Yisheng Receives GMP Certification in China

Yisheng Biopharma, a biopharmaceutical company focusing on research, development, manufacturing, sales and marketing of immunological biologics and vaccines, said that its new rabies vaccine production facility has received a Pharmaceutical GMP Certificate from the China National Medical Products Administration (NMPA) for production of its Yisheng Junan product, the first lyophilized rabies vaccine without an aluminum adjuvant produced in China for medical use. The Yisheng Junan vaccine has been used for more than 15 years by tens of millions of individuals, and represents a significant share of the market for preventive vaccines against rabies infection. The vaccine has demonstrated effective protection, contributing to the fight against rabies infection. The newly constructed state-of-art production facility is operated by the Liaoning Yisheng Biopharma subsidiary.
 
"As a vaccine manufacturer with a history dating back to 1994, Yisheng was the first private biopharmaceutical company to benefit from the dynamic evolution of vaccine technology in China and has long been a leader in technology innovation in rabies vaccine production," said Zhang Yi, chairman, Yisheng Biopharma. "Now, we have invested approximately $60 million to build two new vaccine production facilities and successfully completed the GMP certification process. The purification facility is 4,325 square meters and the packaging facility is 1,558 square meters, allowing for an annual production capacity of over 3 million treatment of courses. Our sales team has already prepared for commercial launch. To ensure high quality and accessibility, we have implemented a distribution method directly supplying vaccine products to regional health authorities at the county level, using an integrated "hub-storage-distribution" distribution system.
 
David Hui Shao, president and chief executive officer, Yisheng Biopharma, said, "Rabies infection is responsible for the death of 60,000 people in over a hundred countries each year. As exposure is common, with 15 million people receiving immunization of rabies vaccine every year in China alone Yisheng has been strategizing to address the problem of rabies infection. Our current focus, following more than ten years of research in the area of preventive vaccines, is the development of a new generation of rabies vaccine, PIKA rabies vaccine, which provides accelerated and strong immune response with the prevention and therapeutic benefits against rabies infection."
 
The PIKA Rabies Vaccine is approaching global Phase 3 clinical development and has been recognized as a National Key Medical project by the China Ministry of Science and Technology and other ministries. Development has been supported with special grant funding from the government of China. The PIKA Rabies Vaccine has also received Orphan Drug Designation from the U.S. FDA for the prevention and treatment of rabies infection. The vaccine was cited by an official rabies working group of the World Health Organization (WHO). Yisheng is moving forward with international studies, including sites in China.

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