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The application for clinical trial of Rico's new adjuvant recombinant quadrivalent HPV epidemic in China was accepted

 Last Update: 2022-11-04
 Source: Internet
 Author: User

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On October 27, Jiangsu Ruike Biotechnology Co.
, Ltd.
(hereinafter referred to as "Ruike Biotechnology" or "the company", stock code: 02179.
HK) is pleased to announce that the company has recently received an acceptance notice issued by the State Medical Products Administration (NMPA) agreeing to accept its self-developed application for clinical trial of
recombinant quadrivalent HPV seedling REC604a.

REC604a is equipped with the new adjuvant BFA04 developed in-house, which aims to reduce the number of inoculation doses by enhancing immunogenicity and cross-protection
.
Reducing the number of doses can help save costs and increase vaccination rates, so it is recommended
by regulatory bodies such as the WHO.
Preclinical studies have shown that BFA04 adjuvant can increase neutralizing antibodies by 7.
7 times
compared with the use of aluminum adjuvant.
Compared with three doses of Merck quadrivalent HPV vaccine Gardasil, the levels of HPV neutralizing antibodies induced by two doses of REC604a were higher than those induced by three doses of Gardasil immunization.
By 24 weeks after the last immunization, the decline in the titers of neutralizing antibodies produced by REC604a immunity was more moderate
than that of Gardasil.

The receipt of the clinical trial acceptance notice of REC604a further demonstrates the company's leading strength in the field of new adjuvant vaccines, enhances the company's core competitiveness and market position, and is expected to provide a better prevention option
for accelerating the improvement of HPV vaccination rate in China.

According to the provisions of Article 32 of the Administrative Licensing Law of the People's Republic of China, after review, it was decided to accept
it.
Within 60 days from the date of acceptance, if no negative or challenging opinions are received from the Drug Review Center, the company may carry out clinical trials
in accordance with the submitted plan.

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