Qingdao Baheal Pharmaceutical Co Ltd, a holding subsidiary of Chinese pharmaceutical giant Baheal Pharmaceutical Group, announced on Tuesday that the first batch of advanced generic medicine the company has developed for type-2 diabetes will soon be delivered to the United States market.
The generic medicine, called "Nida", is an extended-release tablet containing metformin, a chemical widely used in type-2 diabetes management.
The original drug is a best-seller drug for diabetes in the U.S., and Qingdao Baheal Pharmaceutical's generic medicine received approval from the U.S. Food and Drug Administration's under review of generic drug applications, known as abbreviated new drug applications, in late 2018.
The Chinese drug regulator is reviewing the generic under fast track, as the drug has been approved in the U.S., and will hopefully approved for Chinese market in near future, the company said.
In recent years, an increasing number of Chinese pharmaceuticals have filed abbreviated new drug applications to the U.S. authorities for their generics, because the eye the huge U.S. market, but also because Chinese authorities encourage the development of high-quality generics, and would adopt fast-track review for generics that are made in China and have received U.S. approvals, according to Lei Jifeng, company board member of the company.
Qingdao Baheal Pharmaceutical claimed once approved, Nida will be the first osmotic-controlled metformin-based diabetes medicine in China, which uses an advanced controlled-release mechanism to release the metformin, ensuring stable drug effect over a controlled period, and will become a strong competitor against foreign medicines that dominate Chinese diabetes medicine market.
In 2017, about 425 million people were living with diabetes worldwide, and China is home to 114 million diabetes patients, according to International Diabetes Federation.
