On January 11, Gelonghui Health Yuan (600380.SH) announced that the company received a notice from Guangzhou Fermizi Technology Co., Ltd. (Fermizi), and Fermizi received the “Drug Clinical Trial Approval Notice” approved and issued by the State Drug Administration to approve its self-developed FZ008-145 capsule (FZ008-145 for short) to carry out clinical trials. Previously, the Company and Fermizi have signed an agreement. Fermizi will exclusively grant the company the rights of the self-developed new analgesic drug FZ008-145 in Greater China, retaining the rights outside of Greater China.
FZ008-145 is the world's second most selective second-generation Nav1.8 inhibitor independently developed by Fermizi. By blocking the Nav1.8 channel, it blocks the transmission of pain signals from the peripheral nervous system to the central nervous system, thereby producing an analgesic effect. It is intended for the treatment of pain, and is expected to have the advantage of strong, non-addictive analgesia.
According to inquiries, no Nav1.8 inhibitors have been approved for pain treatment at home or abroad. Globally, several Nav1.8 inhibitors have now been clinically studied for acute/chronic pain indications. Among them, Vertex's VX-548 has initiated a number of phase III clinical studies in the US. According to the website of the Drug Evaluation Center of the State Drug Administration, as of the date of this announcement, there have been no reports from manufacturers other than Fermizi.