According to Zhitong Finance App, Yaojie Ankang-B (02617) announced that the company's core product tengotinib (Tinengotinib®, TT-00420) combined with novel endocrine therapy (NHT) is used in the Chinese phase II clinical trial of metastatic castration-resistant prostate cancer (mCRPC) that progresses after treatment, and recently completed the first patient administration.
This trial is an open, multicenter, phase II clinical study to evaluate the safety and efficacy of tengotinib plus NHT in patients with mCRPC progressing after treatment. The main target population of this trial was patients whose disease progressed after receiving novel endocrine treatments (including abiraterone and AR inhibitors) in the past. The main endpoints of the trial included safety assessment, 6-month PFS rate (6mo-PFS), and no progression period in imaging (rPFS).
The global mCRPC drug market reached US$16.13 billion in 2025, and is expected to grow to US$28.09 billion by 2032, with a compound annual growth rate of 8.25%; the domestic market maintained rapid growth. In 2025, China's CRPC treatment market reached 19.443 billion yuan, an increase of 12.3% over the previous year. The growth rate was higher than the overall anti-tumor drug market average, and demand for clinically rigid treatment continued to be released. Among them, although novel endocrine therapeutics can significantly prolong the survival of patients and are the current first-line core treatment plan for mCRPC, the vast majority of patients will eventually develop acquired drug resistance.
Tengotinib is the world's first and only studied drug that simultaneously inhibits the FGFR/JAK pathway and has evidence of clinical efficacy against mCRPC. Recent studies have found that activation of the FGFR and JAK pathways can trigger the transformation of androgen-sensitive cancer cells into neuroendocrine cancer cells, leading to drug resistance. Simultaneously inhibiting the FGFR and JAK pathways can reverse this cellular state change or lineage remodeling, so that cancer cells regain their sensitivity to androgens and become sensitive to NHT treatment. Tengotinib monotherapy has shown encouraging anti-tumor efficacy in patients with mCRPC who have previously received multiple lines of treatment. Furthermore, tengotinib as a monotherapy for mCRPC obtained fast-track certification from the US FDA in June 2025.