11月24日，百奥泰(688177)举行2025年第三季度业绩说明会。公司此前发布的三季报显示，前三季度实 现营业收入6.84亿元，同比增长17.57%；净利润为-2.24亿元，同比有所减亏。 百奥泰是一家从事创新药和生物类似药研发的全球性生物制药企业，目前已推动多款药物获批上市，其 中贝塔宁 （枸橼酸倍维巴肽）已在中国获批上市；阿达木单抗已在中国及英国获批上市、托珠单抗已 在中美欧瑞士英国获批上市；贝伐珠单抗已在中美欧巴西获批上市；乌司奴单抗已在欧美获批。 对于公司报告期内营收增长和亏损收窄的情况，百奥泰董事长、总经理李胜峰在业绩说明会上表示，公 司本季度营收同比增长主要原因来源于国内阿达木单抗注射液和托珠单抗注射液销售收入持续增长。亏 损收窄主要原因为成本费用类增长比例小于营收增长比例。公司将一如既往拓展营收规模，同时继续降 低成本及优化运营效率，争取早日实现盈利。 对于生物类似药在海外的拓展方向，李胜峰称，在海外拓展方面，公司产品如BAT1806（托珠单抗）和 BAT2206（乌司奴单抗）已在美欧获批并已由合作伙伴Organon和Hikma分别在美国市场进行推广，同 时公司还有多个产品已在欧美及其他市场 ...

2025.11.24 本文字数：2412，阅读时长大约4分钟 作者 |第一财经 吴斯旻 近年来，"带量采购"政策让优质优价的仿制药加速临床准入与经济性替代。与此同时，随着"国谈"中生 物药占比增加，"谈判药品同通用名仿制药上市自动属于目录范围"的医保政策则为生物类似药挂网入院 及院内推广提供便利。 双重趋势下，中国仿制药行业的市场竞争加剧——仿制药的研发水平和一致性评价通过率明显提升，却 也面临"品种同质化"和"生产拼成本"等发展困境。 近日，中国医学科学院药物研究所、中国医药工业信息中心和中国食品药品检定研究院联合发布的《中 国仿制药发展报告（2025）》（下称"报告"）显示，中国仿制药市场规模多年维持在9000亿元水平，企 业与品种数量的增加正进一步加剧市场存量竞争。 第一财经梳理报告发现，在化学仿制药领域，2024年，通过一致性评价或视同过评的品种数较三年前增 加了超过2/3，但当年增长主要由少数企业和既往过评品种的持续获批推动；而在生物类似药领域，截 至2024年，我国已有41家制药企业的87款生物类似药（包含胰岛素）获批上市，但仅涉及23个药品通用 名。 此外，有业界观点认为，在中国仿制药行业市场集 ...

2025.11. 24 本文字数：2412，阅读时长大约4分钟 作者 | 第一财经 吴斯旻 近年来，"带量采购"政策让优质优价的仿制药加速临床准入与经济性替代。与此同时，随着"国谈"中 生物药占比增加，"谈判药品同通用名仿制药上市自动属于目录范围"的医保政策则为生物类似药挂网 入院及院内推广提供便利。 双重趋势下，中国仿制药行业的市场竞争加剧——仿制药的研发水平和一致性评价通过率明显提升， 却也面临"品种同质化"和"生产拼成本"等发展困境。 近日，中国医学科学院药物研究所、中国医药工业信息中心和中国食品药品检定研究院联合发布的 《中国仿制药发展报告（2025）》（下称"报告"）显示，中国仿制药市场规模多年维持在9000亿元 水平，企业与品种数量的增加正进一步加剧市场存量竞争。 第一财经梳理报告发现，在化学仿制药领域，2024年，通过一致性评价或视同过评的品种数较三年 前增加了超过2/3，但当年增长主要由少数企业和既往过评品种的持续获批推动；而在生物类似药领 域，截至2024年，我国已有41家制药企业的87款生物类似药（包含胰岛素）获批上市，但仅涉及23 个药品通用名。 此外，有业界观点认为，在中国仿制药行业市 ...

品种同质化加剧，成为仿制药市场竞争的底色。 近年来，"带量采购"政策让优质优价的仿制药加速临床准入与经济性替代。与此同时，随着"国谈"中生物药占比增加，"谈判药品同通用名仿制药上市自动 属于目录范围"的医保政策则为生物类似药挂网入院及院内推广提供便利。 双重趋势下，中国仿制药行业的市场竞争加剧——仿制药的研发水平和一致性评价通过率明显提升，却也面临"品种同质化"和"生产拼成本"等发展困境。 近日，中国医学科学院药物研究所、中国医药工业信息中心和中国食品药品检定研究院联合发布的《中国仿制药发展报告（2025）》（下称"报告"）显示， 中国仿制药市场规模多年维持在9000亿元水平，企业与品种数量的增加正进一步加剧市场存量竞争。 第一财经梳理报告发现，在化学仿制药领域，2024年，通过一致性评价或视同过评的品种数较三年前增加了超过2/3，但当年增长主要由少数企业和既往过 评品种的持续获批推动；而在生物类似药领域，截至2024年，我国已有41家制药企业的87款生物类似药（包含胰岛素）获批上市，但仅涉及23个药品通用 名。 此外，有业界观点认为，在中国仿制药行业市场集中度较低的背景下，不仅要审慎看待仿制研发"扎堆"现象 ...

Core Insights - Xu Ruihua, a professor at Sun Yat-sen University Cancer Prevention and Treatment Center, was elected as an academician of the Chinese Academy of Engineering for his work in developing immunotherapy and understanding gastrointestinal cancers [2][4] - Xu was also featured in Cell Press's "50 Scientists that Inspire" series, highlighting his contributions to cancer research and personalized treatment [2][4] Group 1: Scientific Innovation - Scientific innovation is a multi-dimensional process that involves not only the discovery of new knowledge but also the application of this knowledge to solve real-world problems [5][6] - Key dimensions of scientific innovation include meeting clinical needs, advancing scientific frontiers, and promoting interdisciplinary collaboration [6] - The future of cancer treatment is moving towards precision, personalization, and intelligence, emphasizing the importance of understanding molecular characteristics and biological mechanisms of tumors [6][9] Group 2: Personal Motivation and Challenges - Xu's initial motivation to become a scientist was to save lives, which was reinforced by his clinical experiences and the challenges faced by cancer patients [7][8] - The high incidence and mortality rates of gastrointestinal cancers in China, with 2 million new cases annually, drive Xu's commitment to finding effective treatments [7][8] Group 3: Research Achievements - A significant discovery was made regarding the benefit of immunotherapy for patients with MSI-H/dMMR advanced colorectal cancer, leading to a new treatment method combining HDAC inhibitors, immunotherapy, and anti-angiogenic drugs [8][9] - This research represents a clinical milestone and has the potential to redefine treatment models for advanced colorectal cancer [9] Group 4: Future Outlook - In the next 50 years, precision medicine is expected to dominate cancer treatment, with the integration of big data and artificial intelligence [12] - Immunotherapy will be applied to more cancer types, and liquid biopsy technology will mature, facilitating early detection and monitoring of cancer [12] - A multidisciplinary approach to cancer treatment will become standard, promoting global health through international collaboration [12]

Investment Rating - The investment rating for the company is "Underperform" [2][5][20] Core Insights - The company has announced promising clinical data for its drug 707 in combination with chemotherapy for first-line non-small cell lung cancer (NSCLC) at the STIC conference in 2025, indicating good efficacy and safety [4][6][20] - Pfizer has outlined a global clinical strategy for 707, planning to initiate two key Phase 3 clinical trials for NSCLC and mCRC, along with several other studies targeting various cancers [4][11][20] - The company has completed a significant licensing deal for 707, leading to an upward revision of profit forecasts for 2025-2027 [5][18][20] Summary by Sections Clinical Data - The Phase 2 clinical trial data for 707 in first-line NSCLC showed a confirmed overall response rate (cORR) of 58.6% in non-squamous NSCLC patients and 75.0% in squamous NSCLC patients [6][8] - The trial included 119 non-squamous and 125 squamous NSCLC patients, with a significant portion of patients having low PD-L1 expression [6][8] Safety Profile - The safety data indicated that the incidence of grade 3 or higher treatment-related adverse events (TRAEs) was 39.0% for the 707 group compared to 32.8% for the control group [7][8] - Overall safety was deemed manageable, with the incidence of immune-related adverse events (irAEs) being comparable to historical data [7][8] Financial Projections - The revised profit forecasts for the company are projected to be 9.955 billion, 2.875 billion, and 3.212 billion yuan for 2025, 2026, and 2027 respectively, reflecting a significant increase from previous estimates [19][20] - The company expects robust revenue growth driven by the commercialization of 707 and ongoing clinical developments [19][20]

Group 1 - The 2025 International Lung Cancer Frontier and Innovation Forum was held in Shanghai, focusing on key topics such as clinical prevention and control of lung cancer, breakthroughs in non-small cell lung cancer (NSCLC), and new advancements in immunotherapy for small cell lung cancer (SCLC) [1] - The rise of targeted and immunotherapy has fundamentally reshaped the treatment landscape for lung cancer, with new therapies like antibody-drug conjugates (ADC), bispecific antibodies, T-cell engagers (TCE), and tumor vaccines emerging rapidly [1] - The global incidence of lung cancer remains the highest among malignant tumors, with the company having launched 9 products that benefit over 900,000 patients worldwide, including the first approved PD-1 monoclonal antibody for first-line treatment of SCLC [1] Group 2 - The company's R&D strategy focuses on antibodies and their derivatives, including monoclonal antibodies, bispecific antibodies, multi-specific antibodies, and ADCs, supported by three core technology engines [2] - High-value projects such as HLX3901 and HLX48 are prioritized for future development, while the company continues to build a robust pipeline [2] - Local innovative enterprises have made significant progress over the past decade, providing effective "Chinese solutions" for clinical challenges, emphasizing the need for international collaboration and continuous innovation in tackling lung cancer [2]

Core Viewpoint - The stock of 3SBio surged over 10% to HKD 30.5 following Pfizer's registration of two global Phase III clinical trials for the PD-1/VEGF dual antibody PF-08634404 (SSGJ-707) on Clinicaltrials.gov [1] Group 1: Clinical Trials - Pfizer registered two Phase III clinical trials for PF-08634404, targeting advanced non-small cell lung cancer (NSCLC) and metastatic colorectal cancer [1] - The NSCLC trial aims to enroll 1,500 patients and is expected to complete preliminary results by February 2029, focusing on progression-free survival (PFS) and overall survival (OS) as primary endpoints [1] - The colorectal cancer trial plans to enroll 800 patients, with preliminary results expected by March 2030, comparing against bevacizumab plus chemotherapy, also using OS and PFS as primary endpoints [1] Group 2: Financial Aspects - In May 2025, Pfizer will pay 3SBio a total of USD 1.25 billion upfront, with an additional USD 4.8 billion in milestone payments and a double-digit percentage of sales for the PD-1/VEGF dual antibody [1]

Core Viewpoint - The company, Junshi Biosciences, has received FDA approval for its clinical trial application for JS207, a bispecific antibody targeting PD-1 and VEGF, for use in neoadjuvant therapy for AGA-negative non-small cell lung cancer patients in a Phase II/III study [1][2] Group 1: Product Overview - JS207 is a recombinant humanized bispecific antibody designed to target both PD-1 and VEGF, primarily for the treatment of advanced malignancies [1] - The drug effectively blocks the binding of PD-1 to PD-L1 and PD-L2, as well as the binding of VEGF to its receptors, showcasing both immunotherapy and anti-angiogenic properties [1] - By neutralizing VEGF, JS207 can inhibit endothelial cell proliferation, improve the tumor microenvironment, and enhance the infiltration of cytotoxic T lymphocytes, leading to better anti-tumor activity [1] Group 2: Clinical Development - JS207 is designed based on the clinically validated anti-PD-1 drug, Toripalimab, with a Fab structure to maintain high affinity for PD-1 [2] - The VEGF-targeting component of JS207 has binding affinity comparable to Bevacizumab [2] - Non-clinical in vitro studies indicate that the bispecific antibody shows significantly enhanced PD-1 antigen binding and internalization, as well as synergistic activation of immune cells in the tumor microenvironment compared to the combination of PD-1/PD-L1 and VEGF monoclonal antibodies [2] - As of the announcement date, JS207 has been approved to enter Phase II/III clinical research, with multiple ongoing Phase II studies exploring combinations with chemotherapy, monoclonal antibodies, and antibody-drug conjugates (ADCs) across various cancer types including non-small cell lung cancer, colorectal cancer, triple-negative breast cancer, and liver cancer [2]

Core Viewpoint - The National Healthcare Security Administration (NHSA) emphasizes the continuous improvement of medical insurance coverage since its establishment in 2018, with a total of 3,159 drugs included in the medical insurance catalog, significantly enhancing the coverage for major diseases like cancer [1] Group 1: Misconceptions about Medical Insurance - Misconception 1: Only 2% of drugs are reimbursed by insurance. The NHSA clarifies that this claim misrepresents data by comparing different statistical methods without proper conversion, leading to an incorrect conclusion about the proportion of drugs in the catalog [1] - Misconception 2: Imported drugs are not reimbursed. The NHSA states that reimbursement does not differentiate between manufacturers, as long as the drug is included in the insurance catalog [3] - Misconception 3: Only cheap, old drugs are reimbursed. The NHSA refutes this by highlighting that many new and effective drugs, including cancer treatments, are regularly added to the reimbursement list, often within a year of approval [4] Group 2: Drug Statistics and Approval - The NHSA explains that the total number of drugs in the insurance catalog is based on active ingredients, which counts drugs with the same active ingredient as one, leading to 3,159 drugs in the catalog [1] - An alternative method counts the number of drug approval numbers, resulting in over 150,000 approved drugs in China, with more than 110,000 having sales records. The NHSA indicates that if the approval numbers for the 3,159 drugs in the catalog are calculated, it would exceed 70,000, representing about 63% of the market [2]