On August 30, 2022, Shanghai Zerun Biotechnology Co., Ltd (hereinafter referred to as “Shanghai Zerun”) and its parent company Walvax Biotechnology Co., Ltd (listed on the GEM board of Shenzhen Stock Exchange (stock code: 300142), hereinafter referred to as “Yunnan Walvax”) and Beijing Walvax Innovative Biotechnology Co., Ltd. (hereinafter referred to as “Beijing Walvax”) have received the approval of the Investigational New Drug Application (IND) issued by the National Medical Products Administration (NMPA) for the recombinant protein novel coronavirus variant vaccine (hereinafter referred to as “SARS-CoV-2 Variant Vaccine”), which was developed by Shanghai Zerun.

In order to cope with the ever-changing coronavirus, Shanghai Zerun established a coronavirus vaccine development platform based on CHO cellular antigen expression system and dual adjuvant, and continuously overcame the challenges to finally develop a variant vaccine. Preclinical studies have shown that the variant vaccine cross-neutralizes all variants of interest, including Omicron, and provides significant broad-spectrum protection with significantly higher levels of neutralizing antibodies and cross-neutralization titers than the prototype vaccine. The variant vaccine received Phase I/II clinical trial approval from the African Ministry of Health in Mali on February 16, 2022 (registration number: NCT05490108), and has completed enrollment of all subjects in Phase I clinical trials, with blinded results showing a favorable safety profile. In addition, this variant vaccine has been included in the clinical trial of SARS-CoV-2 variant vaccine booster immunization with different technical routes (registration number: ChiCTR2200062207) organized by the Vaccine R&D Task Force of the Joint Prevention and Control Mechanism of the State Council. Recently, the variant strain vaccine has obtained the clinical trial approval issued by the NMPA. Shanghai Zerun will strictly follow the clinical approval requirements and GCP regulations, and carry out the relevant clinical trials seriously with a high sense of social responsibility and rigorous scientific attitude.

At present, the epidemic situation is still serious as the New Coronavirus continues to mutate. The approval of Shanghai Zerun’s SARS-CoV-2 variant vaccine in China has contributed to the enrichment of China’s SARS-CoV-2 variant clinical vaccine pipeline. This is another important milestone of Shanghai Zerun’s recombinant protein vaccine technology platform, following the approval of the bivalent human papillomavirus vaccine (HPV2 vaccine) “Walrinvax^®” on March 22, this year. Shanghai Zerun owns the independent intellectual property rights of the new vaccine, and has applied for three domestic patents and one international patent, and the antigen protein and adjuvant can be mass-produced in China and controlled independently.

Yunnan Walvax, Shanghai Zerun and Beijing Walvax promise to push forward the innovative research of SARS-CoV-2 variant vaccine and contribute more to the prevention and control of the global epidemic!