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NMPA Commissioner Jiao Hong Investigated the Quality Assurance and Supply Guarantee of the Anti-COVID-19 Innovative Drug XIANNUOXIN®

Release time:2023-02-18

On the morning of Feb. 17, 2023, National Medical Products Administration (NMPA) Commissioner Jiao Hong and her delegation visited Hainan Simcere Pharmaceutical to hold a symposium and investigate the quality assurance and supply manufacturing of the first domestic 3CL anti-COVID-19 innovative drug, XIANNUOXIN®. Xie Jing, Vice Governor of the People's Government of Hainan Province, Yuan Lin, Director of the NMPA's Department of Drug Regulation, Ding Hui, Mayor of Haikou Municipal People's Government, and Zhu Ning, Commissioner of Hainan Medical Products Administration, accompanied her throughout the investigation and participated in the symposium.

During the investigation, Commissioner Jiao Hong and her delegation listened to the report on the quality assurance and supply manufacturing of XIANNUOXIN®, and inspected the production factory of XIANNUOXIN®.

Commissioner Jiao Hong pointed out in the symposium that both clinical research experts and R&D personnel in innovative enterprises, including local governments and regulatory review experts, had made joint efforts to develop and launch domestic anti-COVID-19 innovative drugs in accordance with the laws and regulations required by the NMPA and . Hard work paid off, and XIANNUOXIN® became the first anti-COVID-19 small molecule drug approved after the Chinese New Year. Ms. Hong hopes that Simcere will continue unremitting efforts in continuing the research required for conditional marketing. XIANNUOXIN® offers more treatment options for COVID-19 infections in China, thereby boosting people's confidence in the fight against the pandemic.

Xie Jing, Vice Governor of Hainan Province, expressed gratitude to the NMPA for its attention to the R&D, production, quality assurance, and supply guarantee of XIANNUOXIN®. She stated that the provincial administration will serve its role in making sure that the marketing authorization sponsors fulfill their responsibilities as required by the NMPA, and work together to promote the high-quality production and supply of domestically developed innovative drugs.

The head of Simcere Pharmaceutical reported on the innovative drug R&D and the quality management and planned production capacity of XIANNUOXIN®.