According to Science and Technology Daily, in the process of drug research and development in COVID-19, China deployed three technical routes. In the aspect of antibody drugs, the fastest progress is the neutralization antibody combination therapy jointly developed by Tsinghua University, Shenzhen Third People's Hospital and Tengsheng Chuangchuang. In China, the R&D team submitted the conditional listing application materials to the State Administration of Pharmaceutical Products on 2002 1 year1October 9, and it is expected to be approved before the end of February (1).
Tengsheng Huachuang is the holding company of Tengsheng Boya, which was established in May, 2020 with the joint investment of Tengsheng Boya, Shenzhen Third People's Hospital and Tsinghua University. In the research and development of neutralizing antibody combined therapy drugs in COVID-19, the Third People's Hospital of Tsinghua University and Shenzhen provided professional skills to ensure that all necessary tests, screening, virological tests, biochemical and cell culture characteristics were completed. Tengshengbo Pharmaceutical provides expertise in drug development, antibody optimization, intellectual property protection, project management, contract R&D and production organization management, clinical trials and drug registration supervision. It took less than 20 months from the initial laboratory research to the emergency approval of the State Administration of Medical Products, and it was approved by Ambavirumab/Romivimab, setting a China record.
In official website, the State Pharmaceutical Products Supervision and Administration issued a message to urgently approve Tengsheng Huachuang Pharmaceutical Technology (Beijing) Co., Ltd. (hereinafter referred to as "Tengsheng Huachuang"), COVID-19 neutralizing antibody combination therapy drugs, Ambavavir monoclonal antibody injection (BRII- 196) and Romivir monoclonal antibody injection (BRII- 198). Upon approval, the above two drugs can be used in combination to treat mild and common patients with novel coronavirus infection (coronavirus pneumonia-19) in adults and adolescents (12- 17 years old and weighing ≥40kg), who are accompanied by high-risk factors for progression to severe diseases (including hospitalization or death). Among them, adolescents with indications (12-17 years old and weighing ≥40kg) are conditionally approved.
This approval is based on the phase III clinical trial of ACTIV-2 supported by the National Institutes of Health (NIH), including the positive interim and final results of 847 patients.
The State Administration of Pharmaceutical Products urgently approved the registration application of COVID-19 neutralizing antibody combination therapy drugs Ambavamab injection (BRII- 196) and romisvimab injection (BRII- 198) of Tengshengchuang Medical Technology (Beijing) Co., Ltd., which is the first combination therapy drug with independent intellectual property rights in COVID-19.