2025.12. 08 本文字数：1903，阅读时长大约3分钟 作者 | 第一财经 林志吟 过往，CAR-T这种百万级别的细胞治疗药物，始终无缘走到国家医保目录谈判桌上。如今，这些药 物在商保方面的支付迎来突破。 12月7日，在2025创新药高质量发展大会上，首版《商业健康保险创新药品目录》正式公布，共有5 款CAR-T细胞药物成功进入目录，分别是复星凯瑞的阿基仑赛注射液、药明巨诺的瑞基奥仑赛注射 液、合源生物的纳基奥仑赛注射液、驯鹿生物的伊基奥仑赛注射液、科济药业的泽沃基奥仑赛注射 液。 除了合源生物的纳基奥仑赛注射液是唯一低于百万元的CAR-T，定价为99.9万元/针，其他定价均过 百万，药明巨诺的瑞基奥仑赛注射液定价最高，达到129万元/针。 此次这些药物成功进入《商业健康保险创新药品目录》，利好在哪，后续如何进一步实现可及性？ 利好在哪 这些药物，主要用于血液瘤治疗，有治疗大B细胞淋巴瘤治疗的，也有治疗多发性骨髓瘤的，还有治 疗急性淋巴细胞白血病的。CAR-T细胞药物的出现，给一些血液瘤治愈的可能带来希望。过往数 年，CAR-T细胞治疗产品多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 ...

Core Insights - The introduction of five CAR-T cell therapies into the Commercial Health Insurance Innovative Drug Directory marks a significant breakthrough for these high-cost treatments, which previously struggled to gain access to national insurance negotiations [1][3][4] Group 1: Benefits of Inclusion - The five CAR-T therapies included are aimed at treating various blood cancers, providing hope for potential cures in conditions like large B-cell lymphoma, multiple myeloma, and acute lymphoblastic leukemia [3] - The inclusion of these therapies in the directory is seen as a milestone for improving patient accessibility to innovative drugs in China [4][5] - The pricing of these therapies varies, with the lowest being 999,000 yuan (approximately 99.9 million) for the product from 合源生物, while the highest is 1,290,000 yuan (approximately 129 million) for the product from 药明巨诺 [1] Group 2: Market Dynamics and Cost Considerations - The high production costs of CAR-T therapies, particularly due to the expensive lentiviral vectors sourced from foreign suppliers, have historically limited their pricing and accessibility [3] - Some companies have reported that their CAR-T products will see price reductions of at least 15% upon inclusion in the directory, which is expected to be more favorable than local health insurance programs [5] Group 3: Implementation Challenges - The successful inclusion of CAR-T therapies in the directory raises questions about the practical implementation and accessibility in hospitals, as the directory's effectiveness relies on its adoption at the hospital level [6][7] - Policies such as the "three exclusions" from basic medical insurance and centralized procurement monitoring are designed to alleviate concerns from hospitals and physicians regarding cost assessments, potentially facilitating the entry of these drugs into hospitals [6][7] - There are ongoing discussions about further coordination between the National Medical Insurance Administration and health authorities to ensure that the performance assessments of hospitals do not hinder the adoption of these innovative therapies [7]

北京商报讯（记者 丁宁）12月4日晚间，安科生物（300009）发布公告称，公司参股公司博生吉医药科 技（苏州）有限公司、博生吉安科细胞技术有限公司（以下简称"博生吉安科"）自主研发的PA3-17注射 液新增"针对儿童和青少年复发/难治性T淋巴母细胞白血病/淋巴瘤（R/R T-ALL/LBL）"的适应症临床试 验申请已获受理，并收到国家药品监督管理局行政许可文书《受理通知书》。 公告显示，PA3-17注射液是博生吉安科自主研发的全球首款获得新药临床试验批准的靶向CD7的自体 CAR-T细胞治疗产品，已于8月被国家药品监督管理局药品审评中心（CDE）纳入突破性治疗品种名 单。 ...

Core Insights - Anke Bio announced a strategic partnership with Boshengji Pharmaceutical Technology (Suzhou) Co., Ltd. to promote the sales of the PA3-17 injection product, which is a CAR-T cell therapy targeting CD7 [1] - The PA3-17 injection is the first globally approved CAR-T cell therapy for clinical trials targeting CD7, aimed at treating adult relapsed and refractory CD7-positive hematologic malignancies [1] - The product has been included in the list of breakthrough therapies by the National Medical Products Administration (NMPA) and is currently in a critical Phase II clinical trial [1] Summary by Sections - **Strategic Partnership**: Anke Bio and Boshengji have signed a framework agreement for exclusive agency rights for the PA3-17 injection in Greater China, with a formal agreement to follow after the product's market application submission [1] - **Product Details**: PA3-17 injection is developed by Boshengji's subsidiary and is the first of its kind to receive clinical trial approval, focusing on a significant medical need in hematologic cancers [1] - **Future Collaboration**: Boshengji has committed to prioritizing Anke Bio as the exclusive agency for future product launches, ensuring a long-term collaboration for sales and promotion in the region [1]

Core Viewpoint - Anke Bio has entered into a strategic partnership with Boshengji Pharmaceutical Technology, marking a significant upgrade from previous collaborations to a comprehensive partnership involving capital investment and commercial operations [1][4]. Group 1: Investment and Partnership Details - Anke Bio will invest an additional 30 million yuan in Boshengji, becoming the second-largest shareholder [1][4]. - The partnership includes exclusive agency rights for Anke Bio to market Boshengji's core product, PA3-17 injection, nationwide [1][3]. Group 2: Product and Clinical Development - The collaboration focuses on PA3-17 injection, the world's first targeted CD7 CAR-T cell therapy product approved for clinical trials, developed by Boshengji's subsidiary [3][4]. - PA3-17 injection has shown promising safety and efficacy in Phase I clinical trials for patients with relapsed/refractory T-ALL and T-LBL [3][4]. - The product is included in the National Medical Products Administration's list of breakthrough therapies and is entering the critical Phase II clinical trial stage [3][4]. Group 3: Strategic Implications - The agreement extends beyond PA3-17 injection, granting Anke Bio priority agency rights for future innovative products from Boshengji [4]. - Anke Bio's established marketing system and commercial experience are expected to facilitate rapid market penetration for PA3-17 injection [4]. - This dual approach of "capital investment + exclusive agency" is seen as a strategic move to accelerate the commercialization of innovative drugs in the CAR-T therapy sector in China [4].

Group 1 - Tongxing Technology plans to invest approximately 3.2 billion yuan to establish a 100,000-ton sodium battery anode material and 6GWh cell project in Ping Shan County [1] - The investment includes about 2 billion yuan for the sodium battery anode material project and 1.2 billion yuan for the cell project, aiming to enhance the company's profitability and market competitiveness [1] Group 2 - Haike New Source has signed a strategic cooperation agreement with Kunlun New Materials to purchase approximately 596,200 tons of electrolyte solvent from 2026 to 2028 [2] - This partnership aims to ensure stable raw material supply and enhance Haike New Source's sales and brand influence [2] Group 3 - Wenta Technology's major shareholder, Zhuhai Ronglin, and its concerted action party, Gree Electric Appliances, have reduced their holdings by a total of 12.4443 million shares [3] - After the reduction, they hold a combined 7.83% of the company's shares [3] Group 4 - Redik has signed a strategic cooperation agreement with Aoyi Technology to jointly establish Zhejiang Lei Ao Robot Co., Ltd., focusing on the development of robotic dexterous hand components [4] - The registered capital of the joint venture is 100 million yuan, with Redik contributing 90% [4] Group 5 - Anke Biological has signed an exclusive agency framework agreement for the PA3-17 injection product, the world's first targeted CD7 CAR-T cell therapy approved for clinical trials [5] - The agreement covers exclusive agency rights for the Greater China region upon product launch [5] Group 6 - Tianji Co., Ltd.'s controlling shareholder has pledged 39.965 million shares for its own production and operation needs [6] - The pledge accounts for 64.79% of the shareholder's holdings and 7.97% of the company's total shares [6] Group 7 - Shannon Chip's major shareholder has pledged 1.27 million shares, representing 5.55% of its holdings and 0.27% of the company's total shares [7] - The pledge is for financing purposes [7] Group 8 - *ST Zhengping has completed its stock trading review and will resume trading on November 12 [8] - The company reported normal production and operation conditions without any significant changes [8]

Core Viewpoint - Anke Bio (300009.SZ) has entered into a strategic cooperation with its affiliate, Boshengji Pharmaceutical Technology (Suzhou) Co., Ltd., to exclusively distribute the PA3-17 injection product in Greater China after its market launch, enhancing its position in the CAR-T cell therapy sector [1][2] Group 1 - The PA3-17 injection is the world's first targeted CD7 autologous CAR-T cell therapy product approved for clinical trials, aimed at treating adult relapsed and refractory CD7-positive hematologic malignancies [1] - The product has been included in the breakthrough therapy list by the National Medical Products Administration (NMPA) and is currently in a critical Phase II clinical trial [1] - Boshengji plans to entrust Anke Bio with long-term cooperation for the sales and promotion of PA3-17 in the Greater China market, with a formal exclusive agency agreement to be signed after the product's market application submission [1] Group 2 - The exclusive agency cooperation aims to leverage the strengths of both companies, achieving synergistic development effects [2] - Through the exclusive agency model, the company can quickly introduce innovative drug products, filling existing gaps in the CAR-T cell therapy field and enriching its product matrix [2] - This partnership is expected to enhance the company's core competitiveness in the innovative drug market [2]

Core Viewpoint - Anke Bio (300009.SZ) has entered into a strategic cooperation with its affiliate, Boshengji Pharmaceutical Technology (Suzhou) Co., Ltd., to exclusively distribute the PA3-17 injection product in Greater China after its market launch, enhancing its position in the CAR-T cell therapy sector [1][2] Group 1 - The PA3-17 injection is the world's first targeted CD7 autologous CAR-T cell therapy product approved for clinical trials, aimed at treating adult relapsed and refractory CD7-positive hematologic malignancies [1] - The product has been included in the breakthrough therapy list by the National Medical Products Administration (NMPA) and is currently in a critical Phase II clinical trial [1] - Boshengji plans to entrust Anke Bio with long-term cooperation for the sales and promotion of PA3-17 in the Greater China market, with a formal exclusive agency agreement to be signed after the product's market application submission [1] Group 2 - The exclusive agency cooperation aims to leverage the strengths of both companies, achieving synergistic development effects [2] - Through the exclusive agency model, the company can quickly introduce innovative drug products, filling existing gaps in the CAR-T cell therapy field and enriching its product matrix [2] - This partnership is expected to enhance the company's core competitiveness in the innovative drug market [2]

Group 1 - Braveheart Bio, a biotech startup, has completed a $185 million Series A financing round, led by top life science investment firms. The financing is linked to its sole pipeline product BHB-1893, which originates from China's Heng Rui Medicine. A licensing agreement was established in September 2025 between Heng Rui Medicine and Braveheart Bio for the HRS-1893 project, a small molecule inhibitor of cardiac myosin [1] - Core Medical has been accepted for IPO on the Sci-Tech Innovation Board, becoming the first innovative medical device company to be accepted under the new listing standards. The company has developed five implantable and six interventional artificial heart products, with one implantable product already commercialized and two interventional products in the registration approval stage [2] - Chongqing Precision Bio has received approval from the National Medical Products Administration for its CAR-T therapy product, Pukiorun, aimed at treating acute B lymphoblastic leukemia in children aged 3 to 21. This is the first CAR-T therapy approved in China for treating refractory or relapsed B-ALL in this age group [3] Group 2 - YKYY013, a dual-strand siRNA drug developed by Yuekang Kexin and Tianlong Pharmaceutical, has been approved for clinical trials to treat chronic hepatitis B virus infection. This drug utilizes RNA interference to silence HBV gene transcription, potentially leading to functional cure for hepatitis B [4] - Huahui Anjian has released key clinical data for its monoclonal antibody HH-003, which shows significant efficacy in treating chronic hepatitis D virus infection. The 48-week clinical trial results indicate superior outcomes in composite endpoint response rates, virological suppression, ALT normalization, and liver stiffness improvement compared to the control group [5][6]

Core Insights - The company Kogei Pharmaceutical-B (02171) announced the results of its clinical trial for the CAR-T cell therapy candidate, Shurui Jiao Lun Sai Injection (CT041), targeting Claudin18.2 for pancreatic cancer, which will be presented at the 2025 ESMO annual meeting [1][2] Group 1: Product Overview - Shurui Jiao Lun Sai Injection is a potential first-in-class autologous CAR-T cell therapy targeting Claudin18.2 protein, primarily for treating Claudin18.2 positive solid tumors, including gastric and pancreatic cancers [2] - Ongoing trials include various phases for different indications, such as advanced gastric/esophageal junction adenocarcinoma and adjuvant therapy for pancreatic cancer [2] Group 2: Regulatory Milestones - On June 25, 2025, the National Medical Products Administration (NMPA) of China accepted the New Drug Application (NDA) for Shurui Jiao Lun Sai Injection for treating Claudin18.2 positive advanced gastric/esophageal junction adenocarcinoma patients who have failed at least second-line treatment [3] - The product received priority review status from the NMPA in May 2025 and was designated as a breakthrough therapy by the NMPA in March 2025 [3] - In January 2022, the product was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA in the United States for treating Claudin18.2 positive advanced gastric/esophageal junction adenocarcinoma [3]