WestVac Biopharma has mature insect cell expression platform, mRNA vaccine platform, novel adjuvant platform, bacterial vaccine platform, oncology vaccine and immunotherapy platform, and has more than 20 product pipelines including a series of COVID-19 vaccines, multivalent influenza vaccines, respiratory syncytial virus vaccines, herpes virus and oncology immune preparations.
After the outbreak of the COVID-19 epidemic in early 2020, with the full support of governments at all levels, West China Medical Center of Sichuan University and WestVac Biopharma actively took part in the scientific and technological actions to fight against epidemic, and achieved many breakthroughs through their efforts. West China Medical Center, affiliated to Sichuan University, is the largest national-level medical center in western China. Its State Key Laboratory of Biotherapy is the only State Key Laboratory in the country with the theme of "biotechnology treatment of major human diseases". There are more than 150 R&D personnel with multidisciplinary backgrounds, including 13 Changjiang/Young Changjiang Scholars and 18 winners of the National Outstanding Youth Fund. Published more than 30 high-level papers in journals such as Nature, Science, Nat.Commun, STTT, in particular, the first article on COVID-19 vaccine was published in Nature magazine(Nature, 2020, 586: 572-577)and applied for more than 50 domestic and foreign patents.
WestVac Biopharma's recombinant COVID-19 vaccine has won project approval and funding by vaccines team of State Council's Joint Prevention and Control Mechanism for five consecutive times, from vaccines targeting prototype strains to vaccines targeting variants, to multi-component multivalent vaccines, to COVID-19 vaccine against XBB variant, continues to update technology to fight consecutive variants, providing innovative options for the normalization of the epidemic management and the vaccination of COVID-19 vaccine, contributing China's strength to the global fight against COVID-19 epidemic.
On July 29, 2020, the R&D team of WestVac Biopharma published the first research paper on the COVID-19 vaccine in "Nature" magazine , and adopted an innovative recombinant protein technology--- China's first Recombinant Protein COVID-19 Vaccine (Sf9 cells)—Coviccine®, introduces the gene of the COVID-19 virus into insect cells, prepares the S protein of the COVID-19 virus, induces human body to produce antibodies to block the virus infection, and has achieved large-scale production. The phase I/II clinical trial of Coviccine® was completed in June 2021. At present, the global multi-center phase III clinical trial has been carried out in many countries, and the enrollment and vaccination of nearly 40,000 subjects have been completed, and completed clinical trials in Japan for the purpose of marketing, this is the first COVID-19 vaccine in China to enter clinical trials in developed countries. In February 2023, WestVac Biopharma has obtained Japan's "Certification of Foreign Manufacturers of Pharmaceuticals-Certification of Pharmaceutical Biological Preparations", which shows that WestVac Biopharma has reached the international advanced level in this field. The results of the Coviccine ® test show that the vaccine has good safety and immunogenicity, which fully reflects the advantages and characteristics of the technical route of recombinant protein vaccines. In December 2022, with the approval of relevant national departments, Coviccine®-Recombinant COVID-19 Vaccine (Sf9 Cell) was approved for EUA, and it has been delivered and supplied for vaccination in more than 20 provinces in China. WestVac Biopharma continues to follow up the epidemic trend of the COVID-19 virus, and has developed a Recombinant COVID-19 Trivalent Vaccine (Sf9 cell) against Omicron, which has obtained clinical approval and entered clinical research. It has good protective efficacy against COVID-19 caused by Omicron variant.
The XBB.1.5 variant had gradually become the major circulating variant in various parts of the world by the beginning of 2023. the scientific team of WestVac Biopharma overcame all hurdles and develop the recombinant bivalent COVID-19 (XBB + prototype strain) protein vaccine (Sf9 cell) Coviccine ® bivalent and recombinant trivalent COVID-19 (XBB + BA.5 + Delta variant) trimeric protein vaccine (Sf9 cell).
On June 8th, 2023, Coviccine® Trivalent XBB.1.5-Recombinant COVID-19 Trivalent(XBB.1.5+BA.5+Delta)Protein Vaccine (Sf9 cell) was approved for EUA by relevant authorities in China. This is the first COVID-19 vaccine in the world approved for EUA against XBB descendent lineages of SARS-CoV-2. It demonstrates that China is leading the world in the development of COVID-19 vaccines.
WestVac Biopharma leveraged the rapid response of the insect cell expression platform on constructing the vector for Coviccine® Trivalent XBB.1.5-Recombinant COVID-19 Trivalent (XBB.1.5+BA.5+Delta) Protein Vaccine (Sf9 Cell), which is of high purity and high quality for human use. The subunit vaccine antigen is precisely designed based on the structure of the targeting S-RBD and HR proteins of the COVID-19 subvariants XBB.1.5 and BA.5 and self-assembled into stable trimeric protein particles with squalene-based oil-in-water emulsion adjuvant added after purification and mixing. Novel adjuvant significantly raises the titer of neutralizing antibodies, which enables the trimeric protein vaccine to induce a higher level T-cell immune response. Studies have shown that the vaccine induced a high titer of neutralizing antibodies against multiple subvariants, including Omicron XBB.1.5, XBB1.16, XBB1.9.1, XBB.2.3, BA.5, BF.7, BQ.1, BA.2.75, 14 days after injection of this product, the protective efficacy against XBB.1, XBB.1.5, XBB1.9 is 93.28% with an excellent safety profile, demonstrating that it is a broad-spectrum COVID-19 vaccine against multiple prevalent subvariants locally and internationally.
In addition, in order to improve the safety and accessibility of the vaccine, WestVac Biopharma has also developed a nasal spray recombinant mutant COVID-19 vaccine (Sf9 cells) against variants, which improves the protection efficiency by inducing nasal mucosal immunity. Based on a large number of studies, a nasal spray formulation that can induce a strong immune response has been screened, which can induce a high level of neutralizing antibodies.WestVac Biopharma is also simultaneously carrying out the research and development of new oral anti- COVID-19 virus drugs , and the current test results show that it has good in vivo safety and activity.