March 5, 2026, China –CanSino Biologics Inc. (hereinafter "CanSinoBIO," Stock Codes: 688185.SH, 06185.HK) is pleased to announce that the manufacturing site for its ACYW135 Meningococcal Polysaccharide Conjugate Vaccine (CRM197) MCV4 and 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197/Tetanus Toxoid) PCV13i has successfully passed the Good Manufacturing Practice (GMP) compliance inspection conducted by the Malaysia National Pharmaceutical Regulatory Agency (NPRA) under the Pharmaceutical Inspection Co-Operation Scheme (PIC/S). The Company has recently received a GMP certificate from NPRA.

PIC/S is an internationally recognized authority for pharmaceutical inspection and certification, comprising drug regulatory agencies from dozens of countries. It implements unified standards for GMP inspection and certification of medicinal products for human and veterinary use. GMP compliance inspection is one of the prerequisites for drug registration and marketing approval. On a voluntary basis, PIC/S member countries and participating authorities mutually recognize GMP compliance inspections.

The PIC/S GMP certification confirms that CanSinoBIO's manufacturing site and quality management systems meet internationally recognized standards. This milestone not only facilitates the registration and market entry of MCV4 and PCV13i in Malaysia, but also provides a strong foundation for approvals in other PIC/S member countries, supporting the Company's global landscape of innovative vaccines and reinforcing its international credibility.

As Asia's first and China's only quadrivalent meningococcal conjugate vaccine, MCV4 has been approved for infants and children aged 3 months to 6 years (83 months), providing comprehensive protection from early infancy through school age. In terms of international presence, MCV4 has been steadily advancing its overseas deployment since 2024: it has obtained registration in Indonesia and Halal certification, completed initial shipments and adult clinical trials in Indonesia, demonstrating steady progress in global market development.

PCV13i is China's first 13-valent pneumococcal conjugate vaccine using CRM197 as the main carrier and tetanus toxoid (TT) as the auxiliary carrier. It offers superior protection¹ against the four serotypes (19F, 19A, 7F, and 3) that contribute most heavily to the pneumococcal disease burden in Chinese children. The product was approved for commercialization in June 2025 and was distributed nationwide since September 2025, with vaccination programs launched successively in various regions. CanSinoBIO is actively supporting its global accessibility.

The NPRA PIC/S GMP certification not only demonstrates that CanSinoBIO's production quality system aligns with international standards but also facilitates the entry of its innovative vaccines into additional global markets. As a representative of Chinese innovative vaccine enterprises, CanSinoBIO leverages its R&D capabilities and internationally recognized quality systems to integrate into the global vaccine supply chain and public health network, promoting Chinese innovative vaccines on the international stage.

CanSinoBIO stated that it will continue to advance the research, development, and international deployment of innovative vaccines, continuously enhancing global supply and service capabilities, and fulfilling its mission of "To provide innovative, high-quality and affordable vaccines", contributing to global public health.

Note:

1."Superior protection": According to current clinical data, the GMC level of PCV13i is higher than that of the control group.

Disclaimer:

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