Phase II Study of Combined Pirtobrutinib, Venetoclax and Obinutuzumab (PVO) Time-limited Treatment for Patients With Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL).

To learn if the drug combination pirtobrutinib, venetoclax, and obinutuzumab can help to control relapsed CLL/SLL.

开始日期2025-10-30

申办/合作机构

The University of Texas MD Anderson Cancer Center

[+1]

NCT06948786

/ Not yet recruiting临床2期IIT

PROMOTE-FL: Pirtobrutinib and Mosunetuzumab to Enhance Treatment Efficacy for Patients With Relapsed/Refractory Follicular Lymphoma

This phase II trial tests how well pirtobrutinib and mosunetuzumab work in treating patients with grade 1-3a follicular lymphoma (FL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Pirtobrutinib, a type of tyrosine kinase inhibitor, works by blocking the action of the Bruton tyrosine kinase (BTK) protein. The BTK protein signals cancer cells to multiply, and blocking it may help keep cancer cells from growing. It could also improve T cell fitness and decrease inflammation, therefore, may improve the efficacy and safety of T cell-based therapies, such as mosunetuzumab. Mosunetuzumab is a bispecific antibody that binds both T cells and the lymphoma cancer cells and harnesses T cells to interfere with the ability of cancer cells to grow and spread. Giving pirtobrutinib and mosunetuzumab together may kill more tumor cells in patients with relapsed or refractory grade 1-3a FL and potentially decreases some side effects of mosunetuzumab which are related to T cells being activated (e.g., cytokine release syndrome).

开始日期2025-10-01

申办/合作机构

University of Washington

[+1]

NCT06721013

/ Not yet recruiting临床1/2期

A Phase 1/2, Dose-finding Study Investigating the Safety and Efficacy of Pirtobrutinib in Adults With Immune Thrombocytopenia

The purpose of the phase 1 part of this study is to evaluate how well pirtobrutinib is tolerated and what side effects may occur. The phase 2 part of the study will further investigate efficacy and safety of multiple pirtobrutinib dosages versus placebo.
The study drug will be administered orally in participants with Primary Immune Thrombocytopenia (ITP). Blood tests will be performed to check how much pirtobrutinib gets into the bloodstream and how long it takes the body to eliminate it.
The study will last up to approximately 16 weeks for phase 1 dose-escalation and 28 weeks for phase 2 dose-optimization, excluding screening.

开始日期2025-08-01

申办/合作机构

Eli Lilly & Co.

100 项与匹妥布替尼相关的临床结果

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100 项与匹妥布替尼相关的专利（医药）

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163

项与匹妥布替尼相关的文献（医药）

2025-06-01·INTERNATIONAL JOURNAL OF CANCER

Pirtobrutinib in Chinese patients with relapsed or refractory B‐cell malignancies: A single‐arm, open‐label, phase 2, multicenter trial

Article

作者: Zhang, Liling ; Song, Yuqin ; Guo, Ye ; Qian, Yijiao ; Zhu, Jiankun ; Yang, Haiyan ; Yi, Shuhua ; Zhu, Jun ; Lin, Ningjing ; Zhang, Qingyuan ; Huang, Huiqiang ; Feng, Ru ; Liu, Yanyan ; Zhang, Huilai

Abstract:

Pirtobrutinib, a highly selective, noncovalent (reversible) Bruton tyrosine kinase inhibitor (BTKi), demonstrated clinically meaningful antitumor responses in covalent BTKi pretreated mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in the global phase 1/2 BRUIN study. In this multi‐center, open‐label, phase 2 trial, we investigated the efficacy and safety of pirtobrutinib in Chinese patients with BTKi pretreated relapsed/refractory (R/R) MCL, CLL/SLL, or other B‐cell malignancies. All patients received pirtobrutinib once daily in continuous 28‐day cycles. The primary endpoint was the overall response rate (ORR). Efficacy was assessed in patients with MCL and CLL/SLL with prior BTKi treatment and safety in all enrolled patients who received at least one dose of pirtobrutinib. Among 35 patients with covalent BTKis (cBTKi) pretreated MCL, the ORR was 62.9% (95% CI: 44.9, 78.5), the median duration of response (DOR) was not reached, and the 12‐month DOR rate was 59.7% (95% CI: 35.3, 77.5). Among 11 patients with cBTKi pretreated CLL/SLL, the ORR was 63.6% (95% CI: 30.8, 89.1), and the 12‐month DOR rate was 83.3% (95% CI: 27.3, 97.5). The most common adverse events in the safety population (n = 87) were anemia (32.2%) and neutrophil count decreased (31.0%). Grade ≥3 hemorrhage occurred in 2.3% of patients and there were no cases of atrial fibrillation/flutter. Pirtobrutinib demonstrated clinically meaningful efficacy in Chinese patients with cBTKi pretreated R/R MCL, preliminary antitumor activity in Chinese patients with cBTKi pretreated R/R CLL/SLL and was generally well‐tolerated with no new safety signals observed.

2025-05-01·BIOMEDICAL CHROMATOGRAPHY

High‐Performance Liquid Chromatography–Ultraviolet Assay for the Determination of Pirtobrutinib Levels in a Patient With Mantle Cell Lymphoma

Article

作者: Yasu, Takeo ; Tukada, Masao ; Gando, Yoshito ; Shimoda, Mari

ABSTRACT:

Pirtobrutinib is a Bruton's tyrosine kinase inhibitor used to treat mantle cell lymphoma and chronic lymphocytic leukemia. Pirtobrutinib has a steady‐state trough concentration of > 825 ng/mL, corresponding to a 90% inhibitory concentration of Bruton's tyrosine kinase. Therefore, maintaining stable trough concentrations of pirtobrutinib is clinically important; however, no methods of monitoring pirtobrutinib levels have been developed. In this study, our aim was to develop a method to determine pirtobrutinib levels in human plasma and validate it for therapeutic drug monitoring. Pirtobrutinib and ibrutinib (internal standard) were separated on a reversed‐phase column using a mobile phase comprising 0.5% KH2PO4 (pH 4.5) and acetonitrile (52:48, v/v) at a flow rate of 1.0 mL/min. Ultraviolet detection was performed at 234 nm. Calibration curves for pirtobrutinib were linear (r2 = 0.9998) in the range of 0.25–10 μg/mL. The intraday and interday validation coefficients were 0.72%–2.86% and 1.29%–3.22%, respectively. This study is the first one to develop and validate a method for quantifying pirtobrutinib in human plasma. These findings may support the widespread application of therapeutic drug monitoring for pirtobrutinib.

2025-04-11·ACS Pharmacology & Translational Science

Comprehensive Characterization of Bruton’s Tyrosine Kinase Inhibitor Specificity, Potency, and Biological Effects: Insights into Covalent and Noncovalent Mechanistic Signatures

Review

作者: Servant, Nicole B. ; King, Alastair J. ; Jahic, Mirza ; Darragh, Antonia C. ; Lipner, Justin H. ; Hanna, Andrew M.

Uncovering a drug's mechanism of action and possible adverse effects are critical components in drug discovery and development. Moreover, it provides evidence for why some drugs prove more effective than others and how to design better drugs altogether. Here, we demonstrate the utility of a high-throughput in vitro screening platform along with a comprehensive panel to aid in the characterization of 15 Bruton's tyrosine kinase (BTK) inhibitors that are either approved by the FDA or presently under clinical evaluation. To compare the potency of these drugs, we measured the binding affinity of each to wild-type BTK as well as a clinically relevant resistance mutant of BTK (BTK C481S). In doing so, we discovered a considerable difference in the selectivity and potency of these BTK inhibitors to the wild-type and mutant proteins. Some of this potentially contributes to the adverse effects experienced by patients undergoing therapy using these drugs. Overall, noncovalent BTK inhibitors showed stronger potency for both the wild-type and mutant BTK when compared with that of covalent inhibitors, with the majority demonstrating a higher specificity and less off-target modulation. Additionally, we compared biological outcomes for four of these inhibitors in human cell-based models. As expected, we found different phenotypic profiles for each inhibitor. However, the two noncovalent inhibitors had fewer off-target biological effects when compared with the two covalent inhibitors. This and similar in-depth preclinical characterization of drug candidates can provide critical insights into the efficacy and mechanism of action of a compound that may affect its safety in a clinical setting.

458

项与匹妥布替尼相关的新闻（医药）

2025-06-05

·美通社

和黄医药与信达生物宣布呋喹替尼联合信迪利单抗用于治疗晚期肾细胞癌的中国新药上市申请获受理

香港、上海和新泽西州弗洛勒姆公园 2025年6月5日 /美通社/ -- 和黄医药（中国）有限公司（简称" 和黄医药 "或"HUTCHMED"）（纳斯达克/伦敦证交所：HCM；香港交易所：13）和信达生物制药集团（Innovent Biologics, Inc.，简称"信达生物"或"Innovent"）今日联合宣布呋喹替尼（fruquintinib）和信迪利单抗（sintilimab）联合疗法用于治疗既往接受过一种酪氨酸激酶抑制剂治疗失败的局部晚期或转移性的肾细胞癌患者的新药上市申请已获中国国家药品监督管理局（"国家药监局"）受理。 FRUSICA-2研究的数据支持了此项新药上市申请。FRUSICA-2是一项随机、开放标签、阳性对照的注册研究，旨在评估呋喹替尼和信迪利单抗联合疗法对比阿昔替尼（axitinib）或依维莫司（everolimus）单药疗法用于二线治疗晚期肾细胞癌的疗效和安全性。该研究已达到盲态独立中心阅片（BICR）根据RECIST 1.1标准评估的无进展生存期（"PFS"）的主要终点。该联合疗法亦在包括客观缓解率（"ORR"）和缓解持续时间（"DoR"）在内的次要终点上亦取得改善。安全性特征可耐受，亦没有观察到新的安全信号。FRUSICA‑2研究的数据将提交于近期的学术会议上发表。该项研究的其他详情可登录clinicaltrials.gov，检索注册号 NCT05522231 查看。和黄医药研发负责人兼首席医学官石明博士表示："肾癌在中国仍是一项重大挑战，对于一线治疗失败的患者而言，治疗选择十分有限。此次提交呋喹替尼联合信迪利单抗用于晚期肾细胞癌的新药上市申请，是我们解决这一未被满足医疗需求的重要一步。我们致力推动这一联合疗法惠及肾细胞癌患者。与此同时，我们将持续研究以挖掘该联合疗法更大的潜力，并推进我们管线中其他产品在多个癌症领域的应用，为更多患者带来创新且有效的治疗选择。" 信达生物高级副总裁周辉博士表示："很高兴看到信迪利单抗联合呋喹替尼的第二项新药上市申请获受理，有望为中国晚期肾细胞癌患者提供更有效二线治疗选择。这也是信迪利单抗（达伯舒®）的第10 项受理的新药上市申请，进一步巩固了其作为免疫肿瘤（IO）治疗的基石药物的领先地位，同时也是信达生物对于该品种在生命周期管理和最大化其临床价值方面的重要里程碑。" 呋喹替尼和信迪利单抗的联合疗法于2024年12月取得国家药监局附条件批准，用于治疗既往系统性抗肿瘤治疗后失败且不适合进行根治性手术治疗或根治性放疗的晚期错配修复完整（pMMR）子宫内膜癌患者。该批准是基于FRUSICA-1研究的数据（ NCT03903705 ）。关于肾癌及肾细胞癌 2022年全球估计约新增43.5万例肾癌患者。 [1] 在中国，2022年估计新增7.4万例肾癌患者。 [2] 在所有肾癌病例中，肾细胞癌约占90%。关于呋喹替尼呋喹替尼是一种针对所有三种血管内皮生长因子受体（"VEGFR"）-1、-2和-3的选择性口服抑制剂。 VEGFR抑制剂在抑制肿瘤的血管生成中起到至关重要的作用。呋喹替尼被设计为拥有更高的激酶选择性，旨在降低脱靶激酶活性，从而实现药物暴露、对靶点的持续覆盖以及当潜在作为联合疗法时拥有更高的灵活度。 [3] 关于呋喹替尼获批在中国，呋喹替尼由和黄医药及礼来公司合作研发和商业化，并以商品名爱优特®（ELUNATE®）上市。呋喹替尼已于中国获批用于既往接受过氟尿嘧啶类、奥沙利铂和伊立替康为基础的化疗，以及既往接受过或不适合接受抗血管内皮生长因子（"VEGF"）治疗、抗表皮生长因子受体（"EGFR"）治疗（RAS野生型）的转移性结直肠癌患者。其于2020年1月获纳入中国国家医保药品目录。自呋喹替尼在中国上市以来已惠及超过10万名结直肠癌患者。爱优特®（呋喹替尼）和达伯舒®（信迪利单抗注射液）的联合疗法已于中国获附条件批准用于既往系统性抗肿瘤治疗后失败且不适合进行根治性手术治疗或根治性放疗的晚期错配修复完整（pMMR）子宫内膜癌患者。武田拥有在中国内地、香港和澳门以外进一步开发、商业化和生产呋喹替尼的全球独家许可，并以商品名FRUZAQLA®上市销售。呋喹替尼已于美国、欧洲、日本及全球其他多个国家获批用于治疗经治的转移性结直肠癌。呋喹替尼用于以下研究用途的安全性及疗效尚不明确，不能保证其将在任何国家的研究用途能获得卫生部门批准或商业上市关于呋喹替尼用于二线治疗肾细胞癌目前单药靶向疗法仍然是中国晚期肾细胞癌一线治疗的主要选择之一。然而，对于既往单药靶向疗法失败的晚期肾细胞癌患者，仍然存在未被满足的医疗需求。呋喹替尼和信迪利单抗联合疗法的一项Ib/II期概念验证研究结果于2025年1月在《靶向肿瘤学（Targeted Oncology）》期刊发表。该联合疗法在此类疾病中展示出了良好的疗效和可耐受的安全性。至数据截止日2024年10月9日，该研究中所有20例入组的经治患者均可评估疗效，中位随访时间为45.7个月。确认的ORR为60.0%，DCR为85.0%。中位DoR为13.9个月，中位PFS为15.9个月。中位总生存期（OS）尚未达到，36个月的OS率为58.3%。 [4] 关于信迪利单抗信迪利单抗，中国商品名为达伯舒®（信迪利单抗注射液），是信达生物制药和礼来公司共同合作研发及商业化的创新PD-1 免疫球蛋白G4（IgG4）单克隆抗体，能特异性结合T细胞表面的PD-1分子，从而阻断导致肿瘤免疫耐受的 PD-1/ PD-L1通路，重新启动淋巴细胞的抗肿瘤活性，从而达到治疗肿瘤的目的。 [5] 信迪利单抗已在中国获批并纳入新版国家医保目录七项适应症，协议期内医保目录描述的限定支付范围包括：至少经过二线系统化疗的复发或难治性经典型霍奇金淋巴瘤的治疗；表皮生长因子受体（EGFR）基因突变阴性和间变性淋巴瘤激酶(ALK)阴性、不可手术切除的局部晚期或转移性非鳞状非小细胞肺癌的一线治疗；表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI）治疗失败的 EGFR 基因突变阳性的局部晚期或转移性非鳞状非小细胞肺癌患者的治疗；不可手术切除的局部晚期或转移性鳞状非小细胞肺癌的一线治疗；既往未接受过系统治疗的不可切除或转移性肝细胞癌的一线治疗；不可切除的局部晚期、复发或转移性食管鳞癌的一线治疗；不可切除的局部晚期、复发或转移性胃及胃食管交界处腺癌的一线治疗。此外，信迪利单抗的第八项适应症，即与呋喹替尼的联合疗法用于治疗既往系统性抗肿瘤治疗后失败且不适合进行根治性手术治疗或根治性放疗的晚期错配修复完整（pMMR）的子宫内膜癌患者的新药上市申请已于2024年12月取得国家药监局附条件批准。目前，信迪利单抗的两项新药上市申请正在国家药监局审评中，包括：信迪利单抗联合伊匹木单抗用于可切除的微卫星高度不稳定型（MSI-H）/错配修复缺陷（dMMR）结肠癌患者的新辅助治疗，正在国家药监局审评中，并获纳入优先审评；信迪利单抗联合呋喹替尼用于治疗既往接受过TKI治疗失败的局部晚期或转移性肾细胞癌患者。另外，信迪利单抗的两项临床试验达到研究终点，包括：单药用于晚期/转移性食管鳞癌二线治疗的II期临床研究；单药用于含铂化疗失败的晚期鳞状非小细胞肺癌二线治疗的III期临床研究。声明：信达不推荐任何未获批的药品 / 适应症使用。关于和黄医药和黄医药（纳斯达克/伦敦证交所：HCM；香港交易所：13）是一家处于商业化阶段的创新型生物医药公司，致力于发现、全球开发和商业化治疗癌症和免疫性疾病的靶向药物和免疫疗法。自成立以来，和黄医药致力于将自主发现的候选药物带向全球患者，首三个药物现已在中国上市，其中首个药物亦于美国、欧洲和日本等全球各地获批。欲了解更多详情，请访问： www.hutch‑med.com 或关注我们的领英专页。关于信达生物 "始于信，达于行"，开发出老百姓用得起的高质量生物药，是信达生物的使命和目标。信达生物成立于2011年，致力于研发、生产和销售肿瘤、自身免疫、代谢、眼科等重大疾病领域的创新药物，让我们的工作惠及更多的生命。信达生物已有15个产品获得批准上市，它们分别是信迪利单抗注射液（达伯舒®），贝伐珠单抗注射液（达攸同®），阿达木单抗注射液（苏立信®），利妥昔单抗注射液（达伯华®），佩米替尼片（达伯坦®），奥雷巴替尼片（耐立克®），雷莫西尤单抗注射液（希冉择®），塞普替尼胶囊（睿妥®），伊基奥仑赛注射液（福可苏®），托莱西单抗注射液（信必乐®）, 氟泽雷塞片（达伯特®），匹妥布替尼片(捷帕力®)，己二酸他雷替尼胶囊（达伯乐®），利厄替尼片（奥壹新®）和替妥尤单抗N01注射液（信必敏®）。目前，同时还有3个品种在国家药监局审评中，4个新药分子进入III期或关键性临床研究，另外还有15个新药品种已进入临床研究。信达生物已与礼来、罗氏、赛诺菲、Incyte和MD Anderson 癌症中心等国际合作方达成30多项战略合作。信达生物在不断自研创新药物、谋求自身发展的同时，秉承经济建设以人民为中心的发展思想。多年来，始终心怀科学善念，坚守"以患者为中心"，心系患者并关注患者家庭，积极履行社会责任。信达生物陆续发起、参与了多项药品公益援助项目，让越来越多的患者能够得益于生命科学的进步，买得到、用得起高质量的生物药。截至目前，信达生物患者援助项目已惠及20余万普通患者，药物捐赠总价值36亿元人民币。信达生物希望和大家一起努力，提高中国生物制药产业的发展水平，以满足百姓用药可及性和人民对生命健康美好愿望的追求。详情请访问信达生物网站： www.innoventbio.com 或信达生物领英账号 www.linkedin.com/company/innovent-biologics/ 。声明：信达生物不推荐未获批的药品 / 适应症的使用雷莫西尤单抗注射液（希冉择 ® ）、塞普替尼胶囊（睿妥 ® ）和匹妥布替尼片（捷帕力 ® ）由礼来公司研发。前瞻性陈述本新闻稿包含 1995 年《美国私人证券诉讼改革法案》 " 安全港 " 条款中定义的前瞻性陈述。这些前瞻性陈述反映了和黄医药目前对未来事件的预期，包括对呋喹替尼与信迪利单抗联合疗法用于治疗晚期肾细胞癌患者的治疗潜力的预期，以及呋喹替尼与信迪利单抗联合疗法针对此适应症及其他适应症的进一步临床研究计划。前瞻性陈述涉及风险和不确定性。此类风险和不确定性包括下列假设：支持呋喹替尼与信迪利单抗联合疗法在中国或其他地区获批用于治疗晚期肾细胞癌患者的新药上市申请的数据充足性、获得监管部门快速审批或审批的潜力、呋喹替尼的安全性、和黄医药为呋喹替尼与信迪利单抗联合疗法进一步临床开发计划及商业化提供资金并实现及完成的能力，以及此类事件发生的时间。此外，由于部分研究赖于把其他药物产品如信迪利单抗与呋喹替尼联合使用，因此此类风险和不确定性包括有关这些治疗药物的安全性、疗效、供应和监管批准的假设。当前和潜在投资者请勿过度依赖这些前瞻性陈述，这些陈述仅在截至本新闻稿发布当日有效。有关这些风险和其他风险的进一步讨论，请查阅和黄医药向美国证券交易委员会、 AIM 以及香港联合交易所有限公司提交的文件。无论是否出现新讯息、未来事件或情况或其他因素，和黄医药均不承担更新或修订本新闻稿所含讯息的义务。医疗信息本新闻稿所提到的产品可能并未在所有国家上市，或可能以不同的商标进行销售，或用于不同的病症，或采用不同的剂量，或拥有不同的效力。本文中所包含的任何信息都不应被看作是任何处方药的申请、推广或广告，包括那些正在研发的药物。 [1] The Global Cancer Observatory, kidney cancer fact sheet. https://gco.iarc.who.int/media/globocan/factsheets/cancers/29-kidney-fact-sheet.pdf . Accessed February 19, 2025. [2] The Global Cancer Observatory, China fact sheet. https://gco.iarc.who.int/media/globocan/factsheets/populations/160-china-fact-sheet.pdf . Accessed February 19, 2025. [3] Sun Q, et al. Discovery of fruquintinib, a potent and highly selective small molecule inhibitor of VEGFR 1, 2, 3 tyrosine kinases for cancer therapy. Cancer Biol Ther . 2014;15(12):1635-45. doi: 10.4161/15384047.2014.964087. [4] Xu H, et al. Fruquintinib Plus Sintilimab in Patients with Treatment‑Naïve and Previously Treated Advanced Renal Cell Carcinoma: Results from a Phase Ib/II Clinical Trial. Targeted Oncolog y. 2025; 20:113–125. doi.org/10.1007/s11523-024-01120-6. [5] Wang J, et al . Durable blockade of PD-1 signaling links preclinical efficacy of sintilimab to its clinical benefit. mAbs 2019;11(8): 1443-1451. doi: 10.1080/19420862.2019.1654303.

申请上市

2025-06-05

·PRNewswire

Innovent's IBI363 (PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) Receives Second NMPA Breakthrough Therapy Designation for Immuno-resistant Squamous Non-Small Cell Lung Cancer

SAN FRANCISCO and SUZHOU, China, June 4, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology, and other major diseases, announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted a second Breakthrough Therapy Designation (BTD) to its first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, IBI363, for the treatment of unresectable, locally advanced, or metastatic squamous non-small cell lung cancer (sqNSCLC) that has progressed following anti-PD-(L)1 immunotherapy and platinum-based chemotherapy. To date, IBI363 has received BTDs from China's NMPA CDE and Fast Track Designations (FTDs) from the U.S. FDA for two indications—sqNSCLC and melanoma. The latest BTD further advances IBI363's potential in addressing immunotherapy resistance and cold tumor challenges. The latest data from the Phase 1 clinical study of IBI363 in subjects with squamous non-small cell lung cancer (sqNSCLC) who previously received immunotherapy were reported in an oral presentation at the 2025 ASCO Annual Meeting. Manageable safety, encouraging efficacy, and long-term survival benefits were observed in both immunotherapy-resistant squamous non-small cell lung cancer and wild-type lung adenocarcinoma, offering new therapeutic hope for immunotherapy-resistant patients. At this year's ASCO conference, IBI363 presented breakthrough clinical findings in three immunotherapy-resistant and cold tumor types: non-small cell lung cancer, colorectal cancer, and melanoma, garnering significant attention. Dr. Hui Zhou, Senior Vice President of Innovent, stated, "IBI363 could potentially be a promising next-generation IO agent by combining dual mechanisms—PD-1 blockade and IL-2-driven tumor-specific T-cell populations expansion—thus reshape the tumor microenvironment. Recent regulatory milestones, including multiple FTDs and BTDs, underscore its clinical value in addressing unmet needs. We are accelerating IBI363's global development across multiple tumor types: the first registrational study in acral and mucosal melanoma, a head-to-head trial against pembrolizumab, has already been initiated. We will communicate with regulatory authorities about additional registrational clinical trials for lung cancer and colorectal cancer, bringing innovation therapies at the forefront of immunotherapy to benefit global patients." NMPA Breakthrough Therapy Designation is intended to facilitate and expedite the development and review of investigational drugs for serious diseases or conditions when preliminary clinical evidence indicates substantial improvement over current therapies. BTD qualifies a drug candidate for accelerated review by the CDE and provides the sponsor with timely advice and communication to expedite the approval process, helping to address the unmet clinical needs of patients more swiftly. About Squamous Non-Small Cell Lung Cancer (sqNSCLC) Lung cancer is the most common and deadliest malignancy worldwide, including in China[1], posing a significant public health challenge. Non-small cell lung cancer (NSCLC) accounts for more than 80% of all lung cancer cases[2], with squamous cell carcinoma being one of its two major subtypes[2]. In recent years, immune checkpoint inhibitors have transformed the treatment landscape for NSCLC. However, for patients with NSCLC who have failed immunotherapy and lack driver gene mutations, there remains a significant and urgent unmet need for effective treatment options. The standard second- or third-line treatment, docetaxel, offers limited efficacy, with a median progression-free survival (PFS) of less than four months[3],[4]. While antibody-drug conjugates (ADCs) have shown promise, two large Phase 3 studies in squamous NSCLC have yet to demonstrate satisfactory efficacy[3],[4]. About IBI363 (First-in-class PD-1/IL-2α-bias bispecific antibody fusion protein) IBI363 is a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein independently developed by Innovent Biologics. It functions by both blocking the PD-1/PD-L1 pathway and activating the IL-2 pathway. The IL-2 arm of IBI363 is designed to maintain its affinity for IL-2Rα while reducing binding to IL-2Rβ and IL-2Rγ, thereby minimizing toxicity. The PD-1 binding arm not only blocks PD-1 but also selectively delivers IL-2. This approach targets and activates tumor-specific T cells that express both PD-1 and IL-2α, leading to more precise and effective activation of this T cell subpopulation. IBI363 has demonstrated robust antitumor activity in various tumor-bearing pharmacological models, but also showed outstanding efficacy in PD-1 resistance and metastasis models. At this year's ASCO conference, IBI363 presented breakthrough clinical findings in three immunotherapy-resistant and cold tumor types: non-small cell lung cancer, colorectal cancer, and melanoma, garnering significant attention. In response to urgent clinical needs, Innovent is conducting clinical studies in China, the United States and Australia to further explore the efficacy and safety of IBI363 in various tumor indications, including immune-resistant, cold tumors, and front-line treatments. The first pivotal trial of IBI363 was initiated in 2025 for unresectable locally advanced or metastatic mucosal or acral melanoma who have not received prior systemic therapy. IBI363 has received two fast track designations (FTD) from the U.S. FDA and two breakthrough designations (BTD) from the China NMPA, for the treatment of squamous non-small cell lung cancer and melanoma, respectively. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 15 products in the market. It has 3 new drug applications (NDA) under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Statement: 1) Innovent does not recommend the use of any unapproved drug (s)/indication (s). 2) Ramucirumab (Cyramza) and Selpercatinib (Retsevmo) and Pirtobrutinib (Jaypirca) were developed by Eli Lilly and Company. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

免疫疗法快速通道临床1期临床结果突破性疗法

2025-06-05

·美通社

再获BTD：信达生物IBI363（PD-1/IL-2α-bias双特异性抗体融合蛋白）获国家药品监督管理局纳入突破性治疗药物品种，治疗免疫耐药鳞状非小细胞肺癌

美国旧金山和中国苏州 2025年6月5日 /美通社/ -- 信达生物制药集团（香港联交所股票代码：01801），一家致力于研发、生产和销售肿瘤、自身免疫、代谢、眼科等重大疾病领域创新药物的生物制药公司，宣布其全球首创PD-1/IL-2 α-bias 双特异性抗体融合蛋白IBI363已被中国国家药品监督管理局（NMPA）药品审评中心（CDE）纳入突破性治疗药物（ BTD）品种名单，拟定适应症为经含铂化疗及抗PD - 1/PD - L1免疫治疗失败的局部晚期或转移性鳞状非小细胞肺癌。截至目前， IBI363在鳞状非小细胞肺癌和黑色素瘤的两项适应症已经分别获得中国CDE的BTD认证和美国FDA快速通道资格（FTD）认定，此次BTD标志着IBI363在解决免疫耐药及冷肿瘤治疗难题中再前进一步。 IBI363在既往接受过免疫治疗的鳞状非小细胞肺癌受试者的临床I期研究最新数据在2025年ASCO大会上以口头形式报告。在免疫治疗耐药的鳞状非小细胞肺癌和野生型肺腺癌中，都观察到了可控的安全性、令人鼓舞的疗效和长期生存获益，有望为免疫耐药患者提供新的治疗希望。在今年ASCO会议上，IBI363口头报告了在免疫耐药非小细胞肺癌、结直肠癌、黑色素瘤三项免疫耐药及冷肿瘤中的突破性临床研究结果，并获得广泛关注。信达生物制药集团高级副总裁周辉博士表示："IBI363引领着下一代免疫治疗的进化方向——通过‘PD-1靶向+IL-2激活扩增肿瘤特异性T细胞'的免疫检查点阻断+细胞因子激动双重作用，重塑肿瘤免疫微环境。IBI363在近期接连获得多项FTD和BTD，标志着监管机构认可其针对未满足需求的临床价值。我们正在加速推进IBI363的多瘤种的全球开发，其中头对头帕博利珠单抗的首个注册临床研究在粘膜及肢端型黑色素瘤已启动，公司还将与监管沟通IBI363在肺癌和结直肠癌的注册临床研究方案，以创新疗法开启肿瘤免疫治疗新篇章。" 突破性治疗药物资格认定是为了加快开发针对严重疾病、且已在初步临床试验中显示疗效或安全性方面显著优于现有治疗手段的新药而设计的。获得突破性治疗药物认定能够使该药在研发过程中与 CDE密切交流、获得指导，从而加快新药上市，更早解决中国病患未满足的临床需求。关于鳞状非小细胞肺癌肺癌是全球及中国发病率和死亡率最高的恶性肿瘤 [1] ，是危害公共健康的重大问题。尽管免疫治疗已经彻底改变了非小细胞肺癌的治疗格局，但对于免疫治疗失败且无驱动基因突变的非小细胞肺癌患者，目前仍缺乏有效的治疗手段。标准治疗方案多西他赛疗效有限，ORR不到20%，PFS不到4个月，OS不到12个月 [2-7] 。近年来，虽然免疫联合治疗、抗体偶联药物（Antibody-drug conjugates，ADCs）等新型治疗方案的探索带来了新的希望，但多项针对含铂化疗及免疫治疗失败的非小细胞肺癌人群的大型III期临床研究均未获得令人满意的结果，其中多数研究未达到主要终点 [2-6] 。TROPION-Lung01研究虽然在NSCLC中达到PFS主要终点（未达到OS主要终点），但在鳞状非小细胞肺癌中，试验组的PFS/OS/ORR均未见提升 [7] 。因此，在免疫治疗失败的鳞状非小细胞肺癌中，存在巨大且迫切的未满足的临床需求。关于 IBI363（PD-1/IL-2 α-bias 双特异性融合蛋白） IBI363是由信达生物自主研发的全球首创PD-1/IL-2 α -bias 双特异性融合蛋白，同时具有阻断PD-1/PD-L1通路和激活IL-2通路两项功能。IBI363的IL-2臂经过了设计改造，保留了其对IL-2 Rα的亲和力，但削弱了对IL-2Rβ和IL-2Rγ的结合能力，以此降低毒性；而PD-1结合臂可以同时实现对PD-1的阻断和IL-2的选择性递送。由于新激活的肿瘤特异性T细胞同时表达PD-1和IL-2α，这一差异性策略可以更精确和有效地实现对该 T细胞亚群的靶向和激活。IBI363不仅在多种荷瘤药理学模型中展现出了良好抗肿瘤活性，在PD-1耐药和转移模型中也表现出了突出的抑瘤效力。在今年ASCO会议上，IBI363口头报告了在免疫耐药非小细胞肺癌、结直肠癌、黑色素瘤三项免疫耐药及冷肿瘤中的突破性临床研究结果，并获得广泛关注。从临床迫切需求出发，信达生物正在中国、美国、澳大利亚开展临床研究探索IBI363在针对各种恶性肿瘤的有效性和安全性。IBI363已开出首个关键注册临床研究，用于治疗未经免疫治疗的粘膜型和肢端型黑色素瘤。 IBI363已获美国FDA两项快速通道资格认定，分别用于治疗晚期鳞状非小细胞肺癌和黑色素瘤。IBI363也获得中国NMPA纳入两项突破性疗法认证，治疗晚期黑色素瘤和鳞状非小细胞肺癌。关于信达生物 "始于信，达于行"，开发出老百姓用得起的高质量生物药，是信达生物的使命和目标。信达生物成立于2011年，致力于研发、生产和销售肿瘤、自身免疫、代谢、眼科等重大疾病领域的创新药物，让我们的工作惠及更多的生命。公司已有15个产品获得批准上市，它们分别是信迪利单抗注射液（达伯舒®），贝伐珠单抗注射液（达攸同®），阿达木单抗注射液（苏立信®），利妥昔单抗注射液（达伯华®），佩米替尼片（达伯坦®），奥雷巴替尼片（耐立克®），雷莫西尤单抗注射液（希冉择®），塞普替尼胶囊（睿妥®），伊基奥仑赛注射液（福可苏®），托莱西单抗注射液（信必乐®）, 氟泽雷塞片（达伯特®），匹妥布替尼片（捷帕力®），己二酸他雷替尼胶囊（达伯乐®）和利厄替尼片（奥壹新®）和替妥尤单抗N01注射液（信必敏®）。目前，同时还有3个品种在NMPA审评中，4个新药分子进入III期或关键性临床研究，另外还有15个新药品种已进入临床研究。公司已与礼来、罗氏、赛诺菲、Incyte和MD Anderson 癌症中心等国际合作方达成30多项战略合作。信达生物在不断自研创新药物、谋求自身发展的同时，秉承经济建设以人民为中心的发展思想。多年来，始终心怀科学善念，坚守"以患者为中心"，心系患者并关注患者家庭，积极履行社会责任。公司陆续发起、参与了多项药品公益援助项目，让越来越多的患者能够得益于生命科学的进步，买得到、用得起高质量的生物药。截至目前，信达生物患者援助项目已惠及20余万普通患者，药物捐赠总价值36亿元人民币。信达生物希望和大家一起努力，提高中国生物制药产业的发展水平，以满足百姓用药可及性和人民对生命健康美好愿望的追求。详情请访问公司网站： www.innoventbio.com 或公司领英账号 www.linkedin.com/company/innovent-biologics/ 。声明： 1. 信达生物不推荐未获批的药品 / 适应症的使用。 2. 雷莫西尤单抗注射液（希冉择 ® ）塞普替尼胶囊（睿妥 ® ）和匹妥布替尼片（捷帕力 ® ）由礼来公司研发前瞻性声明本新闻稿所发布的信息中可能会包含某些前瞻性表述。这些表述本质上具有相当风险和不确定性。在使用"预期"、"相信"、"预测"、"期望"、"打算"及其他类似词语进行表述时，凡与本公司有关的，目的均是要指明其属前瞻性表述。本公司并无义务不断地更新这些预测性陈述。这些前瞻性表述乃基于本公司管理层在做出表述时对未来事务的现有看法、假设、期望、估计、预测和理解。这些表述并非对未来发展的保证，会受到风险、不确性及其他因素的影响，有些乃超出本公司的控制范围，难以预计。因此，受我们的业务、竞争环境、政治、经济、法律和社会情况的未来变化及发展的影响，实际结果可能会与前瞻性表述所含资料有较大差别。本公司、本公司董事及雇员代理概不承担 (a) 更正或更新本网站所载前瞻性表述的任何义务;及 (b) 若因任何前瞻性表述不能实现或变成不正确而引致的任何责任。参考文献 [1] Globocan 2022 (version 1.1) - 08.02.2024 [2] Paz-Ares LG, Juan-Vidal O, Mountzios GS, et al. Sacituzumab Govitecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III EVOKE-01 Study. J Clin Oncol. Aug 20 2024;42(24):2860-2872. doi:10.1200/JCO.24.00733 [3] Neal J, Pavlakis N, Kim SW, et al. CONTACT-01: A Randomized Phase III Trial of Atezolizumab + Cabozantinib Versus Docetaxel for Metastatic Non-Small Cell Lung Cancer After a Checkpoint Inhibitor and Chemotherapy. J Clin Oncol. Jul 10 2024;42(20):2393-2403. doi:10.1200/JCO.23.02166 [4] SAFFRON-301: Tislelizumab plus sitravatinib in advanced/metastatic NSCLC progressing on/after chemotherapy and anti–PD-(L)1. WCLC 2024. [5] 65O - Phase 3 LEAP-008 study of lenvatinib plus pembrolizumab versus docetaxel for metastatic non-small cell lung cancer (NSCLC) that progressed on a PD-(L)1 inhibitor and platinum-containing chemotherapy. ESMO IO 2023. [6] Canakinumab in combination with docetaxel compared with docetaxel alone for the treatment of advanced non-small cell lung cancer following platinum-based doublet chemotherapy and immunotherapy (CANOPY-2): A multicenter, randomized, double-blind, phase 3 trial. Lung Cancer . 2024 Mar:189:107451. doi: 10.1016/j.lungcan.2023.107451. Epub 2024 Jan 16. [7] Ahn MJ, Tanaka K, Paz-Ares L, et al. Datopotamab Deruxtecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III TROPION-Lung01 Study. J Clin Oncol. Sep 9 2024:JCO2401544. doi:10.1200/JCO-24-01544

突破性疗法ASCO会议免疫疗法临床1期临床结果

100 项与匹妥布替尼相关的药物交易

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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
慢性淋巴细胞白血病	美国	Loxo Oncology, Inc.	2023-12-01
小淋巴细胞淋巴瘤	美国	Loxo Oncology, Inc.	2023-12-01
套细胞淋巴瘤	欧盟	Eli Lilly Nederland BV	2023-10-30
套细胞淋巴瘤	冰岛	Eli Lilly Nederland BV	2023-10-30
套细胞淋巴瘤	列支敦士登	Eli Lilly Nederland BV	2023-10-30
套细胞淋巴瘤	挪威	Eli Lilly Nederland BV	2023-10-30
复发性套细胞淋巴瘤	美国	Loxo Oncology, Inc.	2023-01-27
难治性套细胞淋巴瘤	美国	Loxo Oncology, Inc.	2023-01-27

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
淋巴瘤	申请上市	加拿大	Eli Lilly Canada, Inc.	2025-03-01
难治性慢性淋巴细胞白血病	申请上市	欧盟	Eli Lilly Nederland BV	2025-02-27
复发性慢性淋巴细胞白血病	申请上市	欧盟	Eli Lilly Nederland BV	2025-02-27
复发性滤泡性淋巴瘤	临床2期	美国	Eli Lilly & Co.	2025-10-01
难治性滤泡性淋巴瘤	临床2期	美国	Eli Lilly & Co.	2025-10-01
免疫性血小板减少症	临床2期	美国	Eli Lilly & Co.	2025-08-01
复发性多发性硬化	临床2期	美国	Eli Lilly & Co.	2024-05-01
复发性多发性硬化	临床2期	波多黎各	Eli Lilly & Co.	2024-05-01
慢性白血病	临床2期	中国	Eli Lilly & Co.	2021-05-14
弥漫性大B细胞淋巴瘤	临床2期	中国	Eli Lilly & Co.	2021-05-14

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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


NCT04849416 (Pubmed \| Int J Cancer) 人工标引	临床2期	套细胞淋巴瘤 \| 慢性淋巴细胞白血病 \| 小淋巴细胞淋巴瘤 ... 更多	87	Pirtobrutinib	-	积极	2025-06-01
				Pirtobrutinib (patients with covalent BTKis pretreated MCL)	壓淵淵積膚築鹽齋醖醖(觸壓醖鏇窪製憲簾膚網) = 鏇築衊簾觸襯鑰鬱鹹鹹鹹製鏇鬱獵選淵醖鏇願 (鑰繭艱選網蓋鑰製網廠, 44.9 ~ 78.5) 更多
NCT06165146 (CTgov)	临床1期	-	16	repaglinide (Period 1: 0.5 mg Repaglinide)	憲構構觸鹹範鏇淵鹹壓(齋選繭範齋製鏇淵網餘) = 淵築憲鹽窪鬱蓋醖艱齋壓鹹糧積鬱蓋襯觸憲製 (鏇願壓膚獵壓窪遞築鬱, 36.9) 更多	-	2025-03-17
				repaglinide+Pirtobrutinib (Period 2: 200 mg Pirtobrutinib QD + 0.5 mg Repaglinide)	憲構構觸鹹範鏇淵鹹壓(齋選繭範齋製鏇淵網餘) = 艱蓋鹹鹹顧願淵鬱顧獵壓鹹糧積鬱蓋襯觸憲製 (鏇願壓膚獵壓窪遞築鬱, 56.1) 更多
NCT06215430 (CTgov)	临床1期	-	16	Warfarin tablet+Omeprazole capsule+Caffeine Tablet (Period 1: Probe Drug Cocktail)	蓋製齋遞窪顧遞鏇憲獵(網醖製範鹽憲廠顧簾蓋) = 獵遞積鏇願衊網鹽繭範膚範願願鬱憲齋觸簾醖 (築醖簾遞範繭醖蓋鬱選, 31.8) 更多	-	2025-03-10
				Warfarin tablet+Omeprazole capsule+Pirtobrutinib+Caffeine Tablet (Period 2: Pirtobrutinib + Probe Drug Cocktail)	蓋製齋遞窪顧遞鏇憲獵(網醖製範鹽憲廠顧簾蓋) = 壓鹹蓋齋艱膚願願衊構膚範願願鬱憲齋觸簾醖 (築醖簾遞範繭醖蓋鬱選, 31.8) 更多
NCT04666038 (BRUIN CLL-321, CTgov)	临床3期	慢性淋巴细胞白血病 \| 小淋巴细胞淋巴瘤	238	Pirtobrutinib (Arm A - Pirtobrutinib)	憲襯鏇醖齋選蓋繭夢膚(選夢製簾網壓糧醖齋簾) = 壓壓淵衊齋鹹築艱範簾糧餘糧糧顧觸衊齋襯醖 (糧範鹽衊齋鑰築範齋蓋, 觸餘築鬱網膚糧餘選鹹 ~ 艱醖蓋憲遞夢選餘膚遞) 更多	-	2025-03-07
				bendamustine+Idelalisib+Rituximab (Arm B - Idelalisib Plus Rituximab or Bendamustine Plus Rituximab)	憲襯鏇醖齋選蓋繭夢膚(選夢製簾網壓糧醖齋簾) = 顧簾壓鹽膚窪構範餘遞糧餘糧糧顧觸衊齋襯醖 (糧範鹽衊齋鑰築範齋蓋, 製壓製醖醖壓壓獵夢齋 ~ 選鏇窪網繭蓋選衊鬱繭) 更多
NCT06215521 (CTgov)	临床1期	-	31	Pirtobrutinib (Treatment A: 900 mg Pirtobrutinib)	糧繭餘淵膚蓋膚願鏇窪(鏇築構壓構觸製遞獵觸) = 網餘鹹窪夢構窪淵淵獵鏇醖獵觸淵顧憲壓餘顧 (構積夢壓積製鹹鬱淵遞, 窪壓糧膚選糧簾齋淵餘 ~ 衊鹽願憲齋壓襯鹽築鹹) 更多	-	2025-02-24
				Placebo+Pirtobrutinib (Treatment B: 900 mg Pirtobrutinib Matched Placebo)	艱獵鬱獵鹽積積憲繭窪(獵襯鏇鹹鹹壓餘鏇鏇鏇) = 鹽壓窪膚襯鏇衊夢製範選簾艱鹹簾齋餘壓製鹹 (齋鑰願醖憲觸構鏇醖網, 淵願醖鑰願構繭積製簾 ~ 製鏇夢願餘淵壓觸糧壓) 更多
NCT06194214 (CTgov)	临床1期	-	16	digoxin+Pirtobrutinib	積選膚鑰鹽構廠簾簾觸(選獵襯繭壓築鑰顧鹹構) = 遞選憲獵鏇繭網鏇窪鹽廠選鬱顧鬱範築顧築鹽 (遞壓淵顧衊衊醖繭製鑰, 21.1) 更多	-	2025-02-21
NCT06181006 (CTgov)	临床1期	-	24	Pirtobrutinib (Cohort 1: 300 mg Pirtobrutinib)	艱願選鹽壓鏇膚壓鏇廠 = 獵壓製艱顧餘艱製網憲選簾窪鑰襯糧衊襯鏇獵 (餘製憲繭夢獵糧選衊壓, 鹹艱鑰糧遞壓網壓齋壓 ~ 網觸憲壓築憲衊繭鬱膚) 更多	-	2025-01-14
				Pirtobrutinib (Cohort 2: 600 mg Pirtobrutinib)	艱願選鹽壓鏇膚壓鏇廠 = 遞觸蓋積憲積齋壓簾艱選簾窪鑰襯糧衊襯鏇獵 (餘製憲繭夢獵糧選衊壓, 網淵製顧製廠鹽築鹹鏇 ~ 製淵願構構廠糧鹽糧範) 更多
NCT06180954 (CTgov)	临床1期	-	9	[14C]-LOXO-305 (Part 1: [14C]-LOXO-305 Oral Solution)	製淵淵積構醖憲願簾獵(窪顧餘築願遞積夢選襯) = 網製鏇襯憲積鹽遞範簾鑰艱鏇糧網蓋鏇獵壓襯 (願繭鹹製積鑰餘蓋製鑰, 14.8) 更多	-	2025-01-13
				LOXO-305 (Part 2: LOXO-305 Oral Tablet + [14C]-LOXO-305 IV Solution)	窪鑰鏇齋鹽衊齋襯獵鹽(網積憲築糧糧鬱齋繭選) = 夢窪窪夢觸窪鏇鏇遞糧構鑰構餘淵範繭鹹獵壓 (糧鬱醖壓範壓築選鹹廠, 28.1) 更多