CAR - T细胞治疗
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安科生物:获CD7-CAR-T细胞药物全国独家商业化权益
Cai Jing Wang· 2025-11-13 20:15
PA3-17注射液是博生吉公司全资子公司博生吉安科细胞技术有限公司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,首个适应症为用于治疗成人复发、难治性CD7阳性血液淋巴系统恶性肿瘤。PA3- 17注射液已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,并进入关键性II期临床试验。 博生吉公司拟委托公司就PA3-17注射液产品未来在大中华区市场销售、推广开展长期合作,待产品提交上市申请后, 双方将另行签订正式的独家代理协议。同时,博生吉公司承诺,其后续其他产品上市后,将优先选择公司作为独家代 理机构,由公司负责产品上市后的推广与销售工作。 (安科生物公告) 近日,安科生物发布公告称,为推动参股公司博生吉医药科技(苏州)有限公司(以下简称"博生吉公司")旗下PA3- 17注射液产品的销售与推广,安徽安科生物工程(集团)股份有限公司(以下简称"公司")与博生吉公司达成战略合 作,于2025年11月11日签署《关 于CD7-CAR-T(PA3-17注射液)等产品独家代理框架协议》,约定PA3-17注射液产品上市后大中华区独家代理的相关 事宜。 ...
安科生物增资博生吉 并获CD7-CAR-T细胞药物全国独家商业化权益
Zhong Guo Zheng Quan Bao· 2025-11-11 14:06
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].
A股公告精选 | 同兴科技(003027.SZ)拟32亿元投建年产10万吨钠电正极材料等项目
智通财经网· 2025-11-11 11:45
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]
安科生物签署PA3-17注射液独家代理框架协议 系全球首款获批新药临床试验的靶向CD7的自体CAR-T细胞治疗产品
智通财经网· 2025-11-11 10:58
智通财经APP讯,安科生物(300009.SZ)发布公告,为推动参股公司博生吉医药科技(苏州)有限公司(以下 简称"博生吉公司")旗下PA3-17 注射液产品的销售与推广,公司与博生吉公司达成战略合作,于2025年 11月11日签署《关于CD7-CAR-T(PA3-17 注射液)等产品独家代理框架协议》,约定PA3-17注射液产品 上市后大中华区(中国大陆及港澳台地区)独家代理的相关事宜。 本次独家代理合作旨在充分整合双方优势资源,实现协同发展的合作效应。公司通过独家代理模式可快 速引入创新药产品,填补现有产品在CAR-T细胞治疗领域的空白,进一步丰富公司产品矩阵,提升公司 在创新药市场的核心竞争力。 PA3-17注射液是博生吉公司全资子公司博生吉安科细胞技术有限公司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,首个适应症为用于治疗成人复发、难治性CD7阳性 血液淋巴系统恶性肿瘤。PA3-17注射液已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,并进入关键性II期临床试验。 博生吉公司拟委托公司就PA3-17注射液产品未来在大中华区市场销售、推广开展长 ...
安科生物(300009.SZ)签署PA3-17注射液独家代理框架协议 系全球首款获批新药临床试验的靶向CD7的自体CAR-T细胞治疗产品
智通财经网· 2025-11-11 10:52
博生吉公司拟委托公司就PA3-17注射液产品未来在大中华区市场销售、推广开展长期合作,待产品提 交上市申请后,双方将另行签订正式的独家代理协议。同时,博生吉公司承诺,其后续其他产品上市 后,将优先选择公司作为独家代理机构,由公司负责产品上市后的推广与销售工作。 本次独家代理合作旨在充分整合双方优势资源,实现协同发展的合作效应。公司通过独家代理模式可快 速引入创新药产品,填补现有产品在CAR-T细胞治疗领域的空白,进一步丰富公司产品矩阵,提升公司 在创新药市场的核心竞争力。 智通财经APP讯,安科生物(300009.SZ)发布公告,为推动参股公司博生吉医药科技(苏州)有限公司(以下 简称"博生吉公司")旗下PA3-17 注射液产品的销售与推广,公司与博生吉公司达成战略合作,于2025年 11月11日签署《关于CD7-CAR-T(PA3-17 注射液)等产品独家代理框架协议》,约定PA3-17注射液产品 上市后大中华区(中国大陆及港澳台地区)独家代理的相关事宜。 PA3-17注射液是博生吉公司全资子公司博生吉安科细胞技术有限公司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,首个 ...
核心医疗冲刺IPO;精准生物自研国内首款儿童白血病 CAR-T治疗产品获批上市|医药早参
Sou Hu Cai Jing· 2025-11-09 23:31
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]
科济药业-B:2025年ESMO年会上呈列的舒瑞基奥仑赛注射液研究成果
Zhi Tong Cai Jing· 2025-10-20 00:54
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]
科济药业-B(02171):2025年ESMO年会上呈列的舒瑞基奥仑赛注射液研究成果
智通财经网· 2025-10-20 00:49
Core Viewpoint - The announcement by Kintor Pharmaceutical regarding the clinical trial results of its CAR-T cell therapy candidate targeting Claudin18.2 for pancreatic cancer has significant implications for the company's future in oncology treatments [1][2]. Group 1: Clinical Trials and Research - The clinical trial CT041-ST-05, focusing on the use of Claudin18.2-targeted CAR-T cells for adjuvant therapy in high-risk pancreatic cancer, was presented at the 2025 ESMO annual meeting [1]. - Multiple clinical trials are underway for the candidate, including studies for advanced gastric/esophageal junction adenocarcinoma and pancreatic cancer, indicating a broad application of the therapy [2]. Group 2: Regulatory Approvals and Designations - The National Medical Products Administration (NMPA) in China accepted the New Drug Application (NDA) for the therapy on June 25, 2025, for treating advanced gastric/esophageal junction adenocarcinoma [3]. - The therapy has received priority review status and breakthrough therapy designation from the NMPA, highlighting its potential significance in treating patients who have failed at least second-line therapy [3]. - In the United States, the therapy was granted Regenerative Medicine Advanced Therapy (RMAT) designation and orphan drug status by the FDA, further emphasizing its innovative nature and potential market impact [3].
诺和诺德口服司美格鲁肽获批新适应证;片仔癀第三季度净利润同比下降28.82%
Mei Ri Jing Ji Xin Wen· 2025-10-19 23:37
Group 1: Novo Nordisk - Novo Nordisk's oral semaglutide (Rybelsus) has received FDA approval for a new indication to reduce cardiovascular risk in high-risk adults with type 2 diabetes, making it the first oral GLP-1 drug to do so [1] - The company has also submitted a supplemental new drug application for its once-daily oral semaglutide (Wegovy) for obesity treatment, with approval expected later this year [1] - The approval of the new indication for oral semaglutide is expected to further solidify Novo Nordisk's market position in the GLP-1 segment [1] Group 2: Sunshine Guohe - Sunshine Guohe plans to invest 15 million yuan to acquire an 8.20% stake in Yuanma Zhiyao, focusing on CAR-T cell therapy and nucleic acid drugs [2] - Yuanma Zhiyao specializes in the innovation and research of circular mRNA CAR-T nucleic acid drugs and is advancing towards clinical research [2] - This investment aligns with Sunshine Guohe's strategic layout in the CAR-T field and is expected to create synergies between the two companies [2] Group 3: Pian Zai Huang - Pian Zai Huang reported a 28.82% year-on-year decline in net profit for Q3, with revenue of 2.064 billion yuan, down 26.28% year-on-year [3] - For the first three quarters, the company recorded a revenue of 7.442 billion yuan, a decrease of 11.93%, and a net profit of 2.129 billion yuan, down 20.74% [3] - The decline in performance is attributed to reduced sales in the pharmaceutical manufacturing industry and a decrease in gross margin [3] Group 4: Kelun Pharmaceutical - Kelun Pharmaceutical's subsidiary, Kelun Botai, received approval for its core product, trastuzumab deruxtecan (舒泰莱), for treating HER2-positive breast cancer [4] - The product showed significant improvement in progression-free survival (PFS) compared to T-DM1 in interim analysis, indicating strong clinical efficacy [4] - This approval marks a key breakthrough for Kelun Botai in the breast cancer field and highlights the ongoing advancements of domestic ADCs in high-end oncology treatment [4]
阳光诺和:拟1500万元认缴元码智药新增注册资本
Zheng Quan Shi Bao Wang· 2025-10-19 07:49
Core Viewpoint - Sunshine Nuohuo (688621) announced an investment of 15 million yuan to acquire an 8.20% stake in Yuanma Zhiyao, which focuses on innovative research and development of circular mRNA CAR-T nucleic acid drugs, aiming to address unmet clinical needs in autoimmune diseases and tumors [1] Group 1 - The company is investing 15 million yuan to increase the registered capital of Yuanma Zhiyao by 110,600 yuan [1] - After the investment, the company will hold an 8.20% equity stake in Yuanma Zhiyao [1] - Yuanma Zhiyao specializes in the innovation and research of circular mRNA CAR-T nucleic acid drugs, aiming to revolutionize the commercialization challenges of CAR-T therapy [1] Group 2 - The investment aligns with the company's overall strategic layout in the field of in vivo CAR-T cell therapy and nucleic acid drugs [1] - The approach of using "nucleic acid drug form" to achieve "cell therapy effects" is intended to provide new solutions for patients with unmet clinical needs [1]