Zai Lab (09688) surged more than 4% in early trading, reaching HK$14.1 with a turnover of HK$59.19 million by the time of reporting. The uptick follows the company's announcement on December 23 that China's National Medical Products Administration (NMPA) has approved the new drug application for xanomeline-trospium chloride capsules (KAI JIE LE) for treating adult schizophrenia. This marks the first schizophrenia therapy with a novel mechanism of action approved in over 70 years, representing a fundamental breakthrough in treatment.
In November 2021, Zai Lab secured exclusive rights from Karuna Therapeutics to develop, manufacture, and commercialize xanomeline-trospium chloride capsules in Greater China for $187 million. The NMPA's approval was based on data from a Phase I pharmacokinetic study in China, a Phase III clinical trial (ZL-2701-001), and three global EMERGENT clinical studies.