Drug Quality 

Drug quality is closely related to patient safety and health. As a pioneer in China's original innovative drug field, the Group's Quality Management Department has established a group-wide drug lifecycle quality management system based on the Quality-by-Design (QbD) concept and risk management principles, in compliance with domestic and international regulations and relevant technical guidelines from the National Medical Products Administration (NMPA), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), U.S. Food and Drug Administration (FDA), World Health Organization (WHO), and other regulatory bodies.This system encompasses the supervision of quality system operations across all group units, quality management throughout the entire Marketing Authorization Holder (MAH) product chain, and the coordinated management of quality units throughout the product lifecycle, thereby achieving comprehensive quality management from the group to its subsidiaries to ensure product quality, patient safety, and patient benefit.

Drug Safety 

Patient safety is our top priority. In accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and referencing the pharmacovigilance systems of international pharmaceutical companies as well as NMPA regulatory requirements, Chipscreen Biosciences has established a pharmacovigilance system covering all products throughout their lifecycle, from first-in-human studies to long-term post-marketing surveillance, always prioritizing patient medication safety. The company has set up an independent Pharmacovigilance Department and established a Drug Safety Committee, under which a Safety Assessment and Emergency Command Team operates to comprehensively strengthen the drug safety defense system. Through multi-channel active collection, standardized reporting, and compliance management, we have established a rigorous and transparent risk management mechanism to safeguard every patient, enabling broader patient access to innovative therapies.