在2025年12月举行的美国血液学会（ASH）年会上，Anitocabtagene autoleucel（anito-cel）在重度预处 理的R/R MM患者中展现出令人振奋的疗效：客观缓解率（ORR）高达96%，完全缓解（CR）或严格完 全缓解（sCR）率达到74%，且缓解持久性良好，安全性可控。这项研究结果不仅为R/R MM患者带来 了新的治疗选择，也进一步巩固了BCMA CAR T疗法在晚期骨髓瘤治疗中的核心地位。 21世纪经济报道记者季媛媛 2月23日，吉利德科学宣布与其长期合作伙伴Arcellx达成最终协议，将以每股115美元现金、总股权价值 约78亿美元的价格收购后者。消息一出，Arcellx盘前股价应声暴涨近80%。 这一收购背后被认为是吉利德旗下Kite Pharma在细胞治疗领域布下的一枚重子。根据协议条款，吉利 德将获得Arcellx的全部控股权，但故事并未结束。Arcellx的股东未来还有机会获得每股5美元的或有价 值权（CVR），而触发条件是核心资产anito-cel在上市后至2029年底，全球累计净销售额达到至少60亿 美元 。 这一"对赌"条款显示了吉利德对anito-cel成为重 ...

东方证券发布研报称，自体CAR-T凭借优异的疗效具备极大的吸引力，2025年全球销售额已接近60亿美 元。近期TCE优异的数据引起市场对自体CAR-T前景的担忧，主要因为疗效接近的情况下自体CAR-T复 杂的制备和使用过程，以及高昂的成本带来的价格劣势格外突出。in vivo CAR-T是解决以上问题极具 潜力的方向，目前整体处于临床早期，初步数据已经验证疗效，安全性有望优于自体CAR-T，MNC已 下场达成众多大额合作交易或收购，国内企业布局数量众多，未来有望达成多项交易。 CAR-T是血液瘤疗效天花板和单次给药即可"治愈"的代名词，全球已有15款自体CAR-T获批，2025年销 售额已达59亿美元(同比+30%)。ASH2025大会披露了BCMATCE(T细胞接合器)特立妥单抗联合达雷妥 尤单抗治疗复杂/难治性多发性骨髓瘤(R/RMM)的MajesTEC-3研究数据，疗效表现不弱于CARVYKTI， PFS率甚至更优，同时安全性良好，这使得自体CAR-T复杂的生产、使用过程和高昂的成本、价格等劣 势凸显，亟需新的突破。 2025年以来，已发生超10项in vivo CAR-T相关交易，阿斯利康、艾伯维、B ...

Core Viewpoint - Gilead Sciences has announced a $7.8 billion acquisition of Arcellx, marking its largest acquisition since 2020, as part of its strategy to expand beyond HIV and liver disease treatments [2][11] Transaction Details - The acquisition includes a cash offer of $115 per share for Arcellx, with an additional $5 per share contingent on achieving specific sales targets, representing a 68% premium over Arcellx's recent average share price [2][5] - The deal is expected to close in the second quarter of 2026, subject to customary closing conditions and regulatory approvals [8] - Gilead currently owns approximately 11.5% of Arcellx's outstanding stock, and the acquisition will eliminate up to $1.5 billion in potential milestone payments [9] Product and Market Context - The acquisition provides Gilead full control of anito-cel, an investigational CAR-T therapy for multiple myeloma, which is currently under FDA review as a fourth-line treatment option [3][5] - Analysts believe anito-cel could become a leading treatment for multiple myeloma, potentially generating multi-billion-dollar sales for Gilead [4][11] - Clinical trials have shown that anito-cel delivers strong and lasting responses, supporting Gilead's push for FDA approval [5] Strategic Implications - Gilead's CEO emphasized the strategic importance of the acquisition, aiming to maximize anito-cel's potential and position it as a foundational treatment for multiple myeloma [7][12] - The acquisition aligns with Gilead's broader growth strategy, which includes diversifying its portfolio beyond traditional areas [11] - Gilead gains proprietary technology and a platform for future cell therapies, strengthening its oncology and advanced therapeutics pipeline [12][13]

阿通社2月9日消息，第四届迪拜干细胞大会在迪拜闭幕，共吸引了500余名医生和研究人员、26位 国际专家参会。会议重点讨论了干细胞监管、临床转化及再生医学前沿应用，涵盖慢性病治疗、CAR-T 疗法、类器官研究和AI成像等方向。大会期间还举办多场实践工作坊，推动科研成果向临床应用转 化。主办方表示，大会已成为连接科研创新与医疗实践的重要国际平台，进一步提升了迪拜在再生医学 领域的区域影响力。 （原标题：第四届迪拜干细胞大会闭幕） ...

2026 年 01 月 29 日 行业日报 看好/维持 医药 医药 太平洋医药日报（20260129）：Immix 在研 NXC-201 获 FDA 突破 性疗法认定 ◼ 走势比较 (10%) 0% 10% 20% 30% 40% 25/2/5 25/4/17 25/6/27 25/9/6 25/11/16 26/1/26 ◼ 子行业评级 | 化学制药 | 无评级 | | --- | --- | | 中药生产 | 无评级 | | 生物医药Ⅱ | 中性 | | 其 他 医 药 医 | 中性 | | 疗 | | 相关研究报告 <<太平洋医药日报（20260128）：罗氏 减重疗法 CT-388 二期临床成功>>-- 2026-01-28 <<太平洋医药日报（20260127）： Sarepta 基因疗法 Elevidys 三期临 床成功>>--2026-01-28 <<太平洋医药日报（20260126）：英矽 智能 ISM8969 获 FDA 批准临床>>-- 2026-01-27 证券分析师：周豫 电话： E-MAIL：zhouyua@tpyzq.com 分析师登记编号：S1190523060002 证券分析师 ...

智通财经APP讯，石药集团(01093)发布公告，集团开发的SYS6055注射液已获得中华人民共和国国家药 品监督管理局(NMPA)批准，可在中国开展临床试验。 本次获批的临床适应症为复发╱难治侵袭性B细胞淋巴瘤。此外，该产品亦具备用于治疗其他CD19阳 性的B细胞恶性肿瘤和自身免疫病的潜力，具有较高的临床开发价值。 该产品为国内首款获批临床的体内CAR-T产品，通过慢病毒载体在体内直接生成靶向CD19 的CAR-T细 胞，可特异性识别和清除靶细胞，从而达到治疗目的。与传统CAR-T产品相比，该产品在成本、可及性 和即时性等方面具备潜在优势。临床前研究显示，该产品可在体内特异性生成CAR-T细胞，具有显着的 抑瘤效果与良好的安全性，并具有成本和时间优势，有望为B淋巴细胞肿瘤患者提供更好的治疗选择。 ...

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對其準 確性或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產 生或因倚賴該等內容而引致之任何損失承擔任何責任。 CSPC PHARMACEUTICAL GROUP LIMITED 石 藥 集 團 有 限 公 司 （股份代號：1093） 自願公告 SYS 6055注射液在中國獲臨床試驗批准 蔡東晨 石 藥 集 團 有 限 公 司（「 本 公 司 」， 連 同 其 附 屬 公 司 統 稱「 本 集 團 」）董 事 會（「 董 事 會 」）欣 然 宣 佈 ， 本 集 團 開 發 的 SYS 6055 注 射 液（「 該 產 品 」）已 獲 得 中 華 人 民 共 和 國 國 家 藥 品 監 督 管 理 局(NMPA)批准，可在中國開展臨床試驗。 香港，2026年1月29日 該產品為國內首款獲批臨床的體內CAR -T產品，通過慢病毒載體在體內直接生成靶向CD19 的 CAR -T 細 胞 ， 可 特 異 性 識 別 和 清 除 靶 細 胞 ， 從 而 達 到 治 療 目 的 。 與 傳 統 CAR -T 產 品 相 比， ...

Core Viewpoint - Legend Biotech (LEGN.US) has experienced significant stock price volatility, with a peak of $45.29 in July 2025 followed by a decline of 55.38%, reaching a low of $20.21 in January 2026, raising questions about its growth potential and market valuation [1][2][6] Stock Performance Analysis - The stock price of Legend Biotech has shown a typical technical regression after a significant rise, with a rapid decline over 14 trading days following its peak on July 23, 2025 [2] - During the decline, trading volume remained low, indicating stable investor sentiment despite the price drop [2] - From August 11 to November 11, 2025, the stock exhibited a sideways movement with low trading volume, suggesting a lack of market support [3] - A notable increase in trading volume on November 12, 2025, marked the beginning of a more pronounced downward trend, culminating in a series of declines [4] Financial Performance Insights - The Q3 2025 financial report highlighted strong sales for the core product, Carvykti, with quarterly sales reaching $524 million, a 83% year-over-year increase, and total sales for the first nine months of 2025 at $1.332 billion, doubling from the previous year [6][7] - However, the report also revealed a significant drop in licensing revenue, which fell to $10.5 million from $17.1 million in the same quarter the previous year, indicating a potential issue with new licensing agreements [7] - The overall costs increased to $113 million, outpacing revenue growth, which raised concerns about profitability despite strong product sales [7] Competitive Landscape - The emergence of Johnson & Johnson's Tec-Dara treatment, which demonstrated superior clinical trial results compared to Carvykti, has raised competitive concerns for Legend Biotech [9] - The market perceives Tec-Dara as a direct competitor to Carvykti, which could impact Legend Biotech's market share and pricing power in the multiple myeloma treatment space [9][10] - Despite the competitive pressures, the current valuation of Legend Biotech, with a price-to-sales ratio of 4.26, is significantly lower than the industry average of 9.27, suggesting potential investment attractiveness for bullish investors [10]

Core Viewpoint - Wells Fargo has initiated coverage and assigned an "overweight" rating to Arcellx (ACLX.US), predicting that its experimental CAR-T therapy "anito-cel" will significantly reshape the treatment landscape for multiple myeloma, with a target price of $100, indicating a potential upside of 53% from the current price [1] Group 1: Company Overview - Arcellx is a clinical-stage biotechnology company focused on developing cell therapy products for cancer and certain autoimmune conditions using its proprietary D-Domain technology platform [4] - The company is a key player in the cell therapy space, but its commercial expansion heavily relies on the potential approval and market launch of its innovative drug pipeline, particularly the core product anito-cel [4] Group 2: Product Insights - Anito-cel is an autologous CAR-T cell therapy targeting BCMA for relapsed/refractory multiple myeloma, developed in collaboration with Kite Pharma, a subsidiary of Gilead Sciences [4][5] - The therapy is expected to gain significant market share in the 4L+ BCMA CAR-T market due to its attractive efficacy and safety profile compared to currently approved competitors [2] - Analysts predict peak sales for anito-cel could reach $1.6 billion in the fourth-line setting, with approximately $690 million attributed to Arcellx, and potentially $3.8 billion after gaining second-line approval, with around $1.5 billion for Arcellx [2] Group 3: Market Dynamics - Despite strong recent clinical trial data from Johnson & Johnson's Tecvayli and Darzalex for multiple myeloma, approximately 30% of patients show extreme resistance to Darzalex, making them ineligible for the Tec-Dara combination therapy [3] - If anito-cel is approved as anticipated in 2026 and leverages its efficacy and safety advantages, it could alter the ranking and market share distribution of BCMA-targeted therapies in the later treatment lines [6]

Core Viewpoint - Wells Fargo initiates coverage and assigns an "overweight" rating to Arcellx (ACLX.US), highlighting its experimental CAR-T therapy "anito-cel" as a potential cornerstone in the management of multiple myeloma, which could significantly reshape treatment paradigms [1][4] Group 1: Company Overview - Arcellx is a clinical-stage biotechnology company focused on developing cell therapy products for cancer and certain autoimmune conditions using its proprietary D-Domain technology platform [3] - The company is collaborating with Kite Pharma, a subsidiary of Gilead Sciences (GILD.US), for the development and commercialization of anito-cel [2][3] Group 2: Product Potential - Anito-cel is a BCMA-targeted autologous CAR-T cell therapy designed for relapsed/refractory multiple myeloma, with expectations for significant market share in the 4L+ BCMA CAR-T market due to its attractive efficacy and safety profile compared to existing approved products [1][2][4] - Analysts project peak sales for anito-cel in the fourth-line setting could reach $1.6 billion, with approximately $690 million attributed to Arcellx, and potentially $3.8 billion after gaining second-line approval, with around $1.5 billion for Arcellx [2] Group 3: Market Impact - The anticipated approval of anito-cel in 2026 could lead to rapid market penetration, fundamentally altering the competitive landscape for BCMA-targeted therapies in multiple myeloma [5] - Despite strong recent clinical trial data from Johnson & Johnson's (JNJ.US) Tecvayli and Darzalex, approximately 30% of patients show extreme resistance to Darzalex, which may limit its effectiveness in certain treatment scenarios [2]