By Fineline Cube 
Changchun High‑Tech (SHE: 000661) announced today that its wholly‑owned subsidiary, GenSci (GeneScience Pharmaceutical), has received clinical trial approval from the National Medical Products Administration (NMPA) for GenSci139 as a monotherapy in the treatment of advanced solid tumors.
Product Highlights – GenSci139
- Bispecific Antibody‑Drug Conjugate (BsADC) – simultaneously targets EGFR and HER2.
- Innovative Linker – internally developed, highly stable, hydrophilic cleavable linker that ensures controlled release of the payload.
- Potent Payload – topoisomerase I inhibitor covalently attached to the BsADC.
- Mechanism of Action
- Binds EGFR / HER2‑expressing tumor cells, blocking EGFR homodimers, HER2 homodimers, and EGFR‑HER2 heterodimers.
- Induces receptor internalization, delivering the topoisomerase I inhibitor directly into the cancer cell to trigger apoptosis.
Clinical Development Pathway
- NMPA Approval – marks the green light to initiate a Phase I/II dose‑escalation study in patients with EGFR‑ and/or HER2‑positive solid tumors.
- Strategic Positioning – GenSci139 is positioned to address unmet needs in patients who have progressed on existing EGFR/HER2‑targeted therapies.
- Future Milestones – Upon successful early‑phase data, GenSci will pursue a global regulatory submission, leveraging the robust pre‑clinical profile of the bispecific platform.
Company & Market Context
- Changchun High‑Tech – a leading Chinese biopharmaceutical developer with a portfolio spanning oncology, immunology, and rare diseases.
- GenSci (GeneScience Pharmaceutical) – an independent research‑driven subsidiary focused on next‑generation antibody‑drug conjugates.
- Competitive Landscape – GenSci139’s dual‑epitope engagement and hydrophilic linker differentiate it from existing EGFR/HER2 ADCs, offering potential for superior efficacy and safety.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech