Yisheng Biopharma Receives GMP Certification from China NMPA for Production of Lyophilized Rabies Vaccine for Preventive Use
BEIJING, July 22, 2019 /PRNewswire/ -- Yisheng Biopharma Co., Ltd. ("Yisheng Biopharma"), 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.
"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," commented Zhang Yi, Chairman of Yisheng Biopharma. "Now, we have invested approximately 60 million USD to build two new vaccine production facilities and successfully completed the GMP certification process. The purification facility is 4325 square meters and the packaging facility is 1558 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.
"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."
About Yisheng Rabies Vaccines
Early rabies vaccines produced in China had low titer levels (1.3 IU/ 2 ml), providing incomplete protection from rabies infection. More concentrated vaccines that include an aluminum adjuvant provide higher titer levels (over 2.5 IU) but these higher concentration vaccines increase the incidence of adverse reactions and side effects induced by impurities. By introducing advanced purification techniques such as column chromatography to improve vaccine quality, Yisheng developed a purified rabies vaccine in 1998 and was the first company to introduce a purified vaccine in China. Our subsequent research demonstrated that the aluminum adjuvant contributed to a slow initiation of immune protection. As rabies vaccines are primarily used for post-exposure protection, the speed of initiating vaccine-induced immunity is critical. In 2003, Yisheng became the first enterprise in China to produce an aluminum-free lyophilized rabies vaccine. Since then, aluminum-free vaccines have become common in China. With years of research into rabies prevention and treatment, Yisheng has developed a proprietary PIKA® Rabies Vaccine which provides accelerated and strong immune response with both prevention and therapeutic benefits against rabies infection. This vaccine can significantly improve immune protection following exposure to the rabies virus.
About Yisheng Biopharma Co., Ltd.
Yisheng Biopharma is a global, fully integrated biopharmaceutical company engaged in discovering, developing and commercializing innovative biotherapeutics for cancer and infectious disease using its novel PIKA® immunomodulating technology. PIKA technology augments both innate and adaptive immune responses through the TLR3, RIG-I and MDA5 pathways. Products in clinical development include YS-ON-001 for the treatment of advanced solid tumors, YS-HBV-001 hepatitis B vaccine, and the PIKA rabies vaccine for accelerated protection against rabies infection. The Company has two marketed products in China and South Asia market. Yisheng Biopharma is headquartered in Beijing with approximately 640 employees in China, Singapore, Cambodia and the U.S.
SOURCE Yisheng Biopharma Co., Ltd.
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