Qilu Pharmaceutical Receives Approval for Two Generic Drugs: Fulvestrant Injection and Octreotide Acetate Microspheres

On August 3, the official website of the National Medical Products Administration showed that Qilu Pharmaceutical's two generic drugs, injectable octreotide acetate microspheres and fulvestrant injection, were approved for marketing. The former is the first approved generic version of octreotide acetate microspheres in China.

Octreotide Acetate Microspheres, originally developed by Novartis, is a long-acting injectable formulation of octreotide, an analog of somatostatin. It requires administration only once a month and is the preferred drug for treating acromegaly and gastroenteropancreatic neuroendocrine tumors. The original drug was first launched in the United States in 1998 and entered the Chinese market in 2003. Qilu Pharmaceutical initiated the development of Octreotide Acetate Microspheres for injection in 2016 and applied for the drug's market approval in January 2022.

Fulvestrant is a new type of estrogen receptor antagonist — a Selective Estrogen Receptor Downregulator (SERD) class of anti-breast cancer therapeutic drug. This medication blocks the nutritive effects of estrogen without possessing any partial agonist (estrogen-like) activity, and its mechanism of action is related to the downregulation of estrogen receptor protein levels.

Fulvestrant, originally developed by AstraZeneca, was approved for marketing in China in 2010. The approved indications include: 1) For postmenopausal women (including natural and artificial menopause) with estrogen receptor-positive locally advanced or metastatic breast cancer who have relapsed after or during anti-estrogen adjuvant therapy, or progressed during anti-estrogen therapy; 2) For hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in patients who have experienced disease progression after prior endocrine therapy.

It is worth mentioning that Qilu Pharmaceutical's anti-infective drug, Meropenem for Injection, has recently been approved for marketing by the National Medical Products Administration. It is a second-generation broad-spectrum carbapenem antibiotic, which is clinically used for infections in adults and children caused by single or multiple bacteria sensitive to meropenem, such as pulmonary infections, urinary tract infections, intra-abdominal infections, gynecological infections, skin and soft tissue infections, meningitis, sepsis, etc.

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