Yisheng Biopharma receives approval from China NMPA for rabies vaccine production facility

Yisheng Biopharma Co., Ltd., a biopharmaceutical company focusing on research, development, manufacturing, sales and marketing of immunological biologics and vaccines, announced 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.

"Rabies infection is responsible for the death of 60,000 people in over a hundred countries each year," said David Hui Shao, Ph.D., President and Chief Executive Officer. "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 over 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. We hope that this innovative product will complete clinical development as quickly as possible, to the benefit of human health as a new weapon against rabies infection."