Core Viewpoint - The company announced that its new adjuvanted recombinant shingles vaccine REC610 has received formal acceptance for its new drug application from the National Medical Products Administration, with acceptance number CXSS2500145 [1] Group 1: Vaccine Development - REC610 is designed to address shingles, a common disease caused by latent viral infection, affecting approximately 6 million people annually in China, with a trend of younger patients [1] - The vaccine utilizes the company's self-developed BFA01 adjuvant, which enhances the production of high levels of VZV glycoprotein E (gE) specific CD4+ T cells and antibodies [1] - Clinical trials for REC610 received approval from the National Medical Products Administration in October 2023, with full enrollment for Phase III trials expected by December 2024 [1] Group 2: Clinical Research - Ongoing clinical research is proceeding according to the protocol, with previous exploratory studies in the Philippines and China yielding expected results, demonstrating good safety and immune response capabilities [1]
瑞科生物：重组带状疱疹疫苗REC610上市申请获药监局受理