Patronus Biotech's RSV Vaccine LYB005 Receives NMPA Approval for Clinical Study

Patronus Biotech’s RSV Vaccine LYB005 Receives NMPA Approval for Clinical Study

Guangzhou Patronus Biotech Co., Ltd., a vaccine start-up specializing in respiratory and infectious diseases, has received approval from China’s National Medical Products Administration (NMPA) to initiate a clinical study for its recombinant respiratory syncytial virus (RSV) vaccine (CHO cells), LYB005.

LYB005’s U-VLP Technology and Clinical Progress
LYB005 is an RSV vaccine developed on Patronus Bio’s Universal Virus-Like Particle (U-VLP) technology platform, which is capable of efficiently activating both adaptive and innate immunity without the need for adjuvants, offering better safety profiles. This innovative approach positions LYB005 as a promising candidate in the field of RSV vaccination.

The global clinical study for LYB005, registered as NCT06442241, commenced earlier this year. All subjects have been dosed, and the study has not reported any vaccine-related severe adverse reactions. The first data readout is anticipated in the first half of 2025, marking a significant milestone in the development of this potential new vaccine.

Implications for Respiratory Syncytial Virus Vaccination
The initiation of the clinical study and the positive preliminary safety data of LYB005 underscore the potential impact of this vaccine on public health, particularly for populations most vulnerable to RSV infections. Successful development and approval of LYB005 could provide a new tool in the prevention and control of respiratory syncytial virus diseases.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry