Celebrating Vebreltinib's 2025 NRDL Inclusion for MET Amplification: Boosting Support for NSCLC Patients

On December 7, 2025, a major positive update was announced regarding China's National Reimbursement Drug List (2025): Vebreltinib Enteric Capsules, hereinafter referred to as "Vebreltinib", a novel MET inhibitor developed by Beijing Pearl Biotechnology Co., Ltd—a wholly-owned subsidiary of Beijing Avistone Biotechnology Co., Ltd.—has been successfully included in the national medical insurance drug list for its newly added indication in 2025: "for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition factor (MET) amplification"[1].This marks the third milestone for Vebreltinib following its inclusion in the medical insurance list in 2024 for two indications—NSCLC with MET exon 14 skipping mutation and glioma[2]. The latest inclusion will further expand the coverage of precision therapy for MET abnormalities, bringing new treatment options to more NSCLC patients with MET amplification.

Snapshot of China's National Reimbursement Drug List (2025)

 01  

Vebreltinib, a Category 1 new drug, is a highly selective c-Met inhibitor. On November 16, 2023, it was conditionally approved in China for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal - epithelial transition factor (MET) exon 14 skipping mutation[3].  On April 23, 2024, it obtained approval in China for adult patients with IDH - mutated astrocytoma (WHO Grade 4) or glioblastoma with a history of low - grade glioma, who carry the PTPRZ1 - MET fusion gene and have failed previous treatments[3]. On June 30, 2025, it was once again conditionally approved in China for the treatment of patients with locally advanced or metastatic non - small cell lung cancer (NSCLC) with mesenchymal - epithelial transition factor (MET) amplification[4]. The inclusion of Vebreltinib's indication for MET amplification in NRDL stems from its excellent efficacy and favorable safety data demonstrated in a pivotal registrational clinical trial (the KUNPENG study, NCT04258033), which provides solid evidence for patients' survival benefits[1,5]. The KUNPENG study is a multicenter, multi - cohort, open - label, single - arm Phase II clinical trial designed to evaluate the efficacy and safety of Vebreltinib in the treatment of advanced NSCLC with MET abnormalities. A total of 86 patients were enrolled in its MET amplification cohort, including 30 previously treated patients and 56 treatment - naive patients. As of November 14, 2024, the study results showed the following:

1. Objective Response Rate (ORR): The ORR in the total population reached 48.8% (95% CI: 38.3 - 59.4) (n=86). Among them, the ORR in the previously treated cohort was 43.3% (95% CI: 25.6 - 61.1) (n=30), and the ORR in the treatment - naive cohort was as high as 51.8% (95% CI: 38.7 - 64.9) (n=56).
2. Disease Control Rate (DCR): The DCR in the total population was 77.9% (95% CI: 69.1 - 86.7) (n=86). The DCR in the previously treated cohort was 73.3% (95% CI: 57.5 - 89.2) (n=30), and that in the treatment - naive cohort reached 80.4% (95% CI: 70.0 - 90.8) (n=56).
3. Duration of Response (DoR): The median DoR in the total population was 12.1 months (95% CI: 6.5 - 16.8) (n=86). The median DoR in the previously treated cohort was 11.0 months (95% CI: 3.7 - NE) (n=30), and the median DoR in the treatment - naive cohort was consistent with that in the total population, at 12.1 months (95% CI: 5.4 - 16.8) (n=56).
4. The incidence of Treatment - Related Adverse Events (TRAEs) of Grade 3 or higher was only 31.4% (n=86).
5. The most common TRAEs were peripheral edema (44.2%) and hypoalbuminemia (33.7%), and most of them were Grade 1 or 2.

 02  

The inclusion of Vebreltinib's MET amplification indication in China's 2025 NRDL will benefit a broader population of lung cancer and glioma patients in China. This decision fully reflects the continuous improvement of China's medical security system under the Healthy China strategy, with the protection of people's health always as the top priority. Avistone  has always adhered to its corporate mission of "delivering high-quality innovative drugs to improve patients' quality of life". We actively respond to national policies and facilitate the local implementation of medical insurance policies, ensuring that high-quality medications can benefit more Chinese patients as soon as possible.We believe that the expanded medical insurance coverage will enhance the affordability and accessibility of our product. Consequently, lung cancer and glioma patients are expected to achieve longer survival and better quality of life, bringing sustained benefits to a large number of patients and their families.

 03  

On NSCLC with MET Exon 14 Skipping

MET exon 14 skipping is an independent prognostic factor associated with poor survival rates in patients with NSCLC[6-9]. For NSCLC patients harboring MET exon 14 skipping, regardless of their prior treatment history, the objective response rate (ORR) to existing MET inhibitors ranges from 49.2% to 75%[10,11-14]. Meanwhile, the incidence of treatment-related adverse events (TRAEs) of grade 3 or higher is relatively high[11-12].

On Glioma

Glioma is an intractable primary malignant intracranial tumor, accounting for approximately 46% of all intracranial tumors[15]. Surgery, radiotherapy and chemotherapy are the traditional treatment strategies for glioma, with unfavorable prognosis. The 5-year overall survival (OS) rate of patients with malignant glioma is less than 10%[16]. Previous studies have found that MET fusions exist in about 12% of gliomas[17]. Among these, the representative PTPRZ1-MET fusion has an incidence of approximately 14% in glioblastomas in patients with a history of low-grade glioma. It usually co - occurs with MET exon 14 skipping and is associated with an even worse prognosis[18].

On Locally Advanced or Metastatic NSCLC with MET Amplification

MET gene amplification is a key oncogenic driver event in locally advanced or metastatic non-small cell lung cancer (NSCLC). It significantly promotes tumor cell proliferation, invasion and distant metastasis by inducing the overexpression of MET protein and the continuous activation of the downstream PI3K/AKT and RAS/MAPK signaling pathways, and is also closely linked to poor prognosis in patients.It is mainly divided into two categories: primary and secondary MET amplification. Primary MET amplification is observed in treatment-naive patients who have not received systemic therapy, with an incidence of about 1%-5%[19,20]. Such patients show limited response to traditional chemotherapy, with an objective response rate (ORR) often below 20% and a median overall survival (mOS) of only 8 - 10 months. Secondary MET amplification is one of the major mechanisms of drug resistance in EGFR-mutated NSCLC patients receiving EGFR tyrosine kinase inhibitor (TKI) therapy, especially the third-generation TKI Osimertinib, with an incidence of 5%-22%[21,22]. Moreover, it significantly shortens the time to new metastases after disease progression in patients on EGFR-TKI therapy and increases the risk of disease progression[10].

References

[1] https://www.nhsa.gov.cn/col/col104/index.html

[2] https://www.nhsa.gov.cn/art/2024/11/28/art_104_14886.html

[3] 伯瑞替尼肠溶胶囊药品说明书[S].国药准字H20230028.（2025年7月23日 ）

[4] https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d

[5] Wu YL, et al. ESMO Asia 2025 Abstract # 976MO

[6] Smyth EC et al. Onco Targets Ther, 2014, 7: 1001-14.

[7] DrilonA, et al. J Thorac Oncol, 2017, 12(1): 15-26

[8] Yeung SF, et al. J Thorac Oncol, 2015, 10(9): 1292-1300.

[9] Tong JH, et al.Clin Cancer Res, 2016, 22(12): 3048-56.

[10] Jin-Ji Yang et al. J Clin Oncol, 2024,42(15):8557.

[11] Yu Y, et al. EClinicalMedicine, 2023, 59: 101952.

[12] Lu S, et alLancet Respir Med, 2021, 9(10): 1154-1164.

[13] Paik  PK, et al. N Engl J Med, 2020, 383(10): 931-943.

[14] Wolf J, et al. N Engl J Med, 2020, 383(10): 944-957.

[15] Louis D N. Annu Rev Pathol, 2006, 1: 97-117.

[16] Qi Y, et al. Front Immunol. 2020 Nov 27;11:578877.

[17] Guo R, et al. Nat Rev Clin Oncol. 2020 Sep;17(9):569-587.

[18] Hu H, et al. Cell. 2018 Nov 29;175(6):1665-1678.e18.

[19] Lu S, et al.Lancet Respir Med, 2021, 9(10): 1154-1164. 

[20] Drilon A, et al. J Thorac Oncol, 2017, 12(1): 15-26.

[21] Paik PK, et al.N Engl J Med, 2020, 383(10): 931-943. 

[22] Wolf J, et al.N Engl J Med, 2020, 383(10): 944-957.

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