CStone Pharmaceuticals receives NMPA IND approval for CS5007

CAR-T Digest - August 2020

21 August 2026: CStone Pharmaceuticals receives NMPA IND approval for CS5007

CStone Pharmaceuticals announced that China’s NMPA has approved the IND application for CS5007, an EGFR/HER3 bispecific ADC, through the innovative drug clinical trial review and approval channel, with the application cleared following initiation of the global phase 1 trial in Australia in June 2026
The global phase 1 study has already started recruitment in Australia, with the first patient successfully enrolled in June 2026, and will now be conducted in China to evaluate CS5007’s safety, tolerability, PK/PD characteristics, preliminary antitumor activity and determine the recommended phase 2 dose
The program addresses a significant unmet need in EGFR-driven solid tumors, where HER3-mediated compensatory signaling can contribute to acquired resistance to EGFR-targeted therapies, highlighting the potential need for approaches capable of simultaneously targeting both pathways
CS5007 is an EGFR/HER3 bispecific ADC designed to simultaneously target EGFR and HER3, enabling dual-pathway tumor targeting and delivery of its cytotoxic payload to tumor cells expressing these receptors
Strategically, the China IND approval strengthens CStone’s Pipeline 2.0 strategy and enables coordinated global development of CS5007 across Australia and China, further advancing the company’s proprietary ADC platform and expanding its clinical-stage ADC portfolio