关键指标,并深入探讨PD-L1表达对治疗疗效的 预测价值。研究结果显示,免疫再挑战治疗在生存获益方面表现出可比或略优的临床疗效,且治疗毒性可 控,PD-L1表达有望成为预测疗效的重要生物标志物。这一成果为晚期胃癌二线治疗提供了极具价值的临 床参考,也为进一步优化免疫再挑战治疗策略奠定了坚实基础。 近年来,烟台毓璜顶医院肿瘤内二科秉持"临床与科研融合、创新与实用并重"的发展理念,持续推动肿瘤 学领域的学术探索与临床转化,为研究生培养提供了优质的科研平台与实践机会。此次李菲的科研成果 入选国际顶级学术会议,不仅彰显了医院在晚期胃癌免疫治疗研究方面的专业实力与 ...

Core Viewpoint - The Chinese stock market experienced a slight decline, with the Shanghai Composite Index closing at 4000.14 points, down 0.07% [1] Market Performance - The Shanghai Composite Index reported a trading volume of 840.47 billion yuan - The Shenzhen Component Index closed at 13240.62 points, down 0.36%, with a trading volume of 1104.57 billion yuan - The ChiNext Index ended at 3122.03 points, down 0.39%, with a trading volume of 487.83 billion yuan [1] Sector Performance - Sectors such as brokerage, automotive, coal, semiconductor, chemical, and steel saw declines - Conversely, sectors including insurance, oil, and pharmaceuticals experienced gains - Innovative drugs, immunotherapy, and brain engineering concepts were particularly active [1]

Core Insights - The article provides an overview of the latest fund net asset values, highlighting the top-performing and bottom-performing funds in the market [1] Fund Performance Summary Top 10 Funds by Net Value Growth - The top 10 funds with the highest net value growth include: 1. E Fund S&P Biotechnology RMB C: 1.5967, growth of 3.31% 2. E Fund S&P Biotechnology RMB A: 1.6184, growth of 3.31% 3. E Fund S&P Biotechnology USD A: 0.2284, growth of 3.30% 4. E Fund S&P Biotechnology USD C: 0.2253, growth of 3.30% 5. Vanguard Growth A: 1.0911, growth of 2.95% 6. Shenwan Hongyuan Medical A: 0.4952, growth of 2.95% 7. Vanguard Growth C: 1.1104, growth of 2.95% 8. Shenwan Hongyuan Medical C: 0.4867, growth of 2.94% 9. Fuguo Medical Innovation A: 1.8086, growth of 2.86% 10. Fuguo Medical Innovation C: 1.7890, growth of 2.86% [2] Bottom 10 Funds by Net Value Decline - The bottom 10 funds with the largest net value decline include: 1. Dongcai Value Start C: 0.8164, decline of 5.32% 2. Dongcai Value Start A: 0.8302, decline of 5.31% 3. HSBC Jintrust Low Carbon Pioneer A: 3.0533, decline of 4.87% 4. HSBC Jintrust Low Carbon Pioneer C: 2.9915, decline of 4.87% 5. HSBC Jintrust Research Selected Mixed: 1.0754, decline of 4.86% 6. HSBC Jintrust Core Growth A: 1.0195, decline of 4.70% 7. HSBC Jintrust Core Growth C: 0.9970, decline of 4.69% 8. Ping An Research Selected Mixed C: 0.8939, decline of 4.65% 9. Ping An Research Selected Mixed A: 0.9228, decline of 4.64% 10. HSBC Jintrust Intelligent Manufacturing Pioneer C: 2.8535, decline of 4.63% [3] Market Overview - The Shanghai Composite Index opened lower but rebounded, closing slightly down, with a trading volume of 1.96 trillion yuan and a stock performance ratio of 1758 gainers to 3563 losers [5] - Leading sectors include insurance, oil, banking, textiles, and household appliances, while the concept of immunotherapy saw a rise of over 2% [6] - Declining sectors include mineral products and electrical equipment, both dropping over 2% [7] Fund Holdings Analysis E Fund S&P Biotechnology Holdings - The fund's top holdings include: 1. CRISPR Therapeutics AG: 2.14% 2. Exelixis Inc: 1.89% 3. AbbVie Inc: 1.89% 4. Madrigal Pharmaceuticals Inc: 1.84% 5. Moderna Inc: 1.83% - The fund has a concentration of 18.47% in its top ten holdings, focusing on the pharmaceutical sector, and has outperformed the market [8] Dongcai Value Start Holdings - The fund's top holdings include: 1. Longi Green Energy: -7.35% 2. Foster: -6.08% 3. Zhongyou Technology: -2.11% 4. Yinke Co.: -0.74% 5. Xinyi Solar: -4.27% - The fund has a concentration of 47.27% in its top ten holdings, focusing on the renewable energy sector, and has underperformed the market [8]

Market Overview - The Shanghai Composite Index experienced a slight decline of 0.07%, closing at 4000.14 points, while the Shenzhen Component Index fell by 0.36% to 13240.62 points, and the ChiNext Index decreased by 0.39% to 3122.03 points. In contrast, the SSE 50 Index rose by 0.32% [1] - The total trading volume across the Shanghai, Shenzhen, and Beijing markets reached 196.5 billion yuan [1] Sector Performance - Sectors such as brokerage, automotive, coal, semiconductor, chemical, and steel saw declines, while insurance, oil, and pharmaceuticals experienced gains. Notably, innovative drugs, immunotherapy, and brain engineering concepts were active [1] - The current market environment shows a divergence in preference for "policy certainty" and "high-growth elasticity," with the Shanghai Composite Index demonstrating relative resilience compared to the ChiNext Index, which is dragged down by technology stocks [1] Investment Insights - The short-term market is expected to continue a structural trend dominated by "new energy + policy themes," with photovoltaic equipment benefiting from the implementation of new energy consumption policies and technological breakthroughs, indicating potential sustained prosperity [1] - After adjustments, the technology growth sector may present rebound opportunities if there are new catalysts in semiconductor domestic substitution or AI applications, although caution is advised regarding high valuation digestion pressure [1] - A balanced investment strategy focusing on "dividend & micro-cap stocks and technology-driven sectors" is recommended. If domestic policies lead to a sustained recovery in the consumer market, there may be further investment opportunities in the consumer sector [1]

人民财讯11月12日电，今日三大指数小幅低开后震荡调整，深证成指、创业板指盘中一度跌逾1%，尾 盘再度反弹，跌幅收窄。截至收盘，沪指跌0.07%，深证成指跌0.36%，创业板指跌0.39%。盘面上，银 行板块走高，农业银行、工商银行创历史新高。石油、天然气板块走强，石化油服、准油股份、胜利股 份等涨停。免疫治疗、创新药概念走高，济民健康、中源协和、开能健康等涨停。纺织服饰板块活跃， 九牧王、七匹狼等涨停。保险、石油、银行、纺织服饰等板块涨幅居前；培育钻石、矿物制品、BC电 池、电气设备等板块跌幅居前。 ...

Group 1 - The immunotherapy sector is experiencing a strong rebound, with companies like Zhongyuan Qihuo and Kaineng Health hitting the daily limit up [1] - Other companies in the sector, such as Jimin Health, Guanhao Bio, Chengda Pharmaceutical, Zexing Pharmaceutical, and Heyuan Bio, are also showing significant gains [1]

Financial Data and Key Metrics Changes - For Q3 2025, the company reported total revenues of approximately $598 million, including Cabozantinib franchise net product revenues of approximately $543 million, which represents a year-over-year growth of about 14% from $478 million in Q3 2024 [7][13] - Gross-to-net for the Cabozantinib franchise in Q3 2025 was 30.4%, with total operating expenses of approximately $361 million, compared to $355 million in Q2 2025 [13][14] - The company reported GAAP net income of approximately $193.6 million, or $0.72 per share basic, and non-GAAP net income of approximately $217.9 million, or $0.81 per share basic [14][15] - Cash and marketable securities at the end of Q3 2025 were approximately $1.6 billion, with share repurchases totaling approximately $99 million during the quarter [15] Business Line Data and Key Metrics Changes - The Cabozantinib U.S. business showed strong growth, with net product revenues growing to $543 million in Q3 2025, and global revenues from the Cabozantinib franchise reaching approximately $739 million [7][8] - Demand in neuroendocrine tumors grew about 50% and contributed approximately 6% of the third-quarter business, with expectations to exceed $100 million in revenue for this indication in 2025 [8][31] - The Zanzalintinib franchise is advancing with seven ongoing pivotal trials, and the company aims to file for regulatory approval in the CRC indication as soon as possible [9][10] Market Data and Key Metrics Changes - Cabozantinib maintained its leadership position as the top TKI for RCC, with a greater than 40% new patient share in the oral second-line plus net segment [7][8] - The company is expanding its GI sales team to accelerate growth in the Cabo net indication before Zanza's anticipated launch [8][34] - Market research indicates that Cabometyx is viewed as the best-in-class oral therapy in neuroendocrine tumors, which is expected to drive prescribing behavior positively [32][33] Company Strategy and Development Direction - The company is focused on building a best-in-class, multi-franchise oncology business, with a commitment to improving the standard of care for cancer patients [6][9] - There is a strong emphasis on the Zanzalintinib franchise as a potential second oncology franchise that could eclipse the size and impact of the Cabozantinib business [9][10] - The company plans to repurchase shares when undervalued and has been authorized to repurchase an additional $750 million of shares [12][15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong performance of the Cabozantinib business and the potential of Zanzalintinib, particularly following positive trial results [6][9] - The company is optimistic about the upcoming NDA filing for Zanzalintinib and the potential for a broad label in CRC, which could significantly enhance its market position [10][73] - Management highlighted the importance of navigating the competitive landscape effectively, especially with the anticipated launch of Zanzalintinib [9][10] Other Important Information - Susan Hubbard, EVP of Public Affairs and Investor Relations, announced her retirement, with Andrew Peters set to take over her responsibilities [38][39] - The company is preparing for an R&D day on December 10th, where more details on the early-stage pipeline and Zanzalintinib trials will be shared [12][27] Q&A Session Summary Question: Can you summarize the post-ESMO feedback on Zanzalintinib results? - Management noted positive feedback from physicians regarding the overall survival benefit and the potential for Zanzalintinib to capture market share in a fragmented market [42][44] Question: Why is Sunitinib the right control for STELLAR-304? - Management explained that Sunitinib is a standard of care in the setting and has a relevant target profile, making it a suitable comparator for the trial [48][50] Question: How does the STELLAR-303 data set expectations for the NLM cut? - Management indicated that the trial was designed to include both liver and non-liver metastases, with results expected to mature around mid-year 2026 [52][55] Question: What is the strategy regarding potential cannibalization between Cabozantinib and Zanzalintinib? - Management expressed confidence in the distinct positioning of Zanzalintinib in the market, emphasizing the growth potential for both products [67][70] Question: Will the NDA submission for Zanzalintinib include both subgroups? - Management confirmed that the NDA will be filed based on the ITT population, which encompasses the entire trial population, allowing for a broad label [72][73]

Financial Data and Key Metrics Changes - The company reported total revenues of approximately $598 million for Q3 2025, which included Cabozantinib franchise net product revenues of approximately $543 million, reflecting a year-over-year growth of about 14% from $478 million in Q3 2024 [7][13] - Non-GAAP net income for Q3 2025 was approximately $217.9 million, or $0.81 per share basic, compared to $193.6 million GAAP net income, or $0.72 per share basic [14][15] - Cash and marketable securities at the end of Q3 2025 were approximately $1.6 billion, with share repurchases totaling approximately $99 million during the quarter [15][16] Business Line Data and Key Metrics Changes - The Cabozantinib business maintained its leadership position as the top TKI for RCC, with net product revenues growing to approximately $543 million in Q3 2025 [7][28] - Demand in neuroendocrine tumors grew about 50% quarter-over-quarter, contributing approximately 6% of total demand for Cabozantinib in Q3 2025 [8][31] - The company expects to exceed $100 million in revenue for the neuroendocrine tumor indication in 2025 [8][32] Market Data and Key Metrics Changes - The Cabozantinib franchise net product revenues generated globally were approximately $739 million in Q3 2025, compared to $653 million in Q3 2024 [7] - Cabometyx's TRX volume grew 21% in Q3 2025 relative to Q3 2024, outpacing the market basket growth rate of 13% [29] - Cabometyx achieved a new patient market share of over 40% in the second-line plus neuroendocrine tumors segment [31] Company Strategy and Development Direction - The company aims to build a best-in-class, multi-franchise oncology business, focusing on improving the standard of care for cancer patients [6] - Zanzalintinib is positioned as the next oncology franchise opportunity, with seven ongoing and soon-to-start pivotal trials [9][12] - The company plans to expedite the build-out of its GI sales team to support the growth of the Cabozantinib neuroendocrine tumor indication and prepare for Zanzalintinib's launch [8][35] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong performance of the Cabozantinib business and the potential of Zanzalintinib to eclipse it [6][9] - The company is optimistic about the regulatory approval process for Zanzalintinib, especially following positive results from the Stellar-303 trial [10][20] - Management highlighted the importance of capital allocation and plans to repurchase shares when undervalued, with an additional $750 million share repurchase program authorized [12][15] Other Important Information - Susan Hubbard, EVP of Public Affairs and Investor Relations, announced her retirement after more than 35 years in the biopharma industry [38] - Andrew Peters will take over investor relations responsibilities, reflecting a strategic move within the company [39] Q&A Session Summary Question: Can you summarize the post-ESMO feedback on Zanzalintinib results? - Management noted positive feedback from physicians regarding the overall survival benefit and the introduction of an immune checkpoint inhibitor in a significant tumor type [41][43] Question: Why is Sunitinib the right control for the Stellar-304 study? - Management explained that Sunitinib is a standard of care in the setting and has a relevant target profile, making it a suitable comparator [47][49] Question: How does the Stellar-303 initial data set expectations for the NLM cut? - Management indicated that the study's design allowed for a broader analysis, and they expect results for the non-liver metastases subgroup to mature around mid-year 2026 [51][54] Question: What is the clinical trial contribution for Cabozantinib in Q3? - There were no clinical trial sales reported in the quarter [58] Question: Is there a risk to the Stellar-303 trial approval? - Management refrained from commenting on external opinions regarding Cabozantinib's usefulness [62] Question: How is the NET launch performing relative to Lutathera? - Management expressed confidence in the strong performance of Cabozantinib in the NET market, indicating a favorable position compared to Lutathera [85]

Core Insights - Shanghai Junshi Biosciences Co., Ltd. (复宏汉霖) announced key updates on its investigational product HLX43, a PD-L1 targeted antibody-drug conjugate for non-small cell lung cancer (NSCLC) treatment at the 2025 International Lung Cancer Frontier and Innovation Forum [1] - HLX43 has received orphan drug designation from the FDA for thymic epithelial tumors, indicating its potential in treating advanced/metastatic solid tumors [1] - The company plans to initiate at least eight Phase III clinical trials for HLX43, with lung cancer indications prioritized [1] Company Developments - CEO Dr. Zhu Jun emphasized the commitment to developing HLX43 despite limited resources, highlighting lung cancer as the leading malignancy in both global and Chinese contexts [2] - Junshi has successfully launched nine products globally, including the first approved PD-1 monoclonal antibody for first-line treatment of small cell lung cancer [2] - Goldman Sachs issued a research report covering Junshi, projecting HLX43 as a core driver for the company's global innovation pipeline and assigning a "buy" rating with a 12-month target price of HKD 100.70 per share [2] Clinical Data - As of October 22, 2025, 174 advanced NSCLC patients were enrolled in the study, with 89 receiving 2.0 mg/kg and 85 receiving 2.5 mg/kg of HLX43 [3] - The overall efficacy of HLX43 was promising, with an objective response rate (ORR) of 33.3% and a disease control rate (DCR) of 75.8% in squamous NSCLC patients [3] - In non-squamous patients, the ORR increased to 48.6% and the DCR reached 94.3% [3] Treatment Potential - Among previously treated squamous NSCLC patients who had undergone docetaxel therapy, the ORR was 38.5% and the DCR was 84.6%, indicating HLX43's significant potential in this population [4] - Docetaxel is currently the standard second-line treatment for squamous NSCLC, with an ORR slightly above 10%, suggesting HLX43 may redefine treatment standards for this disease [4]