ST NOTEC (688076.SH): FLUVISTRAN INJECTION ANDA OBTAINED US FDA MARKETING APPROVAL

Zhitong Finance App News, ST Notch (688076.SH) issued an announcement. Recently, the company received a notice from the US Food and Drug Administration (“FDA”) that the company submitted to the US FDA for a simplified new drug application (“ANDA” for short) has been approved for marketing by the US FDA. The US FDA carried out a comprehensive technical review of the ANDA application data submitted by the company for fluravicin injection, and determined that the company's product was bioequivalent and curative equivalent to the original drug. This drug is the company's first pharmaceutical product approved in the US. It marks a landmark achievement for the company's pharmaceutical products going overseas, and has had a positive impact on increasing international sales of pharmaceutical products.

According to reports, the approved indications for this drug are: for locally advanced or metastatic breast cancer with positive estrogen receptors after menopause (including natural menopause and artificial menopause) that has recurred after treatment with antiestrogen-assisted treatment, or progressing during anti-estrogen therapy; combination treatment with abecilil is suitable for locally advanced or metastatic breast cancer that is hormone receptor (HR) positive and human epidermal growth factor receptor 2 (HER2) negative, for patients with previous endocrine therapy.