Tongyuan Kang (02410) has received conditional approval for its Class 1 new drug, Deutetrabenazine tablets, providing a new option for the clinical treatment of brain metastases in lung cancer with EGFR mutations.

On August 27, 2026, Hong Kong stock innovative drug company Tongyuan Kang Pharmaceutical (02410) announced that its independently developed first-class new drug methanesulfonate deuterated Shenaitini tablets (TY-9591) has been approved for conditional marketing by the National Medical Products Administration (NMPA) of China. This drug is intended for first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion (19DEL) or exon 21 (L858R) substitution mutation, accompanied by central nervous system (CNS) metastases. The approval of this product provides a new domestically developed targeted therapy option for patients with difficult-to-treat EGFR-mutated non-small cell lung cancer with brain metastases and marks a significant clinical breakthrough for a new generation of domestic EGFR-TKIs. Key Registration Study Solidifies Evidence-Based Foundation, Highlights Unique Advantages in Intracranial Treatment The approval for marketing is based on the clinical study data from a pivotal open-label, multicenter, randomized controlled Phase II ESAONA trial. The interim analysis results of this study were presented in a brief oral report at the 2026 ASCO Annual Meeting, garnering widespread attention in the global oncology community. A total of 224 patients were enrolled in this study, randomized at a 1:1 ratio to either the deuterated Shenaitini group (160mg QD) or the osimertinib group (80mg QD), while stratified by EGFR mutation subtype and number of intracranial lesions to ensure baseline balance between the two groups. The primary endpoints were the blinded independent central review (BICR) intracranial objective response rate (iORR) and intracranial progression-free survival (iPFS). As of December 15, 2025, the median follow-up time for the study was 19.12 months. The BICR results indicated that the iORR for the deuterated Shenaitini group reached 95.5%, significantly better than the control groups 79.6% (P=0.0004). Additionally, the median iPFS for the deuterated Shenaitini group was not reached, significantly extending compared to the osimertinib groups median iPFS of 17.51 months (HR=0.46, P=0.0020). The iPFS rates at 18 months and 24 months for the deuterated Shenaitini group were 75.24% and 61.56%, respectively, also significantly higher than the control group, with consistent benefits across all predefined subgroups. From the perspective of systemic anti-tumor efficacy, BICR assessments showed that the ORR for the deuterated Shenaitini group was 89.2%, higher than the control groups 77.9% (P=0.0301). The progression-free survival (PFS) data are still immature, with the median PFS for the deuterated Shenaitini group not reached, outperforming the osimertinib groups 17.22 months (HR=0.64, P=0.0473). Currently, overall survival (OS) data for the study are also not mature, and as of June 10, 2026, the median follow-up time was 15.8 months, with a total of 69 events recorded (maturity 30.8%). The HR for deuterated Shenaitini compared to the osimertinib group was 0.779, P=0.3023. In terms of safety, the overall safety of deuterated Shenaitini is manageable, with most grade 3 or higher adverse events effectively alleviated through symptomatic treatment and dose adjustments. Meeting Unmet Clinical Needs, Promoting the Realization of Value for Domestic Innovative Targeted Drugs EGFR mutations are the most common driver mutations in non-small cell lung cancer, while brain metastases are the most perilous type of metastasis in advanced non-small cell lung cancer, severely threatening patients' survival and quality of life, and have long been a challenge in clinical treatment. Mainstream third-generation EGFR-TKIs currently provide significant improvements in overall survival for patients with EGFR-mutant lung cancer, but their ability to penetrate the blood-brain barrier is limited, and their efficacy in controlling intracranial metastatic lesions still has drawbacks, representing a significant unmet therapeutic need in clinical settings. Deuterated Shenaitini, as a new generation of highly selective, irreversible oral EGFR-TKI independently developed by Tongyuan Kang Pharmaceuticals, is a deuterated innovative derivative of osimertinib. Through molecular structure optimization, its pharmacokinetic characteristics have been improved, significantly reducing the production of toxic metabolites and demonstrating notable clinical advantages, especially in patients with EGFR 19del and L858R sensitive mutation lung cancer brain metastases. Additionally, Tongyuan Kang Pharmaceuticals continues to advance several clinical explorations for monotherapy and combination therapy to further explore the therapeutic potential of the drug. Tongyuan Kang Pharmaceuticals stated: "The successful approval of methanesulfonate deuterated Shenaitini tablets marks an important milestone for the company in transitioning from clinical development to commercialization and is a strong testament to our innovative R&D capabilities. It signifies that we have taken a solid step forward in overcoming the treatment bottleneck of lung cancer. At this new starting point, Tongyuan Kang Pharmaceuticals will adhere to long-termism, continue to invest in original innovation and the exploration of combination therapies, and strive to build a more competitive portfolio of cancer treatment products, actively contributing to the construction of a 'Healthy China' and ensuring that domestically developed innovative achievements truly benefit a broad range of patients."