Kailile Approved for Marketing in China

On [Date], Zai Lab officially announced that the National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) for xanomeline-trospium chloride capsules (brand name: KAIJIELE) for the treatment of adult schizophrenia. This approval marks a significant breakthrough in the field of schizophrenia treatment in China after more than [number] years, introducing the first therapy with a novel mechanism of action, providing patients with a new treatment option.

Functional Features

As a first-in-class innovative therapy, KarXT adopts a unique fixed-dose combination design, consisting of xanomeline, a / type muscarinic acetylcholine receptor agonist, and trospium chloride, a muscarinic receptor antagonist. Unlike traditional antipsychotics that primarily target dopamine or serotonin receptors, this drug exerts its therapeutic effects by precisely activating the and muscarinic receptors in the central nervous system, while utilizing trospium chloride to reduce peripheral side effects. It has demonstrated significant efficacy advantages and good tolerability in clinical studies. Data from the China bridging study showed that at the fifth week of treatment, the total score on the Positive and Negative Syndrome Scale () for patients in the KarXT group was significantly reduced by . points compared to the placebo group. All key secondary efficacy endpoints also achieved statistically significant improvements, with no unexpected safety signals observed.

Market Impact

The journey of Kaitela's listing in China began in [Month] [Year], when Zai Lab secured exclusive development and commercialization rights for the drug in Greater China (including Mainland China, Hong Kong, Macau, and Taiwan) from [Company] for $[Amount] billion. Subsequently, the global research and development of the drug continued to accelerate. In [Month] [Year], Bristol-Myers Squibb (BMS) acquired [Company] for $[Amount] billion, incorporating Kaitela into its core pipeline.

There are over ten million patients with schizophrenia in China, but the treatment rate is less than %. Currently available medications are mostly dopamine receptor antagonists, which have significant side effects (such as weight gain and extrapyramidal symptoms), leading to poor patient adherence. As the first muscarinic receptor agonist, Kaijiele covers all three major symptom domains (positive, negative, and cognitive) with excellent safety (no black box warning), and is expected to become a first-line treatment option, potentially disrupting the existing market landscape. It is projected to achieve rapid uptake, driving expansion of the overall market size (the global antipsychotic drug market already exceeds tens of billions of dollars, and China's share has significant growth potential).