Fermion announces IND Approval of Non-Addictive Pain Relief Drug FZ008-145 by China NMPA

2024-01-10
临床1期临床2期临床申请引进/卖出
GUANGZHOU, China, Jan. 10, 2024 /PRNewswire/ -- Guangzhou Fermion Technology Co., Ltd. (Fermion), a clinical-stage AI-based drug discovery company that specializes in developing drugs for autoimmune diseases and pain, has announced today that China National Medical Products Administration (NMPA) approved the Investigational New Drug (IND) application for its non-addictive pain relief drug FZ008-145.
FZ008-145 is a highly selective second-generation Nav1.8 inhibitorNav1.8 inhibitor, offering powerful, non-addictive pain relief advantages. Currently, the Nav1.8 target has obtained clinical data validation for 5 acute pain and 1 chronic pain proof-of-concept (POC) studies.
In October 2023, Fermion signed an agreement with Joincare Pharmaceutical Group Industry Co., Ltd., granting exclusive rights for the company's independently developed pain medication FZ008-145 in the Greater China region, while retaining rights outside of Greater China.
Founder and CEO of Fermion, Dr. Deco Deng, stated, "In comparison to other therapeutic areas, the central nervous system (CNS) domain presents limited therapeutic options. Existing medications demand improvements in efficacy and safety, addressing substantial unmet clinical needs. Our dedicated research and development efforts, supported by our Drug Studio AI platform, have focused on enhancing target selectivity and tissue targeting to minimize off-target effects, enabling the development of innovative and safer drugs."
Since its establishment in 2019, Fermion has strategically positioned its new drug pipeline within the CNS domain, leveraging its proprietary Drug Studio AI drug development platform. This emphasis on high target selectivity and tissue targeting aims to reduce off-target effects, ensure precise distribution in target tissues, and foster the development of differentiated innovative drugs to enhance safety.
Fermion's commitment to pain relief is underscored by its two candidate pipelines. Alongside FZ008-145, the lead pipeline FZ002-037 has completed Phase I clinical trials and is poised to initiate Phase II concept validation POC trials, positioning it the second globally and the first in China clinical drug with the same target.
The development of these pipelines centers around innovative pain relief targets SSTR4 and Nav1.8. Encouraging progress in the development of innovative drugs based on these targets instills hope for new types of pain relief medication.
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