Drugs / Vebreltinib
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | MET exon 14 skipping non-small cell lung cancer | 2022-09-24 | “The vebreltinib NDA for treatment of NSCLC with MET exon14 skipping mutation was submitted by Beijing Pearl to the China National Medical Products Administration (NMPA) in...” apollomicsinc.com ↗ “2022年9月24日，“伯瑞替尼肠溶胶囊”1类新药注册申请正式获CDE受理。” avistonebio.com ↗ “伯瑞替尼肠溶胶囊的上市申请，于9月24日正式获得国家药品监督管理局受理” avistonebio.com ↗ |
Trials 25
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT07050316 | Mar → Sep 2025 | nervous system disorder | Ceres Brain Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT05367388 | May → Nov 2022 | — | Apollomics Inc. | Unknown | No outcome recorded |
| Phase 1 | NCT04557306 | Sep 2020 → Oct 2021 | cancer | CHABiotech CO., Ltd | Completed | No outcome recorded |
| Phase 1 | NCT02978261 | Sep 2016 → Apr 2018 | glioma | Beijing Pearl Biotechnology Limited Liability Company | Completed | No outcome recorded |
| Phase 1 | NCT02896231 | Apr 2016 → Oct 2019 | non-small cell lung carcinoma | Beijing Pearl Biotechnology Limited Liability Company | Completed | No outcome recorded |
| Phase 1/25 trials | ||||||
| Phase 1/2 | NCT07655622 | Jul 2026 → Dec 2027 expected | non-small cell lung carcinoma | Second Affiliated Hospital of Nanchang University | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07087223 | Apr 2025 → Apr 2027 expected | non-small cell lung carcinoma | Peking University Cancer Hospital & Institute | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06343064 | Jun 2023 → Dec 2026 expected | non-small cell lung carcinoma | Avistone Biotechnology Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04743505 | Jan 2022 → Jan 2027 expected | non-small cell lung carcinoma | Washington University School of Medicine | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03655613 | Sep 2018 → Dec 2021 | hepatocellular carcinoma, renal cell carcinoma | Apollomics (Australia) Pty. Ltd. | Terminated | No outcome recorded |
| Phase 211 trials | ||||||
| Phase 2 | NCT07549061 | Mar 2026 → May 2028 expected | lung neoplasm | Shanghai Chest Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07153887 | Sep 2025 → Jul 2026 overdue | clear cell sarcoma | Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | No outcome recorded |
| Phase 2 | NCT07156604 | Sep 2025 → Sep 2027 expected | non-small cell lung carcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07153770 | Sep 2025 → Sep 2027 expected | non-small cell lung carcinoma | Shanghai Pulmonary Hospital, Shanghai, China | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06780592 | Jan → Dec 2025 overdue | glioblastoma | Huashan Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06739395 | Nov 2024 → Dec 2026 expected | cancer | Tianjin Medical University Second Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06644313 | Nov 2024 → Nov 2029 expected | lung cancer | Shanghai Pulmonary Hospital, Shanghai, China | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06827145 | Oct 2024 → Sep 2026 overdue | non-small cell lung carcinoma | National Cancer Center, China | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06574347 | Aug 2024 → Oct 2026 expected | non-small cell lung carcinoma | Avistone Biotechnology Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT04258033 | Jan 2020 → May 2024 | non-small cell lung carcinoma | Beijing Pearl Biotechnology Limited Liability Company | Completed | No outcome recorded |
| Phase 2 | NCT03175224 | Sep 2017 → Mar 2026 overdue | brain neoplasm, colorectal cancer, gastric cancer, gastroesophageal junction adenocarcinoma +5 | Apollomics Inc. | Recruiting | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT06105619 | Oct 2018 → Apr 2023 overdue | glioblastoma | Beijing Pearl Biotechnology Limited Liability Company | Active not recruiting | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT06930794 | Jul 2025 → Feb 2029 expected | non-small cell lung carcinoma | Beijing Pearl Biotechnology Limited Liability Company | Recruiting | No outcome recorded |
| Phase 3 | NCT06970782 | May 2025 → Dec 2027 expected | non-small cell lung carcinoma | Avistone Biotechnology Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05989542 | Oct 2023 → Sep 2026 overdue | non-small cell lung carcinoma | Beijing Pearl Biotechnology Limited Liability Company | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 23
| Date | Issuer | Release |
|---|---|---|
| 2026-06-02 | Avistone Biotechnology Co., Ltd. | Results VEBrant研究：伯瑞替尼治疗晚期透明细胞肉瘤研究成果亮相2026 ASCO年会 avistonebio.com ↗
总人群ORR为36.8% (n = 19)。 |
| 2026-01-01 | Avistone Biotechnology Co., Ltd. | Regulatory 【新年伊始·医保护航】伯瑞替尼MET扩增NSCLC适应症纳入医保今日正式执行，精准治疗可及性再升级！ avistonebio.com ↗
伯瑞替尼的医保落地，标志着这类患者的精准治疗正式进入“可及性更高、负担更轻松”的新阶段。 |
| 2025-12-06 | Avistone Biotechnology Co., Ltd. | Results KUNPENG研究新进展：伯瑞替尼治疗MET扩增晚期NSCLC研究成果亮相2025 ESMO ASIA年会 avistonebio.com ↗
本次年会上，鞍石生物科技公布了由广东省肺癌研究所吴一龙教授牵头开展的 “伯瑞替尼治疗MET扩增晚期非小细胞肺癌（KUNPENG）”Ⅱ期临床研究成果。 |
| 2025-12-06 | Avistone Biotechnology Co., Ltd. | Results 伯瑞替尼再登世界顶级期刊，《柳叶刀-肿瘤学》发布KUNPENG研究MET扩增最新数据 avistonebio.com ↗
该研究中队列2、队列3的数据结果显示，在MET扩增的晚期 NSCLC 患者中，伯瑞替尼展现出确切的临床获益以及良好的安全性。 |
| 2025-09-08 | Avistone Biotechnology Co., Ltd. | Results 2025世界肺癌大会：鞍石生物科技万比锐®四项MET异常临床研究亮相壁报展示 avistonebio.com ↗
本研究显示，对于 MET 扩增且 PD-L1 阳性的局部晚期或转移性NSCLC患者，采用伯瑞替尼（Vebreltinib）联合替雷利珠单抗（Tislelizumab）进行一线治疗，展现出快速且持久的抗肿瘤活性。 |
| 2025-04-03 | Apollomics Inc. | Results Apollomics Reports Full Year 2024 Financial Results and Highlights Clinical Updates and Business Progress apollomicsinc.com ↗
The data show vebreltinib activity similar to previously announced. |
| 2024-09-16 | Apollomics Inc. | Results Apollomics Presents Vebreltinib Data in Patients with Non-Small Cell Lung Cancer with METex14 Skipping Mutations at European Society for Medical Oncology (ESMO) Congress 2024 apollomicsinc.com ↗ |
| 2024-08-14 | Apollomics Inc. | Results Apollomics Reports First Half 2024 Financial Results and Highlights Vebreltinib Clinical Progress apollomicsinc.com ↗
In August 2024, the Company announced data from its SPARTA Phase 2 clinical trial for 14 patients with non-CNS MET fusion solid tumors, where a 43% objective response rate (ORR) was achieved by RECIST v1.1 criteria. |
| 2024-08-13 | Apollomics Inc. | Results Apollomics Announces Positive Preliminary Data of Vebreltinib in Patients with Non-CNS MET Fusion Solid Tumors from its Phase 2 SPARTA Trial apollomicsinc.com ↗
We are very pleased with the preliminary data showing 43% objective response rate in patients with non-CNS MET fusion solid tumors. |
| 2024-06-04 | Apollomics Inc. | Results Apollomics Announces Vebreltinib Data at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting apollomicsinc.com ↗
Data from Phase 2 and 2/3 trials demonstrate continued efficacy and safety of vebreltinib for treating different tumor types carrying MET-driver alterations |
| 2024-04-25 | Apollomics Inc. | Regulatory Apollomics Announces Approval of Vebreltinib in China as a First-in-Class Treatment for Gliomas with MET Fusion Gene apollomicsinc.com ↗
This supplemental New Drug Application (sNDA) approval makes vebreltinib the world’s first c-Met inhibitor approved for treatment of Central Nervous System (CNS) tumor with c-Met alteration, and follows the NMPA’s November 2023 approval of vebreltinib for the treatment of patients with Met Exon 14 skipping non-small cell lung cancer (NSCLC). |
| 2024-04-10 | Apollomics Inc. | Results Apollomics Presents Vebreltinib Data at the 2024 American Association for Cancer Research (AACR) Annual Meeting apollomicsinc.com ↗
Preclinical studies demonstrate vebreltinib is effective for a variety of tumor types carrying MET-driver alterations, and effective for overcoming MET-amplification dependent resistance to EGFR therapies in EGFR-positive non-small cell lung cancer |
| 2023-12-04 | Apollomics Inc. | Results Apollomics Presents Interim Data from Two Ongoing Phase 2 Clinical Trials with Vebreltinib in NSCLC Patients with MetExon14 Skipping Mutation apollomicsinc.com ↗
Vebreltinib appears efficacious in non-small cell lung cancer (NSCLC) patients with MetExon14 skipping mutation with or without co-occurring MET amplification. |
| 2023-11-16 | Avistone Biotechnology Co., Ltd. | Regulatory 伯瑞替尼一线适应症正式获批，开创肺癌MET靶向治疗新篇章 avistonebio.com ↗
2023年11月16日，国家药品监督管理局（NMPA）发布信息，批准北京鞍石生物科技有限责任公司（鞍石生物科技）全资子公司北京浦润奥生物科技有限责任公司自主研发的1类创新药伯瑞替尼肠溶胶囊（商品名：万比锐®，伯瑞替尼）用于治疗具有间质-上皮转化因子（MET）外显子14跳变的局部晚期或转移性非小细胞肺癌患者。 |
| 2023-11-16 | Apollomics Inc. | Regulatory Apollomics Announces the First Approval of Vebreltinib for MET Exon 14 Skip Non-Small Cell Lung Cancer apollomicsinc.com ↗ |
| 2023-10-26 | Apollomics Inc. | Results Apollomics Announces Report of Activity of Vebreltinib in Glioblastoma Multiforme (GBM) with PTPRZ-MET Fusion apollomicsinc.com ↗
The patient with GBM with PTPRZ-MET fusion who had previously received radiotherapy and temozolomide, was reported to have an impressive Partial Response (PR) after 8 weeks of treatment with vebreltinib monotherapy during participation in the SPARTA study ( NCT03175224 ) . |
| 2023-10-24 | Avistone Biotechnology Co., Ltd. | Results 伯瑞替尼在欧洲肿瘤内科学会（ESMO）2023年年会上公布Ⅱ期部分研究结果 avistonebio.com ↗
本次ESMO年会，鞍石生物旗下全资子公司浦润奥生物在研产品伯瑞替尼（Vebreltinib, bozitinib, PLB1001）Ⅱ期临床试验治疗间质表皮转化因子（MET）外显子14（METex14）跳跃突变的研究结果以Poster（壁报）形式展出。 |
| 2023-10-23 | Apollomics Inc. | Results Apollomics Announces Efficacy of Vebreltinib in NSCLC Patients with MetEx14 Skipping Mutation Achieving an Overall Response Rate (ORR) of 75% apollomicsinc.com ↗
In the Phase 2 KUNPENG clinical trial conducted by Apollomics’ China partner, Avistone Biotechnology Ltd. (Beijing Pearl Biotechnology Ltd.), vebreltinib showed efficacy in patients with locally advanced or metastatic NSCLC harboring Exon-14 skipping mutations, with an ORR of 75%. |
| 2023-07-20 | Avistone Biotechnology Co., Ltd. | Regulatory 鞍石生物MET抑制剂伯瑞替尼肠溶胶囊（Vebreltinib, PLB-1001）提交脑胶质瘤新适应症pre-NDA申请 avistonebio.com ↗
鞍石生物近日宣布，其旗下全资子公司北京浦润奥生物科技MET抑制剂伯瑞替尼肠溶胶囊于2023年6月30日向国家药品监督管理局药品审评中心提交脑胶质瘤新适应症pre-NDA申请，拟用于：经放疗和替莫唑胺治疗后复发或不可耐受的，具有PTPRZ1-MET融合基因的IDH突变型WHO 4级星型细胞瘤或既往有较低级别病史的胶质母细胞瘤成人患者。 |
| 2022-12-22 | Apollomics Inc. | Results CBT Pharmaceuticals Presents Data Demonstrating Anti-Tumor Activity of its Highly Specific c-MET Inhibitor, Bozitinib (CBT-101), at AACR Annual Meeting 2017 apollomicsinc.com ↗
CBT-101 demonstrated improved tumor growth inhibition as compared to other selective c-MET agents in lung, gastric, hepatic, and pancreatic cancer models. |
| 2022-11-27 | Avistone Biotechnology Co., Ltd. | Results 世界肺癌日｜国际肺癌关注月第六期 遇见未来——伯瑞替尼开启肺癌Met靶向治疗新时代 avistonebio.com ↗
伯瑞替尼关键注册临床达到主要终点，显示了卓越的疗效和安全性： |
| 2022-11-15 | Apollomics Inc. | Regulatory Apollomics Inc. Receives FDA Orphan Drug Designation for Vebreltinib (APL-101) for Treatment of Non-Small Cell Lung Cancer with MET Genomic Tumor Aberrations apollomicsinc.com ↗
The FDA granted the Orphan Drug Designation in August. |
| 2022-09-28 | Avistone Biotechnology Co., Ltd. | Regulatory 鞍石生物科技MET抑制剂伯瑞替尼肠溶胶囊（PLB-1001）中国上市许可申请获正式受理关于非小细胞肺癌和MET通路异常关于伯瑞替尼鞍石生物科技创始人石和鹏博士表示： avistonebio.com ↗
9月24日，“伯瑞替尼肠溶胶囊”1类新药注册申请正式获CDE受理。 |
All press releases naming this drug 33 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 27 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Vebreltinib | “APL-101 (Vebreltinib) is an orally available small molecule, which is a tyrosine kinase inhibitor (TKI) for the mesenchymal epithelial transition protein tyrosine kinase...” NCT05367388 ↗14“vebreltinib (also known as bozitinib, APL-101, PLB-1001, and CBT-101), a potent and highly selective inhibitor of c-mesenchymal-epithelial transition (MET)” PMID 39058972 ↗ Jul 2024 |
| Known as | APL-101 | “vebreltinib (also known as bozitinib, APL-101, PLB-1001, and CBT-101), a potent and highly selective inhibitor of c-mesenchymal-epithelial transition (MET)” PMID 39058972 ↗ Jul 2024 |
| Known as | Bozitinib | “vebreltinib (also known as bozitinib, APL-101, PLB-1001, and CBT-101), a potent and highly selective inhibitor of c-mesenchymal-epithelial transition (MET)” PMID 39058972 ↗ Jul 2024 |
| Known as | CBI-3103 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650443 ↗ |
| Known as | CBT-101 | “vebreltinib (also known as bozitinib, APL-101, PLB-1001, and CBT-101), a potent and highly selective inhibitor of c-mesenchymal-epithelial transition (MET)” PMID 39058972 ↗ Jul 2024 |
| Known as | PLB-1001 | “Furthermore, we describe a MET kinase inhibitor, PLB-1001, that demonstrates remarkable potency in selectively inhibiting MET-altered tumor cells in preclinical models.” PMID 30343896 ↗ Oct 20186“vebreltinib (also known as bozitinib, APL-101, PLB-1001, and CBT-101), a potent and highly selective inhibitor of c-mesenchymal-epithelial transition (MET)” PMID 39058972 ↗ Jul 2024 |
| Action | Inhibit | “PLB1001 is a potent selective c-Met inhibitor.” NCT02896231 ↗ |
| Modality | Cell therapy | “CBT101, an Autologous Natural Killer Cell” NCT04557306 ↗ |
| Route | Oral | “PLB1001 administered orally to patients” NCT02978261 ↗ |
| Target | MET | “PLB1001 acts on cancer by blocking abnormal cMET-mediated signaling” NCT02978261 ↗ |