China Accepts Junshi Biosciences’ COVID-19 Drug Application
Junshi Biosciences, a Chinese biopharmaceutical company, announced on January 18 that the country’s medical products authorities had accepted a new drug application for Deuremidevir Hydrobromide Tablets (project code: JT001/VV116) for the treatment of COVID-19. This represents another domestic COVID-19 oral medicine that has been accepted for release recently after Simcere Pharmaceutical’s “Xiannuoxin.”
Junshi Biosciences was established in December 2012, and has more than 50 products under research, covering five major treatment fields, including malignant tumors, autoimmune system diseases, chronic metabolic diseases, nervous system diseases and infectious diseases.
VV116 was jointly developed by Junshi Biosciences, the Shanghai Institute of Materia Medica of Chinese Academy of Sciences, Suzhou Wangshan Wangshui Biomedical Co., Ltd. Junshi Biosciences and Wangshan Wangshui jointly undertake the clinical development and industrialization of the drug in five Central Asian countries, Russia, North Africa and the Middle East.
Before the domestic listing application of VV116 was accepted, the drug was released in Uzbekistan for the treatment of moderate or severe COVID-19 patients.
Junshi Biosciences said that VV116 can non-covalently bind to the active center of novel coronavirus RNA polymerase in the form of triphosphate, which directly inhibits the activity of virus RNA polymerase and blocks the replication of offspring virus, thus achieving an antiviral effect. The company also said that preclinical studies showed that VV116 showed significant antiviral effect on novel coronavirus, and had no genotoxicity.
On December 29, 2022, the New England Journal of Medicine published the results of a Phase III clinical study of this drug compared with Pfizer’s Paxlovid, showing that VV116 had a shorter clinical recovery time and fewer safety concerns.
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On January 5, the same magazine published an exclusive interview, revealing that Pfizer’s Paxlovid has limitations in actual use, and the combined ritonavir can interfere with the metabolism of many drugs, while compared with remdesivir, VV116 can break the limitation of its dosage form and is more convenient to use.
Up to now, three COVID-19 oral medicines – Pfizer’s Paxlovid, Merck’s Molnupiravir and Genuine Biotech’s Azvudine – have been approved in China, with prices of 1,890 yuan ($279)/box, 1,500 yuan/bottle and 270 yuan/box respectively, and are temporarily included in medical insurance reimbursement schemes until March 31 this year.
