Vid-19, the first oral neutralizing drug, has also been approved.
On February 12, the official website of the State Food and Drug Administration issued a document saying 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 the special drug approval procedures, conditionally approved the import registration of the combined packaging of nevitavir tablets / ritonavir tablets (i.e. paxlovid), a covid-19 virus treatment drug of Pfizer.
What are the characteristics of the first covid-19 oral drug? Which pharmaceutical enterprises in China have made layout?
What kind of medicine is paxlovid?
Paxlovid is the second covid-19 drug approved for marketing in China following the approval of covid-19 virus neutralizing antibody of Tengsheng Huachuang Pharmaceutical Technology (Beijing) Co., Ltd.
However, unlike macromolecular drugs such as neutralizing antibody drugs for injection, it is the first imported covid-19 oral drug approved in China.
Covid-19 therapeutic drugs, like vaccines, are regarded as an important tool for global epidemic prevention and control. Globally, many different types of covid-19 therapeutic drugs have made progress, such as covid-19 neutralizing antibody therapy, small molecule covid-19 drugs (including RNA polymerase inhibitors, JAK inhibitors, AR antagonists, 3CL protease inhibitors, etc.).
Paxlovid is an oral small molecule COVID-19 virus for the treatment of in patients with mild to moderate New Coronavirus pneumonia (COVID-19) accompanied by progressive severe risk factors, such as elderly patients, chronic kidney disease, diabetes, cardiovascular disease, chronic lung disease, and other severe high-risk factors in adults with . Patients should use drugs in strict accordance with the instructions under the guidance of doctors, and pay close attention to the interaction information with other drugs listed in the instructions.
In terms of effectiveness, according to the data released by Pfizer at the end of 2021, can reduce the probability of hospitalization or death of mild and moderate adult patients by 89% compared with placebo. also at the end of 2021, the U.S. Food and Drug Administration (FDA) urgently approved Pfizer’s oral covid-19 drug for high-risk groups over the age of 12. Therefore, the drug became the first approved oral covid-19 drug in the United States.
The State Food and Drug Administration attaches great importance to the research and development of covid-19 drugs. In December 2021, the State Food and Drug Administration approved the combined application of monoclonal antibody neutralab and romicwell monoclonal antibody to Tengsheng Huachang medical technology (Beijing) Co., Ltd., which was applied to treat mild and normal adults and adolescents (12-17 years old, weighing more than 40kg) with New Coronavirus infection. among them, the adolescent indication population is subject to conditional approval. This is the first covid-19 therapeutic drug approved in China.
The State Food and Drug Administration mentioned “conditional approval ” in the approval of covid-19 virus treatment drugs of Pfizer and Tengsheng Huachuang Pharmaceutical Technology (Beijing) Co., Ltd., which means that the two companies should continue to carry out relevant clinical research on drugs in the future. the drug administration law requires that for drugs approved with conditions, the holder shall take corresponding risk management measures after the drugs are listed, complete relevant studies such as drug clinical trials within the specified time limit, and apply in the form of supplementary application.
In terms of production capacity and other issues, the reporter of Beijing business daily contacted the relevant person in charge of Pfizer. The other party said that there was no more content to share, and the information disclosed by the State Food and drug administration shall prevail.
layout of China Junshi and other pharmaceutical enterprises
Compared with macromolecular drugs, small molecule oral drugs have the advantages of easy storage and transportation conditions and convenient administration. there are also Shanghai Junshi Biosciences Co.Ltd(688180) , Fujian Cosunter Pharmaceutical Co.Ltd(300436) , developing the pharmaceutical industry and Yunding Xinyao in China.
Covid-19 oral drug of Shanghai Junshi Biosciences Co.Ltd(688180) is a product with rapid progress. in October 2021, Shanghai Junshi Biosciences Co.Ltd(688180) reached a cooperation with Wangshan wangshui biomedical Co., Ltd. to jointly undertake the global clinical development and industrialization of oral nucleoside anti covid-19 virus candidate drug vv116.
The drug has submitted clinical trial applications to the drug regulatory authorities of China and Uzbekistan respectively. Vv116 was authorized to use in Uzbekistan in December 2021. In January 2022, three phase I studies of vv116 in China were completed, and the preliminary results showed that the clinical safety was good.
Some media previously reported that after vv116 passed the clinical trial, is expected to submit a new drug listing application in the second half of 2022. in response to this news, Shanghai Junshi Biosciences Co.Ltd(688180) the relevant person in charge only responded to the reporter of Beijing Business Daily that “is actively promoting the clinical trial of vv116, and is currently preparing the international multi center phase II and phase III clinical trial of the drug”.
Li Ning, CEO of Shanghai Junshi Biosciences Co.Ltd(688180) said at a recent teleconference that the approval of Pfizer paxlovid is a positive encouragement to the company and is currently accelerating the clinical and industrial layout of vv116 international multi center. Vv116’s production capacity has basically been satisfactorily solved under the coordination of national multi departments. The company has reached a cooperation plan with two cdmo production bases and will complete the necessary capacity layout of a considerable scale by the end of March.
In the view of insiders, oral medicine is one of the weapons to end the epidemic. The listing of covid-19 oral medicine means an additional means of anti epidemic. Other pharmaceutical companies are also stepping up their layout. The global multicenter phase III clinical trial of prochloramide in the treatment of mild and moderate covid-19 patients completed the enrollment and administration of China’s first subject in Shenzhen Third People’s hospital. Yunding Xinyao has obtained the global exclusive authorization of a group of 3CL protease inhibitors developed by Singapore experimental drug R & D center. Yunding Xinyao will develop it as an oral anti covid-19 virus drug, and the clinical trial is expected to be launched in the second half of this year
