Acceptance Of The Application For Clinical Trial Of The Company’s Novel Adjuvanted Recombinant HPV 9-Valent Vaccine REC604c In China
Jiangsu Recbio Technology Co., Ltd. (the “Company”, together with its subsidiaries, the “Group”) is pleased to announce that the Group has recently received a notice of acceptance from the National Medical Products Administration to accept the application for a clinical trial of its in-house developed novel adjuvanted recombinant HPV 9-valent vaccine REC604c (the “REC604c”).
REC604c is a novel recombinant HPV 9-valent vaccine that the Company plans to develop for the male and upgraded markets. The product is upgraded on the basis of the previous generation of HPV 9-valent vaccine, equipped with an in-house developed novel adjuvant with the Company’s independent intellectual property rights. REC604c aims to achieve the purpose of reducing vaccination doses by enhancing immunogenicity and cross-protection to effectively improve product accessibility. Preclinical studies have shown that, under identical immune dosage, the immunogenicity induced by the vaccination of two doses of REC604c is generally superior to that induced by three doses of Merck Sharp & Dohme’s Gardasil®9.
HPV infection is not only the main cause of cervical cancer in females, but also can lead to condyloma acuminatum, oral cancer, male reproductive system cancer and other diseases. Published data showed that about 90% of genital warts can be attributed to HPV infection of related types. Globally, United Kingdom, Canada, and Ireland have included HPV vaccination for adolescent males in their national immunization programs, with vaccination strategies largely in line with those for females. At present, there are more than 300 million males of appropriate age in China, and the market potential is yet to be unlocked.
About Recbio
Founded in 2012, Jiangsu Recbio Technology Co., Ltd. (hereafter referred to as Recbio or the Company; stock code: 2179.HK) is an innovative vaccine company propelled by internally developed technologies. Committed to our mission of " Protect human health with best-in-class vaccines", we have cultivated a robust portfolio of vaccine products with exclusive rights, addressing the substantial unmet needs in the realm of high-impact infectious diseases. Over the course of more than two decades, Recbio has meticulously built three pioneering platforms: a novel adjuvant platform, a protein engineering platform, and an immunological evaluation platform, making us one of the few global companies capable of both developing and manufacturing the complete range of novel adjuvants.
Leveraging the close integration of our three platforms, we are consistently creating promising vaccine candidates. Fueled by these innovative platforms, the Company has forged a high-value portfolio of innovative vaccines, encompassing over ten potential blockbuster varieties. These encompass areas such as cervical cancer, shingles, RSV infection, and other prevalent high-burden diseases, and have emerged as leading products in terms of development and clinical progress in China.
Having been honed and refined over the course of a decade, Recbio is poised to reap the benefits as several products are nearing commercialization.