Shanghai, China, November 25, 2025 —— Belief BioMed (BBM),  an innovative biotechnology company focused on developing cutting-edge gene therapies, today announced that it has received National Medical Products Administration (NMPA) clearance of an Investigational New Drug (IND) application for BBM-C101, the company’s cervix High-grade Squamous Intraepithelial Lesion (HSIL) gene therapy candidate.

Dr. Xiao Xiao, Co-founder, Chairman and Chief Science Officer of Belief BioMed, said, “We are pleased to share the good news of the NMPA’s IND clearance of BBM-C101. We sincerely appreciate the NMPA’s efficient review of the IND, and appreciate BBM team’s continuous efforts. We will fully accelerate the progress of clinical research to bring new treatment options to HSIL patients as soon as possible.

This clinical trial is an open-label, multiple-dose clinical study, which was designed to evaluate the safety, tolerability, and efficacy of subcutaneous injection of BBM-C101 in female participants aged 18-45 years with HSIL associated with HPV16 and/or HPV18. Utilizing a non-replicating recombinant adenovirus (rAd) as the vector, BBM-C101 enables the co-expression of HPV antigens and immune activation factors in host cells. Thus, it is intended to offer a potential treatment option for HPV16 and/or HPV18-related HSIL patients.

About Cervix High-grade Squamous Intraepithelial Lesion

High-grade Squamous Intraepithelial Lesion (HSIL) is an abnormal change in cervical basement membrane infected by human papillomavirus (HPV). >30% of HSIL patients are at risk of developing invasive cancer, highlighting the significant importance of timely treatment of HSIL to reduce the risk of cervical cancer development. HPV16 and HPV18 are the main subtypes of HPV that can cause cervical cancer.

About BBM-C101

BBM-C101 is a non-replicating rAd-based gene therapy with independent intellectual property rights owned by BBM. After injection administration, BBM-C101 co-expresses HPV antigens and immune activation factors in local host cells. Through the dual mechanism of "antigen targeting + immune activation", it achieves the effective elimination of lesion tissues associated with HPV infection.

Between February and March 2024, the Investigator-Initiated Trial (IIT, ChiCTR2400086181/ChiCTR2400081919) of BBM-C101 was launched. In November 2025, BBM-C101 received NMPA clearance of an IND application.

About Belief BioMed

Belief BioMed Inc. (BBM) is a global biotech company that integrates the research and development, manufacturing and clinical application of gene therapy products. The company is committed to providing innovative and more effective gene therapies for severe genetic and chronic diseases through safe and efficient viral vector technology. BBM has developed hundreds of key vector technologies, including HEK293 cell suspension serum-free culture process and full-scale chromatography purification process, and has established a commercial production platform for gene therapy drugs. The company has been building up its capabilities in a variety of fields including novel AAV capsids targeting different tissues, efficient transgene expression cassette design, and advanced clinically applicable vector manufacturing process. It has also established an extensive R&D pipeline covering a wide range of unmet clinical needs in different therapeutic areas such as hemophilia, DMD, Parkinson's disease, osteoarthritis, etc. Several product pipelines have entered clinical studies or submitted IND filings. The Biologics License Application (BLA) of a gene therapy for the treatment of adult patients with hemophilia B, has been approved by the NMPA of China. For more information, visit www.beliefbiomed.com.

Statement

This information is only for the purpose of introducing the company's event and information on that date, and is not intended to promote any company's products and/or services, nor should it be construed as providing any advice or recommendation on the selection of any drugs, medical devices and treatment options.

For information about any company products, diseases and/or treatments, please consult a healthcare professional.

BBM-C101 described herein has not been approved for marketing.