China is the first to develop a successful global vaccine

On September 3, the A-type H1N1 flu vaccine developed by Beijing Kexing Biological Products Co., Ltd. received the drug approval number from the State Food and Drug Administration (SFDA). This marked a historic milestone as it became the world's first A-type H1N1 flu vaccine to obtain a production batch number. The entire development process—from receiving the virus strain directly from the World Health Organization (WHO) on June 8—was completed in just 87 days. The rapid development of the vaccine was the result of an unprecedented collaboration between China’s vaccine manufacturers, regulatory bodies, health departments, and disease control agencies. Every step—from research and trial production to clinical trials, on-site inspections, registration reviews, and final approvals—was carried out with intense coordination and speed. The goal was clear: to ensure that people could be vaccinated as soon as possible. “Every day counts,” said one official involved in the project. “If we can develop the vaccine one day earlier, people will be protected one day sooner.” In April 2009, the H1N1 flu virus spread globally, prompting an urgent global response. Vaccination became a key strategy in controlling the outbreak. The faster the vaccine could be developed and distributed, the more lives could be saved. Obtaining the WHO-provided virus strains was the first critical step for vaccine manufacturers. On June 3, at 8 PM, the H1N1 vaccine strain was delivered to Hualan Biological Engineering Co., Ltd. in Henan, marking the beginning of its vaccine development. As the first company in China to receive the strain, Hualan started work immediately. “We all understood the urgency,” said Fan Lan, Executive Vice President of Hualan Bioengineering. “From scientists to managers to frontline workers, everyone worked around the clock. Eating was often forgotten during those three months.” By September 1, Hualan Biological’s split H1N1 vaccine passed expert review by the National Drug Evaluation Center and was expected to receive its SFDA approval by September 4. This timeline closely matched that of Beijing Kexing, which also achieved a similar pace. “China’s large population presents a unique challenge,” said Yin Weidong, director of Beijing Kexing. “If the vaccine can be made available a day earlier, it can protect high-risk groups more quickly, reducing the impact of the pandemic.” Meanwhile, government agencies were actively supporting the effort. From June to August, the SFDA issued several key documents, including guidelines for preparing for H1N1 vaccine production and an emergency plan for expedited vaccine approval. These measures provided a solid policy foundation. Under the principle of “no reduction in procedures, no reduction in standards,” the SFDA required a “three-synchronization” approach in the review and approval process. This meant that technical reviews, enterprise submissions, site inspections, and sample testing were all conducted in parallel, significantly speeding up the process. “This is the power of scientific management,” said Zhang Wei, Director of the Drug Registration Department at the SFDA. “It allows us to optimize workflows and achieve maximum efficiency in vaccine development.” “No matter how much pressure we faced, our only belief was in science,” said another official. Influenza A (H1N1) was a completely new virus when the outbreak began. In the early stages, there was limited knowledge about its behavior, making the race to develop a vaccine even more critical. Through teamwork, innovation, and strict adherence to scientific principles, China managed to bring a safe and effective vaccine to the public in record time.

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