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Health Guard (Kunming) recombinant vaccine project receive drug production license

PublishDate:2024-08-09 16:35Source: YUNNAN DIAN ZHONG NEW AREA

At present, Yunnan Province has introduced the first recombinant vaccine project—Health Guard (Kunming) Biotechnology Co., Ltd.'s recombinant vaccine clinical and industrialization base construction project, which obtained the "Drug Production Liscence" issued by Medical Products Administration of Yunnan Province.

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Health Guard (Kunming) Biotechnology Co., Ltd. is a wholly-owned subsidiary of Beijing Health Guard Biotechnology Co., Ltd. Its recombinant vaccine clinical and industrialization base construction project invested and constructed by Yunnan Dian Zhong New Area, covers an area of around 140 mu with a total investment of 1.195 billion yuan. The overall planned construction area of production equipment exceeds 80,000 square meters. Built in accordance with the construction standards of China, Europe, and Wealth Health Organization GMP, the base includes production workshops for trivalent HPV vaccines and nine-valent HPV vaccines, a quality control building, a power workshop, and other related supporting facilities. It integrates functions such as research and development, production, logistics, and office operations to meet the needs of innovative vaccine R&D implementation and industrialization development.

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Health Guard (Kunming) Biotechnology Co., Ltd. initiated the technology transfer for the trivalent HPV vaccine and the nine-valent HPV vaccine in February 2023 and May 2024, respectively. Trial production began on August 1, 2023.

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Currently, production equipment operates in an orderly manner in the workshops of Airport Industrial Park in Yunnan Dian Zhong New Area. According to the relevant person in charge of the company, the base is designed to produce 10 million doses of the trivalent HPV vaccine, and 30 million doses of the nine-valent HPV vaccine annually. The acquisition of the "Drug Production License" indicates that the company's production management and quality assurance system have been recognized by national regulatory agencies, and is an important milestone in the project's transformation from research and development to commercialization. In the next step, the trivalent HPV vaccine is expected to be launched and available for sale in 2025, while the nine-valent HPV vaccine is expected to be launched in 2026. (Editors: Ines, Lexi)