STA Pharmaceutical has reported rapid growth in companies intending to market their products in China using it as a partner following the Chinese Food and Drug Administration’s (CFDA) announcement of the Market Authorization Holder (MAH) pilot programme last year.
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The MAH pilot programme was launched to allow drug licence holders the use of qualified contract manufacturing service providers in certain geographic areas (10 trial provinces and municipalities), with the aim of increasing innovation as biotech companies would no longer be required to invest in their own manufacturing facilities.
As STA already has existing CFDA approved facilities in China — at both development and commercial scale — and experience with the pilot programme, it anticipates that it will be a big participant of the MAH projects for innovative new chemical entities (NCE). Over the course of the first full year of the pilot programme, STA has already been involved with the development work of eight NCE projects.
“We have seen very quick take-up amongst the Chinese pharma and biotech sectors in 2017. 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,” commented Mei Hao, vice president of Quality Assurance at STA.
In 2018 STA forecasts to continue carrying on 10+ MAH projects, as demand for contract services in China increases quickly. Hao added, “The benefit to speed the new drug into the market for the innovators is huge, which saves vital time and costs. But for STA it’s also a huge opportunity, as we have experience of working with MAH type programmes via our experience with FDA and EMA, not to mention facilities approved by all the major regulators. We are ideally placed to be the contract provider of choice as the program matures and more companies adopt this approach.”
STA Pharmaceuticals is a China-based global API and drug product contract development and manufacturing organisation (CDMO).
