Sino Biopharmaceutical Ltd (HKG: 1177), a leading pharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Novartis AG’s Afinitor (everolimus). This achievement marks a significant milestone as the company’s product is set to enjoy a 12-month exclusivity period, following a successful category 4.1 patent challenge against the originator, making it the first to gain market approval. SinoBio describes this as the first instance a product has secured such exclusivity in China under the country’s relatively new patent linkage system.
Everolimus, a mammalian target of rapamycin (mTOR) inhibitor, was initially approved in the US in 2009 for the treatment of advanced kidney cancer. The drug has since expanded its indications to include advanced pancreatic neuroendocrine tumors (NETs), progressive, nonfunctional gastrointestinal and lung NETs, non-cancerous kidney tumors associated with tuberous sclerosis (TSC), and hormone-receptor positive, HER2-negative breast cancer in postmenopausal women.- Flcube.com
