The Ministry of Health, Labor and Welfare of Japan, has issued a Accreditation Certificate of Foreign Drug Manufacturer to WestVac Biopharma.

The company said that it the first Chinese research-based drug manufacturer to conduct vaccine clinical trials in Japan.

According to WestVac, a foreign manufacturer (a person/a company) intending to manufacture drugs, or quasi-drugs in foreign countries and export them to Japan, is required to be accredited by the Minister of Health, Labour, and Welfare as an “Accredited Foreign Manufacturer”, specified in Article 13-3 of PAL, in the same way that a Japanese manufacturer is licensed, hence, foreign manufacturer accreditation is a prerequisite for the commercialization of a foreign drug product in Japan.

The accreditation is a significant step toward the commercialization of its COVID-19 vaccine in Japan and implies the Japanese authority has acknowledged its COVID-19 vaccine’s safety and efficacy as well as its standardized production management and process, production capability and quality, equipment and environment.

Almost 40,000 patients have been enrolled in a global multicenter Phase III clinical trial launched in multiple countries for Coviccine – Recombinant COVID-19 Vaccine (Sf9 cell) developed by WestVac Biopharma and West China Hospital of Sichuan University.

WestVac said that in Japan, the clinical trial for marketing purposes has been concluded.

According to the company, it is the first Chinese COVID-19 vaccine to enter a clinical trial in a developed country.

WestVac said that the trial has demonstrated exceptional safety and immunogenicity.

In December 2022, Coviccine was approved by the national authority for emergency use and already been on the vaccine procurement list in the bidding process in over 20 provinces in China.

In addition to Coviccine – Recombinant COVID-19 Vaccine (Sf9 cell), the Recombinant Variant COVID-19 Vaccine (Sf9 cell) against variants including Omicron developed by WestVac Biopharma has recently received the Approval for Clinical Trial by NMPA, the phase I/II clinical trials will soon begin.

WestVac Biopharma has made progress in developing the trivalent recombinant protein COVID-19 vaccine, the first trivalent recombinant protein vaccines targeting XBB.1.5 and BA.5 in the world, and is striving to fulfill the national approval requirements as soon as possible.