Chinese R&D sector takes ‘significant step’ as outsourcing demand increases
The China-based global API and drug product contract development and manufacturing organization (CDMO), STA Pharmaceutical, has experienced a rapid increase in demand as more companies look to market products in China, using STA as their partner.
The influx of business follows the launch of the Market Authorization Holder (MAH) pilot program, which the China Food and Drug Administration (CFDA) announced last year.
“The MAH pilot coupled with other regulatory changes, as well a number of promising start-ups are fueling the demand,” Ms. Mei Hao, vice president of quality assurance at STA Pharmaceutical told us.
“We are confident that investments coming from venture capital in China into emerging biotech and pharmaceutical companies will accelerate the pace of innovation across the country,” she said.
The program, which is being piloted across ten provinces and municipalities across China, was launched to enable drug license holders to use contract manufacturing organizations (CMOs) to help streamline drug approvals.
Well-positioned with CFDA-approved facilities at both the development and commercial scale, STA believes it has the potential to be one of the biggest participants of the MAH projects for new chemical entities (NCE).
Hao explained that progress over the past year has been “very good” and that the company has seen “a quick uptake” in demand from its China-based customers.
Additionally, the company’s educational symposiums “have been a big factor in customers committing to working with STA from the outset,” she added.
STA currently has eight MAH development programs underdevelopment, which the company said is the most of any domestic CDMO in the country.
MAH holders are located in Zhejiang, Jiangsu, and Shanghai, and are contracting API and drug products to STA sites at Shanghai, Changzhou, and Wuxi.
All the programs – ranging from investigational new drug (IND) filing preparation to new drug application (NDA) pending – are progressing well, Hao said.
“Customer feedback since the launch has been unanimously positive, and whilst it’s a good news for STA, it is clearly an even more significant step for the Chinese R&D sector,” she added.
The company expects further increases in demand for MAH programs next year as it expects to continue carrying on more than 10 MAH projects in 2018.
To meet this demand, but also to keep pace with global demand, STA has been investing for the last few years. Specifically, the company has initiated the second stage construction of the 39-acre integrated API development and manufacturing site at Changzhou. New commercial drug product plants will be opening in the coming months.