Nuowei Biotech's NWRD08 Plasmid DNA Injection Enters Phase II Clinical Trial for HPV16/18-Positive Cervical HSIL

Data from the Drug Clinical Trial Registration and Information Disclosure Platform shows that a randomized, double-blind, placebo-controlled Phase II clinical study evaluating the efficacy and safety of NWRD08 in patients with HPV16/18-positive cervical HSIL, conducted by Newish Biotechnology (Wuxi) Co., Ltd. / NEWISH, has been initiated. The clinical trial registration number is CTR20253520, with the initial information disclosure date on September 5, 2025.

The drug formulation is an injectable, with a dosage of 2mg for the trial group: 2mg (1 mL)/dose; 4mg for the trial group: 4mg (2 mL)/dose. The treatment schedule is at weeks 0, 4, 8, and 16. The purpose of this trial is to evaluate the efficacy and safety of NWRD08 in patients with HPV16 and/or HPV18 positive cervical HSIL.

NWRD08 Naked Plasmid DNA Injection is a biological product, indicated for patients with cervical HSIL who are positive for HPV16 and/or HPV18. HSIL, or high-grade squamous intraepithelial lesion of the cervix, is a precancerous lesion of cervical cancer, often caused by persistent HPV infection. Most patients have no obvious symptoms, while some may experience abnormal vaginal discharge or contact bleeding, diagnosed through cervical cytology examination and HPV testing.

The primary endpoint of this trial includes the proportion of participants whose cervical histopathology downgraded to non-HSIL (including LSIL or no lesion) at week 36; secondary endpoints include the incidence and severity of local and systemic AEs during the study period, as well as the incidence and severity of adverse reactions at the injection site, among other indicators.

Currently, the experiment status is ongoing (not yet recruiting).

Risk Warning: The market has risks, and investment should be made with caution. This article is automatically published by an AI large model based on a third-party database. Any information appearing in this article (including but not limited to individual stocks, comments, forecasts, charts, indicators, theories, or any form of expression, etc.) is for reference only and does not constitute personal investment advice. Due to issues such as the quality of the third-party database, we are unable to verify or confirm the authenticity and completeness of the data. Therefore, the content of this article may contain inaccuracies, incompleteness, or misleading information. Please refer to official company announcements for specifics. If you have any questions, please contact biz@staff.sina.com.cn.

Editor: Xiaolang Express