Grand Pharmaceutical Group Limited (Grand Pharma, 0512.HK) announced that the Investigational New Drug (IND) Application of ARC01 (A002), a therapeutic tumor vaccine of the Group’s subsidiary Nanjing AuroRNA Biotechnology Co., Ltd. (南京奥罗生物科技有限公司) for human papillomavirus type 16 (HPV-16)-positive late-stage unresectable or recurrent/metastatic solid tumors, has been officially approved by the National Medical Products Administration of China.
ARC01 is the first mRNA therapeutic tumor vaccine for HPV-positive tumors that approved for clinical trials in China, and the drug registration classification is Class 1 therapeutic biological products.
ARC01 uses liposome nanoparticle (LNP) delivery technology and TriMix® immune adjuvant technology. Both of them are exclusive patented technologies that can significantly enhance the body’s immune response, thereby improving the immunotherapy effect of the vaccine.
Grand Pharma has currently completed the establishment of mRNA production technology and LNP delivery technology platform, and has carried out scientific cooperation with many well-known universities and scientific research institutes.
