Betastine Hydrochloride Tablets—Approved for Marketing

On April 7, 2026, our company's betahistine dihydrochloride tablets were approved for market launch under the new chemical drug registration category, equivalent to passing the consistency evaluation. This medication is classified as a Category A drug under the national medical insurance system.

Betahistine affects the histamine system, acting as a partial agonist at histamine H1 receptors and an antagonist at histamine H3 receptors in neural tissues, with no activity at histamine H2 receptors. By blocking presynaptic H3 receptors and inducing H3 receptor downregulation, betahistine enhances histamine turnover and release. It increases blood flow to the cochlear region and the entire brain, improving circulation in the inner ear's stria vascularis; promotes vestibular compensation; and alters neuronal firing in the vestibular nuclei, thereby mitigating the severity and frequency of vertigo episodes.

Betastine Hydrochloride Tablets is a medication that improves blood circulation in the capillaries between microarteries and microveins within the ear, belonging to the histamine class. It is effective in treating dizziness and tinnitus caused by insufficient blood supply to the inner ear. The drug primarily works by relaxing the fine blood vessels around the ear, allowing more blood to deliver nutrients and oxygen to the inner ear region. Betastine Hydrochloride Tablets can effectively alleviate symptoms such as common ear-related vertigo (a sensation of spinning), persistent tinnitus (ringing in the ears), and ear fullness. It is used to treat vertigo, tinnitus, hearing loss, and other symptoms associated with Ménière's disease.