SHR‑A2102 has received BTD from China’s NMPA for the treatment of cervical cancer

CAR-T Digest - August 2020

22 April 2026: SHR‑A2102 has received BTD from China’s NMPA for the treatment of cervical cancer

Jiangsu Hengrui Pharmaceuticals announced that its SHR-A2102 ADC has been granted Breakthrough Therapy Designation (BTD) in China for the treatment of recurrent or metastatic cervical cancer in patients who have progressed after platinum-based chemotherapy and PD-(L)1 inhibitors
This designation addresses a high unmet need setting, where current options are limited standard chemotherapy offers low response rates (<10%) and short survival outcomes, highlighting the need for more effective therapies in heavily pretreated cervical cancer
SHR-A2102 is designed to deliver a topoisomerase 1 inhibitor payload directly into tumor cells, potentially enhancing anti-tumor activity through targeted delivery
The therapy targets Nectin-4, a protein highly expressed in cervical cancer and linked to tumor growth, invasion, and metastasis, reinforcing its potential as a relevant therapeutic target in this disease
Overall, this milestone reinforces SHR-A2102’s expanding clinical potential across multiple tumor types, with ongoing studies in urothelial, lung, esophageal, head and neck, and cervical cancers, strengthening Hengrui’s growing ADC oncology pipeline