Zai Lab Limited has received approval from China’s National Medical Products Administration (NMPA) for the New Drug Application of COBENFY® (xanomeline and trospium chloride) to treat adults with schizophrenia.

再鼎医药有限公司已获得中国国家药品监督管理局（NMPA）批准，COBENFY®（沙诺美林和氯化托品）新药申请用于治疗成人精神分裂症。

COBENFY is the first schizophrenia therapy with a new mechanism of action to be approved in more than 70 years. The treatment works by selectively activating the M1 and M4 receptors in the brain, targeting key disease pathways rather than relying on traditional dopamine-blocking antipsychotics.

COBENFY 是 70 多年来首个获批的具有新作用机制的精神分裂症疗法。该治疗通过选择性激活大脑中的 M1 和 M4 受体，靶向关键疾病通路，而非依赖传统的多巴胺阻断抗精神病药物。

Schizophrenia is a long-term and often disabling mental health condition that affects thinking, emotions, and behaviour. Symptoms are generally grouped into three areas: positive symptoms such as hallucinations and delusions; negative symptoms including reduced motivation, loss of pleasure, and social withdrawal; and cognitive problems such as difficulties with memory, focus, and decision-making.

精神分裂症是一种长期且常常致残的心理健康状况，影响思维、情绪和行为。症状通常分为三个方面：阳性症状，如幻觉和妄想；阴性症状，包括动机减弱、愉悦感丧失和社交退缩；以及认知问题，如记忆、专注和决策困难。

In China, many patients continue to experience limited symptom control or troublesome side effects with existing antipsychotic medicines..

在中国，许多患者在使用现有的抗精神病药物时，仍然存在症状控制有限或副作用困扰的问题。

The approval is supported by results from a Phase 1 pharmacokinetics study conducted in China, a Phase 3 China study (ZL-2701-001), and data from three global EMERGENT clinical studies. These studies showed that COBENFY can provide improvement across positive, negative, and cognitive symptoms, while avoiding several common side effects linked to standard antipsychotics, such as weight gain, raised prolactin levels, and movement-related disorders..

该批准得到了在中国开展的 1 期药代动力学研究、3 期中国研究 (ZL-2701-001) 以及三项全球 EMERGENT 临床研究数据的支持。这些研究表明，COBENFY 能够改善阳性、阴性和认知症状，同时避免了与标准抗精神病药物相关的几种常见副作用，例如体重增加、催乳素水平升高和运动障碍。

China is estimated to have around eight million adults living with schizophrenia, highlighting a significant need for new treatment options. COBENFY offers a different approach that may help patients who do not respond well to current therapies.

据估计，中国约有八百万成年人患有精神分裂症，这凸显了对新治疗方案的显著需求。COBENFY 提供了一种不同的方法，可能有助于对当前疗法反应不佳的患者。

In September, the Chinese Medical Association published the China Schizophrenia Prevention and Treatment Guidelines (2025 Edition), which included COBENFY as a novel treatment option. This marks the first time the therapy has been included in a national-level clinical guideline.

今年9月，中华医学会发布了《中国精神分裂症防治指南（2025版）》，其中将COBENFY纳入了新型治疗选择。这是该疗法首次被纳入国家级临床指南。

Source: zailaboratory.com

来源：zailaboratory.com