Jiangsu Hengrui's SHR-A2102 Earns Breakthrough Therapy Designation for Urothelial Carcinoma

Jiangsu Hengrui’s SHR-A2102 Earns Breakthrough Therapy Designation for Urothelial Carcinoma

Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received breakthrough therapy designation (BTD) from the National Medical Products Administration of China for its pipeline candidate, SHR-A2102. The designation is in recognition of the molecule’s potential in treating locally advanced or metastatic urothelial carcinoma in patients who have previously failed platinum-based chemotherapy and PD-(L)1 inhibitor treatment.

SHR-A2102: An Innovative ADC Targeting Nectin-4
SHR-A2102 is an in-house developed antibody drug conjugate (ADC) that targets Nectin-4, a protein with high expression levels closely associated with tumor development and poor prognosis in urothelial carcinoma. The ADC’s innovative approach offers a new treatment option for patients with limited therapeutic options after conventional treatments have failed.

Global Context and Competitive Landscape
Globally, Pfizer/Seagen’s Padcev (enfortumab vedotin) is a comparable Nectin-4 targeted ADC, indicating a growing interest in Nectin-4 as a therapeutic target for urothelial carcinoma. The BTD for SHR-A2102 highlights the potential of Hengrui Pharmaceuticals’ candidate to compete in the global market and provide an additional treatment option for patients.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry