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 has been officially accepted with acceptance number CXSS2500145 [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 [1]. - REC610 utilizes the company's proprietary adjuvant BFA01, 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 approval for clinical trials in October 2023, with the completion of all participant enrollments for Phase III trials expected by December 2024 [2]. - The clinical study is designed as randomized, double-blind, and placebo-controlled, focusing on the vaccine's efficacy, safety, and immunogenicity in healthy participants aged 40 and above [2]. - Previous exploratory clinical studies in the Philippines and China, using Shingrix® as a positive control, showed that REC610 has good overall safety and induces strong gE-specific immune responses comparable to Shingrix® [2].
瑞科生物-B(02179)：新佐剂重组带状疱疹疫苗REC610的新药上市申请获国家药监局受理