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 ...

慢病毒载体是细胞产品成本最高的原材料。 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。 综合有效性、安全性结果，本研究的临床数据表明，由国产慢病毒载体（JWLV011）生产的瑞基奥仑 赛注射液，与现有慢病毒载体生产的产品具有临床可比性。 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 ...

药明巨诺-B(02126)发布公告，中国国家药品监督管理局(NMPA)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。 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。慢病毒载体是瑞基奥仑赛注射液的重要的生产原材料之一，当前生产中所使用的慢病毒载 体由国外生产商供货，价格贵且供货存在不稳定性，较大地限制了瑞基奥仑赛的商业化生产及临床开 发。药明巨诺研发并新增了自主生产的慢病毒载体(JWLV011)，旨在实现病毒生产工艺优化、品质控制 加强的前提下，确保瑞基奥仑赛注射液的稳定持续供应以及降低成本。 本次申请是基于一项II期单臂研究，目的是评估和论证使用新工艺病毒载体(JWLV011)生产的瑞基奥仑 赛注射液，与使用现有病毒载体生产的瑞基奥仑赛注射液产品可比。目前本研究已完成至少3个月随 访：观察到的3个月最佳客观缓解率(ORR)为66.67%，疾病完全缓解率(CR)为41.67%。最常见的严重不 良事件为血细胞减少;CAR-T相关毒性如细胞因子释放综合征(CRS)，多为1级，无≥3级CRS发生，无任 何级别免疫效应细胞相关神经毒性综合征(ICAN ...

本次申请是基於一项II期单臂研究，目的是评估和论证使用新工艺病毒载体(JWLV011)生产的瑞基奥仑 赛注射液，与使用现有病毒载体生产的瑞基奥仑赛注射液产品可比。目前本研究已完成至少3个月随 访：观察到的3个月最佳客观缓解率("ORR")为66.67%，疾病完全缓解率("CR")为41.67%。最常见的严 重不良事件为血细胞减少；CAR-T相关毒性如细胞因子释放综合征("CRS")，多 为1级，无≥3级CRS发 生，无任何级别免疫效应细胞相关神经毒性综合征("ICANS")发生。综合有效性、安全性结果，本研究 的临床资料表明，由国产慢病毒载体(JWLV011)生产的瑞基奥仑赛注射液，与现有慢病毒载体生产的产 品具有临床可比性。 药明巨诺董事长兼首席执行官刘敏先生表示："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。慢病毒载体的国产替代，对於公司有着重要的战略意义。在成功完成 病毒载体替代後，我们的商业化商品及临床开发的供货将更为稳定，产品成本也将实现大幅度的下降， 较低的成本将使得公司能够更好地应对商业化的竞争以及保险谈判，这使得我们有机会实现倍诺达®商 业化价值的巨大提升。 ...

Core Points - The National Healthcare Security Administration (NHSA) announced changes to the drug list for basic medical insurance, with six drugs undergoing form review changes, including two drugs that did not pass the review [1][3] - The two drugs that failed the review are injectable risperidone microspheres and injectable triptorelin, both of which are exclusive products from Zhejiang Shengzhao Pharmaceutical Co., Ltd. and Ipsen, respectively [2][3] - The injectable risperidone microspheres have a global market size of $490 million in 2022, with expectations to reach 920 million yuan in China by 2030 [3] Drug Review Changes - Six drugs had their form review results changed, with injectable risperidone microspheres and injectable triptorelin being excluded from the basic medical insurance directory [3][4] - Injectable risperidone microspheres, approved in February 2023, is the first generic version in China for treating mental disorders, while injectable triptorelin was approved in 2023 for treating precocious puberty and prostate cancer [3][4] Commercial Health Insurance Innovations - The newly established commercial health insurance innovative drug directory has gained attention, with 121 drugs passing the form review, including CAR-T and nuclear medicine therapies [5] - CAR-T therapy has faced challenges in entering the insurance directory due to high costs, but five CAR-T products have now passed the form review for the commercial health insurance directory [5] - Nuclear medicine, known for its precision in targeting cancer cells, has also seen several products approved, including technetium-99m and fluorine-18 labeled drugs [6] Future Developments - Negotiations and price discussions for the drug directory adjustments will take place from September to October, with results expected to be announced in November [7]

Core Viewpoint - WuXi AppTec's revenue for the first half of 2025 was 106.3 million yuan, with sales of its CAR-T drug, Regiokyuran, amounting to 81 million yuan, which is lower than the sales figures from the same period in 2024 and 2023 [1][2]. Group 1: Company Performance - WuXi AppTec's CAR-T drug sales of 81 million yuan in the first half of 2025 were below the 86.8 million yuan in 2024 and 87.7 million yuan in 2023 [2]. - Legend Biotech reported a global sales figure of 439 million USD (approximately 3.1 billion yuan) for its CAR-T drug in Q2 2025, with total sales for the first half reaching 808 million USD (approximately 5.7 billion yuan), marking a year-on-year growth of 100% [4]. - Legend Biotech's CAR-T product, Carvykti, achieved sales of 4.39 billion yuan in Q2 2025, outperforming major competitors [18]. Group 2: Market Dynamics - The Chinese CAR-T market has seven approved products, with Legend Biotech's sales being significantly higher than its competitors, indicating a strong market presence [3]. - The high cost of CAR-T treatments remains a barrier to market penetration in China, with most patients unable to afford the treatment priced over one million yuan [29]. - The lack of a mature commercialization path for CAR-T products in China is a common challenge faced by companies in this sector [7]. Group 3: Regulatory and Insurance Landscape - Companies are attempting to improve payment capabilities for CAR-T treatments in China, with some products undergoing dual-line applications for basic medical insurance and commercial insurance [31]. - WuXi AppTec's Regiokyuran is priced at 1.29 million yuan, making it one of the most expensive CAR-T products in the market [28]. - The ongoing efforts to include CAR-T products in insurance coverage highlight the industry's struggle to balance pricing and accessibility for patients [30][34]. Group 4: Future Outlook - Legend Biotech's CEO anticipates the company will achieve profitability by 2026, indicating a positive outlook for future financial performance [20]. - The industry is exploring innovative production methods to reduce costs, with WuXi AppTec beginning to source key raw materials from domestic suppliers [35]. - The emergence of in-body CAR-T cell preparation technology may offer new avenues for cost reduction and accessibility in the future [36][37].

Core Viewpoint - The CAR-T therapy market in China is facing challenges with high costs and limited market penetration, but there is potential for price reductions and increased insurance coverage in the future [2][16]. Group 1: Company Performance - WuXi AppTec reported a revenue of 106.3 million yuan in the first half of 2025, with sales of its CAR-T drug, Regiokyron, amounting to 81 million yuan [2]. - Legend Biotech's CAR-T drug achieved global sales of 439 million USD (approximately 3.1 billion yuan) in Q2 2025, with total sales for the first half reaching 808 million USD (approximately 5.7 billion yuan), marking a year-on-year growth of 100% [3][10]. - CStone Pharmaceuticals reported a revenue of approximately 51 million yuan in the first half of 2025, a year-on-year increase of about 703.8%, primarily driven by CAR-T products [6]. Group 2: Market Challenges - Legend Biotech has reportedly canceled its sales and marketing team in China, focusing instead on more profitable overseas markets due to underwhelming domestic sales [4]. - The high cost of CAR-T treatments remains a significant barrier to market penetration, with prices exceeding 1 million yuan per treatment, making it unaffordable for most patients in China [15][16]. - The lack of a clear commercial path for CAR-T products in China is a common challenge faced by companies in this sector [4]. Group 3: Pricing and Insurance - The pricing of CAR-T products varies, with WuXi AppTec's Regiokyron priced at 1.29 million yuan, while the lowest-priced product, CStone's Nakiokyron, is priced at 999,000 yuan [8][15]. - Efforts are being made to improve insurance coverage for CAR-T therapies, with several companies submitting applications for inclusion in basic medical insurance and commercial insurance directories [16]. - The development of commercial insurance in China is seen as a key factor in enhancing payment capabilities for CAR-T treatments, which could lead to price reductions in the next five years [16][17]. Group 4: Technological Innovations - Recent advancements in CAR-T technology, such as in vivo production methods, are gaining attention and may offer solutions to the high costs associated with traditional CAR-T therapies [18]. - The production cost of CAR-T therapies is significant, with estimates indicating that the material cost for each treatment is around 43,000 USD, highlighting the need for cost-effective production methods [17][18].

Core Insights - The National Healthcare Security Administration (NHSA) has published the preliminary review results for the 2025 medical insurance and commercial insurance innovative drug directory, with significant changes in the approval status of six drugs compared to the previous version [1][2]. Summary by Categories Drug Approval Changes - Six drugs have had their approval status changed, with two drugs (Injectable Risperidone Microspheres and Injectable Triptorelin Acetate) being disapproved, while two others (Levodopa Injection and Calcium Gluconate Sodium Chloride Injection) have been approved [1][3]. - The oral suspension of Ursodeoxycholic Acid remains approved, but the conditions for approval have been adjusted [1][3]. Application Statistics - For the 2025 directory adjustment, the NHSA received 718 applications, involving 633 drug generic names, with 535 passing the preliminary review [1][2]. - The approval rate has increased significantly, reaching 84.52% this year, compared to 68.42% in 2023 and 76.66% in 2024 [2]. Notable Drugs - Levodopa Injection, used for Parkinson's disease, has been approved and is not an exclusive product, indicating its potential for broader market access [4]. - Injectable Ceftriaxone Sodium Sulbactam, another approved drug, is noted for its broad antibacterial spectrum and safety profile [4]. - The oral suspension of Ursodeoxycholic Acid has had its approval conditions modified to include rare disease categories [6]. Innovative Drug Directory - The commercial insurance innovative drug directory has been introduced alongside the basic medical insurance directory, with 141 applications received, of which 121 passed the preliminary review [2]. - A significant number of drugs in both directories are new, with 303 in the basic medical insurance directory meeting specific conditions for approval [7]. Rare Disease Drugs - The directories include a total of 37 rare disease drugs in the basic medical insurance directory and 35 in the commercial insurance innovative drug directory, with 19 drugs approved in both [10][11]. - Notable rare disease drugs include those from Merck and other companies, which have gained attention for their potential market impact [11][12]. Market Trends - The introduction of the commercial insurance innovative drug directory is expected to enhance market access for several high-profile drugs, including CAR-T therapies that have previously struggled to gain approval [9][12]. - The performance of rare disease drug companies has seen significant stock price increases, indicating strong market interest and potential for growth [13].

Core Viewpoint - The National Healthcare Security Administration (NHSA) has officially announced the preliminary review results for the adjustment of the 2025 medical insurance and commercial insurance innovative drug catalog, indicating an increase in the number of drugs passing the review and the overall approval rate compared to previous years [1][2]. Summary by Relevant Sections Drug Review Changes - Six drugs underwent changes in their review status, with two drugs, injectable risperidone microspheres and injectable triptorelin, being disapproved, while injectable levodopa and calcium gluconate sodium injection were approved [1][5][6]. - The injectable risperidone microspheres, an exclusive product of Shengzhao Pharmaceuticals, was first launched in mainland China in February 2025 for treating mental disorders [6][7]. - The injectable triptorelin, also an exclusive product, was launched in 2023 for treating prostate cancer and precocious puberty [7]. Approval Statistics - A total of 718 applications were received for the 2025 catalog adjustment, involving 633 drug generic names, with 535 passing the preliminary review, resulting in an approval rate of 84.52% [1][2]. - The approval rates have shown a significant increase over the past three years, with 68.42% in 2023, 76.66% in 2024, and 84.52% in 2025 [2]. Innovative Drug Catalog - The commercial insurance innovative drug catalog was introduced for the first time, with 141 applications received, involving 141 drug generic names, and 121 passing the review [3]. - Among the drugs, 79 were submitted for both the basic medical insurance catalog and the commercial insurance innovative drug catalog [3]. Notable Products - Several notable products are highlighted, including CAR-T products that have previously failed to enter the medical insurance catalog but are now included in the commercial insurance innovative drug catalog [11][12]. - Unique products such as the first and only AKT inhibitor and the only Trop-2 ADC for breast cancer treatment are also included in the catalogs, indicating a focus on innovative therapies [13][14]. Rare Disease Medications - The review process has also included rare disease medications, with 37 drugs in the basic medical insurance catalog and 35 in the commercial insurance innovative drug catalog, of which 19 are approved in both [15][16]. - The approval of rare disease drugs is seen as a significant development, with companies like Beihai Kangcheng gaining attention for their innovative products [20].

Core Insights - The National Healthcare Security Administration (NHSA) has announced the preliminary review results for the 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance drug catalog, with 534 drugs passing the initial review for basic insurance and 121 innovative drugs for commercial health insurance [1][5][17] - The commercial health insurance innovative drug catalog aims to cover high-value innovative drugs that are not included in the basic insurance, focusing on areas such as oncology and rare diseases [6][18] - The process for drugs to be included in the commercial health insurance catalog involves multiple steps, including expert review and price negotiations, making the final inclusion uncertain [3][8][11] Summary by Sections Drug Catalog and Review Process - A total of 534 drugs have passed the initial review for the basic medical insurance catalog, while 121 innovative drugs have been preliminarily approved for the commercial health insurance catalog [1][5] - The review process includes company applications, formal reviews, expert evaluations, and price negotiations, with the initial review only indicating eligibility for further steps [8][12] Market Dynamics and Challenges - The commercial health insurance catalog operates on a voluntary basis, meaning that both pharmaceutical companies and insurers must agree on terms, which introduces uncertainty in market uptake [3][11] - Insurers are concerned about the cost savings from drug pricing and the actual market impact of the new catalog, as well as the compliance issues related to high-priced drugs [3][12] Focus on Innovative Drugs - The new catalog emphasizes innovative drugs that provide significant clinical benefits but are not covered by basic insurance, particularly in oncology and rare diseases [6][18] - The inclusion of CAR-T therapies and rare disease medications indicates a shift towards addressing unmet medical needs in the market [6][19] Implications for Insurance Companies - The commercial health insurance sector is expected to adapt its product offerings based on the new catalog, potentially leading to a more standardized approach across the industry [7][13] - Insurers are encouraged to develop specialized products that cater to high-net-worth individuals seeking coverage for innovative drugs, enhancing their competitive edge [13][19] Future Outlook - The NHSA's initiatives are seen as a critical step towards reforming the payment system for innovative drugs, aiming to alleviate the financial burden on patients and improve access to high-cost treatments [17][18] - The projected growth of the innovative drug market in China suggests a significant opportunity for commercial health insurance to expand its role in covering these therapies [16][19]