By Fineline Cube 
TransThera Sciences (Nanjing) Inc. (HKG: 2617) announced that the China National Medical Products Administration has approved a Phase II clinical trial for its oral small‑molecule kinase inhibitor tinengotinib in combination with the endocrine agent fulvestrant. The study targets patients with previously treated hormone‑receptor positive (HR⁺) and HER2‑negative (HER2⁻) recurrent or metastatic breast cancer.
Tinengotinib: A Multi‑Kinase Inhibitor
- Targets – Fibroblast growth factor receptor (FGFR)/Vascular endothelial growth factor receptor (VEGFR), Janus kinase (JAK), and Aurora kinases.
- Clinical Status – Global Phase III registration, with encouraging monotherapy activity in heavily pre‑treated HR⁺/HER2⁻ breast‑cancer cohorts.
- Rationale for Combination – Preclinical data demonstrate synergistic inhibition of endocrine‑therapy‑resistant tumor cells when tinengotinib is paired with fulvestrant, a selective estrogen‑receptor degrader.
Trial Design and Patient Population
- Phase – II, multi‑center, open‑label.
- Eligibility – Adults with HR⁺/HER2⁻ metastatic breast cancer who have progressed after endocrine therapy, CDK4/6 inhibition, and chemotherapy.
- Endpoints – Progression‑free survival (PFS), overall response rate (ORR), and safety profile of the tinengotinib‑fulvestrant regimen.
Strategic Implications
- For TransThera – The trial represents a pivotal step toward regulatory approval in a high‑need market segment, potentially positioning tinengotinib as a first‑line combination for endocrine‑resistant disease.
- For Patients – Offers a novel therapeutic option that may delay disease progression and improve quality of life after standard therapies fail.
- For the Market – Could stimulate further investment in FGFR/VEGFR‑targeted agents and expand the therapeutic landscape for HR⁺/HER2⁻ breast cancer.-Fineline Info & Tech