Media

2024-01-24
Recently, WestVac Biopharma has received the GMP (Good Manufacturing Practice) certificate from the Federal Commission for Protection against Health Risks (COFEPRIS) in Mexico, a member of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S).
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2024-01-14
On January 13, 2024, the results of the selection for the top 10 medical biotechnology advances in China for 2023, organized by the China Medicinal Biotechnology Association and the journal "Chinese Medicinal Biotechnology" were announced.
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2023-12-26
When one is in trouble, help comes from all directions. WestVac Biopharma will continue to monitor the latest updates on the disaster and cooperate with the local government to ensure the supply of the XBB COVID-19 vaccine. Natural disasters are ruthless, but people are compassionate. May the disaster end soon, and we pray for the safety of the people in the disaster-stricken area.
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About Us

WestVac BioPharma Co., Ltd. is an innovative biopharmaceutical enterprise integrating vaccine R&D, production and sales, including WestVac Biopharma located in Chengdu and WestVac Biopharma (Guangzhou), a wholly-owned subsidiary company of WestVac Biopharma. With the continuous investment and support of many powerful shareholders -- CICC Capital, Shanghai Pharma, Haier Biomedical among others, WestVac BioPharma has been successfully selected into the list of unicorn companies for three consecutive years from 2021 to 2023.

In terms of production, quality, operations management and other areas, WestVac Biopharma has introduced top talents from well-known domestic and international vaccine companies. It has also established a complete production and quality management system to ensure a smooth mass production of vaccines .

WestVac Biopharma has a mature insect cell expression platform, novel adjuvant platform, bacterial vaccine platform, mRNA vaccine platform, tumor vaccine and immunotherapy platform, with more than 20 pipelines including COVID-19 vaccine, multivalent influenza vaccine, respiratory syncytial virus vaccine, herpes virus vaccine, and tumor immunity preparations.

Multi-center Phase III clinical trials of the first generation Recombinant COVID-19 Vaccine (Sf9 cells)-Coviccine, have been rolled out globally in multiple countries including Mexico and the Philippines in 2022, with nearly 40,000 subjects enrolled and vaccinated. The clinical trials in Japan,which were carried out for market access , led to the first Chinese COVID-19 vaccine that entered clinical trials in Japan . In December 2022, Coviccine® was approved for emergency use (EUA) by relevant authorities in China.On February 2023, WestVac Biopharma obtained the certification of "Foreign Manufacturer Accreditation for Pharmaceuticals - Certification License for Biopharmaceuticals" issued by the Ministry of Health, Labour, and Welfare of Japan.

Targeting the major circulating XBB variants in the year 2023, the scientific team of WestVac Biopharma/West China Medical Center, Sichuan University overcame all hurdles and successfully developed Recombinant Trivalent COVID-19 (XBB.1.5 + BA.5 + Delta variant) Trimeric Protein Vaccine (Sf9 cells) and Recombinant COVID-19 (XBB.1.5 variant) Trimeric Protein Vaccine (Sf9 cells). In June 2023, the Coviccine® trivalent XBB.1.5 vaccine was approved for emergency use by the Chinese national authorities. This marked the world's first approval of an emergency-use vaccine targeting the XBB.1.5 and other variants of the novel coronavirus. Free vaccination have been conducted at over 10,000 community vaccination sites in more than 300 cities of China nationwide. In December 2023, the Recombinant COVID-19 (XBB.1.5) Trimeric Protein Vaccine (Sf9 Cell) was also approved for emergency use by the Chinese national authorities. In January 2024, the Recombinant COVID-19 Trivalent (XBB.1.5+BA.5+Delta) Protein Vaccine (Sf9 Cell) and the Recombinant COVID-19 (XBB.1.5) Trimeric Protein Vaccine (Sf9 Cell)  were successfully selected as the "Top 10 Advances of Chinese Medical Biotechnology of the Year " in 2023 by the China Medicinal Biotechnology Association and the journal "Chinese Medicinal Biotechnology".

WestVac Biopharma leverages the rapid response of the insect cell expression platform on constructing the vector for vaccine to produce the Recombinant Trivalent XBB.1.5 Protein Vaccine of high purity and high quality. The subunit vaccine antigen of Coviccine® Trivalent XBB.1.5 Vaccine is carefully designed based on the structural preciseness of the targeting S-RBD and HR proteins of the COVID-19 XBB.1.5 and other subvariants, and self-assembled into stable trimeric protein particles with squalene-based oil-in-water emulsion adjuvant added after purification and mixing. This novel adjuvant significantly raises the titer of neutralizing antibodies, which enables the trimeric protein vaccine to induce a higher level T-cell immune response. Clinical trial data showed that 14 days after receiving the trivalent XBB.1.5 vaccine, high levels of neutralizing antibodies against the SARS-CoV-2 Omicron variants, including JN.1, BA.2.86, EG.5, HV.1, XBB.1, and XBB.1.5, were induced, with geometric mean titers (GMT) ranging from 900 to 3500, representing a 6.9 to 39-fold increase compared to pre-vaccination levels, demonstrating broad-spectrum efficacy. The GMT against JN.1, BA.2.86, and EG.5 variants were increased by 8.28, 10.48, and 14.90 fold respectively. The protective efficacy of this product against symptomatic COVID-19 caused by SARS-CoV-2 was 93.28% (95%CI: 92.76%, 93.81%) at 14 days and 86.18% (95%CI: 84.24%, 88.12%) at 6 months post-vaccination, while maintaining proven safety. These findings indicated that the Coviccine® trivalent XBB.1.5 vaccine represents a new generation of broad-spectrum COVID-19 vaccines targeting various variants, including XBB, prevalent China domestically and internationally, and fully reflects the advantages and characteristics of the recombinant protein vaccine technology using insect cell expression.

A new study published by Professor Wang Pengfei's team at Fudan University in BioRxiv indicates that the Coviccine® trivalent XBB.1.5 vaccine induces a stronger neutralizing antibody response against multiple new SARS-CoV-2 variants such as JN.1, BA.2.86, and BA.2.87.1 (originating in South Africa and recently approved by the World Health Organization (WHO) listed as strains requiring monitoring) compared to XBB strain infected individuals, which were 16.7, 11.9 and 6.0 times higher than those before vaccination respectively, effectively combating a wide range of SARS-CoV-2 variants. It is suggested that the Coviccine® trivalent XBB.1.5 vaccine is a new generation of broad-spectrum COVID-19 vaccine against XBB variants prevalent at home and abroad. It fully embodies the advantages and characteristics of the recombinant protein vaccine technology route expressed in insect cells.

WestVac Biopharma Co., Ltd. is located in in Chengdu Tianfu International Biological City.It has completed construction of 5,000-litre and 3,000-litre insect cell recombinant protein vaccine production lines with an annual production capacity of 100 million doses. The GMP production lines were well established with the “Drug Production License" in place in September, 2021. WestVac Biopharma has received the GMP (Good Manufacturing Practice) certificate from the Federal Commission for Protection against Sanitary Risks (COFEPRIS) in Mexico in January, 2024, a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). This certification covers all the COVID-19 vaccines produced by WestVac Biopharma using insect cells (Sf9), including the Recombinant COVID-19 Trivalent (XBB.1.5+BA.5+Delta) Protein Vaccine (Sf9 Cell) and other COVID-19 vaccine series.  WestVac Biopharma (Guangzhou) is located in Guangzhou Economic Development Zone. It has completed scale-up construction of insect cell recombinant protein vaccine production lines with an annual production capacity of 100 million doses, and obtainedthe “Drug Production License" in February, 2024. 

WestVac Biopharma has established a sound communication mechanism with many international organizations such as the World Health Organization (WHO), Bill & Melinda Gates Foundation, PATH, The Coalition for Epidemic Preparedness Innovations (CEPI), and European Vaccine Initiative (EVI). In the future, WestVac Biopharma will grow into a world leading vaccine and immunotherapy platform in line with its corporate philosophy of "We Initiate Science & Technology Value, Always for Caring". Westvac extensively explores and innovates to prevent and fight human diseases. Westvac brings innovative vaccines and immunotherapies from China to the world for the benefit of mankind.

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Product R&D

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.

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Commercialization

WestVac BioPharma Co., Ltd. is an innovative biopharmaceutical enterprise integrating vaccine R&D, production and sales, including WestVac Biopharma located in Chengdu and WestVac Biopharma (Guangzhou), a wholly-owned subsidiary company of WestVac Biopharma. WestVac Biopharma has a mature insect cell expression platform, mRNA vaccine platform, novel adjuvant platform, bacterial vaccine platform, oncology vaccine and immunotherapy platform. It is committed to develop and produce a variety of innovative vaccines and immunotherapy products.

WestVac Biopharma Co., Ltd. is located in in Chengdu Tianfu International Biological City, has completed construction of 5,000-litre and 3,000-litre insect cell recombinant protein vaccine production lines with an annual production capacity of 100 million doses. The GMP production lines were well established with the “Drug Production License" in place. WestVac Biopharma has received the GMP (Good Manufacturing Practice) certificate from the Federal Commission for Protection against Health Risks (COFEPRIS) in Mexico, a member of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S). This certification covers all the COVID-19 vaccines produced by WestVac Biopharma using insect cells (Sf9), including the Recombinant COVID-19 Trivalent (XBB+BA.5+Delta) Protein Vaccine (Sf9 Cell) and other COVID-19 vaccine series. WestVac Biopharma (Guangzhou) is located in Guangzhou Economic Development Zone, has completed scale-up construction of insect cell recombinant protein vaccine production lines with an annual production capacity of 100 million doses.

In terms of production, quality, operations management, etc., WestVac Biopharma has introduced top talents from well-known domestic and international vaccine companies, established a complete production and quality management system, has more than 500 employees to ensure mass production of vaccines can proceed smoothly.

WestVac Biopharma has established a sound communication mechanism with many international organizations such as the World Health Organization (WHO), Bill & Melinda Gates Foundation, PATH, The Coalition for Epidemic Preparedness Innovations (CEPI).

In the future, WestVac Biopharma will grow into a world leading vaccine and immunotherapy platform in line with the corporate philosophy of "We Initiate Science & Technology Value, Always for Caring", seek innovation in the prevention and overcome of human diseases, bring innovative vaccines and immunotherapies from China to the world for the benefit of mankind.

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