Zai Lab and Bristol Myers Squibb Submit NDA for KarXT (Xanomeline/Trospium Chloride) in China for the Treatment of Schizophrenia

Jan 18, 2025 09:44 CST Updated 09:44

Zai Lab

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Bristol-Myers Squibb

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Today (January 18), the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced,The marketing application for the Class 5.1 new drug, Tezepelumab Chloride Capsules, co-submitted by Bristol-Myers Squibb and Zai Lab, has been accepted.According to the press release issued by Zai Lab, this isFor the treatment of schizophreniaThe new drug KarXT.In September 2024, the U.S. FDA hadApprovalThis product is used to treat adult schizophrenia.At that timeThe FDA press release stated,ThisIs targetedThe first antipsychotic drug targeting cholinergic receptors,Also marks the first new mechanism drug for treating schizophrenia in decades.。

Source of screenshot:CDE Official Website

KarXT (Xanomeline and Trospium Chloride)Oral M1/M4 Muscarinic Acetylcholine Receptor AgonistAndCombination of Muscarinic Receptor Antagonists。KarXTActs as an M1/M4 muscarinic acetylcholine receptor agonist in the central nervous system, and is believed to improve positive, negative, and cognitive symptoms of schizophrenia.。And unlike existing therapies, KarXT does not directly block dopamine receptors.Zai Lab has entered into an exclusive licensing agreement with Karuna Therapeutics (acquired by Bristol-Myers Squibb Company) to gain the rights to develop, manufacture, and commercialize KarXT in Greater China.

According to the introduction in Zai Lab's press release, this NDA is based on the results of a Phase 1 pharmacokinetic (PK) study conducted in China, a Phase 3 clinical study (ZL-2701-001), and the data support from the global EMERGENT series of clinical studies. Among them,China Phase 3 Study Met Primary Endpoint,In the fifth week, compared with placebo, KarXTPositive and Negative Syndrome Scale (PANSS)The total score decreased by 9.2 points, with a statistically significant difference (-16.9 vs. -7.7).。The study also met all key secondary efficacy endpoints, showing significant improvement in PANSS positive symptom subscale scores, PANSS negative symptom subscale scores, PANSS Marder negative symptom factor scores, Clinical Global Impression-Severity (CGI-S) scores, and the percentage of PANSS responders at week five compared to placebo.

According to data from the World Health Organization (WHO)Globally, approximately 24 million people are suffering from schizophrenia, meaning 1 in every 300 people (0.32%) has schizophrenia.Despite the current someTherapies can effectively control certain symptoms, but a significant portion of patients either do not respond to existing treatments or experience unacceptable side effects.The development of new drugs for schizophrenia is challenging, with a high failure rate. The research community has been hoping for new breakthroughs in this field.

ExpectationKarXT will reach more patients as soon as possible, bringing them a new treatment option.

References:

[1] Center for Drug Evaluation (CDE) of the China National Medical Products Administration. Retrieved Jan 18, 2025, from https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c

[2] Strong Start! The NDA for KarXT for the Treatment of Schizophrenia Accepted by the National Medical Products Administration.Retrieved Jan 17，2025, From https://mp.weixin.qq.com/s/HQHn91Y0nU1T3C8xi7r9nA

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