PharmAkea's New Drug Wins Conditional Approval, Shares Surge 29%
Crhk · 1 SOURCESabout 2 hours ago2 MIN
Summary
PharmAkea (02617.HK) announced that its self-developed Class 1 new drug Jie'entai (tiangotinib tablets) has received conditional approval from China's National Medical Products Administration (NMPA). The drug is indicated for adult patients with advanced, metastatic, or unresectable bile duct cancer who have previously received systemic therapy and FGFR inhibitor treatment, and who have FGFR2 fusion or rearrangement. The company's shares surged as much as 29% to HK$14.87 following the announcement, before paring gains to close at HK$12.24, up 6% or HK$0.71 .
Key Points
- Jie'entai is a targeted innovative multi-target small molecule kinase inhibitor for advanced bile duct cancer with FGFR2 fusion or rearrangement .
- The approval was based on a Chinese multi-center, open-label, single-arm Phase II pivotal clinical trial involving 50 patients .
- Clinical results showed 28% objective response rate, 8.5-month median duration of response, and 6-month median progression-free survival .
- The drug previously received priority review and breakthrough therapy designation from Chinese regulators, plus FDA orphan drug and fast track status .
- The global bile duct cancer drug market is projected to reach US$3.2 billion by 2027, with Jie'entai targeting a third-line treatment gap .
Why It Matters
This approval marks a significant milestone for China's domestic pharmaceutical innovation, as Jie'entai addresses an unmet need in third-line treatment for advanced bile duct cancer. The drug's international regulatory recognitions, including FDA and EMA orphan drug designations, position PharmAkea for potential global expansion in the growing oncology market .
This approval marks a significant milestone for China's domestic pharmaceutical innovation, as Jie'entai addresses an unmet need in third-line treatment for advanced bile duct cancer. The drug's international regulatory recognitions, including FDA and EMA orphan drug designations, position PharmAkea for potential global expansion in the growing oncology market .