On July 11, the phase Ib clinical study findings of XIANNUOXIN® were published online in a sub-journal of The Lancet, a worldwide authoritative medical journal. The study indicated that SIM0417 plus ritonavir showed a better therapeutic effect and was well tolerated across all subjects. There were no serious adverse events, or adverse events leading to drug discontinuation or study suspension. This is the first time that an anti-COVID-19 innovative drug developed in China has been published in a journal of The Lancet Group.
In 2019, The Lancet published a color picture of SARS-CoV-2 for the first time and continued to report the COVID-19 authoritatively
XIANNUOXIN® (Simnotrelvir Tablets/Ritonavir Tablets (co-packaged)), jointly developed by Simcere Pharmaceutical (2096. HK) and the institutes including Shanghai Institute of Materia Medica of the Chinese Academy of Sciences, is the first Class I 3CL anti-COVID-19 innovative drug specially approved by the National Medical Products Administration (NMPA) for marketing and is the first domestic innovative drug of Chinese "Anti-epidemic Toolbox" in this year.
The study published in the sub-journal of The Lancet was a randomized, double-blind, placebo-controlled, phase Ib clinical study in China aiming to evaluate the efficacy and safety of SIM0417 plus ritonavir in adults with COVID-19. It was led by Professor Lu Hongzhou, Director of the Third People's Hospital of Shenzhen, the National Clinical Medical Research Center for Infectious Diseases. The study indicated that SIM0417 plus ritonavir showed a better therapeutic effect and the 750 mg SIM0417 plus 100 mg ritonavir was selected as the recommended dose for large clinical trials.
The above sub-journal is known as The Lancet Regional Health - Western Pacific in full.
The screenshot of the publication on The Lancet Regional Health - Western Pacific
XIANNUOXIN® inhibits the 3CL protease required for viral replication and therefore restrains the ability of the virus to infect normal cells and to spread from the source. It was approved for marketing by the NMPA on January 28, and included in the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Version 10) and the scope of national temporary medical insurance for COVID-19.
The paper indicated that the efficacy of SIM0417 showed a pure dose-response relationship. The viral load decrease from baseline in the high dose group was more significant compared with placebo, with a maximum mean difference from baseline of about 99.3% (2.16 ± 0.761 log10 copies/mL) (p = 0.0124) on Day 4. The proportion of positive SARS-CoV-2 in high and low dose groups was lower than the placebo at each post-treatment time point. The median time to sustained alleviation of COVID-19 symptoms was 2 days in high dose group versus 6 days in the placebo group.
The Lancet is one of the four most authoritative medical journals worldwide. The publication of the XIANNUOXIN® study in a sub-journal of The Lancet reflects that the international academic community pays attention to the R&D of anti-COVID-19 drugs in China and recognizes the safety and efficacy of XIANNUOXIN® demonstrated in this study. A 2/3 clinical trial with a large sample size initiated in the second half of 2022 has further confirmed the efficacy and safety of XIANNUOXIN®, with the specific data to be subsequently published in academic journals.