On the 22nd, the Ministry of Health, Labor and Welfare urgently approved the novel coronavirus treatment drug Xocova (common name: ensitrelvir fumaric acid) produced by Shiongi Pharmaceutical, which will be shipped to medical institutions as early as the same day. The full supply will start on the 28th, and the prescription will be earlier than the original plan in early December.
Xocova is an oral antiviral drug, which is administered once a day for 5 days. It inhibits the replication of SARS-CoV-2 by selectively inhibiting the 3CL protease of the virus. In the clinical trial, it can effectively shorten the time required for COVID-19 infected people to disappear from the symptoms of tiredness, fever, runny nose or nasal congestion, sore throat, cough, etc. Shionogi applied for production and sales approval in Japan on February 25, 2022 based on the results obtained from the phase 2b part of the phase 2/3 clinical trial, and required to review under the "conditional approval system". On May 27, Shionogi reapplied for review in accordance with the newly established "emergency regulatory approval system" after the revision of the Drug and Medical Device Law.
It is reported that behind the accelerated research and development of new drugs ofShionogi Pharmaceutical in Japan, there are multiple assistance from Ping An in China, such as capital, business and technology. In July 2021, Ping An Shionogi Co., Ltd., a joint venture between Ping An Pharmaceutical of China and Shionogi Pharmaceutical of Japan, opened in Shanghai. It will provide health management programs including sports, over-the-counter drugs, vaccines, new drugs, etc. at the stages of disease care, prevention, diagnosis, core treatment drugs and follow-up visits. Previously, Isao Teshirogi, the CEO of Shionogi, said that the expected annual sales of Xecova was $2 billion, and submitted a listing application with Ping An Shionogi to the China National Drug Administration Drug Evaluation Center (CDE) on July 4.