CSTONE PHARMA-B (02616) has announced that the Investigational New Drug (IND) application for CS5007, an EGFR/HER3 bispecific antibody-drug conjugate (ADC) and one of the core candidates in the company's Pipeline 2.0, has received rapid approval from China's National Medical Products Administration (NMPA) through the innovative drug clinical trial review channel, with the entire process taking just 23 working days.

This achievement underscores the company's clinical and regulatory team's policy insight, proactive communication capabilities, and forward-looking strategic planning under the new regulatory framework. It also marks regulatory recognition of the molecule's early-stage research data and clinical development plan, laying a solid foundation for subsequent clinical trial advancement. Previously, the global multicenter Phase I clinical trial of CS5007 was initiated in Australia in June 2026, with the first patient enrolled, and this trial will now also be conducted in China concurrently.

Dr. Yang Jianxin, Chief Executive Officer, President of R&D, and Executive Director of CSTONE PHARMA-B, stated: "The smooth IND approval for CS5007 in China represents another significant milestone in the execution of our Pipeline 2.0 strategy. Following the global Phase I clinical launch in Australia in June 2026, the NMPA approval further validates the efficiency of CSTONE PHARMA's globally integrated development model, enabling the simultaneous advancement of innovative pipelines across multiple regions worldwide. This also reaffirms the innovative strength and sustainability of our proprietary ADC platform, which has become a key engine for the company's innovation output. Leveraging our in-house platform and globally integrated clinical development system, we will continue to steadily advance the global clinical development of multiple novel ADCs, fully unlocking pipeline value and delivering innovative treatment options to patients worldwide."

Dr. Shi Qingmei, Chief Medical Officer of CSTONE PHARMA, commented: "EGFR and HER3 are frequently co-expressed in various epithelial-derived solid tumors, and HER3-mediated compensatory signaling pathways are a key driver of acquired resistance to EGFR-targeted therapies, representing a significant unmet clinical need. CS5007 is a differentially designed EGFR/HER3 bispecific ADC that, through its unique molecular structural design, can simultaneously target both signaling pathways, potentially overcoming acquired resistance to EGFR-targeted therapy while exhibiting robust antitumor activity and a favorable safety profile. With the Phase I clinical trial of CS5007 receiving approvals in both Australia and China, we will coordinate and accelerate the advancement of this global multicenter trial, systematically evaluating the candidate drug's safety, tolerability, pharmacokinetic/pharmacodynamic (PK/PD) characteristics, and preliminary antitumor activity. We look forward to this novel ADC molecule benefiting patients worldwide in the near future."