Tongyuankang Pharmaceutical-B (02410): idotinib mesylate tablets (TY-9591 tablets) to be included in priority review

Zhitongcaijing · 4d ago

Zhitong Finance App News, Tongyuankang Pharmaceutical-B (02410) announced that the company is developing a new class 1 drug, edotinib mesylate tablets (TY-9591 tablets), was included in the list of priority review varieties by the National Drug Administration (NMPA) Drug Evaluation Center (CDE). The proposed indications are: having epidermal growth factor receptor (EGFR) exon 19 deficiency (19DEL) or exon 21 (L858R) replacement mutations, accompanied by metastasis or advanced central nervous system (CNS) Metastatic non-small cell lung cancer (NSCLC) adults First-line treatment for patients.

The Board of Directors has also noted recent unusual fluctuations in the price and trading volume of the Company's shares. After making reasonable enquiries, the Board confirmed that, in addition to those disclosed above, as of the date of this announcement, it was unaware of any reason for the fluctuation, or any information required to be disclosed to avoid a false market in the Company's securities, or any insider information required to be disclosed under Part XIVA of the Securities and Futures Ordinance, Chapter 571 of the Laws of Hong Kong.

As of the date of this announcement, the Board of Directors has confirmed that the Group's business operations are normal and stable, that its core business is progressing smoothly, and that there are no important matters requiring disclosure that have attracted the attention of the board of directors and the management of the Company.