Humanwell Pharma Submits First Generic Application for Breakthrough Antidepressant Esketamine Nasal Spray in China

Jun 26, 2026 11:44 CST Updated 11:44

Johnson & Johnson

Medical Device R&D and Manufacturer

On June 24, 2026, according to the latest information displayed on the official website of China's Center for Drug Evaluation (CDE),Yichang Humanwell Pharmaceutical Co., Ltd. under Chemical Drug Registration Category 4DeclaredIND for Esketamine Hydrochloride Nasal Spray Accepted

Esketamine Hydrochloride Nasal Spray byJanssen Pharmaceuticals, a subsidiary of Johnson & JohnsonOriginal research.March 5, 2019,Esketamine Hydrochloride Nasal SprayApproved by the U.S. FDA for marketing, it is the first antidepressant with a novel mechanism of action (NMDA receptor antagonist) in over 30 years.

April 20, 2023, the original research drug was approved for marketing in China, with the trade nameName:‌Spravato®. To date, the original research drug remains the exclusive option in China.

This medication is the first antidepressant approved for use in combination with oral antidepressants to alleviate depressive symptoms in adult patients with major depressive disorder accompanied by acute suicidal ideation or behavior, featuring a novel mechanism of action and route of administration.

Compared with patients with ordinary depression, those who have attempted suicidePatients with depressive symptoms often experience more severe manifestations; however, most existing antidepressant medications require four weeks to achieve full efficacy. Therefore, there is an urgent need for therapeutic regimens that can rapidly alleviate depressive symptoms. Esketamine hydrochloride nasal spray is one such option.

Unlike existing antidepressants that primarily act on monoamine pathways, esketamine hydrochloride nasal spray exerts its antidepressant efficacy by antagonizing N-methyl-D-aspartate (NMDA) receptors and is administered via the intranasal route. Clinical studies have demonstrated that this medication, when combined with oral antidepressants, can rapidly alleviate depressive symptoms in adult patients with acute suicidal ideation or behavior.

It should be noted that the efficacy of this product as monotherapy in preventing suicide or reducing suicidal ideation or behavior has not yet been established. If clinically indicated, hospitalization remains necessary even if the patient’s symptoms improve after the initial dose of this product.

However, it is worth noting that Johnson & Johnson recently received implicit clinical trial approval on April 27, less than two months ago, to conduct clinical trials of monotherapy for adult treatment-resistant depression. Currently, the drug’s market size in China is modest, at only the million-yuan level. If approved, the efficacy of this product as a monotherapy will be confirmed, and its market potential is expected to expand further.

Esketamine is theS-Isomer, which primarily exerts its antidepressant effects by modulating the glutamatergic system in the brain. Glutamate is an important neurotransmitter in the brain, involved in various neural activities. Esketamine can block or attenuate glutamate'sNMDAreceptors; this mechanism of action facilitates increased glutamate release and its binding to glutamate receptors, thereby modulating neurotransmitter signaling in the brain. This process not only helpsto restore and balance the function of the patient's neurotransmitter system, and to rapidly reduce depressive symptoms，thereby exerting antidepressant effects.

Humanwell is the first company to produce a generic version of this product, and no other companies have entered the market yet.

Reference: Beijing Yaoyanhui

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