Anhui Poly has successfully submitted the DMF for Tecovirimat API to the U.S. FDA.
Basic information
（1） Product name: Tecovirimat
（2） Preparation: API
（3） DMF number: 038852
（4） Packing specification: 5kg/drum
（5） Holder: Anhui Poly Pharm. Co.
Tecovirimat is a small molecule, broad-spectrum membrane protein inhibitor that inhibits cell-to-cell and remote transmission of viruses by inhibiting the activity of the orthopoxvirus VP37 protein, preventing orthopoxviral proteins from forming a virus-specific wrapping complex, and preventing the export of infectious enveloped virus particles.Developed by Siga Technologies, Tecovirimat was granted orphan drug designation by the FDA for the treatment of poxvirus infections in 2010 and was approved for marketing in 2018 for the treatment of smallpox disease in adults and pediatric patients weighing no less than 13 kg, making it the first approved anti-smallpox medication. In 2022, the European Drug products Agency approved it for the treatment of smallpox, Mpox, cowpox, and the cowpox complications following smallpox vaccination.According to information published on the U.S. Centers for Disease Control (CDC) website, Tecovirimat has been used in the form of an over-the-counter compassionate use medication for the treatment of patients with Mpox virus infections since the beginning of the Mpox disease outbreak in 2022 and has had a positive effect on reducing the number of viruses in the body.
On September 15, 2023, the National Health Commission (NHC) announced that, according to the relevant provisions of the Law of the People's Republic of China on Prevention and Control of Infectious Diseases, Mpox would be included in Category B infectious diseases for management from September 20, 2023, onwards, and that the preventive and control measures for Category B infectious diseases would be taken. The Mpox Prevention and Control Program developed and issued by the NDCPA and the NHC still focuses on prevention and makes no mention of effective antiviral treatment options.Currently, Tecovirimat has been marketed in foreign countries as injections, capsules, etc., and there are no domestic products on the market for the time being.
Poly Pharm. anti-Mpox varieties: since the outbreak of Mpox disease, company has initiated the generic research and development of Tevirimat APIs and injection in a forward-looking manner, and through more than one year's efforts, the current progress is as follows:
Tecovirimat APIs: has completed the production of the registered batch and has been submitted the DMF documents (DMF No.: 038852) to the U.S. FDA. Subsequently, the API Filling will be submitted to the Center for Drug Evaluation, NMPA.Tecovirimat injection: dual submission for China and the US is underway.
According to the Chinese Center for Disease Control and Prevention (CDC) Mpox Disease Surveillance in August 2023: "From August 1-31, 2023, 501 new confirmed cases of Mpox were reported in Mainland China (excluding Hong Kong, Macao, and Taiwan)", " There were 5 female cases among the cases". Considering that Mpox disease will persist in China for a certain period of time, and the speed of transmission is accelerating, and the infected population and situation are more complicated, Poly Pharm. has expedited the development of the API and the injection of Tecovirimat, which can be used as a temporary safeguard medication in an emergency situation and will be able to do its part in the prevention and control of Mpox disease.
Anhui Poly, a wholly owned subsidiary of Poly Pharm., has completed the construction of Tecovirimat API project this year and put it into production as scheduled, and recently submitted the DMF to the U.S. Company will give full play to the advantages of global registration and manufacturing internationalization, and make use of its internationalized high-end production capacity to help research and develop therapeutic drugs of Mpox. Working Together for Global Mpox Disease Prevention and Control.
Anhui Poly Pharm. is a professional supplier of active ingredients, dedicated to chemically synthetic, biosynthetic and high-quality raw materials and services in fields of pharmaceutical industry, health care and skin care worldwide.
