作为药明巨诺的首款产品，瑞基奥仑赛注射液已有三项适应证在国内获批上市，均聚焦在血液肿瘤领 域。 2025.10. 10 本文字数：1265，阅读时长大约2分钟 作者 | 第一财经 林志吟 10月9日晚间，药明巨诺（02126.HK）宣布，中国药监局已正式受理其倍诺达新增使用国产病毒载 体的上市后补充申请。 瑞基奥仑赛注射液（血液肿瘤适应症的商品名：倍诺达）是药明巨诺在巨诺医疗（百时美施贵宝旗下 的公司）的CAR-T细胞工艺平台的基础上，自主开发的一款靶向CD19的自体CAR-T细胞免疫治疗产 品。 过往数年，CAR-T细胞治疗产品已四次冲击医保谈判失败。业内普遍认为，这与国家医保谈判"50万 不谈，30万不进"的规则有关。 有药企人士曾对第一财经记者表示，受制于生产成本制约，CAR-T药物要通过降价进入医保支付， 还需要时间。 慢病毒载体作为目的基因递送工具，在细胞治疗产品中起着重要的作用，可以实现嵌合抗原受体基因 的转导和整合。慢病毒载体不仅是细胞治疗产品最重要的生产原材料之一，也是成本最高的生产原材 料。 药明巨诺官网截图 截至目前，包括药明巨诺的瑞基奥仑赛注射液在内，国内已获批上市的CAR-T细胞治疗产 ...

有药企人士曾对第一财经记者表示，受制于生产成本制约，CAR-T药物要通过降价进入医保支付，还需 要时间。 10月9日晚间，药明巨诺（02126.HK）宣布，中国药监局已正式受理其倍诺达新增使用国产病毒载体的 上市后补充申请。 瑞基奥仑赛注射液（血液肿瘤适应症的商品名：倍诺达）是药明巨诺在巨诺医疗（百时美施贵宝旗下的 公司）的CAR-T细胞工艺平台的基础上，自主开发的一款靶向CD19的自体CAR-T细胞免疫治疗产品。 作为药明巨诺的首款产品，瑞基奥仑赛注射液已有三项适应证在国内获批上市，均聚焦在血液肿瘤领 域。 截至目前，包括药明巨诺的瑞基奥仑赛注射液在内，国内已获批上市的CAR-T细胞治疗产品数量，已达 到7款，但昂贵的价格却限制了产品的可及性，大部分产品价格过百万元，如药明巨诺的瑞基奥仑赛注 射液价格达到129万元/针。 过往数年，CAR-T细胞治疗产品已四次冲击医保谈判失败。业内普遍认为，这与国家医保谈判"50万不 谈，30万不进"的规则有关。 （文章来源：第一财经） 慢病毒载体作为目的基因递送工具，在细胞治疗产品中起着重要的作用，可以实现嵌合抗原受体基因的 转导和整合。慢病毒载体不仅是细胞治疗产品最重要 ...

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].

Core Viewpoint - Beijing Yimiao Shenzhou Biopharmaceutical Co., Ltd. is advancing its IPO process on the Sci-Tech Innovation Board, having signed a counseling agreement with CITIC Securities on July 23 this year [2]. Company Overview - Founded in 2015, Yimiao Shenzhou focuses on innovative drug development using original research gene cell therapy for major diseases such as cancer and autoimmune diseases [2]. - The company has developed a one-stop platform for gene cell drug research and industrialization, with 7 clinical trial approvals in China and 1 in the United States for CAR-T new drugs [2]. Product Pipeline - The research pipeline includes treatments for hematological tumors such as lymphoma, leukemia, and myeloma, as well as solid tumors like liver cancer, gastric cancer, colorectal cancer, and melanoma [2]. - The CAR-T product IM19 targets relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) and has submitted a New Drug Application (NDA) in China, which has been accepted [3]. - IM96 is the only CAR-T candidate drug globally that has received clinical trial approval in both China and the United States, specifically targeting GUCY2C [4]. Market Position - IM19's innovative CAR molecular design and production process provide more specific therapeutic effects, significantly improving survival time and quality of life for r/r DLBCL patients, thus filling a market gap for domestically developed CAR-T therapies in China [3]. - IM96 has been approved for treating colorectal cancer in China, marking it as the first CAR-T candidate for this indication in the country [4]. Financing and Investment - Yimiao Shenzhou has completed a total of 10 financing rounds since its establishment, with investors including Foothill Ventures, Tsinghua x-lab, and several other venture capital firms and funds [4].

Core Viewpoint - The company Kogei Pharmaceutical-B (02171.HK) announced that its CAR-T cell therapy candidate, Shurijiaolun Sai Injection (CT041), has been prioritized for review by the National Medical Products Administration for treating Claudin18.2 positive advanced gastric/esophagogastric junction adenocarcinoma patients who have failed at least two lines of treatment [1][2]. Group 1 - Shurijiaolun Sai Injection is a potentially first-in-class CAR-T cell therapy targeting Claudin18.2 protein, primarily for advanced gastric/esophagogastric junction adenocarcinoma and pancreatic cancer [2]. - Ongoing clinical trials include a researcher-initiated trial in China (CT041-CG4006, NCT03874897), a confirmatory Phase II trial for advanced gastric/esophagogastric junction adenocarcinoma (CT041-ST-01, NCT04581473), a Phase Ib trial for pancreatic cancer (CT041-ST-05, NCT05911217), and a post-operative consolidation therapy trial (CT041-CG4010, NCT06857786) [2]. - In March 2025, the injection received breakthrough therapy designation from the National Medical Products Administration in China for treating Claudin18.2 positive advanced gastric/esophagogastric junction adenocarcinoma after at least two lines of treatment failure [2]. Group 2 - In January 2022, the injection was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA in the United States for treating Claudin18.2 positive advanced gastric/esophagogastric junction adenocarcinoma [2]. - In September 2020, the injection received Orphan Drug designation from the FDA for treating gastric/esophagogastric junction adenocarcinoma [2].

Core Viewpoint - Acute Myeloid Leukemia (AML) presents significant treatment challenges due to the inherent heterogeneity of leukemic cells and the resistance of leukemia stem cells (LSC) to chemotherapy, leading to poor prognosis and high relapse rates [2][3]. Group 1: AML Characteristics and Challenges - AML is characterized by the obstruction of differentiation and abnormal proliferation of immature myeloid cells, resulting in hematopoietic dysfunction and life-threatening cytopenias [2]. - The incidence of AML increases with age, with over two-thirds of diagnoses occurring in individuals over 55 years old. The overall survival rate is approximately 40%-45% for patients under 65, while it drops to 10%-15% for those over 65 [2]. - More than half of AML patients experience disease relapse within one year, and less than one-third achieve durable remission [2]. Group 2: CAR-T Cell Therapy and CD97 Targeting - CAR-T cell therapy has shown success in treating refractory or relapsed B-cell malignancies but has not met expectations in AML due to the lack of specific targets like CD19 found in B-cells [3]. - Most antigens expressed on AML cells and LSCs are also present on normal cells, particularly hematopoietic stem cells (HSC), leading to off-target toxicity and complications such as neutropenia, anemia, and thrombocytopenia [3]. - A study published on May 26, 2025, identified CD97 as an ideal target for CAR-T cell therapy in AML, demonstrating that CD97-directed CAR-T cells could effectively eradicate AML in various xenograft models [3][9]. Group 3: CD97 Characteristics and Implications - CD97, encoded by the ADGRE5 gene, is a member of the adhesion G protein-coupled receptor family and is associated with promoting the invasion of various cancer cells, including those in AML [5]. - CD97 expression is significantly elevated in primary AML cells and LSCs compared to normal bone marrow cells, and its high expression correlates with poor prognosis in AML patients [5]. - CD97 plays a critical role in the proliferation and survival of AML cells, maintaining their undifferentiated state, making it a promising therapeutic target [5]. Group 4: Research Findings on CD97-targeted CAR-T Cells - The research team utilized CRISPR-Cas9 technology to knock out CD97 in T cells, creating CD97 KO CAR-T cells that effectively eliminate AML cells while showing tolerable toxicity to HSCs [6][9]. - Optimized CD97 KO CAR-T cells demonstrated sustained anti-tumor activity in vitro and in various xenograft mouse models, indicating their potential for durable therapeutic effects [6][9]. - The study supports CD97 as a promising target for CAR-T cell therapy in AML, highlighting the importance of gene editing strategies to mitigate self-targeting issues in T cells [9].

Core Viewpoint - Fosun Pharma's medical device and diagnostic business experienced a revenue decline in 2024, attributed to decreased sales of COVID-19 related products, with a reported revenue of RMB 4.323 billion, down 1.53% year-on-year [2][3] Financial Performance - As of April 3, 2025, Fosun Pharma's stock closed at RMB 25.51, with a slight increase of 0.2% and a trading volume of 166,900 shares, amounting to a total transaction value of RMB 426 million [1] - The company reported a segment loss of RMB 112 million in its medical device and diagnostic business for 2024, which is a year-on-year increase in loss of RMB 14 million [2] - The total amount repurchased for A-shares reached approximately RMB 39.99 million, while H-shares amounted to about HKD 22.91 million as of March 31, 2025 [7] Business Development - Fosun Pharma's CAR-T cell therapy product, Yikaida, was the first approved CAR-T therapy in China, with two indications approved and a third indication currently in bridging clinical trials [3] - The company aims to reduce the cost of CAR-T therapies to below RMB 100,000 by 2028 through advancements in technology and production processes [4] - Multiple CAR-T projects targeting BCMA/CD19 are in preclinical research stages, indicating ongoing innovation in the field [3] Market Activity - On the trading day, the net inflow of main funds was RMB 16.16 million, accounting for 3.8% of the total transaction value, while retail investors saw a net outflow of RMB 20.11 million [6] - The company has been actively repurchasing shares, with a plan to buy back between RMB 300 million to 600 million worth of shares from January 23, 2025, to July 21, 2025 [7]