TIME：August 8, 2003

Source: China Economic Times

Shenzhen Chipscreen Biosciences Co., Ltd. has recently entered into a landmark collaboration with the National Center for Toxicological Research (NCTR) under the U.S. Food and Drug Administration (FDA). The agreement focuses on the joint development of gene expression biochips and associated data analysis platforms for pharmacological and toxicological research in the United States. This marks the first time the FDA has partnered with a Chinese biotechnology company.

Under the terms of the agreement, NCTR will collaborate with Chipscreen Biosciences on the development of key components of ARRAYTRACK, a bioinformatics tool designed for gene expression analysis in toxicology and pharmacology. ARRAYTRACK is widely recognized as one of the most important analytical platforms in the field of biochip applications.

As the FDA’s dedicated toxicological research arm, NCTR plays a critical role in supporting the agency’s regulatory mission. The FDA remains the sole authority responsible for approving drugs for entry into the U.S. market—widely regarded as the largest pharmaceutical market in the world. Securing FDA approval is often seen as a gateway to global market access.

Chipscreen Biosciences, headquartered in Shenzhen, is a leading innovator in China’s drug discovery landscape. The company was founded by a team of U.S.-trained Ph.D. scientists with prior experience at some of the world’s leading pharmaceutical R&D institutions, positioning it at the forefront of original drug innovation in China.