创新药已经突围成功。 "十五五"规划开局之年，医药行业在2026年将呈现创新药爆发、CXO回暖、中药转型、药店收缩、医院 洗牌、并购潮涌的总体格局，行业分化加剧，强者恒强。 创新药：20款重磅新药有望获批 在2025年，共有76个创新药物成功获批上市，数量较上年增长58%。与此同时，创新药对外授权交易活 跃，交易数量突破150起，累计交易总额更是高达1300亿美元以上，彰显了我国创新药产业的强劲发展 势头。 西部证券指出，2026年创新药行情将从"BD为王"转向"数据为王"，全球多中心临床试验数据读出将成 为核心催化。 随着临床数据和上市审批的加速，2026年，中国创新药出海会迎来爆发期。业内预测，2026年将有约20 款重磅新药有望在中国获批上市，涵盖肿瘤、感染性疾病、罕见病、自身免疫性疾病、神经系统疾病等 多个治疗领域。比如，BL-B01D1是百利天恒自主研发的全球首创EGFR×HER3双抗ADC，用于治疗复 发性或转移性食管鳞癌。作为全球首个被纳入优先审评的EGFR×HER3双抗ADC，它填补了PD-1/PD-L1 联合化疗失败患者的治疗空白。此外，BL-B01D1的鼻咽癌适应症也已获优先审评，预计20 ...

Core Insights - The article emphasizes the need to resolve the contradiction between the high costs of CAR-T therapy and the payment system, which relies on both technological cost reduction and the expansion of research pipelines to access a broader patient market [1] - The focus is on the potential market growth in the solid tumor sector, which could significantly alter the CAR-T market landscape [1] Industry Trends - The global CAR-T research initially focused on hematological tumors, with existing products targeting CD19 and BCMA, covering conditions like non-Hodgkin lymphoma (NHL) and multiple myeloma (MM). The research is now expanding towards solid tumors, with the proportion of clinical trials for solid tumors expected to rise from 15% in 2020 to 30% by 2025 [2][3] - The incidence of solid tumors is significantly higher than that of hematological cancers, indicating a potential exponential growth in the patient population. This growth can help distribute costs through economies of scale and enhance market competitiveness [2] Patient Population Insights - In China, the annual incidence rates for NHL and MM are 6.97 and 1-2 per 100,000 respectively, with approximately 40,000 new cases of DLBCL and 14,000-28,000 new cases of MM each year [2] - For solid tumors, the annual incidence of gastric cancer is between 10-20 per 100,000, with 140,000-280,000 new cases annually, and liver cancer has a similar incidence rate with a potential treatable population of 98,000-196,000 patients per year [3] Technical Challenges - Solid tumors present unique challenges for CAR-T therapies, including tumor microenvironment suppression, antigen heterogeneity, infiltration barriers, and T cell exhaustion [4] Domestic Trends - In China, all six approved CAR-T therapies target hematological tumors, but the proportion of clinical trials for solid tumors is expected to reach 42% by 2024. Key drivers for this shift include technological advancements, policy support, and a large patient base for solid tumors [5] Company Pipeline Analysis - Companies are focusing on expanding their CAR-T pipelines to include solid tumors, with several firms reporting promising clinical trial results and plans for future submissions [6][10][15][20][23][35] - For instance, Kexing Biopharm's Claudin18.2 CAR-T for gastric cancer has shown a 22% objective response rate in Phase II trials, while another company, Yuanqi Bio, reported a 56.5% response rate for GPC3 CAR-T in liver cancer [5][10] Market Potential - The potential market for CAR-T therapies in solid tumors is vast, with estimates suggesting that the annual patient population for gastric and liver cancers alone could reach between 126,000 and 280,000, far exceeding the total for hematological cancers [3][5]