4B Technologies' category 1 innovative monoclonal antibody drug approved for clinical trial

Release date: Mar  20,  2023

On March 20, 2023, 4B Technologies announced that its category 1 innovative monoclonal antibody drug 4B01-03 with a novel mechanism of action has been granted clinical trial approval by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. The drug is intended to treat acute optic neuropathy, including acute primary angle-closure glaucoma and acute nonarteritic anterior ischemic optic neuropathy.

Glaucoma is the world's leading cause of irreversible blindness, and Chinese glaucoma patients account for about one-fourth of the global total. Compared to other countries, China has the highest incidence of primary angle-closure glaucoma (PACG), in which retinal ganglion cell (RGC) damage occurs, as a result of pathogenic insults such as high intraocular pressure. If not treated promptly and effectively following acute attacks, PACG patients can suffer from RGC loss and irreversible damage to visual functions.

Acute nonarteritic anterior ischemic optic neuropathy (NAION) is the most common ischemic nerve disease, with an incidence rate of 0.23/10,000 to 1.02/10,000 in China. There is currently no effective treatment, making it an important cause of visual dysfunction in middle-aged and elderly populations. An effective drug that can protect the optic nerve is urgently needed for optic neuropathies in clinical practice.

4B01-03 is a neuroprotective agent with first-in-class potential, originally discovered by Dr. Lu Bai, the founder of 4B Technologies, based on the therapeutic strategy of targeting pathophysiology of disease progression. 4B01-03 exerts its effect by specifically activating downstream signaling pathways of TrkB receptors. Preclinical studies have demonstrated compelling neuroprotective/repair effects and excellent safety profile following intravitreal administration of 4B01-03.

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