This is a long-term follow-up study for participants treated with Galapagos (GLPG) CAR T-cell therapies to evaluate the long-term safety and efficacy of GLPG CAR T-cell products for 15 years post infusion.
Per Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of treated patients is required. The purpose of this study is to monitor all participants exposed to GLPG CAR T-cell therapies for 15 years following their last CAR T-cell infusion to assess the risk of delayed adverse events (AEs) and the long-term benefit/risk profile and to monitor for replication-competent lentivirus (RCL) and CAR-T cell persistence.

开始日期2024-09-09

申办/合作机构

Galapagos NV

CTIS2023-504422-19-00

/ Completed临床1期

A study evaluating the safety, tolerability, and efficacy of GLPG5101 in adults with treatment-refractory active systemic lupus erythematosus

开始日期2023-11-30

申办/合作机构

Galapagos NV

NCT06561425

/ Active, not recruiting临床1/2期

A Phase I/II, Multicenter Study Evaluating the Feasibility, Safety, and Efficacy of Point-of-care Manufactured GLPG5101 (19CP02) in Subjects With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

This study is evaluating whether an experimental treatment called GLPG5101 helps to treat non-Hodgkin lymphoma (NHL) and if it is safe to use.
This study will be carried out in 2 phases:
* The first phase is to see which doses of GLPG5101 work best with the least number of side effects.
* In the second phase, participants will receive the selected dose(s) based on the results in the first phase.

开始日期2022-03-09

申办/合作机构

Galapagos NV

100 项与 GLPG-5101 相关的临床结果

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100 项与 GLPG-5101 相关的转化医学

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100 项与 GLPG-5101 相关的专利（医药）

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项与 GLPG-5101 相关的文献（医药）

2026-02-01·Transplantation and Cellular Therapy

Management Practices of CAR T-cell-Related Inflammatory Toxicities: A Survey of Pediatric CAR T-cell Providers

Article

作者: Ombrello, Amanda K ; Chaudhury, Sonali ; McNerney, Kevin O ; Graham, Andrea K ; Diorio, Caroline ; Maude, Shannon L ; Talleur, Aimee C ; Sanchez-Pinto, Lazaro N ; Shah, Nirali N ; Gardner, Rebecca A ; Annesley, Colleen ; Schultz, Liora M

Immune related adverse events (IRAE) are the most common nonhematologic adverse effects of chimeric antigen receptor (CAR) T-cell therapies. These events can be severe and refractory to upfront management. Tocilizumab is currently the only FDA-approved drug for the treatment of CAR T-cell induced inflammatory toxicities. However, an increasing number of anti-inflammatory therapies are now utilized for prevention and treatment of severe or refractory IRAE. Emerging evidence suggests the potential benefit of prophylactic or preemptive use of anti-inflammatory agents to mitigate severe toxicities. Guidance on the use of alternative anti-inflammatory therapies, preventative strategies, and management of refractory CAR T-cell toxicities is limited, with varying recommendations in society guidelines and the FDA labels for tisagenlecleucel and tocilizumab. Furthermore, there is a lack of pediatric-specific guidance. The primary objective of this study was to characterize CD19-CAR T-cell toxicity management practices for children and young adults with B-acute lymphoblastic leukemia by pediatric CAR T prescribers. A survey consisting of 28 questions focused on CAR T-cell toxicity management practices was distributed to pediatric CAR T-cell treatment centers with responses received between February and March 2024. Sixty unique responses with adequate data were received from 46 institutions. Forty-four respondents (73%) indicated using a preemptive treatment approach, defined as immunomodulatory therapy initiated for low grade toxicity to prevent the development of worsening toxicity, of which 33 (75%) used for high-risk patients and 9 (21%) used for all patients. Conversely, only 8 (14%) respondents indicated using a prophylactic approach defined as immunomodulatory therapy initiated prior to the onset of inflammatory toxicities. The most common feature leading to a patient being considered high-risk was high disease burden. Fifteen percent of respondents initiated tocilizumab for cytokine release syndrome (CRS) at grade 1, 48% at grade 2, and 18.3% at grade 3. Steroids were initiated at grade 2 immune effector cell-associated neurotoxicity syndrome (ICANS) in 43% of respondents and grade 3 in 28% of respondents. Most respondents had experience using alternative anti-inflammatory therapies, including anakinra (80%), siltuximab (50%), ruxolitinib (28%), emapalumab (22%), and dasatinib (15%). Anakinra was most often used for management of refractory CRS, refractory ICANS, or immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS). Most respondents indicated a need to prospectively study anakinra and emapalumab for treatment and/or prevention of CAR T inflammatory toxicities. Themes identified through analysis of semi-structured questions included the need for guidelines on use of alternative therapies, early preventative treatments, initial management of IRAE, and refractory IRAE management. This survey highlights significant practice variability in timing of initiation of CRS and ICANS treatment, frequent use of alternative anti-inflammatory therapies for CAR T toxicity management, and a consensus regarding the need for prospective study of therapies including anakinra and emapalumab. Survey results indicate a need for guidelines on management of CAR-induced inflammatory toxicities at their onset and in the refractory setting, and on the use of alternative therapies.

2025-05-01·European Journal of Hospital Pharmacy

Costs, challenges and opportunities of decentralised chimeric antigen receptor T-cell production: a literature review and clinical experts’ interviews

Review

作者: Stemer, Gunar ; Schnell-Inderst, Petra ; Wild, Claudia ; Mittermayr, Tarquin

The objectives were to summarise the evidence and clinical experts' views comparing the use of decentralised produced chimeric antigen receptor (CAR) T-cell therapies versus commercially available products, regarding drug costs, time to finalised product and other reported advantages, disadvantages, challenges and facilitators. A literature review according to the PRISMA guidelines was conducted in Medline, Embase and Trip databases. Publications were included if they reported information on cost estimates, time to finalised products and other outcomes of interest of a decentralised CAR T-cell production strategy. A structured interview guide was developed and used for qualitative expert interviews. Five experts were purposively selected, and interviews were either conducted face-to-face or online, and recorded for the purpose of transcription. Transcripts were analysed and categories and codes extracted. Reporting is based on the COREQ checklist for reporting qualitative research. Costs of decentralised produced CAR T-cells appear to be lower by a factor two to 14, compared with commercial products. But there is high uncertainty about this estimate, because it is unclear whether cost components included are comparable and due to the heterogeneity of the studies. The most commonly reported advantages were proximity to patients and decreased product risks and costs, whereas the continuing dependency on centrally manufactured reagents and specific characteristics of 'fresh' CAR T-cells are reported as disadvantages. Compliance with regulatory requirements is mentioned as the biggest challenge. The availability of closed-system production devices is reported as one main facilitator, as are clear commitment, secured financing and knowledge transfer from already experienced centres. Apparent cost differences open a field for healthcare decision-makers to discuss and justify investment costs for implementation of a complementing decentralised production programme and to realise other associated benefits of such a strategy, such as flexibility, patient proximity and expanding patient access.

项与 GLPG-5101 相关的新闻（医药）

2026-01-19

·BioSpace

JPM26: Galapagos’ New CEO Is Here to Finally Turn The Ship Around

iStock, Hwangdaesung Henry Gosebruch, who has $3.5 billion in capital to deploy, is thinking broad as he steers the decades-old biotech out of years of turmoil.  Galapagos CEO Henry Gosebruch truly has a clean slate to work with in rebuilding the storied—but chronically unlucky—company. Brought in last year to replace Paul Stoffels , who made multiple attempts to right the ship , Gosebruch’s mandate is to find a whole new direction. The company has suffered from a series of clinical failures, FDA rejections, restructuring and leadership changes. He has cash—about €3 billion ($3.5 billion)—and the board’s backing to find whatever asset, technology or disease area he wants. “On the one hand, it’s like, well, what’s it going to be? But on the other hand, that’s the beauty of what we have, that we can be much more broad in our thinking and really just look at the best opportunity,” Gosebruch told BioSpace on the sidelines of the J.P. Morgan Healthcare Conference last week. This wide-open opportunity is what attracted Gosebruch in the first place—even if the role he was originally offered was quite different. He was brought into the fold in April 2025 to head a proposed spin-out company that would build a brand new pipeline. Barely a month later, the company reversed course on the spin-out idea and announced Stoffels’ departure. Gosebruch instead became CEO of the original Galapagos entity, which would carry on the mission of finding a new pipeline. Deals Almost 5 Years into $5B Galapagos Partnership, Gilead Execs Start Over With New Spinoff Five years ago, Gilead signed a massive deal with Galapagos. After a restructuring, the pharma is still hunting for the potential it saw at the original signing. January 22, 2025 · 5 min read · Annalee Armstrong Read More Later, Galapagos ditched the cell therapy assets that Stoffels had been carefully curating over his nearly five-year term through a series of acquisitions. Explaining the decision to back off cell therapy, Gosebruch said it was a long time coming. The investment needed would have been too great to advance the technology far enough to be competitive. Gosebruch said it would have cost hundreds of millions of dollars. Those conversations were happening well before Gosebruch arrived, but they intensified in the past year. On January 5, the board officially announced the wind-down of cell therapy at Galapagos. Galapagos originally intended to find partners for the existing programs, which include the Phase II CD19 CAR T GLPG5101 for blood cancer, but that has not materialized. “We’re continuing to be open, but at this point, nobody’s come forward, really, with a proposal that makes sense to pursue,” Gosebruch said. New Outlook Of his predecessor Stoffels, Gosebruch expressed his admiration and said the board made the decision to part ways. “Paul for many, many years and I have a lot of respect, but he was very, very focused on cell therapy,” Gosebruch explained. “That was sort of his mission, to bring this set of programs to patients. And I think, given how focused he was on that particular mission, I think he was not focused on opening up to other potential opportunities.” Gosebruch, on the other hand, has an open mind: “My approach will be that I’m not wedded to one area over another; I’m going to be looking more broadly.” Galapagos does have a legacy pipeline consisting of one molecule, a TYK2 small molecule for immunology called GLPG3667. It’s “the one program that survived from the sort of olden days,” Gosebruch said. The therapy is currently being tested in Phase II trials for systemic lupus erythematosus and dermatomyositis. But GLPG3667 may not ultimately stay in Galapagos’ hands either, Gosebruch said. “Now we are thinking about, given that we don’t have the broad development team anymore, we don’t have the big infrastructure anymore that we had back in the day, does it make sense for us to rebuild around that asset, or does it make sense for us to work with a partner who may already have that?” No ‘Synergy’ Here The new CEO was tight lipped on what he wants to bring into Galapagos. He noted that, at the J.P. Morgan conference, he had “a very packed calendar of BD discussions.” He was also meeting with investors to explain the company’s new focus. Immunology and inflammation and solid tumors are likely candidates and would match Galapagos’ historical focus. “I’d love to find a way to still see that vision through,” the CEO said. “And I think there are some very exciting opportunities in immunology.” Gosebruch also spent time at I&I king AbbVie, so assets in this area would be complimentary to his experience, while solid tumors would fit in with long-time partner Gilead. Galapagos still has strong ties with Gilead, which has a major investment in the biotech. Gosebruch said the relationship is strong and that he spent time with the pharma’s leadership even before accepting the role to understand what they want out of the partnership. He doesn’t think Gilead will simply hand off a program to Galapagos—the goal is to spend the capital on hand to find new opportunities, Gosebruch said. Gosebruch added that the company has a team exploring China for opportunities, just like many peers across the biopharma industry. “I think it’s—I’m going to use the word required—actually,” Gosebruch said. “If you want to do BD these days, you have to be in China, at least to understand what’s the competitive landscape.” Special edition Deep Dive: Chinese Biotech Innovation Can’t Be Stopped In this deep dive, BioSpace investigates China’s rise as a biotech powerhouse. October 27, 2025 · 3 min read · Annalee Armstrong Read More One important piece of leverage that Galapagos has in business development discussions is that the biotech has shrunk down over the past year via layoffs. After the cell therapy restructuring is complete, Gosebruch estimated the remaining workforce will be about 35-40 people. So a whole company could join Galapagos without risk of layoffs—which commonly happen after a merger. “One of the things we can offer to a potential transaction party is that if there’s a strong R&D team or a strong commercial team, they could, as a full team, come to Galapagos and be our team going forward,” Gosebruch said. “There won’t be any synergy.” Gosebruch didn’t write off any potential diseases or opportunities and said he plans to be thoughtful—while acknowledging that investors have been very patient amid the restructuring. “I’d rather take more time, be patient and wait for the right opportunity to come our way than rush into anything.” .responsive-container { display: flex; flex-wrap: wrap; border: 1px solid #ededed; font-family: Helvetica, Arial, Sans-Serif; padding: 20px 20px 10px 20px; } .column-left { flex: 1; max-width: 45%; padding: 20px 20px 10px 20px; } .column-right { flex: 2; padding: 20px 20px 10px 20px; } @media (max-width: 768px) { .column-left, .column-right { max-width: 100%; flex: 100%; padding: 10px 0; } } Subscribe to BioPharm Executive! 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临床2期细胞疗法高管变更并购

2025-12-08

·GlobeNewswire-Health Care

Galapagos Presented New ATALANTA-1 Cell Therapy Data in MCL at ASH 2025

High complete response rates and minimal residual disease (MRD) negativity, with durable responses, in high-risk mantle cell lymphoma (MCL) with GLPG5101, a fresh, early memory-enriched CAR T-cell therapy with a 7-day vein-to-vein time Mechelen, Belgium; December 8, 2025, 07:30 CET; Galapagos NV (Euronext & NASDAQ: GLPG) announced new and updated Phase 2 data from the ongoing ATALANTA-1 study with its CD19 CAR T-cell therapy candidate, GLPG5101, during an oral presentation (#662) at the 67th American Society of Hematology (ASH) Annual Meeting. “The new and updated results from the Phase 2 ATALANTA-1 study demonstrate that GLPG5101 offers timely treatment with low rates of high-grade toxicities and durable responses for patients with relapsed or refractory MCL,” said Marie José Kersten, MD, ATALANTA-1 Principal Investigator and Professor of Hematology at Amsterdam University Medical Center. “The short 7-day vein-to-vein time enabled a low dropout rate and eliminated the need for bridging therapy, allowing more patients to receive treatment who otherwise might not have been able to access CAR T-cell therapy.” Summary of ATALANTA-1 data from the MCL cohort (pooled data across two dose levels):As of September 2, 2025 (data cut-off date), 26 heavily pretreated MCL patients had undergone leukapheresis and 25 had received an infusion of GLPG5101 (4% dropout rate). Of these, 24 patients received a fresh product, with 23 infused within seven days after apheresis. Among infused patients (N=24), the objective response rate (ORR) was 100%, with a complete response rate (CRR) of 96%. Duration of response (DOR) and progression-free survival (PFS) rates were both 83% at a median follow-up of 9 months.9 of 10 (90%) of minimal residual disease (MRD)-evaluable patients were MRD-negative at CR and 7 of 9 MRD-negative patients remained in CR at the time of the data cut-off.GLPG5101 showed an encouraging safety profile (N=24). The most common Grade ≥ 3 treatment-emergent adverse events were hematologic. No Grade ≥ 3 CRS was observed, and only one case of Grade ≥ 3 ICANS occurred.GLPG5101 demonstrated robust in vivo CAR T-cell expansion and long-term persistence with an enrichment of early memory phenotypes. Intention to wind down Galapagos’ cell therapy activities As announced on October 21, 2025, and following a comprehensive strategic and evaluation and sales process, Galapagos remains focused on the intention to wind down the cell therapy activities. This intention is subject to the conclusion of consultations with works councils in Belgium and the Netherlands, during which Galapagos will continue to operate the business and conduct ongoing clinical studies. Galapagos would still consider any viable proposal to acquire all, or part of the cell therapy business, should such a proposal emerge during the wind down process. About GLPG5101 and ATALANTA-1 (EudraCT 2021-003272-13; NCT 06561425) GLPG5101 is a second generation anti-CD19/4-1BB CAR-T product candidate, administered as a single fixed intravenous dose. The safety, efficacy and feasibility of decentralized manufactured GLPG5101 are currently being evaluated in the ATALANTA-1 Phase 1/2 study in eight hematological malignancies with high unmet need. The primary objective of the Phase 1 part of the study is to evaluate safety and to determine the recommended dose for the Phase 2 part of the study. Secondary objectives include assessment of efficacy and feasibility of decentralized manufacturing of GLPG5101. The dose levels that were evaluated in Phase 1 are 50×106 (DL1), 110×106 (DL2) and 250×106 (DL3) CAR+ viable T-cells. The primary objective of the Phase 2 part of the study is to evaluate the Objective Response Rate (ORR) while the secondary objectives include Complete Response Rate (CRR), duration of response, progression free survival, overall survival, safety, pharmacokinetic profile, and the feasibility of decentralized manufacturing. Each enrolled patient will be followed for 24 months. The ATALANTA-1 study is currently enrolling patients in the U.S. and Europe. For further information, contact Galapagos:Investor RelationsGlenn Schulman +1 412 522 6239ir@glpg.com Corporate CommunicationsMarieke Vermeersch+32 479 490 603 media@glpg.com Visit us at www.glpg.com or follow us on LinkedIn or X. Forward-looking statementsThis press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These statements are often, but are not always, made through the use of words or phrases such as “anticipate,” “expect,” “plan,” “estimate,” “will,” “continue,” “aim,” “intend,” “future,” “potential,” “could,” “indicate,” “forward,” “may,” as well as similar expressions. Forward-looking statements contained in this press release include, but are not limited to, statements regarding Galapagos’ plans, expectations and strategy with respect to its cell therapy business, including statements regarding its plans, expectations and strategy for GLPG5101 and its other product candidates and partnered programs, Galapagos’ intention to wind down its cell therapy business as part of its ongoing transformation, the expected timing, design and readouts of the ATALANTA-1 study, and the potential benefits of Galapagos’ product candidates. Forward-looking statements involve known and unknown risks, uncertainties and other factors which might cause Galapagos’ actual results to be materially different from those expressed or implied by such forward-looking statements. These risks, uncertainties and other factors include, without limitation, the risk that Galapagos will not be able to successfully implement the winding down of its cell therapy business within the expected timeframe or at all, or if implemented, the wind down will not achieve its anticipated economic benefits; the risk that preliminary or interim clinical results may not be replicated in ongoing or subsequent clinical trials, the risk that ongoing and future clinical studies with Galapagos’ product candidates, including GLPG5101, may not be completed in the currently envisaged timelines or at all, the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements (including that data from the ongoing and planned clinical research programs may not support registration or further development of GLPG5101 due to safety, efficacy or other reasons), Galapagos' reliance on collaborations with third parties (including its collaboration partners Lonza and US WorldMeds), and that Galapagos’ estimations regarding its GLPG5101 development programs and regarding the commercial potential of GLPG5101 may be incorrect, as well as those risks and uncertainties identified in Galapagos’ Annual Report on Form 20-F for the year ended 31 December 2024 filed with the U.S. Securities and Exchange Commission (SEC) and its subsequent filings with the SEC. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The forward-looking statements contained herein are based on management’s current expectations and beliefs and speak only as of the date hereof, and Galapagos makes no commitment to update or publicly release any revisions to forward-looking statements in order to reflect new information or subsequent events, circumstances or changes in expectations. Further, Galapagos cannot assess the impact of each such factor on its business or the extent to which any factor, or combination of factors, may cause actual results to be materially different from those contained in any forward-looking statement. Attachment Galapagos Presented New ATALANTA-1 Cell Therapy Data in MCL at ASH 2025

细胞疗法临床结果ASH会议临床2期免疫疗法

2025-10-25

·药网在线

2025全球医药十大CDMO企业名单

Jefferies分析师团队7月份发布的一份报告描绘了合同开发和制造组织（CDMO）的乐观前景。Miyabi Yamakita及其同事报告称，市场对CDMO服务的需求不断增长，尤其是专注于生产生物制剂的CDMO服务。根据 Jefferies的报告，基于 Statista 的数据和 Jefferies 引用的公司预测，整个 CDMO 市场预计将从 2024 年的 1730 亿美元增长至今年的 1850 亿美元，到 2033 年将达到 3230 亿美元，复合年增长率 (CAGR) 为 7.2%。然而，生物制剂CDMO服务的需求每年增长约15%，几乎是制药需求的三倍，更是制药CDMO服务整体需求的两倍。预计增长的背后是抗体药物和抗体偶联药物（ADC）需求的不断增长。仅抗体药物市场就预计将增长近两倍，从2024年的2460亿美元增长178%，到2034年达到6850亿美元，复合年增长率为10.8%。过去十年，全球药品生产外包给CDMO的比例从2014年的34%上升到2023年的49%。 Jefferies写道：“随着越来越多的抗体药物实现商业化，对中大规模生产的需求不断增长，长期合同正成为关键的增长动力。到2030年，这些顶级CDMO预计将在生物制剂市场占据越来越大的份额，可能超过55%，因为质量、规模和可靠性将成为关键的差异化因素。” 尽管该报告对 CDMO 的未来持乐观态度，但该领域未来的增长仍面临一些挑战，特别是外汇汇率和美国政府实施的一系列关税政策。 7月 23 日，赛默飞世尔科技高级副总裁兼首席财务官 Stephen Williamson 在公司季度收益电话会议上向分析师表示，关税和相关外汇波动的同比影响导致调整后营业收入下降 5%，调整后毛利率下降约 150 个基点（1.5%）。然而，龙沙集团首席执行官Wolfgang Wienand 在公司收益电话会议上告诉分析师，外汇汇率导致销售额下降两个百分点，核心 EBITDA (息税折旧摊销前利润) 下降 1.3 个百分点：“就全年而言，假设 2025 年剩余时间的外汇汇率与 7 月初的汇率一致，我们预计对销售额和核心EBITDA 的影响将为负 2.5% 至负 3.5%。” 不过，Wienand表示，关税对龙沙的影响较小。他说：“我们具有韧性的 CDMO 业务模式和地域多元化的全球业务，包括在美国的大量业务，在很大程度上使我们免受潜在的美国关税的影响，同时使我们能够支持客户应对并尽量减少此类关税的潜在影响。” GEN排名前十的 CDMO中有八家的收入自去年榜单以来有所增长。2024 年，前十大 CDMO 的总收入从 302.37 亿美元增长 5% 至 317.63 亿美元。两年间，总收入从2022 年的 282.2 亿美元增长近 13% 。名单上的另外两家公司中，Recipharm 的收入在将其吸入式和鼻腔药物设备业务剥离为新公司 Bespak 后出现萎缩，而MilliporeSigma/Merck KGaA 的“生命科学服务”业务部门（包括 CDMO 活动）的净销售额在 2024 年同比下降了 8%，原因是上一年非重复项目结束后需求出现波动，加上汇率不利。以下是今年十大CDMO的榜单。这些公司按2024年的收入排名，具体收入由各公司在监管文件或GEN咨询回复中披露。部分CDMO还提供了2025年的季度或半年收入。此外， GEN还首次在今年的榜单中重点介绍了 10 家规模尚不足以跻身前 10 名的“新兴”CDMO，这些 CDMO 是基于近期发布的从设施开业到重要合同的新闻公告。 1. 龙沙集团（Lonza Group）瑞士巴塞尔（Basel, Switzerland） 65.74亿瑞士法郎（81.38亿美元）截至 2025 年上半年，CDMO 业务的 EBITDA 为 9,220 亿瑞士法郎（11.41 亿美元），较 2024 年上半年的 7.59 亿瑞士法郎（约 9.4 亿美元）增长 21%，收入从 25.17 亿瑞士法郎（31.16 亿美元）同比增长 21% 至 30.53 亿瑞士法郎（37.8 亿美元）。将 2025 财年 CDMO 业务的预期上调至 CER 销售额增长 20-21%（高于“接近 20%”），核心 EBITDA 利润率达到 30-31%（高于“接近 30%”）。作为 4 月 1 日生效的简化“一个龙沙”(One Lonza)组织的一部分，用三个 CDMO 部门或“业务平台”（综合生物制剂（Integrated Biologics）、先进合成（Advanced Synthesis）和特定模式（Specialized Modalities））取代了其部门结构。这些平台构成“CDMO 业务”，不包括龙沙的胶囊和健康成分 (CHI) 业务。完成将其位于中国-新加坡广州知识城约 25,000 平方米（269,098 平方英尺）的大分子制造工厂出售给 Joinn Biologics US（昭衍新药），后者是中国 Joinn Laboratories 位于美国加利福尼亚州里士满（Richmond）的实体。 2. 赛默飞世尔科技马萨诸塞州沃尔瑟姆（Waltham, MA） 70亿美元 2025 年第二季度净收入为 16.18 亿美元，较 2024 年第二季度增长 4%，收入同比增长 3%，达到 108.55 亿美元。赛默飞世尔科技发布了一项研究，该研究得出结论：其Accelerator™药物开发平台整合了CDMO和合同研究组织（CRO）的服务，可将肿瘤药物开发时间缩短近三年。这项由公司委托的研究由塔夫茨大学药物开发研究中心进行。赛默飞世尔科技全球生物技术解决方案负责人Daniel Burch医学博士告诉记者： “模式越复杂，我们节省的时间就越多。” 同意以约 41 亿美元现金收购 Solventum 的纯化和过滤业务，并以未公开的价格收购赛诺菲位于美国新泽西州里奇菲尔德（Ridgefield）的无菌生产基地。承诺在四年内投资 20 亿美元，支持美国客户的研发和制造需求。 3. 康泰伦特（Catalent）新泽西州布里奇沃特（Bridgewater, NJ） 44.3亿美元 2024 年 12 月 18 日，诺和诺德控制基金会的资产管理公司 Novo Holdings以 165 亿美元收购了 Catalent，该交易已于 2024 年 12 月 18 日完成。此后，Novo Holdings 以 110 亿美元的预付款将三个 Catalent 工厂（意大利阿纳尼（Anagni）、比利时布鲁塞尔（Brussels）和印第安纳州布卢明顿（Bloomington））出售给诺和诺德，并将位于新泽西州萨默塞特（Somerset）的第四个 Catalent 工厂出售给 Ardena，具体价格未公开。该公司于7月宣布计划斥资4500万美元扩建其位于威斯康星州麦迪逊（Madison）的工厂。该工厂将创造约200个新工作岗位，为新型生物疗法提供开发、制造和分析服务，并拥有该公司的GPEx® Lightning细胞系技术。 1 月份与加拉帕戈斯（Galapagos）启动战略合作，旨在支持比利时药物开发商针对复发/难治性非霍奇金淋巴瘤适应症的 CAR T 疗法候选药物 GLPG5101 的临床研究的“去中心化”生产。 4. 三星生物（Samsung Biologics）韩国仁川（Incheon, South Korea） 4.547 万亿韩元（32.77 亿美元）第二季度综合营业利润为 4,756 亿韩元（3.434 亿美元），同比增长 9.5%；营收为 1.29 万亿韩元（9,313 亿美元），较 2024 年第二季度增长 11.5%。该公司于 4 月 28 日披露，与一家未具名的“美国制药公司”签署了价值 7,373 亿韩元（5.324 亿美元）的生物制剂合同制造合同。推出Samsung Organoids，这是一套先进的药物筛选服务，旨在支持客户进行药物发现和开发。该服务的推出扩展了Samsung Biologics 的业务范围，涵盖临床前研究，服务内容涵盖靶点发现、先导化合物筛选、临床前开发和临床试验规划。 5. 药明生物（WuXi Biologics）中国无锡 186.75亿元人民币（25.9亿美元） 7 月 21 日宣布，五家生产工厂成功通过 FDA 的许可前检查，没有发现任何严重问题或数据完整性问题——中国无锡的两家药物底物工厂（MFG1 和 MFG5）和三家药物产品工厂（DP1、DP2 和 DP5）。在中国成都市温江区开始建设一个占地9.5万平方米（102万平方英尺）的新型微生物生产基地，用于商业化生产。该基地计划于2026年底投入GMP生产。开始建造一个约 30,000 平方米（322,917 平方英尺）的新型模块化生物制剂产品设施，该设施将成为该公司位于新加坡的合同研究、开发和制造 (CRDMO) 中心的一部分。 6. Siegfried 瑞士祖芬根（Zofingen, Switzerland） 12.95亿瑞士法郎（16.07亿美元）任命 Peter Freisler 为首席商务官和执行委员会成员，自 8 月 1 日起生效。Peter 来自 Evonik，在 Evonik 担任过多个高级领导职务，最近担任的是医疗保健业务线全球销售和服务副总裁。为满足日益增长的客户需求，公司已开始扩建位于西班牙巴塞罗那（Barcelona）附近埃尔马斯努（El Masnou）的眼科药物生产基地，以提高其无菌眼药水的生产能力。新增产能将于2027年开始向客户投入使用。披露截至4月10日，受美国潜在关税影响的公司销售额不足1000万瑞士法郎（1240万美元）。 7. Fujifilm Biotechnologies 德克萨斯州大学城/日本东京（College Station, TX/Tokyo, Japan） 2195亿日元（14.96亿美元） 6 月份，Fujifilm Diosynth Biotechnologies 更名为富士胶片生命科学集团（Fujifilm’s Life Sciences Group），同时富士胶片欧文科学公司（Fujifilm Irvine Scientific）也更名为富士胶片生物科学公司（Fujifilm Biosciences）。对其位于德克萨斯州大学城（College Station）的工厂进行 138,000 平方英尺的扩建，专注于生产基因疗法和疫苗。位于北卡罗来纳州霍利斯普林斯（Holly Springs）的一座耗资32亿美元的端到端生物制造工厂一期工程即将完工。预计到今年年底，该工厂的员工人数将从500人增至700人，到2031年将增至1400人。 8.勃林格殷格翰（Boehringer Ingelheim）德国英格尔海姆（Ingelheim, Germany） 12.35亿欧元（14.31亿美元） 2025 年上半年，集团净销售额较 2024 年上半年增长 6.3%，达到 140 亿欧元（160 亿美元）。斥资 3 亿欧元（3.5 亿美元）扩建其位于日本山形（Yamagata）的工厂，其中包括开设一个新的生产部门、改善基础设施以及 6 月份破土动工的附加工厂。扩大 BioXcellence™ 在中国的合同制造服务，该公司位于上海的生物制药工厂有资格参与由中国国家药品监督管理局牵头的促进生物制品分段生产的试点监管改革。 9. Recipharm 瑞典斯德哥尔摩（Stockholm, Sweden） 8.27亿欧元（9.58亿美元）在将吸入式和鼻腔药物设备业务分拆至 Bespak 后，加强了对口服固体剂量、无菌灌装和封口以及 ReciBioPharm 生物制剂和先进治疗药物 (ATMP) 部门的核心关注。该公司表示，已获得多项重要产品开发合同，进一步巩固了其在吹-灌-封技术领域的领先地位。其中一份合同与一家未披露名称的“全球五大眼科组织”签订，涉及快速生产用于I期临床试验的试验材料。另一份合同与一家未披露名称的“全球眼科生物技术公司”签订，将支持其II/III期眼科暂停项目。 ReciBioPharm 从比尔和梅琳达·盖茨基金会获得了一笔为期三年、金额不详的资助，用于加速其 xRNA 连续生产平台的开发，该平台将 RNA 生产时间从 25 天缩短至 5 天，从而改善中低收入国家获得 xRNA 疫苗和治疗的机会。 10. 密理博西格玛/默克集团（MilliporeSigma/Merck KGaA）马萨诸塞州伯灵顿（Burlington, MA） 7.22亿欧元（8.36亿美元）与专门从事无菌注射剂的 CDMO Simtra BioPharma Solutions建立五年战略联盟，为寻求 ADC 和生物偶联、连接子/有效载荷制造、药品制剂开发和灌装/完成能力的生物制药企业提供交钥匙服务。 2025 年上半年，其生命科学服务部门（包括 CDMO 和合同测试服务）的净销售额为 3.22 亿欧元（3.75 亿美元），较 2024 年上半年的 3.51 亿欧元（约 4.09 亿美元）下降 8%。推出 AAW™ 自动化分析工作站，旨在实现以往手动进行的常规实验室实验的自动化，减少手动操作时间，并确保不同实验环境下结果的一致性。AAW 由专注于实验室自动化和无障碍机器人技术的 Opentrons 提供支持。原文：A.Philippidis, Top 10 Contract Development and Manufacturing Organizations 2025. GEN, 2025. （来源：生物制品圈）

抗体药物偶联物财报

100 项与 GLPG-5101 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
血液肿瘤	临床3期	比利时	Galapagos NV	2024-09-09
血液肿瘤	临床3期	荷兰	Galapagos NV	2024-09-09
血液肿瘤	临床3期	西班牙	Galapagos NV	2024-09-09
难治性B细胞淋巴瘤	临床3期	美国	-	2024-07-26
难治性B细胞淋巴瘤	临床3期	比利时	-	2024-07-26
难治性B细胞淋巴瘤	临床3期	荷兰	-	2024-07-26
难治性B细胞淋巴瘤	临床3期	西班牙	-	2024-07-26
慢性淋巴细胞白血病	临床3期	美国	-	2024-07-26
慢性淋巴细胞白血病	临床3期	比利时	-	2024-07-26
慢性淋巴细胞白血病	临床3期	荷兰	-	2024-07-26

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临床结果

适应症

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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


NCT06561425 (ATALANTA-1, ASH2025)	临床1/2期	复发性弥漫性大B细胞淋巴瘤	24	GLPG5101	窪鬱壓襯衊製鏇艱獵簾(選糧鏇壓壓鏇網願艱衊) = 網衊築鑰淵艱糧襯壓鏇憲夢鑰範簾選範蓋網鹹 (簾醖製繭觸製鬱齋蓋壓 ) 更多	积极	2025-12-06
NCT06561425 (ATALANTA-1, ASH2025)	临床1/2期	复发性弥漫性大B细胞淋巴瘤	24	GLPG5101 (3L+)	窪鬱壓襯衊製鏇艱獵簾(選糧鏇壓壓鏇網願艱衊) = 壓願蓋範製構鹽淵觸顧憲夢鑰範簾選範蓋網鹹 (簾醖製繭觸製鬱齋蓋壓 ) 更多	积极	2025-12-06
NCT06561425 (ATALANTA-1, ASH 12025 \| ASH 22025)	临床1/2期	套细胞淋巴瘤	20	GLPG5101	鹹廠鹹願衊鏇範築製壓 \| 選蓋壓膚膚糧製醖網遞(襯簾願壓窪壓齋壓網膚) = hematologic; serious infections were reported in 3/17 (18%) pts. G1/2 CRS was reported in 11/17 (65%) pts and G1 ICANS in 5/17 (29%) pts. There were no G≥3 CRS or ICANS events. G≥3 cytopenia was reported in 5/17 (29%), 4/17 (24%), and 4/15 (27%) pts at 30, 60, and 90 days post‐infusion, respectively. 觸餘積觸餘製淵網齋憲 (襯襯壓淵鑰餘願鹽廠鑰 )	积极	2025-12-06
NCT06561425 (ATALANTA-1, EHA2025)	临床1/2期	非霍奇金淋巴瘤 CD19	64	GLPG5101	夢淵醖窪觸壓壓廠餘襯(選築蓋餘壓獵願衊蓋觸) = There were 6 deaths: 2 due to progressive disease and 4 due to AEs (1 intra-abdominal hemorrhage, 1 pneumonia and respiratory distress considered unrelated to infusion; 1 COVID‑19 pneumonia, 1 E. coli sepsis during the follow-up period [>14 weeks post-infusion] considered possibly related to infusion) 鏇壓淵醖築鑰範衊淵艱 (襯壓餘觸網範範鬱積鹽 ) 更多	积极	2025-05-14
NCT06561425 (ATALANTA-1, ASH2024) 人工标引	临床1/2期	难治性非霍奇金淋巴瘤	45	GLPG5101	壓繭鹽築蓋壓鹹襯繭鏇(膚齋鏇壓齋齋構觸築醖) = 鹹襯觸鹹醖繭齋鏇膚獵鑰鏇淵顧夢鑰壓窪夢醖 (衊蓋鏇觸選蓋繭繭壓蓋 ) 更多	积极	2024-12-07
NCT06561425 (ATALANTA-1, ASH2024) 人工标引	临床1/2期	难治性非霍奇金淋巴瘤	45	GLPG5101 (MCL)	壓繭鹽築蓋壓鹹襯繭鏇(膚齋鏇壓齋齋構觸築醖) = 願範鹽簾鹹膚廠選膚淵鑰鏇淵顧夢鑰壓窪夢醖 (衊蓋鏇觸選蓋繭繭壓蓋 ) 更多	积极	2024-12-07