Zhitong Finance App News, Cornerstone Pharmaceutical-B (02616.HK) announced that the new drug clinical trial application (IND) of CS5007 (EGFR/HER3 bispecific antibody conjugate drug [ADC]), one of the company's pipeline 2.0 core drug candidates, was quickly approved through the China National Drug Administration (NMPA) innovative drug clinical trial review and approval channel. The whole process took only 23 working days. This achievement not only reflects the company's clinical and registration team's policy insight, proactive communication ability and forward-looking strategic layout under the new regulatory framework, but also marks that the molecule's early development data and clinical development plan have been confirmed by the regulatory authorities in stages, laying a solid foundation for the promotion of subsequent clinical trials. Previously, the global multi-center phase I clinical trial of CS5007 was initiated in Australia in June 2026 and the first patient enrollment was completed. The trial will also be carried out simultaneously in China.

Zhitong Finance App News, Cornerstone Pharmaceutical-B (02616.HK) announced that the new drug clinical trial application (IND) of CS5007 (EGFR/HER3 bispecific antibody conjugate drug [ADC]), one of the company's pipeline 2.0 core drug candidates, was quickly approved through the China National Drug Administration (NMPA) innovative drug clinical trial review and approval channel. The whole process took only 23 working days. This achievement not only reflects the company's clinical and registration team's policy insight, proactive communication ability and forward-looking strategic layout under the new regulatory framework, but also marks that the molecule's early development data and clinical development plan have been confirmed by the regulatory authorities in stages, laying a solid foundation for the promotion of subsequent clinical trials. Previously, the global multi-center phase I clinical trial of CS5007 was initiated in Australia in June 2026 and the first patient enrollment was completed. The trial will also be carried out simultaneously in China.