February [6], 2026—TYK Medicines (Stock Code: 02410.HK) announced today that the New Drug Application (NDA) for its self-developed asandeutertinib (TY-9591), targeting non-small cell lung cancer (NSCLC) with brain metastases, has been formally accepted by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). This is the first new-generation EGFR-TKI specifically targeting brain metastasis of lung cancer.

The indication applied for asandeutertinib is: first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who harbor epidermal growth factor receptor (EGFR) exon 19 deletion (19DEL) or exon 21 (L858R) substitution mutations and have central nervous system (CNS) metastases.

This NDA submission is based on results from a pivotal, multicenter, randomized, open-label, active-controlled registration clinical study (ESAONA) (NCT05948813) conducted in China. Designed as a superiority trial, the study evaluated the efficacy and safety of asandeutertinib versus osimertinib as first-line therapy in NSCLC patients with brain metastases. Led by Professor Shi Yuankai from the Cancer Hospital of the Chinese Academy of Medical Sciences, the trial involved over 50 research centers nationwide. The results are slated for publication in an international academic conference or journal in the near future.

Previously, in September 2025, TYK Medicines presented interim results from the ESAONA study in an oral presentation at the WCLC 2025. As of February 28, 2025, an interim analysis based on data from 224 patients showed: the intracranial objective response rate (iORR) assessed by Blinded Independent Central Review (BICR) per RECIST v1.1 was significantly higher in the asandeutertinib at 92.8%, compared to 76.1% in the osimertinib (p=0.0006). The investigator-assessed iORR was 90.1% vs 74.3% (p=0.0023) per RANO-BM, both demonstrating clinically meaningful and statistically significant differences. Asandeutertinib demonstrated significantly higher confirmed BICR-iORR in subgroups of female, age < 65, never smokers, ECOG PS of 1, EGFR 19Del, intracranial lesions ≤ 3, and no visceral metastases. Data for intracranial Progression-Free Survival (iPFS), PFS, and Overall Survival (OS) remained immature.

In January 2026, asandeutertinib was included in the CDE’s priority review and approval process, which is expected to further expedite its path to market.

Furthermore, several studies investigating asandeutertinib both as monotherapy and in combination regimens are currently underway in China.

Professor Shi Yuankai, Cancer Hospital of the Chinese Academy of Medical Sciences: Brain metastases in lung cancer present a significant challenge in clinical management. They not only severely impact patients’ quality of life and neurocognitive function but are also a major cause of clinical treatment failure and patient mortality. Available clinical data support the encouraging clinical efficacy and favorable safety profile of asandeutertinib as monotherapy for brain metastases of NSCLC. We look forward to its marketing authorization, which would provide more treatment options for these patients.

Mr. Chen Xiugui, Senior Vice President of TYK Medicines: Asandeutertinib is the first self-developed product from TYK Medicines to submit the NDA application, reflecting our differentiated, science-driven product development strategy focused on unmet clinical needs. We extend our gratitude to all the investigators, patients, CROs, and suppliers involved in this study for their efforts and trust. The submitted NDA materials strictly adhere to NMPA’s technical requirements and quality standards. We will collaborate closely with regulatory authorities to facilitate the approval of this important product, in order to serve a broad population with brain metastases of lung cancer. We will also further explore combination therapies to address additional practical clinical needs.

Dr. Wu Yusheng, Chairman and CEO of TYK Medicines: TYK Medicines has been dedicated to novel drug innovation in the pursuit of health since its inception. The NDA submission for asandeutertinib is a crucial milestone, marking the company’s entry into the commercialization phase. Based on globally competitive clinical data, we believe that asandeutertinib offers new hope for these patients. This NDA submission is just the beginning. We remain committed to addressing unmet clinical needs and continue to intensify our focus on oncology research, with persistent efforts in clinical value-oriented innovation and drug development. We strive to meet the public’s aspirations for a better life and benefit a broader patient population.”

About Asandeutertinib
Asandeutertinib, developed by TYK Medicines, is an oral, new-generation, highly selective EGFR-TKI that exhibits high potency, ATP-competitive binding, and an irreversible mechanism of action. As a deuterated analog of osimertinib that’s already on the market, it exhibits distinct pharmacokinetic characteristics that significantly reduce the generation of the toxic metabolite AZD5104 (TY9591-D1), offering clear clinical advantages. It has shown significant efficacy, particularly in NSCLC patients with brain metastases and EGFR L858R mutation. TYK Medicines has initiated multiple clinical trials in China evaluating asandeutertinib as monotherapy and in combination for treating advanced NSCLC.