On November 14, 2025, Chengdu Olymvax Biopharmaceuticals Inc. (hereinafter referred to as “Olymvax”, stock code: 688319) officially received the audit result notice from the Food and Drug Administration (FDA) of the Philippines. In the comprehensive on-site audit from November 10 to 14, 2025, the Company successfully obtained the authoritative evaluation of “Satisfactory Compliance” relying on its perfect quality management system, standardized operation and management processes and excellent product quality, marking that its international compliance capacity has been highly recognized by the Philippine regulatory authorities and adding heavy support for overseas market expansion.
As a Sci-Tech innovation board listed enterprise focusing on the R&D, production and sales of human vaccines, since its establishment in 2009, Olymvax has always taken “Providing safe, effective and high-quality human vaccines” as its core mission, and built a two-wheel driven product strategy of “Innovative Vaccine Development + Traditional Vaccine Upgrading”. This Philippine FDA audit covered key links such as quality system, production facilities, material management, laboratory system and data integrity. The audit team conducted strict verification on the Company’s full life cycle operation process in accordance with “RA 9711; AO 2012-0008; PIC/S GMP Part I (PE 009-14) and its related Annexes; other FDA Rules and Regulations” and Philippine regulatory requirements. The final “Satisfactory Compliance” conclusion confirms the Company’s international standards in production management, quality control and other aspects, and also lays a solid foundation for its products to enter the Philippine and Southeast Asian markets.
Mr. Fan Shaowen, Chairman and General Manager of Olymvax, stated: “The successful passing of the Philippine FDA audit is an important milestone in the advancement of the Company’s internationalization strategy. As a leading enterprise in the domestic adsorbed tetanus vaccine market share, we not only deeply cultivate the domestic market, but also actively expand overseas layout. At present, we have reached cooperation with partners from Bangladesh, the Philippines and other countries and promoted export-related work.”
After passing the audit, Olymvax will further accelerate the market access process in Southeast Asia, and continue to expand the global cooperation network relying on the endorsement of international authoritative certification. In the future, the Company will continue to adhere to the development positioning of “Internationally Renowned, Domestically Leading”, take compliance system construction as the support and innovative R&D as the core driving force, let high-quality vaccine products benefit consumers in more countries and regions, and contribute Chinese biopharmaceutical power to the global public health cause.