WuXi STA enables Ascletis to receive NDA Approval from China FDA for Ganovo (R)
SHANGHAI, June 14, 2018 /PRNewswire/ -- STA Pharmaceutical Co., Ltd. (WuXi STA), a subsidiary of WuXi AppTec, congratulates its partner Ascletis for receiving approval from National Drug Administration of China (CNDA, former CFDA) of its Category 1 new drug, Ganovo® (also known as Danoprevir or ASC08), to treat viral hepatitis C. Ganovo® is the first Direct-acting Anti-viral Agent (DAA) developed by a domestic company in China and has been selected as a National Science and Technology Major Project for "Innovative Drug Development". With this approval, WuXi STA became the first Contract Development and Manufacturing Organization (CDMO) to support the launch of innovative drugs in China since the implementation of Marketing Authorization Holder (MAH) pilot program.
The approval of Ganovo® marked a critical milestone in the history of the "MAH" policy in China. The collaboration between WuXi STA and Ascletis originated in 2012. Via its industry leading process development and manufacturing technology platform and global standard quality system, WuXi STA supported the process optimization and process validation of Ganovo® Active Pharmaceutical Ingredient (API) as well as the Ganovo® NDA submission and approval. In December 2017, WuXi STA's Jinshan API manufacturing site successfully passed the pre-approval inspection by CNDA as part of the Ganovo® NDA application process. As a pioneer of "MAH", WuXi STA is helping many innovative drug development partners in China including Ascletis to optimize their manufacturing processes, significantly reduce commercial production costs, mitigate business risk, and improve operational efficiency.
"The successful development of Ganovo® fulfilled our commitment to deliver affordable innovative drugs for the Chinese patients." said Jinzi J. Wu, Ph.D., Ascletis' founder, President and CEO. "We sincerely appreciate the dedicated support from WuXi STA over the past six years which is crucial to the approval of Ganovo®."
"Congratulations to our partner Ascletis for reaching this milestone. The strong support received from the Chinese government for new drugs and the successful implementation of 'MAH' pilot was integral to reaching this milestone. We now look forward to enabling more partners to launch their innovative medicines both in China and internationally for benefit of patients around the world." said Dr. Minzhang Chen, CEO of WuXi STA.
Ascletis' mission is to become a world-class biotechnology company addressing unmet medical needs in three therapeutic areas: anti-viral, cancer and fatty liver disease, for the patients in China and worldwide. Led by a management team with deep expertise and a proven track record, we have developed an integrated anti-viral platform covering the entire value chain from discovery and development to manufacturing and commercialization. For more information, please visit: http://www.ascletis.com
About WuXi STA
STA Pharmaceutical Co., Ltd. (WuXi STA), a subsidiary of WuXi AppTec, is a leading pharmaceutical development and manufacturing capability and technology platform company serving the life science industry, with operations in Chinaand the United States. As a premier Contract Development and Manufacturing Organization (CDMO), WuXi STA offers our worldwide partners efficient, flexible and high-quality solutions for Active Pharmaceutical Ingredients (APIs) and finished dosage forms.
For more information, please visit: http://www.STApharma.com