A GCO Trial Exploring the Efficacy and Safety of Tarlatamab Versus Investigator-choice Chemotherapy in Pre-treated Patients With Advanced, Pulmonary or Gastroenteropancreatic Poorly Differentiated Neuroendocrine Carcinomas (NECs)

Based on the efficacy of tarlatamab in patients with small-cell lung cancer, we aim to assess the efficacy of tarlatamab in patients with Advanced, pulmonary (large-cell only) or gastroenteropancreatic neuroendocrine carcinoma.

开始日期2025-09-01

申办/合作机构

Intergroupe Francophone Cancerologie Thoracique

NCT06898957

/ Recruiting临床1期

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination With YL201 With or Without Anti-PD-L1 in Subjects With Extensive Stage Small Cell Lung Cancer

The primary objective of this study is to evaluate the safety and tolerability of tarlatamab in combination with YL201 with or without anti-PD-L1.

开始日期2025-05-30

申办/合作机构

Amgen, Inc.

[+1]

NCT06893783

/ Not yet recruiting临床2期IIT

A Phase II Trial of Tarlatamab, a DLL3-targeted Bispecific T-cell Engager, in Patients With Advanced Extrapulmonary Neuroendocrine Carcinoma (DeLLight)

This is a phase 2 single-arm, open-label clinical trial designed to evaluate the efficacy and safety of tarlatamab in patients with relapsed extrapulmonary neuroendocrine carcinoma (EPNEC) who have previously received platinum-based first-line chemotherapy. Participants will receive tarlatamab on Cycle 1 Day 1 (C1D1), Day 8 (C1D8), and Day 15 (C1D15), followed by administration every two weeks thereafter. No placebo control is included in this study.

开始日期2025-05-23

申办/合作机构

Asan Medical Center

[+3]

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项与塔拉妥单抗相关的文献（医药）

2025-12-31·mAbs

Antibodies to watch in 2025

Review

作者: Kapoor, Vaishali ; Kaplon, Hélène ; Crescioli, Silvia ; Visweswaraiah, Jyothsna ; Reichert, Janice M. ; Wang, Lin

The commercial development of antibody therapeutics is a global enterprise involving thousands of biopharmaceutical firms and supporting service organizations. To date, their combined efforts have resulted in over 200 marketed antibody therapeutics and a pipeline of nearly 1,400 investigational product candidates that are undergoing evaluation in clinical studies as treatments for a wide variety of diseases. Here, we discuss key events in antibody therapeutics development that occurred during 2024 and forecast key events related to the late-stage clinical pipeline that may occur in 2025. In particular, we report on 21 antibody therapeutics granted a first approval in at least one country or region during 2024, including bispecific antibodies tarlatamab (IMDELLTRA®), zanidatamab (Ziihera®), zenocutuzumab (BIZENGRI®), odronextamab (Ordspono®), ivonescimab (®), and antibody-drug conjugate (ADC) sacituzumab tirumotecan (®). We also discuss 30 investigational antibody therapeutics for which marketing applications were undergoing review by at least one regulatory agency, as of our last update on December 9, 2024, including ADCs datopotamab deruxtecan, telisotuzumab vedotin, patritumab deruxtecan, trastuzumab botidotin, becotatug vedotin, and trastuzumab rezetecan. Of 178 antibody therapeutics we include in the late-stage pipeline, we summarize key data for 18 for which marketing applications may be submitted by the end of 2025, such as bi- or multispecific antibodies denecimig, sonelokimab, erfonrilimab, and anbenitamab. Key trends in the development and approval of antibody formats such as bispecifics and ADCs, as well as clinical-phase transition and global approval success rates for these antibody formats, are reported.

2025-05-01·CLINICAL PHARMACOKINETICS

Population Pharmacokinetics of Tarlatamab, a Half-Life Extended DLL3-Directed Bispecific T-Cell Engager in Patients with Previously Treated Small Cell Lung Cancer

Article

作者: Parkes, Amanda ; Chen, Po-Wei ; Houk, Brett E ; Lin, Chih-Wei ; Martinez, Pablo ; Minocha, Mukul ; Kong, Stephanie ; Anderson, Erik S

BACKGROUND AND OBJECTIVE:

Tarlatamab is a first in class, half-life extended delta-like ligand 3 (DLL3) directed bispecific T-cell engager (BiTE®) immunotherapy that has shown durable efficacy in patients with previously treated small cell lung cancer (SCLC). The purpose of this analysis was to develop a population pharmacokinetic (PK) model for tarlatamab.

METHODS:

This analysis includes data from 420 patients with previously treated small cell lung cancer (8509 samples) pooled across the Phase 1 DeLLphi-300 study (dose range 0.003-100 mg every 2 weeks and 200 mg every 3 weeks) and Phase 2 DeLLphi-301 study (10 mg and 100 mg every 2 weeks). The data were analyzed using a nonlinear-mixed effects modeling approach implemented in NONMEM (v7.5) software and validated using standard statistical approaches. The effects of intrinsic and extrinsic factors on PK parameters and exposures of tarlatamab were evaluated, and the impact of identified covariates were further assessed using simulations.

RESULTS:

Tarlatamab serum concentration data were best described by a two-compartment model with linear elimination. Tarlatamab clearance (CL) and central volume of distribution (V_C) were 0.649 L/day and 3.44 L, respectively, for a typical 73-kg individual. The model-estimated median terminal phase elimination half-life was 11.2 days. Tarlatamab pharmacokinetics were not impacted by age, sex, ethnicity, estimates of renal and hepatic function, prior lines of therapy, or baseline disease status. The presence of antidrug antibody (ADA) at any time during the study and bodyweight were found to be statistically significant covariates on CL, and Asian race and bodyweight were found to be statistically significant covariates on V_C; however, they did not lead to a clinically meaningful impact on exposures.

CONCLUSIONS:

The pharmacokinetics of tarlatamab was well-described by a two-compartment model with linear elimination. No clinically significant differences were observed on the basis of age, sex, bodyweight, race, ethnicity, estimates of renal and hepatic function, prior lines of therapy, baseline disease status, or emergence of ADA. These results support that no dose adjustment is required on the basis of any of the evaluated covariates.

2025-04-01·ESMO Open

Safety of tarlatamab with 6-8-h outpatient versus 48-h inpatient monitoring during cycle 1: DeLLphi-300 phase 1 substudy

Article

作者: Felip, E ; Jiang, W ; Loong, H H ; Paz-Ares, L ; Steeghs, N ; Parkes, A ; Hamidi, A ; Jost, P J ; Gadgeel, S M ; Dowlati, A ; Stec, R ; Reguart, N ; Carlisle, J W ; Chiang, A C ; Olmedo Garcia, M E

BACKGROUND:

Tarlatamab, a bispecific T-cell engager immunotherapy targeting delta-like ligand 3, has demonstrated promising survival outcomes in small-cell lung cancer (SCLC). Given the risk of cytokine release syndrome (CRS), initial clinical trials incorporated 48-72-h inpatient monitoring in cycle 1.

METHODS:

Patients with previously treated SCLC were enrolled into DeLLphi-300 part F, which evaluated the safety of tarlatamab 10 mg every 2 weeks (Q2W) with 6-8-h outpatient monitoring following cycle 1 doses. The primary endpoint, safety, was compared with patients from DeLLphi-300 part A receiving tarlatamab 10 mg Q2W with 48-h inpatient monitoring for cycle 1 doses.

RESULTS:

In cycle 1, the rates of treatment-related adverse events and hospitalizations, including emergency room visits, were similar between outpatient (n = 30) and inpatient (n = 58) groups (93% versus 100% and 27% versus 34%, respectively). The incidence of all grade and serious CRS during cycle 1 was similar between outpatient and inpatient groups (any grade: 60% versus 62%; serious: 17% versus 22%). The median time to CRS resolution was 3 days for both groups.

CONCLUSIONS:

Safety outcomes, including hospitalization rates, were similar in this first-in-human study following tarlatamab 10 mg Q2W administration with 6-8-h outpatient versus 48-h inpatient monitoring in cycle 1.

311

项与塔拉妥单抗相关的新闻（医药）

2025-05-09

·PRNewswire

April Recap: 15 Top Health Press Releases

A roundup of the most newsworthy healthcare press releases from PR Newswire, including Eli Lilly's GLP-1 medication study results and business updates from Crunch Fitness and Regulus Therapeutics. NEW YORK, May 9, 2025 /PRNewswire/ -- With thousands of press releases published each month, it can be difficult to keep up with everything on PR Newswire. To help healthcare journalists and consumers stay on top of the month's most popular releases and newsworthy trends, here's a recap of some of the past month's most read- and engaged-with stories. The list below includes the headline (with a link to the full text) and an excerpt from each story. Click on the press release headlines to access accompanying multimedia assets that are available for download. Continue Reading PR Newswire Monthly Health Press Release Roundup, April 2025. Photos provided by Ro, Garmin International, Inc. and Visit Myrtle Beach. Lilly's oral GLP-1, orforglipron, demonstrated statistically significant efficacy results and a safety profile consistent with injectable GLP-1 medicines in successful Phase 3 trial "As a convenient once-daily pill, orforglipron may provide a new option and, if approved, could be readily manufactured and launched at scale for use by people around the world," said David A. Ricks, Lilly chair and CEO. The Elizabeth Taylor AIDS Foundation Issues Emergency Grant Cycle to Address Forthcoming Gap Funding Providing financial resources to organizations in need, the initiative will be aimed at ensuring that critical, wrap-around health services for HIV treatment & prevention and programs focused on Transgender communities can continue to operate into the near future. Crunch Fitness Announces Strategic Investment from Leonard Green & Partners Under the terms of the agreement, LGP will acquire a majority interest in Crunch Fitness from TPG Growth, the middle market and growth equity platform of global alternative asset management firm TPG, and Crunch's minority shareholders. Novo Nordisk warns consumers about counterfeit Ozempic® (semaglutide) injection 1 mg in the US Novo Nordisk has become aware of several hundred units of Ozempic® (semaglutide) injection 1 mg distributed outside the Novo Nordisk authorized supply chain in the US. The US Food and Drug Administration (FDA) has also updated its website with information about these counterfeit versions of Ozempic. IMDELLTRA® Demonstrated Superior Overall Survival in Small Cell Lung Cancer IMDELLTRA demonstrated statistically significant and clinically meaningful improvement in overall survival (OS) compared to local standard-of-care (SOC) chemotherapy. Jay Bradner, M.D., executive vice president, Research and Development, at Amgen, commented on the "overwhelming clinical benefit" stating the results "affirm IMDELLTRA as standard of care." Infant Immunization Week: Protecting Our Youngest Against Measles and More As National Infant Immunization Week arrives, Fidelis Care, along with other health experts and The Centers for Disease Control and Prevention (CDC), urge parents to ensure their children receive timely vaccinations, including the measles-mumps-rubella (MMR) vaccine, to safeguard their health and prevent the spread of infectious diseases. Johnson & Johnson MedTech Announces Completion of First Cases with OTTAVA™ Robotic Surgical System OTTAVA is designed as a multi-specialty soft-tissue surgery robot, supporting a broad range of procedures across patient anatomy and surgical specialties, including the most complex surgeries that require a multi-quadrant approach. H.I.G. Capital Completes Acquisition of GetixHealth GetixHealth provides leading revenue cycle management (RCM) solutions to healthcare providers, featuring a comprehensive suite of services that includes patient responsibility management, eligibility and enrollment, third-party claims resolution, patient access, and insurance billing. SHIELD-Utah Study Shows Novavax's COVID-19 Vaccine Induces Lower Reactogenicity Symptoms Compared to mRNA Preliminary data showed Novavax's non-mRNA JN.1 COVID-19 vaccine induced lower frequency and severity of short-term side effects and impact on daily life compared with Pfizer-BioNTech mRNA vaccine. Breakthrough Prize Announces 2025 Laureates in Life Sciences, Fundamental Physics, and Mathematics "This year's Breakthrough Prize laureates have made amazing strides – including treatments for major diseases affecting millions of people worldwide – showing once again the transformative power of curiosity-driven basic science," said Priscilla Chan and Mark Zuckerberg. Ginkgo Bioworks Teams Up with Partners on ARPA-H Project to Stabilize Pharmaceutical Supply Chains - Using Amber Waves of Grain Ginkgo Bioworks and partners were awarded a $29 million contract by ARPA-H to develop distributed manufacturing of essential medicines using wheat germ cell-free expression systems. Kaiser Permanente Debuts Largest Hospital-based Renewable Microgrid in U.S. With 2MW of solar generation and 9MWh of battery storage, the system supports California's clean energy transition, reduces emissions, and saves money while boosting backup generation with renewable power. The Revival of the Ice Bucket Challenge Supports and Highlights the Critical Need for Mental Health Awareness and Discussions: The new viral sensation Takes Over Instagram Quickly Raising Thousands to Benefit the Work of Active Minds More than a decade after the original Ice Bucket Challenge captured global attention in support of the fight against ALS, The University of South Carolina's MIND club (Mental Illness Needs Discussion) has launched a bold, reimagined Ice Bucket Challenge focused on mental health. As part of their campaign, participants are encouraged to donate to Active Minds, the nation's leading nonprofit organization mobilizing youth and young adults to transform mental health norms. Meet vívoactive 6, the latest health and fitness smartwatch from Garmin vívoactive 6 includes Garmin's suite of popular fitness, wellness and smart features, plus an even brighter AMOLED display and up to 11 days of battery life. Regulus Therapeutics Enters into Agreement to be Acquired by Novartis AG Novartis will acquire Regulus for $7.00 per share in cash, with the potential to receive an additional $7.00 per share in cash through a contingent value right, for a total equity value of up to approximately $1.7 billion For more news like this, check out all of the latest health-related releases from PR Newswire. Trending Topics Among the health news that was distributed in April, the PR Newswire team was able to spot several larger stories that highlight the trends shaping the industry. GLP-1 Accessibility: GLP-1 medications maintained their position as healthcare's dominant topic, with April announcements focusing on expanding legitimate access while combating counterfeit products. Novo Nordisk secured two significant victories: successfully blocking unauthorized compounded versions of Wegovy® and Ozempic® while simultaneously expanding patient access through strategic telehealth partnerships. Manufacturing capacity grew with SHL Medical's new $220 million U.S. facility for autoinjectors, while innovation accelerated with Galmed's sublingual semaglutide formulation and Lilly's successful Phase 3 trial results for its oral GLP-1 medication. Consumer-focused initiatives included Ro's partnership with Charles Barkley as a GLP-1 celebrity ambassador and sPiLLRx's launch of an anonymous community platform for medication users, highlighting how companies are anticipating diverse consumer needs while working to maintain medication accessibility. National Autism Awareness Month: April brought significant attention to autism awareness and acceptance, with a notable focus on research findings and innovative support services. New CDC data, shared by The Autism Community in Action, revealed an increase in autism rates, now affecting 1 in 31 U.S. children. Organizations responded with expanded services, such as Goldfish Swim School's new adaptive lesson program and Myrtle Beach's enhanced sensory-friendly initiatives. Healthcare innovations were also prominent, with Acclaim Autism implementing Appian AI technology to reduce patient intake time by 83%, allowing children to receive care months sooner while maintaining HIPAA compliance. National Infant Immunization Week: As measles outbreaks continued to concern health officials, National Infant Immunization Week (April 21-28) generated substantial attention for the importance of childhood vaccinations. HealthTrackRx emerged as a key player, identifying over 10% of nationwide measles cases in their first week of testing. The company also partnered with the CDC to launch a rapid PCR test for H5N1, demonstrating the growing integration between private diagnostic companies and public health infrastructure to address multiple concurrent health threats. Health insurers joined the conversation with Fidelis Care urging parents to maintain vaccination schedules, emphasizing prevention as a cornerstone of pediatric health. Advocacy also expanded globally through Education Cannot Wait's campaign highlighting vaccination as an essential component of international education standards for children in crisis regions. Looking ahead: PR Newswire anticipates significant wire activity in May around Mental Health Awareness Month, National Nurses Week (May 6-12) and Skin Cancer Awareness Month. Early May announcements are expected to recognize National Women's Health Month, likely with maternal health innovations around Mother's Day. Aging and caregiving themes will also likely dominate coverage as organizations prepare for Older Americans Month with activities and resources. Do you have a health press release to distribute? Sign up with PR Newswire to share your story with the audiences who matter most. Helping Journalists Stay Up to Date on Industry News These are just a few of the recent press releases that consumers and the media should know about. To be notified of releases relevant to their coverage area, journalists can set up a custom newsfeed with PR Newswire for Journalists. Once they're signed up, reporters, bloggers, and freelancers have access to the following free features: Customization: Users can create customized newsfeeds that will deliver relevant news right to their inbox. Newsfeed results can be targeted by keywords, industry, subject, geography, and more. Photos and Videos: Thousands of multimedia assets are available to download and include in a journalist or blogger's next story. Subject Matter Experts: Journalists will have access to ProfNet, a database of industry experts to connect with as sources or for quotes in their articles. Related Resources: Our journalist- and blogger-focused blog, Beyond Bylines, features regular media news roundups, writing tips, upcoming events, and more. About PR Newswire PR Newswire is the industry's leading press release distribution partner with an unparalleled global reach of more than 440,000 newsrooms, websites, direct feeds, journalists and influencers and is available in more than 170 countries and 40 languages. From our award-winning Content Services offerings, integrated media newsroom and microsite products, Investor Relations suite of services, paid placement and social sharing tools, PR Newswire has a comprehensive catalog of solutions to solve the modern-day challenges PR and communications teams face. For 70 years, PR Newswire has been the preferred destination for brands to share their most important news stories across the world. For questions, contact the team at [email protected]. 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临床结果临床3期疫苗并购

2025-05-09

·医药投资部落

A股“医药一哥”，迈向盈利新纪元

2025年，在持续低迷近4年之后，A股医药板块迎来了一个历史性的事件。截至2025年5月8日收盘，科创板上市的创新药企业百济神州，以超过3300亿人民币的市值，继续稳居医药板块市值第一名。在成功实现科创板IPO仅3年多的时间以后，百济神州正式加冕A股“医药一哥”的桂冠。这不仅是A股医药板块估值体系切换的标志性事件，更是整个创新药产业发展过程中的里程碑：以百济神州为代表的新一代创新药企业，凭借全球创新价值的势能，从此站到了舞台的中央。迈向可持续盈利自从以未盈利创新药公司的身份登陆科创板之后，“何时可以盈利”甚至“有没有可能盈利”，成为了长期萦绕在百济神州周围的热门话题之一。之所以产生类似疑问，其背景是百济神州每年断档式领先同行的巨额研发费用投入，以及由此而产生的财务亏损。在A股传统的医药估值体系之下，这些都成为部分对于创新药产业发展规律缺乏足够认知的投资者，所犹豫甚至质疑的因素。毫无疑问，百济神州实现盈利的这一天，将会成为其发展过程中的一个至关重要的拐点时刻。这一天的实际到来，或许将比绝大部分人预想得都要早。2024年，在去除各类非现金项目的影响后，百济神州成功实现全年非GAAP经营利润为正。从财务学原理而言，非现金项目在利润中被扣除，其本质是历史成本的当期摊销，实际上并不消耗当期现金；经营利润为正，意味着百济神州的主营业务收入已经能够覆盖当期的实际运营成本，其本质是公司已经开始具备自我造血能力。 2025年5月7日，百济神州发布一季度A股业绩快报，再次创造历史：业绩快报显示，百济神州一季度实现营收80.48亿元，不仅同比增长50.2%，而且实现营业利润、利润总额由亏损转为盈利。同时，美股财报显示，在美国通用会计准则（GAAP）下，百济神州首次实现季度盈利。根据百济神州的业绩指引数据，2025年全年营业收入预计将介于人民币352亿元至381亿元之间，2025年全年的预期经营利润为正且经营活动产生现金流为正。以一季度强劲的增长数据来看，实现上述预期的概率正在稳步上升，2025年极有可能是百济神州历史上第一次实现正式盈利的转折性年份。对于市场长期关注的“能否盈利”的问题，这是百济神州用实际行动，做出的最具说服力的回答。任何一家创新药企业，从创立到实现盈利，都是一段异常艰难而光辉的旅程，对于百济神州这种连续多年超过100亿人民币研发投入的的巨大体量而言，其间的困难和挑战更是远超外界的想象。如果2025年全年利润为正的目标实现，这将是对百济神州多年艰苦卓绝的努力，所给予的肯定和褒奖，公司也将从此迈入全新的发展纪元。泽布替尼：渐入佳境的全球性大药百济神州出类拔萃的财务数据背后的核心驱动力，是旗下的头号商业化产品泽布替尼在全球血液瘤治疗领域的迅速崛起。2024年，泽布替尼全球收入超过26亿美元，成功跻身当年全球药物销售金额排行榜的Top70，如果细分到肿瘤治疗领域，其销售额甚至已经可以排入Top20。这已经是一款实至名归的全球性大药。泽布替尼的成功模式极为硬核，这款药物并非在一个蓝海市场中轻松地跑马圈地，而是在与多家跨国药企的竞品同场激烈竞争之下，凭借自身卓绝的实力，在全球创新药成熟市场中硬是打下一片江山。2024年第四季度，泽布替尼在美国BTK抑制剂市场的份额超过了三分之一，和最大的竞品伊布替尼的份额已经极为接近。2025年第一季度，泽布替尼在美国市场销售额达40.41亿元，同比增长61.9%，不仅在美国市场首次超越伊布替尼和阿卡替尼，坐稳市场份额的头把交椅，并且是CLL和所有其他已获批适应症新患者治疗领域的领导者。在欧洲市场，受益于在所有主要国家的市场份额提升，泽布替尼2025年一季度的销售额为8.36亿元，同比增长75.4%。之所以能够取得如此优异的市场表现，在于泽布替尼以头对头对照试验的方式，证明了自身相对于伊布替尼具备PFS与ORR的双重优效性，是同类药物中的“BIC”。相比之下，阿卡替尼也尝试了与伊布替尼的头对头试验，但最终结果仅是“非劣”。在这种高质量循证医学证据的支撑之下，2023年版的美国 NCCN指南中，泽布替尼推荐级别列为一类优先推荐，而伊布替尼在一线和二线慢淋治疗由“优先推荐”更为“其他推荐”。在销售数据突飞猛进的同时，泽布替尼在2025年还成功地在专利领域打赢了一场保卫战。2025年4月29日，美国专利商标局（简称“USPTO”）作出了一项最终书面决定，宣布艾伯维旗下的Pharmacyclics公司在专利授权后复审（简称“PGR”）程序中受到质疑的803专利的全部权利无效。简而言之，上述803专利是在泽布替尼上市之后，伊布替尼的拥有者艾伯维专门申请一项专利。2023年6月，在拿到专利授权之后，Pharmacyclics公司就向百济神州发起专利诉讼，声称百济神州侵犯了其知识产权。最终，百济神州以其完备的体系化专利布局，成功反制，完美地打赢了这次专利保卫战，这为泽布替尼在全球的深入推广扫清了潜在障碍，也为这款全球大药的发展前景更添了一份确定性。目前，泽布替尼在全球75个市场获批，同时本季度在11个市场新增纳入或扩大报销范围，潜在市场空间进一步打开。泽布替尼的发展历程，是百济神州在全球化道路上不懈探索前行的典型范例，也是创新药走向全球市场的标杆。泽布替尼在全球创新药市场让人振奋的高速增长，生动地诠释了创新药市场的终极魅力：谁能证明自己的疗效是同类药物中的最佳，谁就能拿走最大的市场份额，就能获得让全行业为之侧目的高额回报。看似波诡云谲、高不可攀的全球创新药市场，底层逻辑就是如此简单而纯粹。百济神州的成功之处，正是在纷繁芜杂的创新药行业当中，牢牢把握了这种“简单底层逻辑”：瞄准全球范围内未被满足的临床刚需，始终坚持以“FIC”或者“BIC”作为药物开发的核心准则，成功实现了创新药在全球市场的价值闭环。更多的“重磅炸弹”在路上泽布替尼的大放异彩，绝非偶然。泽布替尼的成功，百济神州完全有能力复制。经过多年的布局和建设，百济神州已经完成高度全球化的研发与运营体系的构筑，这是泽布替尼赖以成功的关键性基础设施，也是在全行业都极为稀缺的核心资产。在这一高效的全球化体系的支撑和赋能之下，更多的潜在“重磅炸弹”级别的创新药，将源源不断地产生。在已商业化的管线中，百济神州另一款核心自研产品PD-1抗体百泽安®（替雷利珠单抗）销售稳健增长，2024全年销售额为44.67亿元，同比增长17.4%。2025年第一季度，替雷利珠单抗继续保持快速增长趋势，其销售额为12.45亿元，同比增长19.3%，在中国PD-1药物市场继续处于领先地位。在百济神州的在研管线中，多款在细分领域极具潜力的候选药物都取得了喜人的进展。首先是在血液瘤领域，继泽布替尼之后，百济神州正通过后续BCL2抑制剂索托克拉（Sonrotoclax）和BTK CDAC BGB-16673的开发，持续巩固自身在全球血液瘤治疗领域的领先地位。2025年4月底，百济神州正式提交BCL2抑制剂索托克拉在中国市场的新药上市申请，并已纳入优先审评程序，拟用于治疗既往接受过治疗的慢性淋巴细胞白血病（CLL）/小淋巴细胞淋巴瘤（SLL）成人患者。此外，百济神州已计划对索托克拉治疗R/R MCL适应症的二期临床试验进行数据读出，并有望针对该项适应症在2025年下半年递交全球潜在加速上市申请。目前，全球仅有艾伯维和罗氏联合开发的BCL2抑制剂维奈克拉（Venetoclax）获批上市，其销售额已于2024年达到了25亿美元。索托克拉一旦成功上市，不仅将会成为百济神州旗下另一款潜在的世界级大药，还很有希望通过“BCL2+BTK”的联用方式，显著扩展泽布替尼的临床应用场景。目前，除了索托克拉单药治疗的探索，百济神州已开展了四项索托克拉联用泽布替尼的联合治疗相关临床研究。百济神州另一款针对BTK耐药性问题的管线BGB-16673，具备在血液瘤领域显著改变现有临床治疗格局的潜力。相比于传统BTK抑制剂易引发耐药性的痛点，BTK降解剂独辟蹊径，无论突变位点如何（如C481S、T474I、L528W），只要BTK蛋白存在，BTK降解剂即可通过泛素化标记将其清除，这种新机制有望显著缓解BTK耐药性问题。目前，BGB-16673是临床进度最快的BTK降解剂，百济神州已启动 BGB-16673对比医生选择的治疗方案用于治疗R/R CLL的3期临床试验，并预计将于2025 年下半年启动BGB-16673“头对头”对比非共价BTK抑制剂匹妥布替尼（pirtobrutinib）用于治疗R/R CLL 患者的3期临床试验。由此可见，在血液瘤领域，继成功上市泽布替尼之后，百济神州还有长期而系统的研发规划，已经构筑了包含多个基石性产品的在研管线，有望在未来很长时间内巩固现有优势，深化血液肿瘤产品的领先地位。同时，在实体瘤治疗领域，百济神州也正在通过多样化的分子类型和作用机制，紧锣密鼓地拓展产品组合，目前相关临床试验的规模体量迅速增加，在自有临床体系的加持下，推进的效率也非常之高。以新一代CDK4抑制剂BGB-43395为例，该管线针对现有同类药物的安全性痛点，旨在增效减毒，实现CDK抑制剂的升级迭代。在多个早期临床和临床前数据中，已观察到BGB-43395令人鼓舞的PD数据以及初步临床疗效；BGB-43395在开启临床试验1年左右的时间内，入组患者已经超过300例，预计在2025年上半年将取得概念验证数据。目前，全球4款主要的CDK4/6抑制剂合计销售金额已经超过127亿美元，BGB-43395有望在该领域重现泽布替尼的传奇。针对肺癌治疗，百济神州正在推进与安进合作的塔拉妥单抗（AMG757，DLL3 x CD3双特异性T细胞接合器）用于二线治疗小细胞肺癌，相应的三期临床试验公布了积极的数据读出。同时，百济神州预计将于2025年下半年完成BGB-58067（PRMT5抑制剂）和BG-89894（MAT2A抑制剂）联合治疗临床试验的首例患者入组。针对胃肠道癌症，百济神州与Zymeworks/Jazz合作的泽尼达妥单抗（靶向HER2的双特异性抗体）进入到了关键阶段，预计将于2025年下半年对一线治疗HER2阳性胃食管腺癌3期临床试验，进行主要无进展生存期数据读出。总之，在血液瘤领域大杀四方的同时，百济神州在实体瘤领域的研发进展一点也没有松懈，目前多款管线都持续取得了关键的重大进展。假以时日，百济神州完全有希望在更多的肿瘤治疗领域实现自身的领导性地位。结语百济神州迈向可持续盈利的新纪元，不仅是简单的财务数据的转折，更是医药产业升级换代的时代缩影，给创新药产业的发展带来了弥足宝贵的信心和有益的启示。百济神州的传奇历程，其意义已经超越了一家制药公司本身，它雄辩地证明了通过“原始创新+全球化深度布局+资本赋能”的组合拳，创新药的商业模式所能具备的强大生命力和足以让资本市场为之热血沸腾的光明前景。无论成为A股“医药一哥”，还是未来可能的首次实现全年盈利，都只是百济神州的短期里程碑，这家公司的上限或将超过所有人的想象。A股终将迎来属于自己的全球化大药企。

财报IPO

2025-05-08

·Pharma CMC

百济神州2025一季度业绩公布，营收超80亿！

5月7日晚，百济神州发布2025年第一季度业绩。报告期内，百济神州营业总收入为80.48亿元，较上年同比上升50.2%；2025年第一季度归属于母公司所有者的净利润为-0.95亿元。报告期末，百济神州总资产为421.26亿元。百济神州2025年第一季度产品收入为79.85亿元，上年同期产品收入为53.25亿元，产品收入的增长主要得益于其自研产品百悦泽®（泽布替尼胶囊）,以及百泽安®（替雷利珠单抗）和安进授权产品的销售增长。2025年第一季度，百悦泽®全球销售额总计56.92亿元，同比增长63.7%，在血液肿瘤领域进一步巩固领导地位。其中，美国销售额总计40.41亿元，同比增长61.9%。百悦泽®欧洲销售额总计8.36亿元，同比增长75.4%，主要得益于该产品在所有欧洲主要市场的市场份额提升，其中包括德国、意大利、西班牙、法国和英国。中国销售额总计5.90亿元，同比增长43.1%，主要得益于该产品在已获批适应症领域的销售增长。2025年第一季度，百泽安®的销售额总计12.45亿元，同比增长19.3%。百泽安®销售额的增长，主要得益于在中国获批新适应症纳入医保所带来的新增患者需求以及药品进院数量的增加。目前，百泽安®在中国获批14项适应症，其中符合纳入条件的13项适应症已纳入国家医保目录。截止报告期末，百济神州内部全球研发（包括临床运营及开发）团队拥有约3700人。百济神州表示，公司正在大力推进新一代自主研发管线产品的全球临床布局和进展，其中：索托克拉（在研BCL2抑制剂，英文通用名：sonrotoclax）：用于治疗华氏巨球蛋白血症的全球2期临床试验持续入组患者。索托克拉：已基于BGB-11417-202试验，在中国申报上市，用于治疗复发或难治性（R/R）CLL。索托克拉：用于治疗R/R套细胞淋巴瘤（MCL）的3期CELESTIAL试验（BGB-11417-302）完成首例受试者入组。索托克拉：联合泽布替尼用于治疗初治CLL的3期CELESTIAL试验（BGB-11417-301）完成最后一例受试者入组。BGB-16673（BTK CDAC）：用于治疗R/R CLL的潜在可注册2期临床试验持续入组患者，预计将于2026年进行数据读出。BGB-16673：已启动对比医生选择的治疗方案（IR/VR/BR）用于治疗R/R CLL的3期临床试验。塔拉妥单抗（AMG757，DLL3xCD3 BiTE）：与安进公司合作开展的用于小细胞肺癌二线治疗的3期临床试验公布积极的数据读出。抗TIGIT抗体：终止欧司珀利单抗作为肺癌潜在治疗方案的临床开发。

财报临床3期临床2期

100 项与塔拉妥单抗相关的药物交易

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研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
小细胞肺癌	加拿大	Amgen, Inc.	2024-09-01
广泛期小细胞肺癌	美国	Amgen, Inc.	2024-05-16

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
局限期小细胞肺癌	临床3期	美国	百济神州（北京）生物科技有限公司	2024-01-23
局限期小细胞肺癌	临床3期	美国	Amgen, Inc.	2024-01-23
局限期小细胞肺癌	临床3期	日本	Amgen, Inc.	2024-01-23
局限期小细胞肺癌	临床3期	日本	百济神州（北京）生物科技有限公司	2024-01-23
局限期小细胞肺癌	临床3期	阿根廷	Amgen, Inc.	2024-01-23
局限期小细胞肺癌	临床3期	阿根廷	百济神州（北京）生物科技有限公司	2024-01-23
局限期小细胞肺癌	临床3期	澳大利亚	Amgen, Inc.	2024-01-23
局限期小细胞肺癌	临床3期	澳大利亚	百济神州（北京）生物科技有限公司	2024-01-23
局限期小细胞肺癌	临床3期	奥地利	Amgen, Inc.	2024-01-23
局限期小细胞肺癌	临床3期	奥地利	百济神州（北京）生物科技有限公司	2024-01-23

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05740566 (DeLLphi-304, Company_Website) 人工标引	临床3期	小细胞肺癌	-	IMDELLTRA	齋築衊顧製艱鹽繭夢獵(獵範鏇蓋積構獵鹽膚壓) = IMDELLTRA demonstrated statistically significant and clinically meaningful improvement in overall survival (OS) compared to local standard-of-care (SOC) chemotherapy. 壓餘構壓淵簾積鏇範簾 (衊願鬱襯簾製膚鑰願蓋 ) 达到	积极	2025-04-11
				SOC
NCT05060016 (DeLLphi-301, Pubmed \| Adv Ther)	临床2期	小细胞肺癌	100	Tarlatamab 10 mg	艱蓋築艱願願選淵鬱齋(簾構淵齋蓋觸鏇鏇窪獵) = generally of mild to moderate severity occurring rarely or occasionally 獵積膚網遞顧鏇網鹹獵 (艱膚願鹹積鹽鏇願鹽願 ) 更多	积极	2025-04-01
ESMO_ELCC2025	N/A	小细胞肺癌	-	Tarlatamab 10 mg	遞鏇憲獵夢衊餘齋齋網(繭顧範願選鬱範夢鏇遞): OR = 2.8 (95% CI, 1.44 ~ 5.83) 更多	积极	2025-03-26
				Physicians' choice of therapies
NCT03319940 (DeLLphi-300, ESMO_IO2024)	临床1期	小细胞肺癌 delta-like ligand 3	88	Tarlatamab 10 mg Q2W outpatient monitoring	網構淵鬱艱構簾鏇蓋壓(積選願獵鬱簾顧憲衊膚) = 範衊獵鬱獵簾築鏇鑰鬱淵鹹積廠築顧鑰鑰膚鬱 (繭遞鹹築艱遞網壓齋築 ) 更多	积极	2024-12-12
				Tarlatamab 10 mg Q2W inpatient monitoring	網構淵鬱艱構簾鏇蓋壓(積選願獵鬱簾顧憲衊膚) = 獵範糧觸廠積築衊積糧淵鹹積廠築顧鑰鑰膚鬱 (繭遞鹹築艱遞網壓齋築 ) 更多
NCT05740566 (DeLLphi-301, Pubmed \| Future Oncol)	临床2期	小细胞肺癌 DLL3	-	Tarlatamab 10 mg	簾膚築鹹蓋醖選壓壓願(遞夢襯醖憲選鬱窪艱鏇) = 壓願鏇構糧獵艱夢製範繭醖憲艱餘觸蓋淵餘鹹 (衊淵遞遞網鏇願廠壓簾 ) 更多	积极	2024-11-12
				Tarlatamab 100 mg	簾膚築鹹蓋醖選壓壓願(遞夢襯醖憲選鬱窪艱鏇) = 繭繭簾糧鹹廠構獵鬱構繭醖憲艱餘觸蓋淵餘鹹 (衊淵遞遞網鏇願廠壓簾 ) 更多
NCT05361395 (DeLLphi-303, WCLC2024) 人工标引	临床1期	广泛期小细胞肺癌一线 \| 维持	88	tarlatamab with atezolizumab	蓋膚糧願襯鑰鑰淵齋衊(壓醖繭築顧範餘餘構廠) = None 積顧製觸繭鏇獵憲遞窪 (鬱積簾製築鹹鏇鹹積鹹 ) 更多	积极	2024-09-09
				tarlatamab with durvalumab
NCT05060016 (DeLLphi-301, WCLC2024) 人工标引	临床2期	小细胞肺癌二线	186	Tarlatamab 10 mg	製鏇膚鹹範鑰顧觸範網(膚鏇窪鏇網齋簾構衊壓) = 鹽築積遞醖膚鹽獵顧簾製齋構顧鏇遞構夢遞顧 (齋繭憲蓋範鏇獵鏇願鏇, 30.7 ~ 50.7) 更多	积极	2024-09-09
				Tarlatamab 100 mg	製鏇膚鹹範鑰顧觸範網(膚鏇窪鏇網齋簾構衊壓) = 壓壓網顧夢鏇蓋鹽齋觸製齋構顧鏇遞構夢遞顧 (齋繭憲蓋範鏇獵鏇願鏇, 22.6 ~ 43.1) 更多
NCT06211036 (DeLLphi-305, WCLC2024)	临床3期	广泛期小细胞肺癌维持 delta-like ligand 3 (DLL3)	550	Tarlatamab 10 mg + Durvalumab	蓋醖構襯積選獵網糧鏇(夢夢簾壓鹽獵淵夢願鏇) = 醖餘淵鹹夢範鑰網獵鏇餘遞艱糧繭膚鏇遞餘艱 (願繭網鏇顧築蓋蓋膚鑰 )	积极	2024-09-08
NCT04702737 (SCLC, ASCO2024) 人工标引	临床1期	神经内分泌前列腺癌 DLL3 Expression	40	Tarlatamab	襯憲願齋衊艱鏇襯鏇獵(獵鹽鏇願範繭觸鹹憲廠) = 積獵顧膚鬱獵願顧淵餘醖觸鹹壓網範繭壓鬱鬱 (鏇顧顧範蓋遞範構鬱網 ) 更多	积极	2024-05-24
				Tarlatamab (DLL3+)	顧遞鹽衊壓網構衊鹹鹹(衊觸壓醖選繭遞鏇範鹹) = 壓遞鬱製積觸製鑰繭蓋膚膚醖醖襯鏇憲廠壓網 (願醖鑰選構網觸夢積鏇, 6.4 ~ 47.6) 更多
NCT05060016 (DeLLphi-301, ASCO2024)	临床2期	小细胞肺癌 delta-like ligand 3	186	Tarlatamab 10 mg Q2W	簾窪獵鏇築憲觸糧餘鑰(齋餘構簾遞鬱糧鹹構壓) = 9.4% and 1.8% 膚餘觸選構鹹鑰齋襯築 (鹹顧網觸鹽獵鹽憲憲顧 )	积极	2024-05-24