华东医药 20251028 摘要 华东医药前三季度营收稳健增长 8.53%，医药工业板块营收 110.45 亿 元，同比增长 11.1%，归母净利润 24.75 亿元，同比增长 15.62%。 创新产品收入及销售代理服务收入达 16.75 亿元，同比大幅增长 62%，显示创新驱动增长的态势。 公司医药工业研发投入达 21.86 亿元，同比增长 35.99%，直接研发支 出 17.67 亿元，同比增长 53.76%，占医药工业营收比例达 16.21%， 研发力度显著增强，为未来创新提供坚实基础。 肿瘤领域，多个 ADC 创新靶点项目形成梯度化布局，HDM2005 等项 目进入临床试验阶段，HDM2027 获美国 FDA 快速通道认定，预示着公 司在肿瘤治疗领域的潜力。 内分泌领域，司美格鲁肽注射液糖尿病适应症上市申请通过临床核查， GLP-1 口服小分子 1,002 体重管理适应症三期临床完成入组，代谢管线 布局全面，有望在未来贡献业绩。 自身免疫领域，乌司奴单抗注射液新增儿童斑块状银屑病适应症获批， 克罗恩病上市申请获受理，与全信生物合作开发 QS005 进入三期临床， 有望覆盖银屑病患者全周期用药需求。 Q ...

Summary of Key Points from the Conference Call of 科济药业 Company Overview - **Company**: 科济药业 (Kojin Pharmaceutical) - **Industry**: Cell Therapy, specifically CAR-T therapy Core Insights and Arguments - **NDA Submission and Commercialization**: 科济药业 has submitted an NDA for CT041, which has been accepted by CDE, with commercialization expected in 2026. The product shows a 100% Overall Response Rate (ORR) in postoperative adjuvant therapy for pancreatic and gastric cancers, with significant efficacy data presented at ASCO and published in The Lancet [2][3] - **Clinical Trial Results**: In a randomized controlled trial, patients treated with CT041 had a median survival of 9.9 months compared to 3.98 months for those not treated, indicating a survival extension of approximately 6 months [2][5] - **Commercialization Strategy**: The company plans to independently commercialize new products, leveraging its leading position in the solid tumor market and experience from collaboration with 华东医药 (East China Pharmaceutical) to implement flexible pricing strategies [2][6] - **Cost Reduction and Efficacy Gap**: While the cost of universal CAR-T therapy has significantly decreased, there remains a gap in efficacy compared to autologous CAR-T therapies. The company is focused on optimizing its technology platform to enhance efficacy [2][7] - **BCM Universal CAR-T Data**: The 0,590 project shows promising data with some patients achieving complete remission lasting 20-23 months, outperforming competitors like Besayda and 艾乐哲, which have median durations of response (DOR) of only 7-8 months [2][8][12] Additional Important Content - **Future Product Development**: 科济药业 is developing new products such as 0,596 and 2,219, targeting multiple myeloma and B-cell tumors, and plans to conduct clinical research in solid tumors and autoimmune diseases [2][9] - **Financial Outlook**: The company expects to have sufficient cash flow until 2028 and aims to secure 300 effective orders in collaboration with 华东医药 by the end of 2025 [2][10][14] - **Impact of Insurance Reforms**: The company is actively collaborating with commercial insurance and public health insurance to optimize payment conditions for its therapies, which could enhance market access [2][11] - **Market Size for Gastric Cancer**: There are approximately 2 million new gastric cancer cases annually, and the company’s initial commercialization strategy targets high-net-worth individuals in major hospitals [2][20] - **Commercialization Team Structure**: The commercialization team will consist of around 40-50 people, focusing on major cities and key medical centers [2][21] - **Upcoming Data Releases**: The company plans to disclose more data on the 05,796 project at the ASH conference and may submit IND applications for further clinical trials [2][22] This summary encapsulates the critical insights and developments regarding 科济药业's strategies, clinical advancements, and market positioning within the cell therapy industry.