On January 28, 2023, the novel anti-COVID-19 drug, XIANNUOXIN® (Simnotrelvir Tablets/Ritonavir Tablets (co-packaged)), jointly developed by Simcere Pharmaceutical Co., Ltd. (2096.HK, hereinafter referred to as Simcere), Shanghai Institute of Materia Medica (SIMM), and Wuhan Institute of Virology (WIV) of the Chinese Academy of Sciences (CAS), has received special drug approval procedures for emergency application at National Medical Products Administration (NMPA) with conditional requirements. XIANNUOXIN is approved for adults suffering from "mild to moderate COVID-19."
The XIANNUOXIN® Phase III study is the first clinical study in the world to to be conducted among the Chinese patient population infected with the SARS-CoV-2 Omicron variant and has completed patient enrollment. The trial design is guided by the international prevailing standard. The study is also the first phase III registered clinical study in the world that set continuous recovery of 11 symptoms as the primary endpoint. The recommended dosage is a combined use of 0.750 g simnotrelvir (0.375 g × 2) and ritonavir (0.1 g × 1), administered once every 12 hours for 5 consecutive days.
The study recruited symptomatic adult patients over 18 years of age with mild to moderate COVID-19, who had been infected with SARS-CoV-2 within the last 5 days, and had COVID-19 symptoms for no more than 3 days. The primary endpoint for the study was the time between the first administration and the first continuous recovery of 11 targeted COVID-19 symptom and the secondary endpoints include virological indicators, etc. The 11 targeted COVID-19 symptoms include cough, nasal obstruction or rhinorrhea, pharynx pain or dry throat, shortness of breath or dyspnea, headache, feeling hot or pyrexia, chills or shiver (or cold intolerance), muscle pain or generalized pain (or sore), nausea, vomiting, and diarrhea.
The result of the study confirms that XIANNUOXIN® can safely treat Chinese adults with mild to moderate COVID-19 effectively and provide obvious clinical benefits.
Acceleration of recovery from symptoms and shortening of the course of infection: Among 1,208 symptomatic adult patients with mild to moderate COVID-19 infection, compared to placebo, XIANNUOXIN® effectively shortened the time to continuous recovery of 11 targeted symptoms by roughly 1.5 days for mild to moderate COVID-19 and 2.4 days for the subgroup of high-risk severe COVID-19 patients. At the same time, clinical data also indicates that earlier use of XIANNUOXIN® can achieve increased efficacy.
Demonstration of strong anti-viral effects: The XIANNUOXIN® group saw a rapid and significant decline in viral load. After administration on the 5th day, the viral load dropped by over 96% at the maximum compared to that of the placebo group.
Shortening of nucleic acid conversion time: Nucleic acid conversion time in XIANNUOXIN® group is approximately 2.2 days shorter than that in the placebo group.
Detailed data are expected to be released in medical journals or seminars in the near future.
XIANNUOXIN® (Simnotrelvir Tablets/Ritonavir Tablets (co-packaged)) is a new oral small molecule drug against COVID-19. Simnotrelvir targets 3CL protease that is essential for SARS-CoV-2 viral replication. A combination with low-dose ritonavir can help slow simnotrelvir being metabolized or divided in human bodies and thus improve anti-COVID-19 effect.
3CL protease is the major protease that is identified in coronavirus and plays an essential role in virus replication. 3CL cleavage site is highly conservative and invulnerable to virus mutation, so the drug has broad-spectrum activity against coronavirus. There are no known 3CL homologs in human hosts, so the drug is highly selective and specific with lower risk of side effects. No genotoxicity was identified in XIANNUOXIN® through preclinical studies and multiple clinical studies confirmed a strong safety profile.
As China's first 3CL anti-COVID-19 drug with independent intellectual property rights, successful launch of XIANNUOXIN® is expected to bring more effective treatment options to Chinese patients in need.
Ren Jinsheng, Chairman of Simcere said: "After the outbreak started, Simcere rapidly reached the decision to invest resources to research and develop treatments for COVID-19. In this, Simcere adhered to its strategy of collaborative innovation. Facing the intense challenges caused by the pandemic, Simcere always worked closely with relevant scientific research institutes and clinical centers across the country. Through concerted efforts, we developed China's first oral 3CL small molecule drug against COVID-19. In this process, we would like to show our gratitude of the strong support from all departments related to the Joint Prevention and Control Mechanism under the State Council, Jiangsu Provincial Government, and Hainan Provincial Government. Simcere will continue to deliver on our mission of "providing today's patients with medicines of the future,” and we are honored to provide patients suffering from COVID-19 a potential best-in-class treatment option with XIANNUOXIN®, as well as contribute to the nation's prevention and control of COVID-19 through breakthrough scientific discovery and technology innovation."
About XIANNUOXIN®
XIANNUOXIN® (Simnotrelvir Tablets/Ritonavir Tablets (co-packaged)) is a new oral small molecule drug against COVID-19. Simnotrelvir targets 3CL protease that is essential for SARS-CoV-2 viral replication. A combination with low-dose ritonavir can help slow simnotrelvir being metabolized or divided in human bodies and thus improve anti-COVID-19 effect. In preclinical animal experiments, XIANNUOXIN® showed its highly effective and broad-spectrum activity against coronavirus and no genotoxicity was identified. On November 17, 2021, Simcere entered into a technology transfer contract with the SIMM and the WIV of the CAS, pursuant to which the Group obtained development, production, and commercialization rights on an exclusive basis of simnotrelvir (SIM0417) worldwide.