Westgene Biopharma has received approval from the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) in China for its new drug research application (IND) for “WGc-043 Injection.” The approval, dated August 6, 2024, grants Westgene Biopharma the green light to initiate Phase I clinical trials. “WGc-043 Injection” is the world’s first mRNA vaccine targeting Epstein-Barr virus (EBV) related tumors to receive IND approvals in both China and the U.S.
The WGc-043 mRNA vaccine received IND approval in the U.S. in May of this year, with indications in both countries targeting EBV positive tumors: for adult patients with advanced solid tumors positive for EBV who have undergone at least two lines of systemic treatment, and for adult patients with recurrent or refractory EBV positive hematological tumors. WGc-043 offers a novel mRNA immunotherapy treatment option for end-stage EBV positive solid and hematological tumor patients. “We will now conduct clinical trials in China to expedite the commercial use of the WGc-043 mRNA vaccine,” said Professor Song Xiangrui, co-founder and general manager of Westgene Biopharma. With the support of high-quality preliminary trial data, the WGc-043 mRNA vaccine is confident of demonstrating excellent safety and anti-tumor activity in clinical trials.
mRNA therapeutic cancer vaccines represent one of the significant breakthroughs in the mRNA innovation drug field and cancer immunotherapy. International pharmaceutical giants such as Merck (MSD), Moderna, and BioNTech have intensively invested in this domain with varying developmental progress. The IND approval of Westgene Biopharma’s oncological therapeutic vaccine pipeline “WGc-043 Injection” further validates the maturity of its mRNA core technologies in delivery vectors and sequence design, accelerating the commercialization process of efficient and low-toxicity anti-tumor mRNA vaccines globally.- Flcube.com
