▎WuXi AppTec Content Team Report

Central Nervous System (CNS) and Psychiatric SystemDiseases often have complex mechanisms, and the development of new drugs is challenging, with unmet clinical needs for patients. This article will review 9 drugs.New drugs in the CNS field expected to be approved for marketing by NMPA in 2025*, The indications they cover include schizophrenia, Alzheimer's disease, narcolepsy, insomnia, and so on.(* The statistical scope of this article covers new drugs submitted to the CDE for marketing application from January 2023 to January 2025;New drugs only include those registered as Category 1, Category 3.1, and Category 5.1.Only counting new drugs expected to be approved for the first time, excluding new indications)

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YANGTZE RIVER PHARMACEUTICAL GROUP: Fazaneru

Mechanism of Action: Dual Orexin Receptor Antagonist

Indications: Insomnia

In January 2025, the marketing application for Fazanlecin Tablets, a Class 1 new drug developed by Hai'an Pharmaceutical, a wholly-owned subsidiary of Yangtze River Pharmaceutical Group, was accepted by the CDE. Public information indicates that this is a...Dual orexin receptor antagonist (YZJ-1139 tablet), which can simultaneously inhibit orexin receptor type 1 and type 2, accelerate sleep onset, and prolong deep sleep duration.Yangtze River Pharmaceutical Group has completed a Phase 3 clinical trial of YZJ-1139 tablets for the treatment of insomnia, targeting insomnia characterized by difficulty falling asleep and/or maintaining sleep.

Wingthink Bio: Cinnarizine

Mechanism of Action: Inhibition of voltage-gated sodium channels and positive allosteric modulation of GABAA receptors

Indications: Epilepsy

In December 2024, the marketing application for cenobamate tablets submitted by SK Life Science and YiSi Bio was accepted by the CDE.AcceptanceCinoxamate is a CNS innovative drug that YeeS Biotech licensed from SK Biopharmaceuticals in 2021.It can reduce seizures or even achieve zero seizures by inhibiting voltage-gated sodium channels and positively allosterically modulating GABAA receptors.Since Xinoamine Tablets were successively approved for marketing in the United States, the European Union, and the United Kingdom from 2019 to 2021, they have been widely used for treatment.Partial Seizures in Adult Epilepsy Patients。

Wingthink Bio: Sofantel

Mechanism of Action: Dual-Action Dopamine and Norepinephrine Reuptake Inhibitor

Indications: Excessive Sleepiness

In December 2024, the marketing application for Solriamfetol Tablets submitted by Wingthink Bio and other companies was accepted by the CDE.Acceptance. Sofantrel is aDual-Action Dopamine and Norepinephrine Reuptake Inhibitor, This product is used to treat excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea syndrome (OSA).Narcolepsy is a disabling neurological disorder where patients are unable to regulate the sleep-wake cycle normally, leading to symptoms of excessive sleepiness.SuanfetopIt can play a role in promoting patients to stay awake through a dual mechanism, including increasing the levels of dopamine and norepinephrine. The productWill not stimulate dopamine release, thereby reducing the patient's risk of addiction.。

Tonghua Golden-Horse: Octahydroaminoacridine

Mechanism of Action: Acetylcholinesterase Inhibitor

Indications: Alzheimer's Disease

In August 2024, Tonghua Golden-Horse Pharmaceutical Industey Co., Ltd. submittedClass 1 New DrugThe marketing application for Amber Octahydro Aminocridine Tablets has been accepted.This is a small-molecule acetylcholinesterase inhibitor developed by Tonghua Golden-Horse Pharmaceutical Industey Co., Ltd., which can simultaneously inhibit acetylcholinesterase and butyrylcholinesterase, and is mainly developed for the treatment of mild to moderate Alzheimer's disease.。

Simcere: Darilixin

Mechanism of Action:DualOrexin Receptor Antagonist

Indications: Insomnia

In July 2024, the new drug application for Simcere's Dalirelin Hydrochloride Tablets was accepted by the CDE.Acceptance。Daridorexant Hydrochloride Tablets, developed by Idorsia, is an anti-insomnia drug, and it is aDoubleOrexin Receptor AntagonistSimcere has exclusive rights to develop and commercialize this product in the Greater China region. Unlike traditional sedative-hypnotic drugs that promote sleep by sedating the brain,Daridorexant blocks the binding of orexin neuropeptides (orexin A and orexin B) to their receptors.Reduce excessive central arousal,Help patients fall asleep and stay asleep。Since it only blocks the initiation of orexin receptors, it can reduce wakefulness drive and induce sleep without altering the proportion of sleep stages and without residual effects the next day.

Eisai: LemborexantRaw

Mechanism of Action:Dual Orexin Receptor Antagonist

Indications: Insomnia

January 2024,Eisai's Leborex Tablets（lemborexant）Marketing ApplicationCD ObtainedE-acceptance。Lemborexant Tablets are a dual orexin receptor antagonist, which has previously been approved for marketing in the Hong Kong region of China.For the treatment of insomnia in adults, particularly difficulty falling asleep and/or maintaining sleep.。Lemborexant is a small molecule drug that competitively binds to two orexin receptor subtypes, OX1R and OX2R, inhibiting orexin neurotransmission and regulating the sleep-wake rhythm. As a competitive antagonist,Lemborexant has a stronger inhibitory effect on OX2R, which can suppress both REM and non-REM sleep drive, thereby providing patients with faster sleep onset and better sleep maintenance.。

AstraZeneca（AstraZeneca）：Relizumab

Mechanism of Action: Long-acting Complement C5 Protein Inhibitor

Indications: Neuromyelitis optica spectrum disorders, etc.

Ravulizumab is developed by AstraZeneca.A Long-Acting Complement C5 Protein Inhibitor. It can provide immediate, complete, and sustained complement inhibition.The unique design gives this product a longer half-life than the first-generation C5 complement inhibitors. After the initial dose, adult patients can expect subsequent...Only requires intravenous injection once every 8 weeks.. This product has been approved by the FDA for the treatment of paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, myasthenia gravis, neuromyelitis optica spectrum disorder, etc.Neuromyelitis Optica Spectrum Disorders (NMOSD) are inflammatory demyelinating diseases of the central nervous system mediated by the immune system, with optic neuritis and myelitis as the main clinical manifestations., The main cause is related to aquaporin-4 (AQP4) antibodies.In China, the first of this productThe marketing application was accepted by the CDE in December 2023, and the second marketing application was also accepted by the CDE in October 2024.

References:

[1] Official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China.

[2] Official websites of various companies and publicly available information