Changes in Hong Kong stocks | Tongyuankang Pharmaceutical-B (02410) rose more than 5% in early trading. The company is preparing an NDA application for TY-9591 conditional listing

The Zhitong Finance App learned that Tongyuankang Pharmaceutical-B (02410) rose more than 5% in early trading. As of press release, it had risen 3.73% to HK$13.35, with a turnover of HK$21.546 million.

According to the news, at the World Lung Cancer Conference in September this year, the idotinib tablets released by Tongyuankang Pharmaceutical attracted great attention from peers in a critical phase II clinical trial targeting non-small cell lung cancer brain metastasis. According to reports, idotinib tablets (TY-9591) are highly selective small molecule inhibitors developed by Tongyuankang Pharmaceutical for classic EGFR mutations. The company completed the enrollment of 224 patients with conditions for marketing in November 2024, and submitted pre-listing (pre-NDA) applications in April 2025. It is expected that the conditional listing application will be officially submitted in the 4th quarter of 2025.

The company stated at the interim results meeting that it is currently preparing an NDA application for TY-9591 conditional marketing to be used for first-line treatment of epidermal growth factor receptor (EGFR) mutation lung cancer brain metastasis, and is undergoing registered phase III clinical trials of TY-9591 monotherapy in China to use it for locally advanced (stage IIIb to IV) of EGFRL858R mutations or first-line treatment of metastatic NSCLC.