Lisocabtagene maraleucel

10月13日，强生公布2026年第三季度业绩，第三季度营收253.99亿美元。在创新制药的六大板块中，其中最引人注目的增长引擎，无疑是CAR-T产品Carvykti（西达基奥仑赛）。 Carvykti在截至2026年9月30日止季度的贸易销售净额约为7.1亿美元。结合上半年12.54亿美元的收入，Carvykti前三季度累计销售约19.64亿美元，同比增长47.4%。从季度走势看，该产品Q1销售5.97亿美元（+62%），Q2达6.57亿美元（+49.4%），Q3进一步攀升至7.1亿美元，环比持续放量。 强生管理层在财报电话会上指出，Carvykti的增长得益于在更前线治疗场景中的使用扩展以及更多治疗中心的加入，目前已覆盖全球超过20个市场。按照当前增速，Carvykti全年销售额有望突破27亿美元，进一步逼近强生此前给出的30亿美元年度销售展望。 从全球研发格局来看，中国已在CAR-T在研管线中占据领先地位。有券商医药行业分析师对21世纪经济报道记者表示，全球CAR-T在研管线TOP10机构中，中国机构占据过半席位。但“在研”与“获批”之间存在巨大鸿沟，实体瘤CAR-T的研发挑战让不少药企选择收缩战线甚至退出。 眼下，全球CAR-T市场正在经历高速增长。根据行业机构数据，2025年，全球7款CAR-T疗法的销售总额从2024年的45亿美元攀升至59.67亿美元，同比增长31.66%。其中，强生/传奇生物的西达基奥仑赛全年净销售额逼近19亿美元，同比近乎翻倍，已迈入“十亿美元分子”俱乐部。行业机构预测，全球CAR-T细胞治疗市场预计2032年将达到2638.6亿元人民币，年复合增长率为29.4%。 中国市场同样在快速扩容。据行业机构数据，2025年中国CAR-T市场规模约38.2亿元人民币。然而，这一数字与全球近60亿美元的规模相比仍有数量级差距。 而Carvykti的强劲增长，正在重塑全球CAR-T市场的竞争版图。2025年全球7款获FDA批准的CAR-T药物总销售额达59.67亿美元，其中Carvykti、吉利德Yescarta及BMS Breyanzi三款头部产品合计贡献47.4亿美元，占总规模的79%。 在BCMA CAR-T细分赛道，Carvykti的领先优势更为显著。2025年Carvykti全年销售额达18.87亿美元，同比激增96%。作为对照，BMS的Abecma——曾经的全球首款BCMA CAR-T——在2026年Q1销售额同比下滑21%至8100万美元，两者的差距从2024年的3.4倍扩大至4.4倍，且仍呈加速扩大态势。 更值得关注的是，自2026年Q2起，BMS已不再单独披露Abecma季度销售额，将其归入“其他成长产品”合并科目，这一举措被业界解读为该产品竞争力的进一步弱化。 Carvykti的压倒性优势根植于临床数据的差异。CARTITUDE-1试验中位随访超5年的数据显示，约三分之一患者在单次输注后实现5年以上无疾病进展，中位总生存期达60.7个月。CARTITUDE-4研究则显示中位无进展生存期达50.4个月，Carvykti是唯一显示总生存期获益的BCMA CAR-T产品。这种临床价值的代际差距，正在直接转化为医生的处方偏好。 BCMA CAR-T赛道的竞争格局并非一成不变。2026年2月，吉利德以78亿美元收购Arcellx，其核心资产anito-cel针对四线复发/难治性多发性骨髓瘤的上市申请已获FDA受理，PDUFA目标审查日期为2026年12月23日。若顺利获批，BCMA赛道将形成Carvykti、Abecma与anito-cel三强竞争的局面。 从目前的商业化表现来看，Carvykti的领先身位已相当稳固。强生已启动产能扩张计划，目标从现有1万剂提升至2万剂。传奇生物将生产成功率提高至99%，2026年Q1最终产品交付日期的订单按时放行率超过95%，制约CAR-T商业化放量的产能瓶颈正被逐步突破。 传奇生物方面此前表示，随着规模不断扩大，运营杠杆效应正在推动利润率持续改善，公司有望在2026年实现整体盈利。 与BCMA赛道“一超”格局形成呼应的是，CD19 CAR-T赛道也在经历一轮权力更迭。2026年Q1，BMS的Breyanzi增长56%至4.11亿美元，一举超越吉利德Yescarta成为CD19赛道新晋销冠。Breyanzi凭借覆盖五个淋巴瘤亚型的适应症广度——包括2025年12月获批的边缘区淋巴瘤（全球首个且唯一获批用于MZL的CAR-T）——以及压缩至22至24天的生产周期，正在快速蚕食Yescarta的市场份额。 相比之下，吉利德Yescarta在2026年Q2销售额为3.46亿美元，同比下降12%；Tecartus下降24%至7000万美元。吉利德在财报中将原因归为“同类内外竞争加剧”，暗示BMS的Breyanzi正在蚕食其市场份额。老牌产品诺华Kymriah则已被归入“Established Brands”队列，不再单独披露季度销售数据，战略收缩意味明显。 值得关注的是，强生在多发性骨髓瘤领域的布局并非单一押注CAR-T。其3款双抗产品Tecvayli（BCMA/CD3）、Talvey（GPRC5D/CD3）和Rybrevant（EGFR/cMET）前三季度合计收入21.37亿美元，同比增长61.2%。其中Tecvayli收入7.74亿美元（+56.7%），Talvey收入4.97亿美元（+58.3%）。强生管理层在Q3电话会上披露，Tecvayli销售额增长77.3%，新Phase 3数据显示Talvey联合方案将疾病进展或死亡风险降低89%。 在强生的战略框架中，Darzalex（CD38单抗）、Tecvayli（BCMA/CD3双抗）、Carvykti（BCMA CAR-T）以及Talvey（GPRC5D/CD3双抗）构成了从单抗、双抗到CAR-T的完整防线。临床研究也在验证序贯治疗策略的价值——NCCN最新指南推荐在CAR-T治疗前使用talquetamab作为桥接治疗，以帮助患者维持符合Carvykti治疗的条件并改善预后。 展望全年，强生预计全年收入增长7.2%-7.6%至1010亿-1014亿美元，创新制药板块的肿瘤业务仍将是核心增长动力。Carvykti若全年突破27亿美元，将进一步拉大与竞品的差距，并将BCMA CAR-T赛道的竞争门槛提升至新的高度。 从更长的周期看，CAR-T赛道的竞争正在从单一靶点比拼升级为平台能力的综合较量。分析师普遍将Carvykti视为多发性骨髓瘤领域的同类最佳CAR-T疗法，预计其销售峰值将超过50亿美元，更有乐观机构给出80亿美元的峰值预期。与此同时，自免CAR-T和体内CAR-T正在成为下一代技术竞争的制高点——强生已携手Sail切入自免赛道，礼来收购Orna和Kelonia布局体内CAR-T，BMS则以15亿美元收购Orbital Therapeutics押注下一代技术。 对于中国创新药行业而言，Carvykti的商业化突破具有标杆意义。作为首个由中国Biotech主导研发并在全球市场取得商业成功的CAR-T产品，它证明了国产创新药在高度竞争的全球市场中实现临床价值与商业价值统一的可能性。随着传奇生物有望在2026年实现整体盈利，中国CAR-T企业的全球化叙事正在从“故事”变为“业绩”。

First clinical evaluation of Xenetic's systemic DNase technology as an adjunct to CAR T-cell therapy in an investigator-initiated study conducted at Tel Aviv Sourasky University Medical Center Initial efficacy data expected in Q2 2027 FRAMINGHAM, MA / ACCESS Newswire / October 15, 2026 / Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing difficult to treat cancers, today announced that its collaboration partner, PeriNess Ltd. ("PeriNess"), has informed the Company that the first patient has been dosed in an investigator-initiated clinical study evaluating systemic recombinant human DNase in combination with anti-CD19 CAR T-cell therapy in patients with large B-cell lymphoma ("LBCL") at the Tel Aviv Sourasky University Medical Center ("Ichilov Center") in Israel. The milestone marks the first clinical evaluation of Xenetic's systemic DNase technology as an adjunct to CAR T-cell therapy. The study, sponsored by the Ichilov Center, was approved by the Israeli Ministry of Health and the applicable Institutional Review Board in June 2026 and is designed to evaluate whether degradation of cell-free chromatin and neutrophil extracellular traps (NETs) can improve CAR T-cell expansion, persistence and clinical response. The study is enrolling 12 patients with LBCL who have stable or progressive disease prior to lymphodepletion therapy, a population with a historically poor prognosis and one-year progression-free survival of approximately 20% to 30%. Patients will receive a commercial anti-CD19 CAR T-cell product, tisagenlecleucel, axicabtagene ciloleucel or lisocabtagene maraleucel, in combination with DNase I administered as a 50 mL intravenous infusion at 1.0 mg/kg on Days 0, 3, 6, 10 and 15 following CAR T-cell infusion. Clinical efficacy will be evaluated by objective response rate (ORR) at one and three months following CAR T-cell infusion, duration of response (DOR), disease control rate (DCR) and overall survival (OS) at 12 months. The study also includes a translational component designed to assess biomarker response, including circulating cell-free DNA and NET markers, as well as anti-CD19 CAR T-cell expansion and persistence. Dr. Ron Ram, Professor of Medicine and Head of the Bone Marrow Transplantation Unit at the Ichilov Center, is the principal investigator of the study. "Advancing this approach into patients provides an important opportunity to evaluate this biological hypothesis in a clinical setting," said Dr. Ram. "Accumulation of cell-free chromatin and NETs within the tumor microenvironment may contribute to CAR T-cell dysfunction through impaired expansion, exhaustion and immunosuppression. By targeting these mechanisms with DNase I, we aim to determine whether we can create a more favorable environment for CAR T cells to expand, persist and deliver improved clinical responses, particularly in patients entering treatment with stable or progressive disease." "The initiation of this study represents a significant step forward for Xenetic as our systemic DNase technology enters clinical evaluation alongside what we believe to be one of the most important advances in cancer immunotherapy," said James Parslow, Interim Chief Executive Officer and Chief Financial Officer of Xenetic. "Our preclinical work has demonstrated the potential for DNase to enhance CAR T-cell expansion, persistence and functionality, improve tumor control, delay relapse and prolong survival across multiple leukemia and lymphoma models. We are pleased to be working with PeriNess and the experienced team at the Ichilov Center and look forward to the continued advancement of the study." About Xenetic Biosciences Xenetic Biosciences, Inc. is a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing difficult to treat cancers. The Company's proprietary DNase technology is designed to improve outcomes of existing treatments, including immunotherapies, by targeting neutrophil extracellular traps (NETs), which are involved in cancer progression. Xenetic is currently focused on advancing its systemic DNase program into the clinic as an adjunctive therapy for pancreatic carcinoma and locally advanced or metastatic solid tumors. For more information, please visit the Company's website at and connect on X , LinkedIn , and Facebook . Forward-Looking Statements This press release contains forward-looking statements that we intend to be subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," "remain," "focus", "confidence in", "potential", "continues", "warrants", "provides", "opportunity", "aim" and other words of similar meaning, including, but not limited to, all statements regarding the status, target and aim of, and anticipated results from, the investigator-initiated clinical study evaluating systemic recombinant human DNase in combination with anti-CD19 CAR T-cell therapy in patients with LBCL at the Ichilov Center in Israel; our expectations with respect to working with PeriNess and continued advancement of the study; anticipated treatments under the Phase 1b study; our focus on advancing innovative immuno-oncology technologies addressing difficult to treat cancers, the DNase platform improving outcomes of existing treatments, including immunotherapies, by targeting neutrophil extracellular traps (NETs), which are involved in cancer progression; and our focus on advancing our systemic DNase program into the clinic as an adjunctive therapy for pancreatic carcinoma and locally advanced or metastatic solid tumors. Any forward-looking statements contained herein are based on current expectations and are subject to a number of risks and uncertainties. Many factors could cause our actual activities, performance, achievements, or results to differ materially from the activities and results anticipated in forward-looking statements. Important factors that could cause actual activities, performance, achievements, or results to differ materially from such plans, estimates or expectations include, among others, (A) risks related to the proposed acquisition of Santersus AG (the "Proposed Transaction"), including (i) the risk that the conditions to the closing of the Proposed Transaction are not satisfied, including the failure to timely obtain stockholder approval for the transaction, if at all; (ii) uncertainties as to the timing of the consummation of the Proposed Transaction and the ability of each of Xenetic and Santersus to consummate the Proposed Transaction; (iii) risks related to each parties' ability to manage its operating expenses and its expenses associated with the Proposed Transaction pending closing; (iv) risks related to the failure or delay in obtaining required approvals from any governmental or quasi-governmental entity necessary to consummate the Proposed Transaction; (v) the risk that as a result of adjustments to the exchange ratio, Xenetic stockholders and Santersus stockholders could own more or less of the combined company than is currently anticipated; (vi) risks related to the market price of Xenetic common stock relative to the value suggested by the exchange ratio; (vii) unexpected costs, charges or expenses resulting from the Proposed Transaction; (viii) potential adverse reactions or changes to business relationships resulting from the announcement or completion of the Proposed Transaction; (ix) the uncertainties associated with Xenetic platform technologies, as well as risks associated with the clinical development and regulatory approval of product candidates, including potential delays in the commencement, enrollment and completion of clinical trials; (x) risks related to the inability of the combined company to obtain sufficient additional capital to continue to advance these product candidates and its clinical programs; (xi) uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; (xii) risks related to the failure to realize any value from product candidates being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; (xiii) risks associated with the possible failure to realize certain anticipated benefits of the Proposed Transaction, including with respect to future financial and operating results, (xiv) risks related to the inability of the combined company to maintain compliance with Nasdaq listing requirements following closing of the Proposed Transaction, and the potential need for the combined company to effect a reverse stock split in order to satisfy Nasdaq listing requirements; (xv) risks related to the combined company raising additional working capital and financing its business; (B) unexpected costs, charges or expenses resulting from our manufacturing and collaboration agreements; (C) unexpected costs, charges or expenses resulting from the licensing of the DNase platform; (D) uncertainty of the expected financial performance of the Company following the licensing of the DNase platform; (E) failure to realize the anticipated potential of the DNase or PolyXen technologies; (F) the ability of the Company to obtain funding and implement its business strategy; and (G) other risk factors as detailed from time to time in the Company's reports filed with the SEC, including its annual report on Form 10-K, as amended, periodic quarterly reports on Form 10-Q, current reports on Form 8-K and other documents filed with the SEC. The foregoing list of important factors is not exclusive. In addition, forward-looking statements may also be adversely affected by general market factors, general economic and business conditions, including potential adverse effects of public health issues, and geopolitical events, such as the conflicts in Ukraine and in the Middle East, on economic activity, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new product candidates and indications, manufacturing issues that may arise, patent positions, litigation, and shareholder activism, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and the Company does not undertake any obligation to update forward-looking statements, except as required by law. Contact: JTC Team, LLC Jenene Thomas (908) 824-0775 xbio@jtcir.com SOURCE: Xenetic Biosciences, Inc. 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