Chengda Bio’s Trivalent Influenza Vaccine Moves Closer to Market with Regulatory Acceptance
By Thomas Yuan

BENXI — On the evening of March 20, Chengda Biotechnology announced that its trivalent influenza vaccine, developed by its wholly owned subsidiary Chengda Bio (Benxi) Co., Ltd., has received an "Acceptance Notice" from China’s State Food and Drug Administration for domestic production registration and marketing authorization.

The approval marks a significant regulatory step in the company’s effort to expand its vaccine portfolio and support national public health measures. Designed to combat seasonal influenza, the split-virus vaccine offers protection against three circulating strains and is expected to play a crucial role in reducing the burden of respiratory infectious diseases, particularly among high-risk populations.

A Preventive Solution for a Persistent Threat

Influenza remains one of the most widespread and persistent global health threats, often causing annual epidemics that lead to serious complications like pneumonia, bronchitis, and myocarditis, especially in the elderly and immunocompromised individuals. For these groups, even a routine flu infection can significantly worsen pre-existing health conditions.

Chengda Bio emphasized that the accepted vaccine candidate has shown strong safety and immunogenicity in earlier testing, helping to stimulate protective immune responses against the target virus strains. As a cost-effective and scalable preventive measure, the trivalent vaccine is aligned with national health goals to reduce disease burden, lower hospitalization rates, and safeguard vulnerable populations.

Expanding Vaccine Capabilities

This regulatory milestone further strengthens Chengda Bio’s position in the biopharmaceutical sector, where the company is already engaged in the co-development of a 15-valent HPV vaccine alongside Kangleweishi Biotechnology. That product recently advanced to Phase II clinical trials, reinforcing Chengda’s long-term strategy of offering both preventive health products and high-value medical solutions targeting widespread viral infections.

The production application for the trivalent influenza vaccine also highlights Chengda’s expanding manufacturing capacity, reflecting growing capabilities in both vaccine formulation and regulatory compliance.

With influenza remaining a global concern and vaccine coverage still suboptimal in many regions, Chengda Bio’s entry into the flu vaccine market represents a timely step toward enhancing both domestic supply chains and international competitiveness in medical technology and public health preparedness.

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