On May 31, 2024, Innopharmax obtained US FDA preliminary go-ahead for the IND application of phase 3 clinical trial of new drug D07001, for the indication in late stage Biliary Tract Cancer (BTC). The phase 3 clinical trial is expected to have D07001 in combination with capecitabine (Xeloda), which has its niche effect in the treatment of late stage BTC.
BTC is a rare disease that is difficult to treat, and there is currently no effective treatment. According to Coherent Market Insights report, the global BTC market is expected to exceed $1.6 billion USD in 2030. The launch of D07001 in the future would not only provide new treatment options for patients with BTC, but also improve their quality of life. The orphan drug exclusivity and patent protection would enable Innopharmax to continue to create steady profit stream.
Strategically, Innopharmax is also initiating clinical trial application of D07001 in late stage pancreatic cancer. If launched, the global market is expected to expand by 10 times.