Core Viewpoint - The company has received formal acceptance from the National Medical Products Administration for the new drug application of its adjuvanted recombinant shingles vaccine REC610, indicating progress in its development and potential market entry [1] Group 1: Vaccine Development - REC610's new drug application acceptance number is CXSS2500145, marking a significant milestone for the company [1] - The vaccine targets shingles, a common disease caused by latent viral infection, which affects approximately 6 million people annually in China, with a trend of younger patients being affected [1] - REC610 utilizes the company's self-developed BFA01 adjuvant, which enhances the immune response by promoting high levels of VZV glycoprotein E (gE) specific CD4+ T cells and antibodies [1] Group 2: Clinical Trials - REC610 received a clinical trial approval notice from the National Medical Products Administration in October 2023, with the notice number 2023LP02151 [2] - The Phase III clinical trial is set to complete enrollment of all participants by December 2024, and is currently following the clinical protocol for subsequent observational visits [2] - The clinical study is designed as a randomized, double-blind, placebo-controlled trial to evaluate the vaccine's efficacy, safety, and immunogenicity in healthy participants aged 40 and above [2]
瑞科生物-B(02179.HK)：公司新佐剂重组带状疱疹疫苗REC610新药上市申请获国家药品监督管理局受理