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 Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and referencing the pharmacovigilance systems of international pharmaceutical companies as well as the regulatory requirements of the NMPA, we have established a cross-system, cross-departmental, and cross-subsidiary pharmacovigilance system at the group company level. A dedicated Pharmacovigilance Department has been set up to oversee the continuous lifecycle safety risk monitoring, assessment, and management of drugs from their entry into first-in-human clinical trials, through clinical development, to post-marketing stages. This includes timely communication with regulatory authorities and submission of relevant reports as required by regulations to ensure patient medication safety. We have also developed a series of standard operating procedures and conduct regular training for all employees, requiring them to promptly report any issues related to drug safety or quality.