CSTONE PHARMA-B (02616.HK): IND of CS5007 (EGFR/HER3 bispecific ADC) approved by NMPA, fast-tracked in 23 working days

NewTimeSpace News: On 21 August 2026, CStone Pharmaceuticals (stock code: 02616) announced in a voluntary announcement that the investigational new drug (IND) application of CS5007, one of the core candidates in the Company's Pipeline 2.0, an EGFR/HER3 bispecific antibody-drug conjugate (ADC), has been rapidly approved by China's National Medical Products Administration (NMPA) through the innovative drug clinical trial review and approval channel, taking only 23 working days in total. Previously, the global multi-center Phase I clinical trial of CS5007 was initiated in Australia in June 2026 with the first patient enrolled, and the trial will also be conducted in China simultaneously.

According to the announcement, the global multi-center Phase I clinical trial of CS5007 is a first-in-human study employing a single-agent dose escalation and dose expansion design, aiming to evaluate its safety, tolerability, PK/PD profile and preliminary anti-tumor activity in patients with advanced solid tumors who have progressed after standard treatment or lack effective treatment options, and to determine the recommended Phase II dose (RP2D), with approximately 310 patients expected to be enrolled. Founded in late 2015, CStone is an innovative biopharmaceutical company focused on oncology, immunology and inflammation, having successfully launched 4 innovative drugs, with a current pipeline of 16 drug candidates including ADCs, multispecific antibodies, immunotherapies and precision therapies.

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