Brincidofovir (alias CMX001), an API developed and manufactured by Poly Pharm., has continued to develop customers since its successful development, and has now completed kilogram orders from international customers and delivered successfully. New orders are being scheduled and will be delivered on schedule.
In addition, another Mpox API, Tecovirimat (alias ST-246, renamed Tecovirimat), has completed its validation approval and stability study, and is expected to be submitted to the U.S. DMF for filing at the end of August.
Brincidofovir (alias CMX001) is an orally active lipophilic form of cidofovir (CDV) with greater ex vivo and in vivo activity against certain herpesviruses, adenoviruses, and orthopoxviruses than CDV. It is an antiviral drug used to treat cytomegalovirus, adenovirus, smallpox and Ebola virus infections. On June 04, 2021, the U.S. FDA approved Brincidofovir tablets and oral suspension for the treatment of smallpox.
Tecovirimat (alias ST-246) is a potent inhibitor of orthopoxvirus proteins, with strong activity against viruses of the orthopoxvirus genus such as smallpox virus, Mpox virus, and cowpox virus. On July 13, 2018 the U.S.FDA approved it for the treatment of smallpox and granted orphan drug designation. In 2021, the European Medicines Agency approved it for the treatment of smallpox, Mpox, cowpox, and complications of cowpox following smallpox vaccination.
Anhui Poly, a wholly owned subsidiary of Poly Pharm., completed the construction of Brincidofovir and Tecovirimat API projects this year and put them into production and supply as scheduled. 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 providing chemically synthesized and biosynthesized high-quality specialty ingredients and services to the global pharmaceutical, healthcare, and skin care sectors.
