更新于：2024-06-19
GLPG-5201
更新于：2024-06-19
概要
基本信息
原研机构 |
在研机构 |
非在研机构- |
最高研发阶段临床2期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评- |
关联
1
项与 GLPG-5201 相关的临床试验A Phase I/II study to evaluate the feasibility, safety and preliminary efficacy of point-of-care manufactured anti-CD19 CAR T in subjects with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). - Euplagia-1
开始日期2022-02-21 |
申办/合作机构- |
100 项与 GLPG-5201 相关的临床结果
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100 项与 GLPG-5201 相关的转化医学
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100 项与 GLPG-5201 相关的专利（医药）
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132
项与 GLPG-5201 相关的文献（医药）2024-03-01·Advanced science (Weinheim, Baden-Wurttemberg, Germany)
CAR‐Aptamers Enable Traceless Enrichment and Monitoring of CAR‐Positive Cells and Overcome Tumor Immune Escape
Article
作者: Yang, Li-Ting ; Abudureheman, Tuersunayi ; Chen, Kaiming ; Duan, Cai-Wen ; Zhou, Hang ; Liang, Ai-Bin ; Zhu, Jian-Min ; Zheng, Wei-Wei
Abstract:
Chimeric antigen receptor (CAR)‐positive cell therapy, specifically with anti‐CD19 CAR‐T (CAR19‐T) cells, achieves a high complete response during tumor treatment for hematological malignancies. Large‐scale production and application of CAR‐T therapy can be achieved by developing efficient and low‐cost enrichment methods for CAR‐T cells, expansion monitoring in vivo, and overcoming tumor escape. Here, novel CAR‐specific binding aptamers (CAR‐ap) to traceless sort CAR‐positive cells and obtain a high positive rate of CAR19‐T cells is identified. Additionally, CAR‐ap‐enriched CAR19‐T cells exhibit similar antitumor capacity as CAR‐ab (anti‐CAR antibody)‐enriched CAR‐T cells. Moreover, CAR‐ap accurately monitors the expansion of CAR19‐T cells in vivo and predicts the prognosis of CAR‐T treatment. Essentially, a novel class of stable CAR‐ap‐based bispecific circular aptamers (CAR‐bc‐ap) is constructed by linking CAR‐ap with a tumor surface antigen (TSA): protein tyrosine kinase 7 (PTK7) binding aptamer Sgc8. These CAR‐bc‐aps significantly enhance antitumor cytotoxicity with a loss of target antigens by retargeting CAR‐T cells to the tumor in vitro and in vivo. Overall, novel CAR‐aptamers are screened for traceless enrichment, monitoring of CAR‐positive cells, and overcoming tumor cell immune escape. This provides a low‐cost and high‐throughput approach for CAR‐positive cell‐based immunotherapy.
2024-01-01·Journal of ethnopharmacology
The Qi Yin San Liang San decoction enhances anti-CD19 CAR-T cell function in the treatment of B-cell lymphomas
Article
作者: Zhang, Xiaotian ; Cui, Xinming ; Wang, Peipei ; Wang, Weijia ; Dong, Shi ; Lan, Ting ; Zhang, Liubo ; Gao, Can ; Jiang, Miao ; Wang, Jianxun ; Shi, Yuanyuan ; Li, Xiaorui ; Wang, Jiali
ETHNOPHARMACOLOGICAL RELEVANCE:
Adoptive T-cell therapy with anti-CD19 chimeric antigen receptor (CAR)-expressing T cells is a new approach for treating advanced B-cell malignancies. However, CAR-Tcell therapies for tumors are challenging due to tumor heterogeneity, cytokine release syndrome (CRS), and CAR-T cell exhaustion. The Qi Yin San Liang San (SLS) decoction has a significant curative effect in treating tumors and can improve clinical efficacy when combined with tumor immunotherapy. However, there has been no in vitro or in vivo pharmacodynamic evaluation of SLS in combination with immunotherapy, and the underlying immunological mechanism remains unclear.
AIM OF THE REVIEW:
The study objective was to determine the auxiliary effect and potential mechanism of SLS as an adjuvant treatment with anti-CD19 CAR-T cells for B-cell lymphomas.
MATERIALS AND METHODS:
Network pharmacology analyses, in vitro and in vivo studies, and transcriptome sequencing analyses were performed.
RESULTS:
Forty-two components were detected in SLS by HPLC. Sixteen pharmacologically active ingredients were analyzed by searching the TCMSP database. The predicted targets included IL-2, IL-6, IL-10, TNF-α, CASP7, and CASP9. In vitro studies revealed that SLS can dose-dependently promote the killing effect of unmodified T and anti-CD19 CAR-T cells against Raji cell lines. Meanwhile, SLS inhibited unmodified T and anti-CD19 CAR-T cell exhaustion, promoted anti-CD19 CAR-T cell proliferation, reduced the levels of IL-6, IL-10, and TNF-α, and increased granzyme B levels. In vivo studies, SLS effectively improved the anti-tumor function of anti-CD19 CAR-T cells, prolonged the survival of the mice, and reduced the levels of IL-6, GM-CSF, and IL-17. Subsequently, the transcriptomic analysis showed that SLS inhibited the IL-17 signaling pathway and the apoptosis signaling pathway of T cells. In addition, SLS downregulated the expression of IL-17A, IL-6, TNF-α, GM-CSF, S100A8, CASP 7, CASP 9, and CASP 10 in anti-CD19 CAR-T cells. SLS regulated the IL-17 signaling pathway and apoptosis signaling pathway in anti-CD19 CAR-T cells.
CONCLUSION:
SLS plays a potential auxiliary role in enhancing the function of anti-CD19 CAR T cells in the treatment of B-cell lymphoma, improving the killing ability of these cells, reducing the potential risk associated with inflammation, and providing synergistic and attenuating effects. The mechanism of SLS is partially mediated by the apoptosis and IL-17 signaling pathways (such as IL-17A, IL-6, TNF-α, GM-CSF, and Granzyme B).
2024-01-01·EClinicalMedicine
Donor-derived Anti-CD19 CAR T cells GC007g for relapsed or refractory B-cell acute lymphoblastic leukemia after allogeneic HSCT: a phase 1 trial
Article
作者: Yang, Luxin ; Shen, Lianjun ; Li, Wenling ; Liu, Lizhen ; Huang, He ; Zhao, Lu ; Cao, W William ; Ye, Yishan ; Wang, Dongrui ; Wang, Manning ; Wang, Lu ; Gao, Lei ; Gao, Shichun ; Zhang, Xi ; Lai, Xiaoyu ; Liu, Jia ; Luo, Yi
Background:
Although chimeric antigen receptor-modified T cells (CAR T) cell therapy has been widely reported in improving the outcomes of B-cell acute lymphoblastic leukemia (B-ALL), less research about the feasibility and safety of donor-derived CAR T after allogeneic hematopoietic stem cell transplantation (allo-HSCT) was reported.
Methods:
This phase 1 clinical trial aims to evaluate safety and efficacy of donor-derived anti-CD19 CAR T cells (GC007g) in B-ALL patients who relapsed after allo-HSCT. This trial is registered with ClinicalTrials.gov, NCT04516551.
Findings:
Between 15 March 2021 and 19 May 2022, fifteen patients were screened, three patients were excluded due to withdraw of consent, donor's reason, and death, respectively. Patients received donor-derived CAR T cells infusions at 6 × 105/kg (n = 3) or 2 × 106/kg (n = 6) dose level. The median time from HSCT to relapse was 185 days (range, 81-2063). The median age of patients was 31 years (range 21-48). Seven patients (77.8%) had BCR-ABL fusion gene. CAR T cells expanded in vivo and the median time to reach Cmax was 9 days (range, 7-11). One patient had hyperbilirubinemia after GC007g infusion which was defined as a dose-limiting toxicity. All patients experienced CRS and hematological adverse events. Three patients had acute graft-versus-host-disease (grade I, n = 1; grade II, n = 1; grade IV, n = 1) and all resolved after treatment. They received CAR T cells from matched sister, haploidentical matched father and sisiter, respectively. At 28 days after infusion, all patients achieved complete remission with/without incomplete hematologic recovery (CRi/CR) with undetectable MRD. At a median follow-up of 475 days (range 322-732), seven patients remained in CR/CRi while two had CD19-negative relapse. The overall response rates (ORR) were 100% (9/9), 88.9% (8/9), and 75% (6/8) at 3 month, 6 month, and 12 month, respectively. The 1-year progression-free and overall survival were 77.8% and 85.7%, respectively.
Interpretation:
GC007g expanded and induced durable remission in patients with B-ALL relapsed after allo-HSCT, with manageable safety profiles.
Funding:
Gracell Biotechnologies Inc.
21
项与 GLPG-5201 相关的新闻（医药）2024-05-16
Pictured: Healthcare worker carrying an IV bag/iStock, Sergey Mikheev
Belgian biotech Galapagos announced on Wednesday that it is enlisting Blood Centers of America in its strategic goal of decentralizing the manufacturing of CAR-T cell therapeutics in the United States.
The partners did not disclose the specific financial details of the deal but said it would give Galapagos access to Blood Centers of America’s (BCA) more than 50 community blood centers across 43 states, enabling the biotech to manufacture its CAR-T cancer therapies closer to treatment centers.
The agreement will also allow Galapagos to deploy its decentralized CAR-T manufacturing platform in the U.S., with the ability to deliver “fresh, fit cells with a vein-to-vein time of seven days,” according to the announcement.
Galapagos CEO Paul Stoffels in a statement called Wednesday’s agreement a “major milestone” for the biotech’s expansion in the U.S., enabling it to “establish centers for support of our pivotal studies, with the potential to be used for commercial introduction.”
The partnership will also allow Galapagos to “efficiently scale up decentralized CAR-T therapy manufacturing” by leveraging BCA’s extensive nationwide network of blood centers, whose existing infrastructure will help “harmonize operations” across the U.S.
Through the collaboration, Galapagos is looking to solve many of what it calls the “limitations” of currently available CAR-T therapies and give physicians more control over treatment while also improving patient experience.
Galapagos said it will use BCA’s apheresis capacities as needed. The network of blood centers will also help support site initiations and onboarding, according to the announcement, which will speed up Galapagos’ campaign to decentralize its CAR-T therapies and ensure quality.
Galapagos is currently working on three clinical CAR-T programs. The most mature of these is GLPG5101, which is a CD19-directed therapy currently in Phase II for relapsed or refractory non-Hodgkin lymphoma. It is running another CD19 program called GLPG5201, which is in Phase I for relapsed or refractory chronic lymphocytic leukemia and Richter transformation.
The third program is GLPG5301, a BCMA-directed CAR-T therapy undergoing Phase I assessment for relapsed or refractory multiple myeloma.
The BCA deal follows Galapagos’ previous agreement with Thermo Fisher Scientific, announced in January 2024, for manufacturing and logistics support for the biotech’s hemato-oncology programs in the San Francisco area. In November 2023, Galapagos entered into a similar but separate agreement with Landmark Bio, which will serve as Galapagos’ strategic point-of-care manufacturing partner in Boston.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
临床1期临床2期免疫疗法细胞疗法
2024-05-02
Advanced potentially best-in-class cell therapy and small molecule R&D pipeline comprising four clinical assets and >15 discovery programs in oncology and immunologyExecuted agreements with BridGene Biosciences and Thermo Fisher Scientific, and investment in Frontier MedicinesTransferred Jyseleca® business to Alfasigma S.p.A., freeing up resources to invest in growth areasGroup net revenues in the first quarter of €100 millionCash and current financial investments of €3.6 billion on 31 March 2024Reconfirmed 2024 cash burni guidance of €280 million to €320 million, not including potential business development opportunities
Webcast presentation with management on 3 May 2024, at 14:00 CET / 8:00 am ET, www.glpg.com
Mechelen, Belgium; 2 May 2024, 22:01 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) today announced its first quarter 2024 financial results and provided a business update and outlook for the remainder of 2024.
“We are moving forward with a renewed focus, a differentiated and expanding R&D pipeline, and competitive technology platforms to bring innovation to patients around the world. We continue to build a strong team of global leaders and we expanded our U.S. footprint,” said Dr. Paul Stoffels1, CEO and Chairman of the Board of Directors of Galapagos. “As we look forward to the year ahead, we strive to make important progress in our clinical programs, achieving regulatory milestones to initiate clinical development of our CAR-T programs in the U.S., and expanding our decentralized CAR-T network in the U.S. and Europe. In parallel, we will continue to build our early-stage pipeline of cell therapy and small molecule investigational medicines in oncology and immunology, both internally and through external partnerships.”
Thad Huston, CFO and COO of Galapagos, concluded: “We are committed to investing in our internal R&D pipeline, while we continue to actively pursue business development opportunities. We are broadening our oncology and immunology portfolio and will capitalize on opportunities that are aligned with our strategic objectives.”
First quarter 2024 and recent business update
At the Annual and Extraordinary Shareholders’ Meetings held on 30 April 2024, all proposed resolutions were approved (see: press release of 30 April 2024). Presented our innovative decentralized CAR-T manufacturing and 7-day vein-to-vein approach to hematological cancer care at the EBMT-EHA and EBMT annual meetings with new preliminary translational and previously published encouraging clinical data of our CD19 CAR-T candidates. The data support the promise of GLPG5101 in relapsed/refractory non-Hodgkin lymphoma (NHL) and GLPG5201 in relapsed/refractory chronic lymphocytic leukemia (CLL) and Richter transformation (RT), in addressing the critical needs of patients facing poor prognosis. Discontinued the development of CD19 CAR-T candidate in refractory systemic lupus erythematosus. Transferred the Jyseleca® business to Alfasigma per 31 January 2024. Signed a strategic collaboration and license agreement with BridGene Biosciences to further strengthen our growing early-stage oncology precision medicine pipeline. Entered into a strategic collaboration agreement with Thermo Fisher Scientific for decentralized CAR-T manufacturing in the San Francisco area.Participated with an investment of $40.0 million in the Series C financing round of precision oncology pioneer Frontier Medicines.
Financial performanceFirst quarter 2024 key figures (consolidated)(€ millions, except basic & diluted income per share)
Three months ended 31 March
% Change
2024
2023
Total net revenues
62.4
58.6
+7%
Cost of sales
(2.5)
-
R&D expenses
(71.6)
(52.5)
+36%
G&Aii and S&Miii expenses
(30.8)
(27.1)
+14%
Other operating income
9.4
6.8
+37%
Operating loss
(33.1)
(14.2)
Fair value adjustments and net exchange differences
30.6
(9.7)
Net other financial result
25.4
12.5
Income taxes
0.6
0.2
Net profit/loss (-) from continuing operations
23.5
(11.2)
Net profit from discontinued operations, net of tax
66.7
34.4
Net profit of the period
90.2
23.2
Basic and diluted earnings per share (€)
1.4
0.4
Current financial investments, cash & cash equivalents
3,557.9
4,005.5 (*)
(*) Including €15.4 million of net accrued interest income
DETAILS OF THE FINANCIAL RESULTS OF THE FIRST THREE MONTHS OF 2024As a consequence of the transfer of our Jyseleca® business to Alfasigma, the revenues and costs related to Jyseleca® for the first quarter of 2024 are presented separately from the results of our continuing operations in the line ‘Net profit from discontinued operations, net of tax’ in our consolidated income statement. The comparative first quarter of 2023 has been restated accordingly for the presentation of the results related to the Jyseleca® business.
Results from our continuing operationsTotal operating loss from continuing operations for the three months ended 31 March 2024 was €33.1 million, compared to an operating loss of €14.2 million for the three months ended 31 March 2023.
Total net revenues for the three months ended 31 March 2024 amounted to €62.4 million, compared to €58.6 million for the three months ended 31 March 2023. The revenue recognition related to the exclusive access rights granted to Gilead for our drug discovery platform amounted to €57.6 million for the first three months of both 2024 and 2023. Our deferred income balance at 31 March 2024 includes €1.2 billion allocated to our drug discovery platform that is recognized linearly over the remaining period of our 10-year collaboration. Cost of sales for the three months ended 31 March 2024 amounted to €2.5 million and related to the supply of Jyseleca® to Alfasigma under the transition agreement. The related revenues are booked in total net revenues.R&D expenses in the first three months of 2024 amounted to €71.6 million, compared to €52.5 million for the first three months of 2023. This increase was primarily explained by higher costs for CAR-T and small molecule programs in oncology.G&A and S&M expenses amounted to €30.8 million in the first three months of 2024, compared to €27.1 million in the first three months of 2023. This increase was primarily due to an increase in legal and professional fees, mainly related to business development activities. Other operating income amounted to €9.4 million in the first three months of 2024, compared to €6.8 million for the same period last year. This increase is mainly due to €2.2 million of recharges for transition services to Alfasigma for the months of February and March 2024.
Net financial income in the first three months of 2024 amounted to €56.0 million, compared to net financial income of €2.8 million for the first three months of 2023.
Fair value adjustments and net currency exchange gains in the first three months of 2024 amounted to €30.6 million, compared to fair value adjustments and net currency exchange losses of €9.7 million for the first three months of 2023, and were primarily attributable to €12.4 million of unrealized currency exchange gains on our cash and cash equivalents and current financial investments at amortized cost in U.S. dollars, and to €17.6 million of positive changes in fair value of current financial investments.Net other financial income in the first three months of 2024 amounted to €25.4 million, compared to net other financial income of €12.5 million for the first three months of 2023, and was primarily attributable to €25.2 million of interest income, which increased significantly due to the increase in interest rates.
Net profit from continuing operations for the first three months of 2024 was €23.5 million, compared to a net loss from continuing operations of €11.2 million for the first three months of 2023.Results from discontinued operations
(€ millions)
Three months ended 31 March
% Change
2024
2023
Product net sales
11.3
26.7
-58%
Collaboration revenues
26.0
93.6
-72%
Total net revenues
37.3
120.3
-69%
Cost of sales
(1.9)
(3.6)
-47%
R&D expenses
(13.4)
(51.0)
-74%
G&A and S&M expenses
(9.2)
(31.1)
-71%
Other operating income
53.9
1.5
Operating profit
66.7
36.1
Net financial result
0.1
(1.3)
Income taxes
(0.1)
(0.4)
Net profit from discontinued operations
66.7
34.4
Total operating profit from discontinued operations amounted to €66.7 million in the first three months of 2024, compared to an operating profit of €36.1 million in the same period last year.
Product net sales of Jyseleca® in Europe were €11.3 million for the first three months of 2024 consisting of sales to customers in January 2024. Product net sales to customers for the first three months of 2023 amounted to €26.7 million. As from 1 February 2024, all economics linked to the sales of Jyseleca® in Europe are to the benefit of Alfasigma.Collaboration revenues for the development of filgotinib with Gilead amounted to €26.0 million for the first three months of 2024, compared to €93.6 million for the same period last year. The sale of the Jyseleca® business to Alfasigma on 31 January 2024 led to the full recognition in revenue of the remaining deferred income related to filgotinib. Cost of sales related to Jyseleca® net sales were €1.9 million for the first three months of 2024. Cost of sales related to Jyseleca® net sales for the first three months of 2023 amounted to €3.6 million. R&D expenses for the development of filgotinib for the first three months of 2024 amounted to €13.4 million, compared to €51.0 million in the first three months of 2023. As from 1 February 2024, all filgotinib development expenses are recharged to Alfasigma.G&A and S&M expenses related to the Jyseleca® business amounted to €9.2 million in the first three months of 2024, compared to €31.1 million in the first three months of 2023. As from 1 February 2024, all remaining G&A and S&M expenses relating to Jyseleca® are recharged to Alfasigma.Other operating income for the first three months of 2024 amounted to €53.9 million (€1.5 million for the same period last year) and comprised €53.2 million related to the preliminary calculation of the gain on the sale of the Jyseleca® business to Alfasigma. This preliminary result at 31 March 2024 of the transaction is considering the following elements:
€50.0 million of upfront payment received at closing of the transaction of which €40.0 million was paid on an escrow account. This amount will be kept in escrow for a period of one year after the closing date of 31 January 2024. We gave customary representations and warranties which are capped and limited in time (at 31 March 2024, this €40.0 million is presented as “Escrow account” in our balance sheet).€13.2 million of cash received at closing of the transaction from Alfasigma for preliminary settlement for net cash and working capital and an additional adjustment estimated at €1.1 million related to settlement for completion accounts.€47.0 million of estimated fair value on 31 January 2024 of the future earn-outs payable by Alfasigma to us (the fair value of these future earn-outs at 31 March 2024 is presented on the lines “Non-current contingent consideration receivable” and “Trade and other receivables”).€40.0 million of liability towards Alfasigma on 31 January 2024 for R&D cost contributions of which €5.0 million was paid in the first quarter of 2024 (at 31 March 2024, €35.0 million of liabilities for R&D cost contribution is presented in our balance sheet in “Other non-current liabilities” for €10.0 million and on the line “Trade and other liabilities” for €25.0 million).
Net profit from discontinued operations related to Jyseleca® amounted to €66.7 million for the first three months of 2024, compared to a net profit amounting to €34.4 million for the first three months of 2023.
Cash, cash equivalents and current financial investments totaled €3,557.9 million as of 31 March 2024, as compared to €3,684.5 million as of 31 December 2023. Total net decrease in cash and cash equivalents and current financial investments amounted to €126.6 million during the first three months of 2024, compared to a net decrease of €88.6 million during the first three months of 2023. This net decrease was composed of (i) €125.2 million of operational cash burn, (ii) €36.9 million for the acquisition of financial assets held at fair value through profit or loss, (iii) €38.7 million of net cash in related to the sale of the Jyseleca® business to Alfasigma of which €40.0 million has been transferred to an escrow account, offset by (iv) €36.8 million of positive exchange rate differences, positive changes in fair value of current financial investments and variation in accrued interest income.
Outlook 2024
Financial outlook
For the full year 2024, we reconfirm our cash burn guidance of €280 million to €320 million (compared to €414.8 million for the full year 2023), not including future potential business development opportunities.
R&D Outlook We are progressing three CAR-T Phase 1/2 studies in hemato-oncology:
GLPG5101 in relapsed/refractory NHL; GLPG5201 in relapsed/refractory CLL, and RT; andGLPG5301 in relapsed/refractory multiple myeloma.
We are progressing two Phase 2 studies with TYK2 inhibitor GLPG3667, in systemic lupus erythematosus and in dermatomyositis. We plan to file Investigational New Drug applications in the U.S. to progress clinical development of our CAR-T programs in hemato-oncology. We will further upscale our CAR-T network and operations in the U.S. and Europe.
Business development
We will continue to evaluate business development opportunities that fit our strategy to accelerate and expand our pipeline of potential best-in-class investigational medicines in our therapeutic focus areas of oncology and immunology.
Conference call and webcast presentationWe will host a conference call and webcast presentation on 3 May 2024, at 14:00 CET / 8:00 am ET. To participate in the conference call, please register in advance using this link. Dial-in numbers will be provided upon registration. The conference call can be accessed 10 minutes prior to the start of the call by using the conference access information provided in the email received after registration, or by selecting the “call me” feature.
The live webcast is available on glpg.com or via the following link. The archived webcast will be available for replay shortly after the close of the call on the investor section of the website.
Financial calendar 2024
1 August 202430 October 2024
Half-year 2024 resultsThird quarter 2024 results
(webcast: 2 August 2024)(webcast: 31 October 2024)
About GalapagosWe are a biotechnology company with operations in Europe and the U.S. dedicated to developing transformational medicines for more years of life and quality of life. Focusing on high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class small molecules, CAR-T therapies, and biologics in oncology and immunology. With capabilities from lab to patient, including a decentralized CAR-T manufacturing network, we are committed to challenging the status quo and delivering results for our patients, employees, and shareholders. For additional information, please visit www.glpg.com or follow us on LinkedIn or X (formerly Twitter).
For further information, please contact:
Media inquiries:Marieke Vermeersch +32 479 490 603 media@glpg.com
Jennifer Wilson + 44 7539 359 676media@glpg.com
Investor inquiries:Sofie Van Gijsel +1 781 296 1143ir@glpg.comSandra Cauwenberghs +32 495 58 46 63ir@glpg.com
Forward-looking statementsThis press release contains forward-looking statements, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as “believe,” “anticipate,” “expect,” ”intend,” “plan,” “seek,” “upcoming,” “future,” “estimate,” “may,” “will,” “could,” “would,” “potential,” “forward,” “goal,” “next,” “continue,” “should,” “encouraging,” “aim,” “progress,” “remain,” “explore,” “further,” as well as similar expressions. These statements include, but are not limited to, the guidance from management regarding our financial results (including guidance regarding the expected operational use of cash for the fiscal year 2024), statements regarding our regulatory outlook, statements regarding the amount and timing of potential future milestones, and other payments, statements regarding our R&D plans, strategy and outlook, including progress on our oncology or immunology portfolio, our CAR-T-portfolio and our SIKi-portfolio, and potential changes of such plans, statements regarding our pipeline and complementary technology platforms facilitating future growth, statements regarding our regulatory and R&D outlook, statements regarding the expected timing, design and readouts of ongoing and planned clinical trials, including but not limited to (i) GLPG3667 in SLE and DM, (ii) GLPG5101 in rrNHL, (iii) GLPG5201 in rrCLL, and (iv) GLPG5301 in rrMM, statements regarding our commercialization efforts for filgotinib, our product candidates, and any of our future approved products, if any, statements regarding our expectations on commercial sales of any of our product candidates (if approved), statements related to the timing for submission of an Investigational New Drug application and the clinical development of our CAR-T program, and statements related to our portfolio goals and business plans. Galapagos cautions the reader that forward-looking statements are based on our management’s current expectations and beliefs and are not guarantees of future performance. Forward-looking statements may involve known and unknown risks, uncertainties and other factors which might cause our actual results, financial condition and liquidity, performance or achievements, or the industry in which we operate, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if Galapagos’ results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Such risks include, but are not limited to, the risk that our expectations and management’s guidance regarding our 2024 operating expenses, cash burn and other financial estimates may be incorrect (including because one or more of our assumptions underlying our revenue and expense expectations may not be realized), the risk that ongoing and future clinical trials may not be completed in the currently envisaged timelines or at all, the inherent risks and uncertainties associated with competitive developments, clinical trials, recruitment of patients, product development activities and regulatory approval requirements (including the risk that data from our ongoing and planned clinical research programs in DM, SLE, relapsed/refractory NHL, rrCLL, rrMM and other immunologic and oncologic indications or any other indications or diseases, may not support registration or further development of our product candidates due to safety or efficacy concerns or other reasons), risks related to the acquisitions of CellPoint and AboundBio, including the risk that we may not achieve the anticipated benefits of the acquisitions of CellPoint and AboundBio, the risk that the preliminary and topline data from the ATALANTA-1, EUPLAGIA-1 and PAPILIO-1-studies may not be reflective of the final data, risks related to our reliance on collaborations with third parties (including, but not limited to, our collaboration partners Gilead, Lonza, BridGene Biosciences and Thermo Fisher Scientific), the risk that the transfer of the Jyseleca® business will not have the currently expected results for our business and results of operations, the risk that our plans with respect to CAR-T may not be achieved on the currently anticipated timeline or at all, the risk that our estimates of the commercial potential of our product candidates or expectations regarding the costs and revenues associated with the commercialization rights may be inaccurate, the risk that we will not be able to continue to execute on our currently contemplated business plan and/or will revise our business plan, the risks related to our strategic transformation, including the risk that we may not achieve the anticipated benefits of such exercise on the currently envisaged timeline or at all. A further list and description of these risks, uncertainties and other risks can be found in our filings and reports with the Securities and Exchange Commission (SEC), including in our most recent annual report on Form 20-F filed with the SEC and our subsequent filings and reports filed with the SEC. Given these risks and uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. In addition, even if the result of our operations, financial condition and liquidity, or the industry in which we operate are consistent with such forward-looking statements, they may not be predictive of results, performance or achievements in future periods. These forward-looking statements speak only as of the date of publication of this release. We expressly disclaim any obligation to update any such forward-looking statements in this release to reflect any change in our expectations or any change in events, conditions or circumstances, unless specifically required by law or regulation.
Addendum
Consolidated statements of income and comprehensive income/loss (-) (unaudited)
Consolidated income statement
Three months ended31 March
(thousands of €, except per share data)
2024
2023
Total net revenues
62,432
58,574
Cost of sales
(2,548)
-
Research and development expenses
(71,614)
(52,559)
Sales and marketing expenses
(2,907)
(1,017)
General and administrative expenses
(27,881)
(26,034)
Other operating income
9,387
6,838
Operating loss
(33,131)
(14,198)
Fair value adjustments and net currency exchange differences
30,613
(9,697)
Other financial income
25,707
13,358
Other financial expenses
(254)
(844)
Profit/loss (-) before tax
22,935
(11,380)
Income taxes
568
185
Net profit/loss (-) from continuing operations
23,503
(11,195)
Net profit from discontinued operations, net of tax
66,717
34,402
Net profit
90,220
23,207
Net profit attributable to:
Owners of the parent
90,220
23,207
Basic and diluted earnings per share
1.37
0.35
Basic and diluted earnings/loss (-) per share from continuing operations
0.36
(0.17)
Consolidated statement of comprehensive income/loss (–)
Three months ended31 March
(thousands of €)
2024
2023
Net profit
90,220
23,207
Items that will not be reclassified subsequently to profit or loss:
Re-measurement of defined benefit obligation
74
-
Items that may be reclassified subsequently to profit or loss:
Translation differences, arisen from translating foreign activities
79
(59)
Realization of translation differences upon sale of foreign operations
4,095
-
Other comprehensive income/loss (-), net of income tax
4,248
(59)
Total comprehensive income attributable to:
Owners of the parent
94,468
23,148
Total comprehensive income attributable to owners of the parent arises from:
Continuing operations
23,392
(11,179)
Discontinued operations
71,076
34,327
Total comprehensive income, net of income tax
94,468
23,148
Consolidated statements of financial position (unaudited)
(thousands of €)
31 March 2024
31 December 2023
Assets
Goodwill
69,715
69,557
Intangible assets other than goodwill
125,998
127,906
Property, plant and equipment
125,059
126,321
Deferred tax assets
1,107
1,126
Non-current R&D incentives receivables
144,775
141,252
Non-current contingent consideration receivable
42,739
-
Other non-current assets
65,516
29,645
Non-current assets
574,909
495,807
Inventories
80,558
73,978
Trade and other receivables
54,611
28,449
Current R&D incentives receivables
37,436
37,436
Current financial investments
3,484,560
3,517,698
Cash and cash equivalents
73,372
166,803
Escrow account
40,222
-
Other current assets
15,711
15,140
Current assets from continuing operations
3,786,470
3,839,504
Assets in disposal group classified as held for sale
-
22,085
Total current assets
3,786,470
3,861,589
Total assets
4,361,379
4,357,396
Equity and liabilities
Share capital
293,937
293,937
Share premium account
2,736,994
2,736,994
Other reserves
(5,530)
(5,890)
Translation differences
2,687
(1,201)
Accumulated losses
(133,080)
(228,274)
Total equity
2,895,008
2,795,566
Retirement benefit liabilities
2,270
2,293
Deferred tax liabilities
22,728
23,607
Non-current lease liabilities
3,837
4,944
Other non-current liabilities
42,887
31,570
Non-current deferred income
1,012,435
1,071,193
Non-current liabilities
1,084,157
1,133,607
Current lease liabilities
4,140
4,652
Trade and other liabilities
145,551
135,201
Current tax payable
62
56
Current deferred income
232,461
256,270
Current liabilities from continuing operations
382,214
396,179
Liabilities directly associated with assets in disposal group classified as held for sale
-
32,044
Total current liabilities
382,214
428,223
Total liabilities
1,466,371
1,561,830
Total equity and liabilities
4,361,379
4,357,396
Consolidated cash flow statements (unaudited)
Three months ended31 March
(thousands of €)
2024
2023
Net profit of the period
90,220
23,207
Adjustment for non-cash transactions
(13,367)
34,340
Adjustment for items to disclose separately under operating cash flow
(25,638)
(9,972)
Adjustment for items to disclose under investing and financing cash flows
(57,736)
(2,426)
Change in working capital other than deferred income
(46,217)
8,273
Decrease in deferred income
(81,974)
(150,517)
Cash used in operations
(134,712)
(97,095)
Interest paid
(432)
(2,944)
Interest received
13,461
5,823
Corporate taxes paid
(751)
(651)
Net cash flows used in operating activities
(122,434)
(94,868)
Purchase of property, plant and equipment
(3,742)
(4,264)
Purchase of and expenditure in intangible fixed assets
(2,520)
(20)
Purchase of current financial investments
(420,158)
(1,008,866)
Investment income received related to current financial investments
4,653
2,345
Sale of current financial investments
489,651
722,137
Cash out from sale of subsidiaries, net of cash disposed
(1,339)
-
Acquisition of financial assets held at fair value through profit or loss
(36,880)
-
Net cash flows generated from/used in (-) investing activities
29,665
(288,669)
Payment of lease liabilities
(1,168)
(1,960)
Proceeds from capital and share premium increases from exercise of subscription rights
-
1,770
Net cash flows used in financing activities
(1,168)
(190)
Decrease in cash and cash equivalents
(93,937)
(383,727)
Cash and cash equivalents at beginning of the year
166,810
508,117
Decrease in cash and cash equivalents
(93,937)
(383,727)
Effect of exchange rate differences on cash and cash equivalents
499
(254)
Cash and cash equivalents at end of the period
73,372
124,135
Consolidated statements of changes in equity (unaudited)
(thousands of €)
Share capital
Share premium account
Translation differences
Other reserves
Accumulated losses
Total
On 1 January 2023
293,604
2,735,557
(1,593)
(4,853)
(496,689)
2,526,026
Net profit
23,207
23,207
Other comprehensive income/loss (-)
(111)
52
(59)
Total comprehensive income/loss (-)
(111)
52
23,207
23,148
Share-based compensation
13,663
13,663
Exercise of subscription rights
333
1,437
1,770
On 31 March 2023
293,937
2,736,994
(1,704)
(4,801)
(459,821)
2,564,604
On 1 January 2024
293,937
2,736,994
(1,201)
(5,890)
(228,274)
2,795,566
Net profit
90,220
90,220
Other comprehensive income
3,888
360
4,248
Total comprehensive income
3,888
360
90,220
94,468
Share-based compensation
4,974
4,974
On 31 March 2024
293,937
2,736,994
2,687
(5,530)
(133,080)
2,895,008
1 Throughout this press release, ‘Dr. Paul Stoffels’ should be read as ‘Dr. Paul Stoffels, acting via Stoffels IMC BV’
i The operational cash burn (or operational cash flow if this liquidity measure is positive) is equal to the increase or decrease in our cash and cash equivalents (excluding the effect of exchange rate differences on cash and cash equivalents), minus:• the net proceeds, if any, from share capital and share premium increases included in the net cash flows generated from/used in (-) financing activities• the net proceeds or cash used, if any, related to the acquisitions or disposals of businesses; the acquisition of financial assets held at fair value through profit or loss; the movement in restricted cash and movement in current financial investments, if any, the cash advances and loans given to third parties, if any, included in the net cash flows generated from/used in (-) investing activities• the cash used for other liabilities related to the acquisition of businesses, if any, included in the net cash flows generated from/used in (-) operating activities.This alternative liquidity measure is in our view an important metric for a biotech company in the development stage. The operational cash burn for the first three months of 2024 amounted to €125.2 million and can be reconciled to our cash flow statement by considering the decrease in cash and cash equivalents of €93.9 million, adjusted by (i) the net sale of current financial investments amounting to €69.5 million, (ii) the cash-out related to the sale of subsidiaries of €1.3 million, and (iii) the acquisition of financial assets held at fair value through profit or loss of €36.9 million.ii General and administrativeiii Sales and marketing
Attachment
Galapagos reports first quarter 2024 financial results
引进/卖出财报临床2期细胞疗法
2024-04-04
Two oral presentations and one poster on encore preliminary data from Phase 1/2 CD19 CAR-T studies in non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL) / Richter transformation (RT)
Mechelen, Belgium; 4 April 2024, 22:01 CET – Galapagos NV (Euronext & NASDAQ: GLPG) today announced that four abstracts, including two oral presentations on encore preliminary clinical and translational data for its seven-day vein-to-vein CAR-T product candidates GLPG5101 and GLPG5201, will be presented at the 50th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT) to be held in Glasgow, UK, on 14-17 April 2024.
ATALANTA-1 and EUPLAGIA-1 are ongoing Phase 1/2 open-label, multi-center studies designed to assess the safety, efficacy and feasibility of point-of-care manufactured GLPG5101 and GLPG5201 in patients with relapsed/refractory NHL, and relapsed/refractory CLL and RT, respectively. The primary objective of the Phase 1 part of the studies is to evaluate the safety and preliminary efficacy to determine the recommended dose for the Phase 2 part of the study. The primary objective of the Phase 2 part of the studies is to assess the Objective Response Rate (ORR) and the secondary objectives include the analysis of the Complete Response (CR), duration of response, progression free survival, overall survival, safety, pharmacokinetic profile, and feasibility of point-of-care manufacturing. GLPG5101 and GLPG5201 are second generation anti-CD19/4-1BB CAR-T product candidates, administered as a single fixed intravenous dose.
“We are committed to accelerating breakthrough innovations to extend the reach of CAR-T therapies to patients with rapidly progressing cancers,” said Dr. Jeevan Shetty, M.D., Head of Clinical Development Oncology at Galapagos. “We believe that the preliminary safety and efficacy data from our ongoing Phase 1/2 studies with our CD19 CAR-T therapy candidates in patients with relapsed/refractory NHL, CLL and RT, combined with our unique, innovative decentralized manufacturing approach that enables a seven-day vein-to-vein time, support the promise of GLPG5101 and GLPG5201 in addressing the critical needs of patients facing poor prognosis.”
The following table provides a summary of Galapagos’ presentations at EBMT 2024:
Abstract Title
Authors/Presenter
Presentation date/time
Galapagos encore abstracts
Seven-Day Vein-to-Vein Point-of-Care Manufactured CD19 CAR T-Cell Therapy (GLPG5101) in Relapsed/Refractory Non-Hodgkin Lymphoma (NHL): Results from the Phase 1 ATALANTA-1 Trial
Marie José Kersten, Kirsten Saevels, Sophie Servais, Yves Beguin, Joost S.P. Vermaat, Eva Santermans, Stavros Milatos, Maike Spoon, Marte C. Liefaard, Claire Vennin, Margot J. Pont, Anna D.D. van Muyden, Maria T. Kuipers, Sébastien Anguille
Oral presentation number: OS16-04Date: 17 April, 12:57-13:06 (session runs 12:30-13:45)Session: Oral Session 16: CAR-T outcomes in ALL
Seven-Day Vein-to-Vein Point-of-Care–Manufactured CD19 CAR T-Cell Therapy (GLPG5201) in Relapsed/Refractory Chronic Lymphocytic Leukemia Including Richter Transformation: Results from the Phase 1 EUPLAGIA-1 Study
Valentin Ortiz-Maldonado, Nuria Martinez-Cibrian, Julio Delgado, Sergi Betriu, Leticia Alserawan, Ana Triguero, Nadia Verbruggen, Maike Spoon, Marte C. Liefaard, Anna D.D. van Muyden, Natalia Tovar
Oral presentation number: OS16-05Date: 17 April, 13:06-13:15 (session runs 12:30-13:45)Session: Oral Session 16: CAR-T outcomes in ALL
EUPLAGIA-1: Seven-Day Vein-to-Vein Point-of-Care Manufactured GLPG5201 Anti-CD19 CAR-T Cells Display Early Phenotypes in Relapsed/Refractory CLL, including RT
Esmée P. Hoefsmit, Sandra Blum, Claire Vennin, Kirsten Van Hoorde, Sergi Betriu,Leticia Alserawan, Julio Delgado, Nadia Verbruggen, Anna D.D. van Muyden, Henriëtte Rozema, Ruiz Astigarraga, Margot J. Pont
Poster number: A073Date: 15 April, 18:00-19:00Session: Printed poster: CAR-based Cellular Therapy - Clinical
PAPILIO-1: Phase 1/2, Multicenter, Open-Label Study to Evaluate Feasibility, Safety and Efficacy of Point-of-Care–Manufactured Anti-BCMA CAR T-Cell Therapy (GLPG5301) in Relapsed/Refractory Multiple Myeloma
Niels W.C.J. van de Donk, Sébastien Anguille, Jo Caers, Marte C. Liefaard, Christian Jacques, Anna D.D. van Muyden
Poster number: P049Date: 14 April, 08:30-18:00Session: ePoster: CAR-based Cellular Therapy - Clinical
About Galapagos’ decentralized CAR-T manufacturing platform Galapagos’ decentralized, innovative CAR T-cell manufacturing platform near the point-of-care offers the potential for the administration of fresh, fit cells with a vein-to-vein time of seven days, greater physician control and a significantly improved patient experience. The platform consists of an end-to-end xCellit® workflow management and monitoring software system, a decentralized, functionally closed, automated manufacturing platform for cell therapies (using Lonza’s Cocoon®) and a proprietary quality control testing and release strategy.
About the ATALANTA-1 study (EudraCT 2021-003272-13)ATALANTA-1 is an ongoing Phase 1/2, open-label, multicenter study to evaluate the safety, efficacy and feasibility of point-of-care manufactured GLPG5101, a CD19 CAR-T product candidate, in patients with relapsed/refractory non-Hodgkin lymphoma (rrNHL). GLPG5101 is a second generation anti-CD19/4-1BB CAR-T product candidate, administered as a single fixed intravenous dose. The primary objective of the Phase 1 part of the study is to evaluate the safety and preliminary efficacy to determine the recommended dose for the Phase 2 part of the study. Secondary objectives include assessment of efficacy and feasibility of near the point-of-care manufacturing of GLPG5101. The dose levels that were evaluated in Phase 1 are 50x106 (DL1) and 110x106 (DL2) and 250x106 (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 (CR), duration of response, progression free survival, overall survival, safety, pharmacokinetic profile, and the feasibility of point-of-care manufacturing. Each enrolled patient will be followed for 24 months.
About the EUPLAGIA-1 study (EudraCT 2021-003815-25)EUPLAGIA-1 is an ongoing Phase 1/2 open-label, multi-center study evaluating the safety, efficacy and feasibility of point-of-care manufactured GLPG5201, a CD19 CAR-T product candidate, in patients with relapsed/refractory chronic lymphocytic leukemia (rrCLL) and small cell lymphocytic lymphoma (rrSLL), with or without Richter transformation (RT). GLPG5201 is a second generation anti-CD19/4-1BB CAR-T product candidate, administered as a single fixed intravenous dose. Patients with CD19+ rrCLL or rrSLL with ≥2 lines of prior therapy are eligible to participate, and patients with RT are eligible regardless of prior therapy. The primary objective of the Phase 1 part of the study is to evaluate the safety and preliminary efficacy to determine the recommended dose for the Phase 2 part of the study. The dose levels that were evaluated in the Phase 1 part of the study are 35x106 (DL1) and 100x106 (DL2) CAR+ viable T cells. The primary objective of the Phase 2 part of the study is to assess the Objective Response Rate (ORR) and the secondary objectives include the analysis of the Complete Response (CR), duration of response, progression free survival, overall survival, safety, pharmacokinetic profile, and feasibility of point-of-care manufacturing.
About GalapagosWe are a biotechnology company with operations in Europe and the US dedicated to developing transformational medicines for more years of life and quality of life. Focusing on high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class small molecules, CAR-T therapies, and biologics in oncology and immunology. With capabilities from lab to patient, including a decentralized, point-of-care CAR-T manufacturing network, we are committed to challenging the status quo and delivering results for our patients, employees and shareholders. For additional information, please visit www.glpg.com or follow us on LinkedIn or X (formerly Twitter).
Contact
Media inquiries:Marieke Vermeersch +32 479 490 603 media@glpg.com
Jennifer Wilson + 44 7539 359 676media@glgp.com
Investor inquiries:Sofie Van Gijsel +1 781 296 1143ir@glpg.comSandra Cauwenberghs +32 495 58 46 63ir@glpg.com
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,” as well as similar expressions. Forward-looking statements contained in this release include, but are not limited to, statements regarding preliminary, interim and topline data from the EUPLAGIA-1 and ATALANTA-1 studies and other analyses related to Galapagos’ CD19 CAR-T program, statements related to Galapagos’ plans, expectations and strategy with respect to the EUPLAGIA-1 and ATALANTA-1 studies, and statements regarding the expected timing, design and readouts of the EUPLAGIA-1 and ATALANTA-1 studies, including the expected recruitment for such trials. 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 preliminary or interim clinical results may not be replicated in ongoing or subsequent clinical trials; the risk that ongoing and future clinical studies with GLPG5201 and 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 GLPG5201 and GLPG5101 due to safety, efficacy or other reasons), Galapagos' reliance on collaborations with third parties (including its collaboration partner Lonza) and that Galapagos’ estimations regarding its GLPG5201 and GLPG5101 development programs and regarding the commercial potential of GLPG5201 and 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 2022 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.
Attachment
GLPG PR_EBMT_ENG
细胞疗法临床1期免疫疗法
100 项与 GLPG-5201 相关的药物交易
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研发状态
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 淋巴细胞白血病 | 临床2期 | - | 2023-02-10 | |
| 小淋巴细胞淋巴瘤 | 临床2期 | 西班牙 | 2022-02-21 | |
| 慢性淋巴细胞白血病 | 临床2期 | - | - |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
临床1期 | 慢性淋巴细胞白血病 CD19 | 14 | 鏇膚壓範製築獵衊築醖(淵鹹蓋齋淵築顧鑰鏇積) = most treatment emergent adverse events (TEAEs) of Grade 1 or 2, mostly hematological. 蓋範構網簾齋觸構憲蓋 (餘遞憲廠願壓鹹齋築艱 ) 更多 | 积极 | 2023-12-09 | ||
临床1/2期 | 12 | GLPG5201 35×10^6 | 膚鬱顧鬱繭顧廠願範選(餘壓鹹壓網齋鹹膚糧築) = Most treatment emergent adverse events were Grade 1–2; most Grade ≥3 events were hematological. Six (50%) pts had Grade 1–2 cytokine release syndrome (CRS), with no CRS Grade ≥3. No neurotoxicity was reported. 襯築衊衊繭獵獵觸鏇觸 (獵獵鑰窪觸膚糧簾鬱鹽 ) | 积极 | 2023-12-09 | ||
GLPG5201 100×10^6 | |||||||
临床1/2期 | 非霍奇金淋巴瘤 CD19 Positive | 14 | (Phase 1) | 鬱憲簾糧鹹膚鏇願襯築(築夢窪壓願網糧積夢鬱) = 製醖網糧鬱範壓顧積廠 顧簾衊艱壓醖蓋蓋齋鹽 (膚窪製遞遞顧鏇醖膚顧 ) 更多 | 积极 | 2023-12-09 | |
临床1/2期 | 7 | 築繭顧觸壓艱窪築蓋襯(窪鬱積鏇衊構襯淵廠遞) = 壓選廠糧繭襯壓範鏇積 製壓鑰繭鏇鏇襯鹽齋獵 (憲淵製壓網鹹餘壓願壓 ) 更多 | - | 2023-06-08 |
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