Breaking News | Avistone Biotechnology-安比锐®(Andamertinib) Approved in China for EGFR Exon 20 Insertion Mutated NSCLC

On 30 April 2026, Andamertinib Benzoate Capsules (安比锐^®, hereinafter referred to as Andamertinib), an EGFR exon 20 insertion (ex20ins) inhibitor independently developed by Avistone Pharmaceutical (Ningbo) Co., Ltd. (Ningbo Avistone), a wholly-owned subsidiary of Beijing Avistone Biotechnology Co., Ltd, was granted conditional approval by the National Medical Products Administration (NMPA). It is indicated for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have experienced disease progression during or following platinum-based chemotherapy, or who are intolerant to platinum-based chemotherapy, and who have been confirmed by testing to have an exon 20 insertion mutation in the epidermal growth factor receptor (EGFR).¹

1 Research Focus Targeted Precision Therapy for NSCLC with EGFR Exon 20 Insertion Mutations

The application for Andamertinib in China for the treatment of adult patients with locally advanced or metastatic non‑small cell lung cancer (NSCLC) harboring confirmed epidermal growth factor receptor (EGFR) exon 20 insertion mutations, whose disease has progressed during or after prior platinum‑containing chemotherapy or who are intolerant to such chemotherapy, was accepted by the NMPA in May 2025 and granted priority review and approval status, based on positive results of the KANNON study (NCT06015503)². This is the first indication of Andamertinib approved in China. It will provide a novel precision targeted therapy for patients with NSCLC harboring EGFR ex20ins mutations, a refractory molecular subtype, and fulfill the unmet clinical needs.

The KANNON study is a multicenter, single-arm Phase II clinical trial designed to evaluate the efficacy and safety of Andamertinib 240mg once daily (QD) in patients with EGFR ex20ins mutated non-small cell lung cancer (NSCLC). A total of 92 patients with locally advanced or metastatic EGFR ex20ins mutated NSCLC who had previously received platinum-based chemotherapy and/or immunotherapy were enrolled, among whom 89 patients were included in the full analysis set (FAS). Enrolled patients covered 28  ex20ins mutation subtypes, with the most prevalent subtypes - 769_ASV (27.0%) and 770_SVD (21.3%). In total, 98.9% of patients had received prior chemotherapy, 44.9% had received immunotherapy, 59.6% had received targeted therapy, and 16.9% had been treated with EGFR-TKIs and/or Amivantamab. Brain metastases were presented in 42.7% patients.

As of September 6, 2025, study results showed that the Independent Review Committee (IRC) assessed and confirmed objective response rate (ORR) was 42.7% (95% CI, 32.4–53.0), the disease control rate (DCR) was 86.5% (95% CI, 79.4–93.6), the median duration of response (mDoR) was 8.7 months (95% CI, 5.65–11.96), the median progression-free survival (mPFS) was 6.2 months (95% CI, 4.63–7.85), and the 12-month overall survival（OS） rate reached 70.5% (95% CI, 59.51–79.02). The long-term survival data are particularly impressive, with the median overall survival (OS) not yet reached.

The result of Andamertinib demonstrates a manageable safety profile:

• Grade ≥3 treatment-related adverse events (TRAEs) occurred in 40.2% of patients, with the most common being diarrhea (12.0%) and rash (7.6%)；
• Only 2.2% of patients discontinued treatment due to TRAEs, which is substantially lower than the 4%–10% reported for comparable agents ⁶；
• No interstitial lung disease (ILD) or grade ≥3 electrocardiogram QT- prolonged was reported.

A total of 38 patients with baseline brain metastases were enrolled in the KANNON study. The IRC-assessed and confirmed ORR was 47.4% (95% CI, 31.5–63.2), indicating promising intracranial therapeutic activity. This provides a novel treatment option for patients with clinically refractory brain metastases.

2 Conclusion

In a new era of continuous breakthroughs in precision oncology diagnosis and therapy, Andamertinib, independently developed by Avistone Biotechnology with global intellectual property rights, has achieved groundbreaking outcomes from the KANNON study. It has opened up a novel therapeutic pathway with definitive survival benefits for patients with EGFR ex20ins mutated NSCLC, a clinically refractory subtype. The Phase III clinical trial of Andamertinib for the first-line treatment of EGFR ex20ins NSCLC is progressing steadily. Meanwhile, given its broad-spectrum EGFR mutation inhibitory activity, the expansion of Andamertinib’s indication has great clinical value. Studies are currently ongoing in indications such as EGFR-TKI resistance with MET aberrations and PACC-mutated NSCLC. With the advancement of successive clinical trials and continuous accumulation of clinical data, we anticipate that this innovative Chinese drug will obtain approval for additional new indications in the future. It will benefit more lung cancer patients and inject strong Chinese momentum into the global field of precision lung cancer therapy!

3 About EGFR Exon 20 Insertion (ex20ins) Mutations

EGFR mutations are one of the most common driver genes in non-small cell lung cancer (NSCLC), with EGFR exon 20 insertion (ex20ins) mutation representing a specific molecular subtype. In China, EGFR ex20ins mutations account for 0.3–2.9% of all NSCLC patients and 2%–5% of EGFR-mutated NSCLC patients³. Due to its unique molecular structure, patients with this mutation exhibit intrinsic resistance to first-, second- and third-generation EGFR-TKIs. The median progression-free survival (mPFS) after disease progression on platinum chemotherapy is merely 2–4 months⁶. Current clinical treatment options are limited, resulting in substantial unmet clinical needs.

4 About Andamertinib

Andamertinib Benzoate Capsule is a Chinese innovative EGFR small-molecule inhibitor with global intellectual property rights, independently developed by Avistone Biotech. It features high selectivity and blood-brain barrier penetration capability. Preclinical studies have demonstrated that it potently and irreversibly targets EGFR ex20ins mutations. Meanwhile, it also exhibits potent activity against other EGFR subtypes including PACC, Del19, L858R and T790M mutations, with high target selectivity.

On April 9, 2025, Avistone Biotechnology submitted a New Drug Application (NDA) to the Center for Drug Evaluation (CDE), National Medical Products Administration (NMPA). The application was officially accepted on May 22, 2025 and granted the priority review and approval status⁷.

References

1.  https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20260430162657119.html.

2. Jin-Ji Yang, Yu Mu, , Zhe-Hai Wang, et al.Andamertinib in Advanced Non-Small-Cell Lung Cancer with EGFR Exon 20 Insertions After Platinum-Based Chemotherapy or Immunotherapy: Results from the Phase 2 KANNON Study[J]. Journal of Thoracic Oncology, 2025.https://doi.org/10.1016/j.jtho.2025.11.008

3.中国临床肿瘤学会非小细胞肺癌专家委员会. EGFR 20 外显子插入突变非小细胞肺癌规范化诊疗中国专家共识（2024 版）. 中国肺癌杂志, 2024, 27(7): 485-494.

4. Wang M, Fan Y, Sun M, et al. Sunvozertinib for patients in China with platinum-pretreated locally advanced or metastatic non-small-cell lung cancer and EGFR exon 20 insertion mutation (WU-KONG6): single-arm, open-label, multicentre, phase 2 trial[J]. Lancet Respir Med, 2024, 12(2): 217-224. https://doi.org/10.1016/S2213-2600(23)00379-X.

5. Liu Y, Cheng Y, Yu Y, et al. 1848MO-Phase II study of firmonertinib in patients with previously treated advanced/metastatic non-small cell lung cancer (mNSCLC) with EGFR exon 20 insertion (ex20ins) mutations[C]. 2025 European Society for Medical Oncology (ESMO) Congress, Madrid, Spain, 2025.https://cslide.ctimeetingtech.com/esmo2025/attendee/confcal/session/list?q=1848 MO.

6. Park K, Haura EB, Leighl NB, et al. Amivantamab in EGFR Exon 20 Insertion-Mutated Non-Small-Cell Lung Cancer Progressing on Platinum Chemotherapy: Initial Results From the CHRYSALIS Phase I Study[J]. J Clin Oncol, 2021, 39(30): 3391-3402. https://doi.org/10.1200/JCO.21.00662.

7. 北京鞍石生物科技股份有限公司.鞍石生物科技苯甲酸安达替尼胶囊 (PLB1004 胶囊) NDA 申请获正式受理并纳入优先审评 [EB/OL]. 2025-05-22. https://www.avistonebio.com/news_detail/100.html.

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