Hengrui Pharma Secures Breakthrough Therapy Designation for SHR‑1501 in China

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (HKG: 1276, SHA: 600276) announced that its investigational injectable SHR‑1501 has been added to the National Medical Products Administration’s (NMPA) list of proposed Breakthrough Therapy Designations (BTDs). The designation targets the combination of SHR‑1501 with Bacillus Calmette‑Guérin (BCG) for patients who remain unresponsive to BCG therapy in non‑muscle‑invasive carcinoma in situ (CIS) of the bladder.

What Is SHR‑1501?

• Mechanism of Action: SHR‑1501 is a self‑developed interleukin‑15 (IL‑15) fusion protein that selectively expands T cells, B cells, and natural killer (NK) cells—boosting the immune system’s ability to attack tumor cells.
• Synergy with BCG: When paired with BCG, SHR‑1501 enhances the intravesical immune response, generating a stronger anti‑tumor effect while avoiding the regulatory T‑cell expansion and apoptosis associated with IL‑2.
• Competitive Landscape: The only approved IL‑15‑based therapy in the United States is Nogapendekin Alfa Inbakicept (Anktiva) from Altor BioScience. No comparable IL‑15 agents have been approved in China to date.

Strategic Significance

• Accelerated Development: The BTD status expedites clinical trial timelines and streamlines regulatory review, positioning SHR‑1501 as a potential first‑in‑class therapy for BCG‑unresponsive CIS.
• Portfolio Expansion: Adding a BTD‑designated product strengthens Hengrui’s oncology pipeline and signals its commitment to innovative immunotherapies.
• Market Opportunity: BCG‑unresponsive CIS affects roughly 10% of bladder‑cancer patients annually in China, representing a significant unmet need that SHR‑1501 could address.

Next Steps

Hengrui is preparing to launch a Phase II/III study to evaluate the safety, tolerability, and efficacy of the SHR‑1501/BCG combination. The company will also engage with key opinion leaders and patient advocacy groups to refine trial design and ensure robust data collection. If early results are favorable, Hengrui plans to seek full NMPA approval and pursue global regulatory submissions by 2028.-Fineline Info & Tech