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Yuan Lin, the director of the Drug Regulation Department of the National Medical Products Administration, and his team visited Lijuzhou Group for inspection and research.
Release time:
2023-02-22
On February 20, Yuan Lin, Director of the Drug Regulation Department of the National Medical Products Administration, along with Fang Wei, a member of the Party Leadership Group and Deputy Director of the Guangdong Provincial Drug Administration, and Li Guohui, Director of Drug Safety of the Henan Provincial Market Supervision Administration, visited the Livzon Group for an inspection and research. Tang Yanggang, Executive Director and President of Livzon Group, warmly welcomed Yuan Lin and his team in the group exhibition hall.
In the group exhibition hall, President Tang Yanggang introduced the company's development history, main business, and achievements in research and development innovation to Yuan Lin and his team. Director Yuan listened while communicating with President Tang and expressed appreciation for the development achievements of Livzon Group in recent years.
During the subsequent discussion, Hu Zhenxiang, Deputy General Manager of R&D at Livzon Monoclonal Antibody Company, reported in detail to Yuan Lin and his team on the research and development and production status of two products: the recombinant novel coronavirus fusion protein vaccine (Livzon V-01) and tocilizumab injection (brand name "Anweitai"). When focusing on the report of the Livzon V-01 vaccine, Hu Zhenxiang introduced that the Livzon V-01 vaccine was developed in collaboration with the Institute of Biophysics of the Chinese Academy of Sciences, using innovative molecular design and possessing independent intellectual property rights. It was approved for emergency use as a national sequential booster immunization in September 2022, and the vaccination work for the first and second booster doses is currently underway. As the world's first sequential immunization vaccine with high protective clinical results against Omicron, Livzon V-01, with its "upgraded" recombinant protein immunogenicity and unique molecular design, makes the vaccine more effective and safer. In reporting on the tocilizumab injection (brand name "Anweitai"), Hu Zhenxiang stated that the tocilizumab injection was officially approved for market launch by the National Medical Products Administration in January 2023, and the use of tocilizumab for the treatment of severe COVID-19 patients has been included in the national "Diagnosis and Treatment Plan for Novel Coronavirus Infection" and "Diagnosis and Treatment Plan for Severe Cases of Novel Coronavirus Infection." Livzon Group has now established a vaccine production workshop with an annual production capacity of 3.5 billion doses of vaccine bulk and 1.5 billion doses of formulation, as well as a tocilizumab production workshop with an annual capacity of 2.2 million doses, which can provide a continuous and stable supply of medicines for epidemic prevention and control.
After listening to the report, Director Yuan Lin fully affirmed Livzon Group's rapid development of the COVID-19 vaccine and inquired with great interest about the quality management of vaccine production. Director Yuan stated that vaccine production is related to the safety of people's lives, and vaccine production enterprises must strictly implement the primary responsibility of the holder. Quality management should cover the entire product lifecycle and run through the entire production process. At the same time, Livzon should also build a good vaccine traceability system and carry out post-marketing drug vigilance and monitoring work. Livzon Group has over thirty years of experience in drug research and development and production, and has established a complete production quality management system. We believe that under the guidance of the national bureau and provincial and municipal bureaus, we have the capability to ensure the safety of every vaccine and every bottle of COVID-19 severe medication for the health of the people!
Gao Yan, Director of the Comprehensive Division of the Drug Regulation Department of the National Medical Products Administration; Guo Changmao, Deputy Director of the Southern Pharmaceutical Economic Research Institute of the National Medical Products Administration; Wu Jie, Director of the Network Supervision Center of the Southern Pharmaceutical Economic Research Institute of the National Medical Products Administration; Zhan Bingquan, Comprehensive Division of the Drug Regulation Department of the National Medical Products Administration; Luo Yubing, Director of the Drug Supervision Division of the Guangdong Provincial Drug Administration; Zhang Xiaobin, Director of the Circulation Division of the Henan Provincial Drug Administration; Zhao Yihua, Second-level Researcher of the Zhuhai Market Supervision Administration; Yang Daihong, Vice President of Livzon Group; Zhou Peng, Vice President of Livzon Group; Yang Jiaming, Executive Deputy General Manager of the Monoclonal Antibody Company; Liu Daping, Head of Vaccine Production of the Monoclonal Antibody Company; and Ran Yongmei, Deputy General Manager of Quality of the Monoclonal Antibody Company participated in the above activities.
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