Johnson & Johnson's Breakthrough Therapy INLEXZO Receives FDA Approval Addressing Unmet Clinical Needs in Bladder Cancer Treatment

(Source: Shanghai Securities Research)

Johnson & Johnson's INLEXZO Receives FDA Approval, Becoming the First Intravesical Continuous-Release Anticancer Drug Delivery System.Recently, the U.S. FDA officially approved Johnson & Johnson's innovative drug INLEXZO (Gemcitabine Intravesical Drug Delivery System) for marketing, used to treat adult patients with non-muscle invasive bladder cancer (NMIBC) who are unresponsive to Bacillus Calmette-Guérin (BCG) and carry carcinoma in situ (CIS). INLEXZO is the first and only drug delivery system that continuously releases anticancer drugs intravesically, designed to treat NMIBC patients who are unresponsive to BCG and carry CIS. INLEXZO is an intravesical drug delivery system aimed at achieving sustained local release of gemcitabine within the bladder. The system is implanted into the bladder by healthcare professionals via a catheter, a process that takes less than five minutes without anesthesia, and patients require no further monitoring after placement. The device can remain in the bladder for three weeks per treatment cycle, with up to 14 cycles of treatment possible. This design allows the drug to be continuously released within the bladder, maintaining localized drug exposure for weeks without causing systemic side effects. The approval was supported by data from the SunRISe-1 (NCT04640623) single-arm, open-label Phase 2b clinical study. The results showed that 82% of BCG-unresponsive NMIBC patients treated with INLEXZO achieved complete response, meaning no signs of cancer were detected after treatment (95% Confidence Interval [CI], 72, 90). This high response rate demonstrated strong durability, with 51% of patients maintaining complete response for at least one year.

The number of newly diagnosed bladder cancer patients is on the rise, indicating an urgent clinical need.According to the "Expert Consensus on Early Diagnosis and Treatment of Bladder Cancer (2024 Edition)", bladder cancer is one of the common malignant tumors of the urinary system. The latest released data shows that in 2022, China is expected to have 92,900 new cases of bladder cancer, including 73,200 male cases, with its incidence ranking eighth among all malignant tumors in men; an estimated 41,400 deaths are expected, including 32,500 males. Bladder cancer is one of the malignant tumors that seriously threaten the life and health of the Chinese people. How to effectively reduce the disease burden of bladder cancer is a major public health issue that needs to be urgently addressed. Muscle invasion and distant metastasis are the main factors leading to death or poor prognosis in bladder cancer patients. The five-year overall survival rate for patients with muscle-invasive bladder cancer (MIBC) is about 50%, while the five-year overall survival rate for patients with metastatic bladder cancer is as low as 5%. In contrast, the five-year survival rate for patients with non-muscle-invasive bladder cancer (NMIBC) is as high as 90%. According to Pharma Intelligence data, the number of global patients has exceeded 3 million, of which about 75% of patients are diagnosed with non-muscle-invasive bladder cancer. BCG intravesical instillation is currently the standard treatment, but a significant proportion of patients do not respond to BCG treatment. Traditionally, these patients can only opt for radical cystectomy. There is an urgent clinical need for an effective treatment option that preserves the bladder. Regarding the R&D pipeline in China,Hengrui MedicineSHR-1501 (intravesical instillation) combined with Adebrelimab Injection (intravenous injection) for the treatment of non-muscle-invasive bladder cancer continues to advance in clinical trials;Asia Pacific PharmaHexvix (generic name: Hexaminolevulinate Hydrochloride for Instillation) is currently the world's only approved imaging agent for assisting in the diagnosis or surgery of bladder cancer. Products under research, such as APL-1202 and APL-2401, have demonstrated good safety and efficacy in the field of bladder cancer treatment.Rongchang BioThe IND for the Phase II clinical trial of Vedotin combined with Toripalimab Injection for the treatment of perioperative muscle-invasive bladder cancer (MIBC) was approved in 2022, and patient recruitment had been completed as of June 2025.

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Report Title: "Johnson & Johnson's Breakthrough Therapy Receives FDA Approval, Highlighting Unmet Clinical Needs in Bladder Cancer Treatment — Weekly Pharmaceutical and Biotechnology Industry Report (20250908-0912)"

Analyst: Zhang Linwan

SAC Number: S0870523010001

Publication Date of the Research Report: September 15, 2025

Publishing Institution: Shanghai Securities Co., Ltd.

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