Key clinical data has met research expectations, TYK MEDICINES-B (02410) shows high value potential.

TYK MEDICINES-B(02410) announced on March 9, 2025, that its independently developed TY-9591 (brand name: Cardasha) has shown significant and clinically meaningful improvements compared to osimertinib (brand name: Tagrisso) as a first-line treatment for EGFR-mutated lung cancer with brain metastasis in a phase II clinical trial. According to the researcher's data, TY-9591 demonstrated statistical significance and significant clinical benefits. In this trial, a total of 224 subjects were enrolled, with the proportions of patients with exon 19 deletions and exon 21 L858R mutations being 53.1% and 46.9%, respectively, consistent with the genetic mutation levels seen in real-world patients. The overall safety of the TY-9591 group was good, with no new safety signals observed. The trial results showed that the primary endpoint of intracranial objective response rate (iORR) was achieved, with TY-9591 demonstrating statistically significant and clinically meaningful improvements compared to osimertinib in both the overall population and different subgroups (including genetic subtypes, number of intracranial lesions, ECOG scores, etc.). Therefore, in the treatment of EGFR-mutated lung cancer with brain metastasis, TY-9591 from TYK MEDICINES-B is the first and only drug globally to show significant superiority over osimertinib in a head-to-head clinical study. Lung cancer is the most common malignant tumor in China, with non-small cell lung cancer (NSCLC) accounting for around 85% of all new cases of lung cancer. EGFR mutation is one of the most common genetic mutations in NSCLC, with approximately one-third of NSCLC patients globally carrying EGFR activating mutations, and around 50% of NSCLC patients in Asian populations having EGFR mutations. The market for lung cancer brain metastasis in China is projected to continue growing, with an estimated increase in new cases from 137,600 in 2017 to 171,400 in 2024, and an expected total of nearly 220,000 new cases by 2033, indicating significant market potential. TY-9591, as the fastest-developing third-generation EGFR-TKI candidate for NSCLC brain metastasis, is expected to address the urgent medical needs in the treatment of NSCLC and lung cancer brain metastasis in China, showcasing high market prospects and significant commercial value. In the context of the continuous support for the development of the innovative drug market in China, the pace of transitioning from "imitation" to "innovation" in the Chinese innovative drug market is accelerating. In the future, more local pharmaceutical companies like TYK MEDICINES-B will demonstrate China's independent research and development capabilities in head-to-head trials, actively promoting more local pharmaceutical companies to stand on the world stage of innovative drugs.