Ruike Bio (02179) issued an announcement that the company recently received an acceptance notice issued by the National Medical Products Administration, agreeing to accept the clinical trial application of its independently developed new adjuvant recombinant nine-valent HPV vaccine REC604c. REC604c is a new recombinant nine-valent HPV vaccine that the company plans to develop for the male market and the upgraded market. The product is upgraded on the basis of the previous generation of nine-valent HPV vaccine and is equipped with a new adjuvant with independent intellectual property rights of the company. It aims to enhance immunogenicity and cross-protection, reduce the number of vaccination doses, and improve the accessibility of the product.

Preclinical studies have shown that at the same immune dose, the immunogenicity induced by two injections of REC604c is generally better than the three-injection immune level of Merck Gardasil®9. HPV infection is not only the main cause of cervical cancer in women, but can also lead to genital warts, oral cancer, and male reproductive system cancer. At present, there are more than 300 million men of childbearing age in China, and the market potential is yet to be released.

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