LUYE PHARMA (02186.HK): therapeutic mRNA vaccine LY01620 to initiate Phase II clinical trial in China, HPV viral clearance rate nearly 90%
NewTimeSpace News: On 20 August 2026, Luye Pharma Group Ltd. (stock code: 02186) announced in a voluntary announcement that its self-developed messenger RNA (mRNA) vaccine LY01620 is about to initiate a Phase II clinical trial in China, which intends to enroll patients with histologically confirmed HPV16-positive cervical high-grade squamous intraepithelial lesions (HSIL) to further evaluate the efficacy and safety of LY01620.
According to the announcement, LY01620 is a therapeutic mRNA vaccine registered as a Class 1 therapeutic biological product, targeting the E6 and E7 protein antigens of HPV16 subtypes; it utilizes mRNA to express HPV-specific antigens E6/E7, eliminating HPV-infected cervical epithelial cells through inducing specific T-cell immunity to block the carcinogenesis process. The Phase I clinical study of LY01620 has achieved positive results supporting the Phase II study: it significantly activated cellular and humoral immunity, with an HPV viral clearance rate of nearly 90% and histological improvement approaching the level of standard surgical treatment, while being non-invasive and not affecting fertility, with overall good safety and tolerability.
The announcement states that, compared with traditional surgical treatment, therapeutic vaccines can be applied at different disease stages after HPV infection to block progression to cervical cancer; the Group's proprietary mRNA technology platform has established a full-process closed loop covering antigen screening, mRNA sequence optimization, proprietary delivery vector system development and GMP scaled production, enabling continued development of personalized and universal mRNA vaccine products.
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