BEIJING—The Center for Drug Evaluation (CDE) has indicated that two Chinese companies, Foshan Ruidio Pharmaceutical Co., Ltd and Chengdu Institute of Biological Products Co., Ltd., part of Sinopharm, are on the path to priority review for their respective medical innovations. Ruidio’s Technetium [99mTc] hydrazine nicotinamide polyethylene glycol bicyclic RGD peptide injection, known as 99mTc-3PRGD2, has completed its Phase III clinical study, reaching all primary and secondary endpoints, positioning itself as the world’s first broad-spectrum tumor imaging agent for SPECT imaging diagnosis. This Category 1 drug, developed by Peking University, has shown to enhance the accuracy of diagnosing lung tumor lymph node metastasis, filling gaps left by other imaging techniques .
The Chengdu Institute’s tetravalent recombinant human papillomavirus (HPV) vaccine, targeting types 6, 11, 16, and 18, is poised to become China’s first domestically produced HPV vaccine suitable for women aged 18-45 years. The vaccine, cultivated using Hansenula yeast, is designed to prevent cervical cancer and associated precancerous conditions caused by high-risk HPV types, as well as infections caused by HPV6 and HPV11. The product is expected to expand the range of preventive options available in the country, joining the existing vaccines including Walvax Bio’s bivalent HPV vaccine and GSK’s Cervarix, among others .
This priority review status not only underscores the potential impact of these drugs and vaccines on public health but also reflects the CDE’s commitment to accelerating the availability of innovative treatments in China.- Flcube.com
