CANSINOBIO receives NMPA approval for China’s first component-based DTcP vaccine for infants

Bulletin Express04-12

CanSino Biologics Inc. (CANSINOBIO) announced that the National Medical Products Administration of China has approved the New Drug Application for its Diphtheria, Tetanus and Pertussis (Acellular, Three Components) Combined Vaccine, Adsorbed (DTcP Infant, trade name: Tripecia®), intended for children below two years of age.

The DTcP Infant vaccine is positioned as the first diphtheria, tetanus and acellular pertussis (components) vaccine to reach the Chinese market. Unlike the co-purified manufacturing process used by existing domestic products, CANSINOBIO purifies each pertussis antigen separately and blends them in a defined ratio, a step designed to enhance batch-to-batch consistency and overall product stability.

Management highlighted that the approval lays critical groundwork for two future product lines: 1. An absorbed diphtheria, tetanus and acellular pertussis (components) combined vaccine for individuals aged six years and above; and 2. Additional multivalent vaccines built on the DTcP components platform.

The company noted that the DTcP Infant filing is the first within its broader diphtheria–tetanus–pertussis portfolio to clear the NDA milestone. Experience gained in clinical development, quality control and large-scale manufacturing is expected to streamline subsequent launches across the pipeline and strengthen the commercial product mix.

CANSINOBIO cautioned shareholders and potential investors to exercise care when dealing in its shares following the announcement, dated 12 April 2026.

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