CanSino Biologics Receives NMPA Approval for Bivalent COVID-19 mRNA Vaccine

CanSino Biologics Inc., a leading Chinese vaccines specialist, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its innovative bivalent COVID-19 mRNA vaccine. This development signifies a significant step forward in the company’s efforts to combat the evolving SARS-CoV-2 virus.

Preclinical Study Results
Preclinical studies have demonstrated that CanSino’s bivalent COVID-19 mRNA vaccine elicits a more extensive neutralizing antibody response against various strains of the virus, including the original strain, Omicron BA.1, BA.2.75, BA.4/5, and XBB.1, compared to monovalent COVID-19 vaccines. These findings suggest that the bivalent vaccine may offer broader protection against different variants of the virus. Additionally, toxicological studies have indicated that the vaccine candidate has a favorable safety profile.

Convidecia Launch and Production Update
During the pandemic, CanSino successfully launched its Convidecia (recombinant novel coronavirus vaccine (adenovirus type 5 vector)) with special military approval, followed by conditional approval in China in February 2021. However, in response to changes in the external market environment, SPH CanSinoBio, a joint venture between Shanghai Pharmaceutical Group and CanSinoBio responsible for the manufacturing of Convidecia, has decided to suspend production of COVID-19 vaccines for 180 days starting April 4. This decision comes amidst CanSino’s withdrawal of more than RMB 800 million (USD 116.2 million) worth of COVID-19 vaccine-related inventory, indicating a potential impairment.

Conclusion
CanSino Biologics’ receipt of NMPA approval for its bivalent COVID-19 mRNA vaccine trial is a promising development in the ongoing fight against COVID-19. The company’s commitment to vaccine innovation and adaptability in the face of market changes reflects its resilience and dedication to public health.-Fineline Info & Tech

Fineline Info & Tech