Jiangsu Sinopep-Allsino Biopharmaceutical Co., Ltd. (stock abbreviation: ST Nuotai, 688076) recently received notice from the U.S. Food and Drug Administration (FDA) that the Abbreviated New Drug Application (ANDA) it submitted for fulvestrant injection has been granted marketing approval. Following a full technical review of the application, the FDA determined that the company's product is bioequivalent and therapeutically equivalent to the reference listed drug.
The ANDA number is 216722. The product is an injectable formulation with a strength of 250 mg/5 mL (50 mg/mL). The approved indication is for estrogen receptor-positive, locally advanced or metastatic breast cancer in postmenopausal women (including natural and artificial menopause) with disease recurrence during or after anti-estrogen adjuvant therapy or progression during anti-estrogen therapy; and in combination with abemaciclib for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in patients whose disease progressed following prior endocrine therapy.
Fulvestrant is a competitive estrogen receptor antagonist with an affinity similar to that of estradiol. It blocks the trophic action of estrogen without any partial agonist (estrogen-like) activity, and its mechanism is associated with downregulation of estrogen receptor (ER) protein levels. The reference drug FASLODEX, developed by AstraZeneca, was launched in the United States in April 2002 and is now approved in the U.S., Europe, China and many other markets.
Fulvestrant injection is the company's first formulation product approved in the United States, marking a milestone in the overseas expansion of its formulation business and supporting the international sales of its products. The company noted that the product has not yet been registered or filed in China and has generated no revenue, and that its production and sales are subject to uncertainties arising from overseas regulations, market conditions and supply-demand dynamics.

Source: https://www.cls.cn/detail/2522791