J&J(US:JNJ) Zhi Tong Cai Jing·2025-09-10 06:57Core Viewpoint - Johnson & Johnson's innovative therapy Inlexzo has received FDA approval, marking it as the first intravesical drug release system capable of continuously releasing chemotherapy drugs in the bladder, which is expected to generate significant revenue for the company [1][2]. Group 1: Product Details - Inlexzo is approved for treating adult patients with non-muscle invasive bladder cancer (NMIBC) who have not responded to Bacillus Calmette-Guérin (BCG) therapy or are not candidates for radical cystectomy [1]. - The system allows for sustained local release of gemcitabine in the bladder for several weeks, with a treatment cycle lasting three weeks and up to 14 cycles possible [1]. - The approval is based on the SunRISe-1 Phase 2b clinical study, which showed an 82% complete response rate among BCG-unresponsive NMIBC patients, with 51% maintaining complete response for at least one year [1][2]. Group 2: Market Potential - Johnson & Johnson views Inlexzo as a key growth pillar, with expectations of additional therapies utilizing the same technology, predicting peak annual sales exceeding $5 billion [2]. - The company estimates that Inlexzo will be applicable to approximately 2,000 patients annually in the U.S. with high-risk NMIBC who continue to have disease after treatment, and is conducting further trials to expand its potential patient base to around 85,000 bladder cancer patients each year [2]. Group 3: Strategic Importance - Johnson & Johnson has faced pressure to separate its pharmaceutical business from its slower-growing device division, often citing Inlexzo as an example of the advantages of their combined capabilities [3]. - The bladder oncology department head emphasized that Inlexzo represents a milestone product that showcases the company's unique capabilities in the field [3].