Bendao Gene Initiates Patient Recruitment for World's First Gene Therapy for HPV-16 Related High-Grade Cervical Lesions

Shanghai Bendao Gene Technology Co., Ltd. has begun patient recruitment for a clinical study at the Obstetrics and Gynecology Hospital of Fudan University (Shanghai Red House Obstetrics and Gynecology Hospital). The trial tests BD114, what the company describes as the world's first gene therapy product targeting high-grade squamous intraepithelial lesions of the cervix caused by HPV-16 infection.

The study has passed scientific review by the hospital's scientific review committee and received ethics committee approval. Professor Sui Long serves as principal investigator.

Who Qualifies

The recruitment criteria are specific. Researchers are seeking women between 18 and 50 years old who are premenopausal and have no future fertility needs. Candidates must have confirmed HPV-16 infection with cervical high-grade squamous intraepithelial lesions, with no other high-risk HPV types present.

Participants must commit to long-term follow-up and comply with study protocols that include gynecological examinations, blood tests, urine analysis, and electrocardiograms. The company notes that final eligibility rests with study physicians.

Those interested can contact Ms. Wang at 18917699181 for additional information.

A Broader Pipeline

Bendao Gene positions itself as a biotech company focused on reshaping treatment for major and difficult diseases through advanced delivery technology. The company operates two core platforms: BD-VLP, a virus-like particle mRNA/RNP delivery system, and BDlenti, a next-generation lentiviral vector platform.

These platforms support a pipeline targeting ophthalmology, neurological diseases, hematology, viral infections, and oncology. Two earlier products—BD111 and BD211—have advanced to Phase I-II clinical stages.

The company operates a 4,000-square-meter GMP pilot production and R&D facility and has established a Joint Gene Therapy Research Center with Shanghai Jiao Tong University's Institute of System Biomedical Medicine.

Bendao Gene's research findings have appeared in Nature, Nature Nanotechnology, Nature Biotechnology, Nature Biomedical Engineering, and Cell Stem Cell. The company has also entered collaboration agreements with unnamed international pharmaceutical firms for novel gene therapies targeting major neurological diseases.