On February 11, 2023, the first 3CL anti-COVID-19 innovative drug developed in China, XIANNUOXIN®, was launched and put into production. The launch and production ceremonies were held in Jiangsu and Hainan provinces, respectively. Leaders of the CPC and government leaders of the two provinces, as well as heads of relevant authorities, and key medical institutions attended the events, visited the production lines of Simcere Pharmaceutical Group (2096.HK), and handed over the first box of XIANNUOXIN®. These leaders expressed high expectations for the drug's role in fighting against the next wave of COVID-19 pandemic and contributing to China's economic development.
Hu Guangjie, Deputy Governor of Jiangsu Provincial People's Government, Chen Zhichang, Mayor of Nanjing, and other provincial and municipal leaders, heads of Department of Industry and Information Technology, Health Commission, Market Regulation, Medical Products Administration, Medical Insurance, and other departments of Jiangsu Province and Nanjing City, as well as presidents of Jiangsu Province Hospital and Nanjing Drum Tower Hospital attended the ceremony in Nanjing Biotech and Pharmaceutical Valley.
Ni Qiang, Deputy Governor of Hainan Provincial People's Government, Director of the Free Trade Port Working Committee of the Provincial Party Committee, Ding Hui, Mayor of Haikou City, heads of the Provincial Department of Industry and Information Technology, Health Commission, Medical Products Administration, and Medical Insurance Bureau, heads of Haikou municipal authorities, as well as heads of Hainan General Hospital, the Second Affiliated Hospital of Hainan Medical University, and Haikou People's Hospital attended the production ceremony in Haikou Medicine Valley.
The launch and production ceremonies of XIANNUOXIN were held in Jiangsu and Hainan provinces respectively on Feb. 11
XIANNUOXIN® received conditional marketing approval from the National Medical Products Administration (NMPA) on January 28, 2023, with the NMPA Approval No. of H20230001. It is the first Class 1 innovative drug approved by the NMPA in 2023 and the first self-developed 3CL-targeting anti-COVID-19 drug with independent intellectual property rights in the country. Simcere Pharmaceutical Group immediately started the production process and completed all required steps quickly after approval, launching the drug a mere 12 days later. Since the launch date, the drug has started to be supplied to medical institutions.
Yang Xuepeng, member of the Standing Committee of Nanjing Municipal Party Committee and Secretary of Party Working Committee of Jiangbei New Area, said that XIANNUOXIN®, as China's first 3CL anti-COVID-19 innovative drug with independent intellectual property rights, inspired the biopharmaceutical industry in Nanjing to develop innovative drugs that may compete with market-dominant imported drugs, and brought more effective treatments to patients infected with COVID-19.
Ding Hui, Mayor of Haikou City, said that the approval for and quick production and launch of XIANNUOXIN®, is a testament to Simcere's societal responsibilities and speaks to the ability of the pharmaceutical group to quickly address a major clinical need. Enterprises are encouraged to further tap Simcere’s potential and expand production capacity t to meet the demand that will be needed for for anti-COVID-19 drugs against the next wave of COVID-19 pandemic.
From application to approval, the XIANNUOXIN® project has received professional guidance and strong support from the leaders of the Joint Prevention and Control Mechanism and Scientific Research Group under the State Council, Jiangsu Provincial Government, Hainan Provincial Government, and National Medical Products Administration.
XIANNUOXIN®
Clinical studies have shown that XIANNUOXIN® offers three major benefits: rapid and substantial reduction of viral load, a shortened course of disease and time to get a negative result for patients infected with COVID-19, and safer and more reliable 3CL targets. Clinical research data comparison shows that XIANNUOXIN® has similar safety characteristics and better efficacy than similar imported 3CL anti-COVID-19 oral drugs. Patients receiving a complete 5-day course of treatment with XIANNUOXIN® saw a substantial decrease in viral load by 1.43 log10 copies/mL (96.28%).
The clinical data of XIANNUOXIN® suggest that the efficacy will be better if it is used as early as possible within the first 72 hours of infection. To effectively protect vulnerable groups with high risks of infection, such as seniors and people having immunodeficiency or underlying diseases, at the initial production capacity escalation period, Simcere Pharmaceutical Group, relying on relevant data, distributed the first batch of XIANNUOXIN® to the areas where the drug was in urgent need, trying its best to improve the accessibility of XIANNUOXIN® for people infected with COVID-19 nationwide.
Experts at the ceremony said that although COVID-19 infection incidence is low and occurs sporadically in several places in China, we should not let our guard down. The concentration of antibodies will decrease, and the benefits of herd immunity will disappear, which means there may be outbreaks afterward, and we must be fully prepared. It is expected that XIANNUOXIN® will become another effective treatment to fight against the next wave of COVID-19. As the economy is seeing strong development and social activities are getting back to normal, XIANNUOXIN® is expected to contribute to China's economic development and the public's health.