On February 12, the official website of the State Food and Drug Administration said that the State Food and Drug Administration conducted emergency review and approval in accordance with the relevant provisions of the Drug Administration Law and in accordance with the special drug approval procedures, and conditionally approved the import registration of Pfizer's new coronavirus treatment drug nematvir tablets/ritonavir tablets combination packaging (i.e., Paxlovid). This is the second new crown drug approved for listing in China after the approval of the new coronavirus neutralizing antibody of Tengsheng Huachuang Pharmaceutical Technology (Beijing) Co., Ltd. However, unlike large molecule drugs such as injectable neutralizing antibody drugs, Paxlovid is the first imported COVID-19 oral drug approved in China. What are the characteristics of the first COVID-19 oral drug? Which pharmaceutical companies in China have laid out their layouts?
Conditional approval for listing
Following the approval of the first COVID-19 neutralizing antibody drug, the first COVID-19 oral drug has also arrived. On February 12, the official website of the State Food and Drug Administration disclosed that the State Food and Drug Administration carried out emergency review and approval in accordance with the relevant provisions of the Drug Administration Law and in accordance with the special approval procedures for drugs, and conditionally approved the import registration of Pfizer's new coronavirus treatment drug nematvir tablets/ritonavir tablets combination packaging (i.e., Paxlovid).
Paxlovid is an oral small molecule coronavirus treatment for the treatment of mild to moderate coronavirus pneumonia (COVID-19) in adults with a high risk factor for progression to severe illness, such as patients with severe risk factors such as advanced age, chronic kidney disease, diabetes, cardiovascular disease, and chronic lung disease. Patients should strictly follow the instructions under the guidance of a physician, and pay close attention to the interaction information with other drugs listed in the instructions during use.
The State Food and Drug Administration attaches great importance to the research and development of new crown drugs. In December 2021, the State Food and Drug Administration approved the listing application of tengsheng Huachuang Pharmaceutical Technology (Beijing) Co., Ltd.'s monoclonal neutralizing antibody ambavir monoclonal antibody ampavirinumab/romimab for the treatment of mild and ordinary adults and adolescents (12-17 years old, weight ≥40 kg) infected with the new coronavirus. Among them, adolescents (12-17 years old, weight ≥40kg) are conditionally approved. This is the first approved COVID-19 treatment in mainland China.
Tengsheng Huachuang Pharmaceutical Technology (Beijing) Co., Ltd. new crown drug is an injection, its approved dose is "1 gram of ampavirinumab + 1 clomilisvir maclizumab", respectively, after 100 ml of saline intravenous infusion, completed within 1 hour, after the completion of injection, there is no need for a second injection treatment.
The approved Paxlovid is a compound formulation consisting of the 3CL protease inhibitor nematvir tablets and ritonavir tablets, and the treatment is treated with two 150 mg nematvir tablets and one 100 mg ritonavir tablets to treat covid-19 patients twice daily for 5 days.
The State Food and Drug Administration mentioned "conditional approval for listing" in the approval of the new coronavirus treatment drugs of Pfizer and Tengsheng Huachuang Pharmaceutical Technology (Beijing) Co., Ltd., which means that the two companies will continue to conduct relevant clinical research on the drugs in the future. The Drug Administration Law requires that for drugs with conditional approval, the holder shall take corresponding risk management measures after the drug is listed, and complete relevant research such as drug clinical trials in accordance with the requirements within the prescribed time limit, and declare them in the form of supplementary applications.
In response to problems such as production capacity, the Beijing Business Daily reporter contacted the relevant person in charge of Pfizer, who said that there was no more content to share, subject to the information disclosed by the State Food and Drug Administration.
Junshi and many other pharmaceutical companies layout
Compared with large molecule drugs, small molecule oral drugs have the advantages of easy storage and transportation conditions and convenient consumption. Enterprises in the mainland that lay out new crown oral medicines include Junshi Biology, Guangshengtang, Pioneering Pharmaceutical and Genting Xinyao.
Junshi Bio's new crown oral drug is a product with rapid progress. In October 2021, Junshi Bio reached a cooperation with Wangshan Wangshui Biomedical Co., Ltd. to jointly undertake the clinical development and industrialization of oral nucleoside anti-new coronavirus candidate VV116 on a global scale. Clinical trial applications for the drug were submitted to the drug regulatory authorities in China and Uzbekistan, respectively. In December 2021, VV116 was licensed in Uzbekistan. In January 2022, three of the Phase I studies of VV116 in China were completed, and preliminary results showed good clinical safety.
Some media have previously reported that after VV116 passes clinical trials, it is expected to submit a new drug listing application in the second half of 2022. In response to this news, the relevant person in charge of Junshi Biology only responded to the Beijing Business Daily reporter, saying that "the clinical trial of VV116 is being actively promoted, and the international multi-center phase II and III clinical trials of the drug are currently being prepared."
Li Ning, CEO of Junshi Biotech, said at a recent conference call that the approval of Pfizer Paxlovid is a positive encouragement to the company and is currently accelerating the clinical and industrialization layout of VV116 international multi-center. VV116 under the coordination of national multi-sectoral coordination, the production capacity has been basically satisfactorily solved. The company has reached a cooperation plan with two CDMO production bases, and will complete the necessary large-scale production capacity layout by the end of March.
In the eyes of industry insiders, oral drugs are one of the weapons to end the epidemic, and the listing of new crown oral drugs means that there is one more means to fight the epidemic. Other pharmaceutical companies are also stepping up their layout. Pioneering PharmaceuticalSpecific Pkrutamine for the Treatment of Mild and Moderate Covid-19 Patients with Global Multi-Center Phase III Clinical Trial recently completed the enrollment and administration of China's first subject in Shenzhen Third People's Hospital. Genting Shinyao has received exclusive global authorization from a group of 3CL protease inhibitors developed by the Singapore Centre for Experimental Drug Discovery, which Genting Shinyao has developed as an oral anti-coronavirus drug, and clinical trials are expected to start in the second half of this year. Beijing Business Daily reporter Yao Qian
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