BCG for Intravesical Instillation is the lyophilised powder of live Bacillus Calmette-Guérin (BCG) bacteria derived from Mycobacterium bovis, strain RIVM. The product has been approved for marketing in many countries in Europe, including Germany, France, Ireland and Italy.
There were approximately 78,100 new cases of bladder cancer in 2014 in China, with an incidence of 5.71 per 100,000, among which non-muscular invasive bladder cancer (NMIBC) accounted for nearly 80% of all initial diagnoses. Approximate 63.4% of NMIBC patients (about 40,000 per year) are at intermediate or high risk. For the high-risk and some intermediate-risk NMIBC patients, postoperative intravesical BCG is recommended to prevent recurrence and disease progression, based on both international and Chinese domestic treatment guidelines. The treatment is a well-established immunotherapy for bladder cancers. However, there has been a worldwide BCG shortage, including in China, in recent years. The introduction of BCG for Intravesical Instillation will greatly improve the availability of BCG for bladder cancer patients.