2025 年 08 月 23 日 科济药业-B(02171.HK) 自体 CAR-T 进入兑现阶段，通用型 CAR- T 快速推进中 事件：公司发布 2025 年中期业绩，报告期内公司实现营业收入 0.51 亿元，实现归母净利润-0.75 亿元。 自体 CAR-T：Claudin18.2 CAR-T 舒瑞基奥仑赛 NDA 获受理， BCMA CAR-T 泽沃基奥仑赛持续放量。2025 年上半年，公司两款自 体 CAR-T 药物均取得较大进展，其中舒瑞基奥仑赛注射液新药上 市申请（NDA）获 CDE 受理，用于治疗 Claudin18.2 表达阳性、至 少二线治疗失败的晚期胃/食管胃结合部腺癌（G/GEJA）；泽沃基 奥仑赛完成认证及备案的医疗机构覆盖全国 20 多个省市，科济 药业共计从商业化合作伙伴华东医药获得 111 份有效订单。 通用型 CAR-T：多个产品正在快速开发中。其中，靶向 BCMA 通 用型 CAR-T 细胞产品 CT0596 正在中国开展研究者发起的临床试 验。初步临床数据已于 2025 年 5 月在公司官网发布，根据初步安 全性及疗效数据，CT0596 用于 R/R MM 患者总体耐受性 ...

Summary of CARsgen Therapeutics Earnings Review Company Overview - **Company**: CARsgen Therapeutics (2171.HK) - **Industry**: Biotechnology, specifically focusing on CAR-T therapy Key Financial Highlights - **Sales Growth**: 1H sales of zevor-cel reached Rmb 48 million, representing a 55% increase half-on-half, exceeding the guidance of Rmb 39 million [1] - **Order Confirmation**: 111 confirmed orders for zevor-cel were received in 1H25 from Huadong Medicine, indicating strong market demand [1] - **Adjusted Net Loss**: The adjusted net loss narrowed to Rmb 134 million from Rmb 289 million in 1H24, attributed to increased revenue and improved gross profit margin (GPM) of 55% compared to 36% in 2H24 [2] - **Operating Expenses**: Administrative expenses decreased by 55% year-on-year to Rmb 39 million, and R&D expenses fell by 47% to Rmb 130 million due to the completion of trials for CT041 [2] Market Dynamics - **Market Penetration**: The growth in market orders for zevor-cel appears to be slowing after initial adoption, with future growth dependent on the expansion of commercial insurance coverage [1] - **Insurance Coverage**: Management highlighted the importance of the recently introduced commercial insurance novel drug list by NHSA in expanding patient coverage for zevor-cel [1] Upcoming Catalysts - **CT041 (CLDN18.2 CAR-T)**: Preliminary data for pancreatic cancer treatment is expected at ESMO2025, with China approval anticipated in 1H26 [3] - **CT0596 (allogeneic BCMA CAR-T)**: Data update at ASH2025 with IND submission by year-end 2025 [3] - **KJ-C2219 (allogeneic CD19/CD20 CAR-T)**: Preliminary data sharing expected in 1H26 [3] Investment Thesis - **Product Pipeline**: CARsgen's leading product, zevor-cel, is already launched in China, with potential for global market expansion. The company is also advancing its allogeneic CAR-T programs [8] - **Market Challenges**: The low affordability of treatments in the Chinese market is seen as a significant barrier to achieving peak sales, emphasizing the need for global market access [8] - **Stock Rating**: The stock is rated as "Sell" with a 12-month target price of HK$15.26, reflecting concerns over the current market valuation and the need for positive clinical trial results to justify higher valuations [9][10] Risks and Considerations - **Upside Risks**: Significant progress in US trials, global business development collaborations, and better-than-expected results from allogeneic CAR-T assets could positively impact the stock [9] - **Cash Position**: The company reported Rmb 1.26 billion in cash and equivalents as of June 30, with a goal to maintain cash runway until 2028 [2] Conclusion CARsgen Therapeutics is navigating a complex landscape in the biotechnology sector, with promising growth in its zevor-cel product but facing challenges related to market penetration and affordability. The upcoming catalysts and ongoing focus on allogeneic CAR-T therapies will be critical in determining the company's future performance and stock valuation.

Summary of Key Points from Kogei Pharmaceuticals Conference Call Company Overview - **Company**: Kogei Pharmaceuticals - **Industry**: Biotechnology, specifically focusing on CAR-T cell therapy Core Insights and Arguments 1. **Product Development**: Kogei's CT041 product is expected to be commercialized by 2026, showing significant improvements in median PFS (Progression-Free Survival) and OS (Overall Survival) for gastric cancer patients despite complex baseline conditions [2][3][7][8] 2. **Clinical Trial Results**: The GPRC5D CAR-T (CD071) demonstrated a 100% Overall Response Rate (ORR) and a 70% Complete Response (CR) rate in newly diagnosed multiple myeloma, with good safety profiles [2][10] 3. **Financial Performance**: In the first half of 2025, Kogei reported revenues of approximately 51 million RMB and a gross profit of about 30 million RMB, with low sales expenses [6][15] 4. **Cash Reserves**: The company has cash and bank deposits of around 1.26 billion RMB, expected to last until 2028, with projected losses significantly reduced compared to 2024 [6][16] 5. **Strategic Partnerships**: Kogei is collaborating with Zhuhai Hengqin Softbank to develop universal CAR-T projects, indicating a strategic move towards expanding its product pipeline [2][5] Additional Important Content 1. **Regulatory Milestones**: Kogei's CT041 was included in the breakthrough therapy list by the Chinese FDA, which allows for priority review [3] 2. **Market Potential**: The gastric cancer market in China has approximately 2 million patients, providing a substantial target audience for Kogei's products [17] 3. **Global Expansion Plans**: The company is actively exploring opportunities in overseas markets, including partnerships in regions like Hong Kong, Taiwan, Singapore, South Korea, and Japan, as well as strategies for the U.S. market [17][31] 4. **Technological Innovations**: Kogei's "Thank You" and "Thank You Plus" platforms address challenges in universal CAR-T therapies, such as T cell HVGR issues [4][12] 5. **Clinical Trial Adjustments**: The company is adjusting its clinical trial protocols based on previous experiences, particularly concerning safety and efficacy in different patient populations [19][20] Future Plans 1. **Focus on CAR-T Development**: Kogei plans to continue advancing its universal CAR-T products across various targets and indications, including CD19/20 for B-cell tumors and autoimmune diseases [11][35] 2. **Commercialization Strategy**: The company is working on balancing patient needs with corporate returns, especially in light of new insurance policies that may affect pricing and market access [30][33] 3. **Employee Adjustments**: A reduction in workforce is noted due to strategic realignment and increased production efficiency, with expectations of future hiring as commercialization progresses [37][38] This summary encapsulates the key points from Kogei Pharmaceuticals' conference call, highlighting the company's advancements, financial health, strategic initiatives, and future outlook in the CAR-T therapy landscape.

Core Viewpoint - Kintor Pharmaceutical has shown significant stock performance, with an approximately eightfold increase since its low in September 2024, despite still being in a loss position [1] Financial Performance - For the first half of 2025, Kintor reported revenue of approximately 51 million yuan, a year-on-year increase of about 703.8%, primarily driven by sales of its CAR-T product, SaiKezai [1] - The net loss for the same period was approximately 75.48 million yuan, a reduction of over 78% compared to the previous year [1][2] - Cost control measures, including reduced R&D and administrative expenses, contributed to the narrowing of net losses [2] Product Development and Market Strategy - Kintor's first CAR-T product, SaiKezai, was launched on March 1, 2024, and has secured 111 effective orders from its commercial partner, East China Pharmaceutical [3] - The company is optimistic about the sales growth of SaiKezai due to ongoing marketing efforts and expanded insurance coverage [3] - Kintor is also advancing its CAR-T product, ShuRuiJiAoLunSai, aimed at treating solid tumors, with an NDA submission expected to be approved between Q1 and Q2 of next year [3] Cost and Accessibility Challenges - The high production costs of CAR-T therapies remain a significant barrier to accessibility, with domestic pricing generally around one million yuan [1][4] - Kintor is shifting its strategic focus towards developing universal CAR-T therapies, which are expected to have more significant economies of scale [5] Insurance and Policy Developments - The recent introduction of a dual-track system for insurance coverage, including a commercial insurance innovation drug directory, may improve patient access to CAR-T therapies [6] - SaiKezai is among five CAR-T products included in the initial review list for the commercial insurance innovation drug directory, which could lower patient financial burdens [6] - Kintor is actively collaborating with East China Pharmaceutical to secure policy support related to SaiKezai [6] Industry Context - The establishment of a national commercial insurance directory is expected to address disparities in drug coverage across regions, enhancing the sustainability of insurance support for innovative therapies [7]

Core Viewpoint - Kintor Pharmaceutical's H1 financial results show a significant reduction in net loss, driven by increased product sales, particularly from its CAR-T therapy, with a focus on the upcoming NDA submission for its CT041 product targeting solid tumors [1][2]. Financial Performance - Kintor reported revenues of approximately 51 million yuan in H1 2025, a substantial increase from 6.34 million yuan in the same period of 2024, primarily due to sales growth from its product, Sai Ke Zai [1]. - The gross profit for the period was around 29 million yuan, with a net loss of 75 million yuan, which is a reduction of 277 million yuan compared to the previous year [1]. Product Development and Market Position - The company submitted a New Drug Application (NDA) for CT041, which is the first and only CAR-T cell product submitted for treating solid tumors globally [1]. - CEO Li Zonghai indicated that the review process for CT041 is proceeding normally, with optimistic expectations for approval in Q1 or Q2 of next year [2]. Market Strategy and Opportunities - Kintor is actively exploring commercial opportunities both domestically and internationally, including partnerships with overseas pharmaceutical companies [2]. - The company is focusing on expanding its market presence in the post-operative treatment of gastric cancer, which currently lacks effective therapies beyond chemotherapy [2]. Insurance and Pricing Strategy - Kintor is engaged in discussions regarding the inclusion of its products in the commercial insurance innovation drug directory, which could enhance patient access [3]. - The company is considering the implications of pricing strategies if its products are included in insurance coverage, emphasizing a comprehensive approach beyond simple price reductions [3].

科济药业-B(02171)绩后涨超3%，截至发稿，涨3.68%，报21.96港元，成交额1640.76万港元。 消息面上，8月14日，科济药业-B公布2025年中期业绩，收益为5096.1万元，同比增长703.8%；毛利 2936.9万元，同比增长约17.16倍；净亏损7548.3万元，同比收窄78.53%；每股亏损0.14元。公告称，亏 损减少主要是由于期内的研发开支减少、行政开支减少、外汇收益净额上升及毛利上升。 ...

消息面上，8月14日，科济药业-B公布2025年中期业绩，收益为5096.1万元，同比增长703.8%；毛利 2936.9万元，同比增长约17.16倍；净亏损7548.3万元，同比收窄78.53%；每股亏损0.14元。公告称，亏 损减少主要是由于期内的研发开支减少、行政开支减少、外汇收益净额上升及毛利上升。 本文源自智通财经网 智通财经获悉，科济药业-B(02171)绩后涨超3%，截至发稿，涨3.68%，报21.96港元，成交额1640.76万 港元。 ...

Core Viewpoint - Kintor Pharmaceutical Co., Ltd. reported significant growth in its mid-year results for 2025, leading to a stock price increase of over 3% following the announcement [1] Financial Performance - Revenue reached 50.961 million HKD, representing a year-on-year increase of 703.8% [1] - Gross profit amounted to 29.369 million HKD, showing a year-on-year growth of approximately 1,716% [1] - Net loss narrowed to 75.483 million HKD, a reduction of 78.53% compared to the previous year [1] - Earnings per share reported a loss of 0.14 HKD [1] Contributing Factors - The reduction in losses was attributed to decreased research and development expenses, lower administrative costs, an increase in net foreign exchange gains, and higher gross profit [1]

Core Insights - The company reported a revenue of 50.961 million, representing a year-on-year increase of 703.8% [1] - Gross profit reached 29.369 million, showing a significant year-on-year growth of approximately 1716% [1] - The net loss narrowed to 75.483 million, a reduction of 78.53% compared to the previous year [1] - The loss per share was recorded at 0.14 yuan [1] Financial Performance - Revenue: 50.961 million, up 703.8% year-on-year [1] - Gross Profit: 29.369 million, up approximately 1716% year-on-year [1] - Net Loss: 75.483 million, down 78.53% year-on-year [1] - Loss per Share: 0.14 yuan [1] Factors Influencing Performance - The reduction in loss was primarily attributed to decreased R&D expenses, lower administrative costs, an increase in net foreign exchange gains, and higher gross profit [1]

公告称，亏损减少主要是由于期内的研发开支减少、行政开支减少、外汇收益净额上升及毛利上升。 智通财经APP讯，科济药业-B(02171)公布2025年中期业绩，收益为5096.1万元，同比增长703.8%;毛利 2936.9万元，同比增长约17.16倍;净亏损7548.3万元，同比收窄78.53%;每股亏损0.14元。 ...