Recco Bio-B (02179) announces development progress of shingles vaccine and nine-valent HPV vaccine

Zhitong Finance App News, Recco Bio-B (02179) announced that the new drug marketing application for the new adjuvant recombinant herpes zoster vaccine REC610 (REC610) under development by the company was officially accepted by the Drug Evaluation Center of the China Drug Administration on December 29, 2025. The acceptance number is CXSS2500145. As of the date of this announcement, the candidate vaccine has successfully completed on-site inspection of drug clinical trials and on-site inspection of drug registration and production, and will continue to cooperate with the supervisory authorities to advance the review.

According to the company's domestic stock issuance announcement dated November 11, 2024 and the 2025 Interim Report, the timeline for submitting an HPV product listing application was originally scheduled to be submitted before June 30, 2026. As of the date of this announcement, the company had not completed the submission of the listing declaration before that point. Based on the actual progress of product clinical follow-up and the implementation of production process verification, the registration application materials will still require more time to be further improved, and the company will re-coordinate and adjust the listing application submission schedule. In order to speed up HPV pipeline development and registration, the company has completed the adjustment of the core management team in the HPV production sector to strengthen the overall management of the entire process of clinical execution, registration reporting, and process verification to ensure the efficient progress of all aspects. Currently, the overall HPV R&D pipeline progress is still within the company's control. If there is significant progress such as submitting a listing application in the future, the company will promptly fulfill its information disclosure obligations in strict accordance with the “Hong Kong Stock Exchange Limited Securities Listing Rules”.