STA sees rapid growth in MAH programs in China

STA sees rapid growth in MAH programs in China
Credit: Dmitry Kalinovsky

A new Market Authorisation Holder pilot programme has seen contract manufacturer STA Pharmaceutical see an uptick in companies looking to use its services to market their products in China.

The MAH pilot was launched to allow drug license holders to use qualified contract manufacturing service providers in certain geographic areas, thereby increasing innovation as biotechs would no longer need to invest in their own manufacturing facilities.

Since STA has existing Chinese Food and Drug Administration approved facilities in China and extensive experience with the pilot program, it is poised to be one of the biggest participants of the MAH projects for innovative new chemical entities.

In just the first full year of the pilot, STA is already undertaking the development work for eight new chemical entities projects – the most of any domestic CDMO in the country, it said.

“We have seen very quick take-up amongst the Chinese pharma and biotech sectors in 2017,” said STA Vice President of Quality Assurance Mei Hao.

“But we anticipate  an acceleration of demand next year as both Chinese customers and, increasingly western drug makers looking to file NDAs in China, begin programs with us.

In 2018 STA forecasts to continue carrying on 10+ MAH projects, as demand for contract services in China increases quickly.