HENGRUI PHARMA's Injectable SHR-A2102 Designated as Breakthrough Therapy for Second Time

Stock News04-16

HENGRUI PHARMA (01276) announced that its subsidiary Shanghai Hengrui Pharmaceutical Co., Ltd.'s injectable SHR-A2102 has been included in the Breakthrough Therapy Designation list by the Center for Drug Evaluation of the National Medical Products Administration. This marks the second time SHR-A2102 has received this designation.

Injectable SHR-A2102 is a proprietary Nectin-4-targeting antibody-drug conjugate (ADC) independently developed by the company, with a topoisomerase I inhibitor (TOP1i) as its payload. Multiple studies indicate that high expression of Nectin-4 in tumors is closely associated with cancer progression and poor prognosis.

The drug has undergone multiple Phase I-III clinical studies covering advanced urothelial carcinoma, bladder cancer, esophageal cancer, lung cancer, and head and neck cancer. Its monotherapy application for locally advanced or metastatic urothelial carcinoma in patients who have failed prior platinum-based chemotherapy and PD-(L)1 inhibitor treatment was previously included in the Breakthrough Therapy list in December 2024.

Currently, there is only one similar product approved globally - Enfortumab vedotin (brand name: Padcev). According to EvaluatePharma database queries, the global sales of this product are projected to reach approximately $2.473 billion in 2025.

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