体内CAR - T技术
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利好不断!这一板块多股拉涨!龙头股开年涨幅近70%
Zheng Quan Ri Bao Wang· 2026-01-08 03:57
沉寂已久的创新药板块,在2026年开年以来迎来强势拉升。 1月8日早间开盘,A股创新药概念板块延续强势,海南海药(000566)、奥锐特(605116)、必贝特-U早间一度涨停,苑东生物、泰恩康(301263)、汇宇 制药-W、奥赛康(002755)、上海谊众等多只个股跟涨,截至记者发稿时,海南海药、必贝特-U涨幅回落。值得一提的是,2026年开年以来,创新药概念 板块4连涨;成份股中,10余只个股4个交易日累计涨幅逾20%,龙头股必贝特-U股价累计涨幅逼近70%。 消息面上,近期创新药行业在政策及基本面方面利好消息不断。如1月7日据央视新闻消息,国家药监局为加快临床急需境外已上市药品在境内上市,满足患 者临床用药迫切需求,国家药监局进一步优化这类药品审评审批。鼓励申请人在中国开展全球同步研发、同步申报上市;鼓励临床急需境外已上市的原研药 及仿制药在境内申报。 | 成分股 | 新闻 | 资金 | F10 | 研究 | | --- | --- | --- | --- | --- | | 名称代码 | | 最新价 | 涨跌幅 ◆ | 涨跌: | | 必贝特-U | | 48.96 | 18.26% | 7.5 | ...
资本赋能硬科技 锋寻生物体内CAR-T首个临床数据有望明年Q2读出
Zheng Quan Ri Bao Wang· 2025-12-19 11:27
锋寻生物CEO施凯凯在接受记者采访时透露,基于该技术平台,公司针对血液瘤的候选药物GI-001将于 近期启动首次人体临床试验(IIT),预计在2026年第二、三季度读出首批临床数据。临床前数据显示,该 产品在肿瘤清除能力和安全性上均表现出显著优势。 资料显示,CAR-T疗法虽在血液瘤治疗领域疗效卓著,但商业化路径长期受制于复杂的生产工艺。传 统"体外制备"模式需提取患者细胞、体外扩增后再回输,周期长达2至4周,单次费用往往突破百万元。 高昂的成本与漫长的等待期,导致大量患者因支付能力不足或窗口期病情恶化而错失治疗良机。 据介绍,该技术路线无需将患者细胞取出体外,而是通过单次静脉注射病毒载体,直接在患者体内完成 T细胞的基因改造与激活。这一变革将过去耗时数周的体外生产环节压缩为一次30分钟内的静脉输注, 并有望实现药物的标准化生产。这意味着,治疗成本或将大幅降低,且能做到"即时可用",极大地提升 了药物的可及性。 记者近日从南通锋寻生物科技有限公司(以下简称"锋寻生物")获悉,其自主开发的多维度优化体内CAR- T技术平台已取得关键突破,展现出一定的产业化前景。据悉,该技术有望打破传统CAR-T疗法"制备 难、 ...
华邦健康(002004) - 002004华邦健康投资者关系管理信息20251020
2025-10-21 01:16
Company Overview - Founded in 1992, Huabang Life Health Co., Ltd. is a leading enterprise in the field of dermatological clinical medications and health [1] - The company operates in five major sectors: pharmaceuticals, medical services, agricultural chemicals, new materials, and tourism, with three listed subsidiaries [1] - Future strategy focuses on the development of a comprehensive health industry chain, integrating raw materials, formulations, functional skincare products, and medical services [1] Pharmaceutical Business - The pharmaceutical segment is stable, focusing on the R&D, production, and sales of pharmaceutical formulations and active pharmaceutical ingredients (APIs) [3] - The product matrix includes treatments for common skin conditions such as dermatitis, eczema, allergies, acne, and psoriasis, catering to all age groups [3][4] - The company has three major API production bases, ensuring a steady supply of core products and establishing long-term partnerships with international pharmaceutical companies [3] Impact of Drug Procurement Policies - The impact of national drug procurement policies on the company is currently limited due to the slower inclusion of dermatological medications in procurement [6] - The company is actively working on the consistency evaluation of generic drugs and controlling production costs to prepare for future procurement participation [6] - A comprehensive product matrix in dermatology allows the company to mitigate risks associated with procurement by promoting alternative products [6] Medical Services - The company has developed a layered business ecosystem that includes basic medicine, rehabilitation medicine, and health management services [7] - Facilities like Chongqing Songshan Hospital focus on basic medical treatment, while others specialize in rehabilitation and health management [7] Dividend Policy - The company has maintained a high dividend payout policy, distributing approximately 3 billion CNY since 2018 [9] - Plans to sustain a high dividend basis and explore diversified distribution methods in the future [9] Shareholding in Pruijin - The company holds a total of 13.2% equity in Pruijin, making it the third-largest shareholder [10] Collaboration with KITE Pharma - Pruijin has entered a global collaboration with KITE Pharma for in vivo editing therapies, receiving an upfront payment of 120 million USD and potential milestone payments totaling up to 1.52 billion USD [11] Advantages of In Vivo CAR-T Technology - In vivo CAR-T technology simplifies treatment by eliminating complex steps, reducing costs, and allowing for large-scale production [12]
13亿美元!科弈药业CAR-T授权出海,市场影响几何
2 1 Shi Ji Jing Ji Bao Dao· 2025-07-22 09:52
Core Viewpoint - The strategic partnership between Koyi Pharmaceutical and ERIGEN LLC marks a significant advancement in the global CAR-T therapy landscape, particularly with the development of the first dual-target CAR-T product KQ-2003, which targets BCMA/CD19 [1][2][3] Company Summary - Koyi Pharmaceutical has entered into an exclusive overseas licensing agreement with ERIGEN LLC for KQ-2003, covering global rights outside Greater China, excluding India, Turkey, and Russia [1] - The agreement includes a milestone payment of $15 million and potential future payments of up to $1.32 billion, along with a sales share of up to $800 million based on net sales in the licensed regions [1][2] - KQ-2003 has demonstrated a 100% overall response rate (ORR) in clinical trials for patients with relapsed/refractory multiple myeloma, showcasing its potential effectiveness [3][6] Industry Summary - The global cell and gene therapy market has seen rapid growth, with projections indicating it will exceed $30.54 billion by 2025 and reach $21.8 billion for CAR-T therapies by 2030, particularly in the multiple myeloma segment [4] - The CAR-T market is becoming increasingly competitive, with major players like Novartis and Gilead, as well as emerging companies like Legend Biotech and Koyi Pharmaceutical, vying for market share [4][5] - Traditional CAR-T therapies face challenges such as high costs (over $400,000 per treatment), production bottlenecks, and limited efficacy in solid tumors, prompting a shift towards more accessible and cost-effective solutions [5][6][7] - The development of "universal CAR-T" therapies, which utilize healthy donor cells, is seen as a potential game-changer in overcoming the limitations of personalized CAR-T treatments [6][8]