The board of directors Simcere Pharmaceutical Group Limited announced that, on July 8, 2024, XIANNUOXIN ® (Simnotrelvir Tablets/Ritonavir Tablets (co-packaged)), an innovative drug of the Group, has been reviewed and approved by the National Medical Products Administration of China (the "NMPA") for conversions from conditional approval to regular approval. The indication is to treat adult patients infected with mild to moderate novel coronavirus (COVID-19). XIANNUOXIN became the first oral anti-SARS-CoV-2 drug which has obtained regular approval in China.

XIANNUOXIN ® (Simnotrelvir Tablets/Ritonavir Tablets (co-packaged)) is an oral small molecule anti-SARS-CoV-2 innovative drug. Simnotrelvir targets 3CL protease which is essential for SARS-CoV-2 virus replication, and its combination with low-dose Ritonavir helps to slow down the metabolism and clearance of Simnotrelvir in body in order to improve the antiviral effect. On November 17, 2021, the Group entered into a technology transfer contract with Shanghai Institute of Materia Medica and Wuhan Institute of Virology, Chinese Academy of Sciences, pursuant to which, the Group obtained the development, production and commercialization rights on an exclusive basis of Simnotrelvir worldwide.

The results of phase II/III clinical studies (NCT05506176) show that XIANNUOXIN can accelerate the recovery from symptoms, shorten the duration of the disease, reduce viral load of 96.9% rapidly and significantly, and demonstrate good safety. On January 28, 2023, XIANNUOXIN was conditionally approved for marketing by the NMPA and became the first domestic 3CL anti-SARS-CoV-2 innovative drug. On December 13, 2023, XIANNUOXIN was officially included in the 2023 New National Reimbursement Drug List.