China-based Chongqing Zhifei Biological Products Co., Ltd (SHE: 300122) has announced that its clinical trial filing for an in-house developed therapeutic BCG vaccine has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step in the development of a new treatment option for bladder cancer, one of the most common malignant tumors of the urinary system.
Clinical Need and Vaccine Profile
Bladder cancer is a significant health concern, with more than 70% of cases initially diagnosed as non-muscle invasive bladder cancer (NMIBC). Research indicates that the disease has a high recurrence rate of 50% to 70% and a progression rate of 10% to 20% after NMIBC surgery. To address these challenges, intravesical chemotherapy and/or BCG infusion therapy are often used to reduce tumor recurrence, prevent tumor progression, and eliminate residual lesions that may remain after transurethral bladder tumor resection.
The BCG vaccine, an immunotherapeutic agent, is made by culturing and collecting BCG bacteria to prepare a high-concentration suspension, which is then freeze-dried with an appropriate stabilizer. It is used to treat bladder carcinoma in situ and prevent recurrence, as well as to prevent the recurrence of bladder papilloma in the Ta (non-invasive papillary carcinoma) or T1 (tumor invading upper and subcutaneous connective tissue) stage after transurethral resection.
Future Outlook
The acceptance of the clinical trial filing by the NMPA highlights Zhifei Biological Products’ commitment to advancing innovative treatments for bladder cancer. With its therapeutic BCG vaccine poised to enter clinical trials, the company is well-positioned to address significant unmet needs in this area. The ongoing development efforts underscore Zhifei’s dedication to improving patient outcomes through novel immunotherapeutic approaches.-Fineline Info & Tech
