EVT201 APPROVED BY THE CHINESE NATIONAL MEDICAL PRODUCTS ADMINISTRATION (“NMPA”) AS A NOVEL SHORT-TERM TREATMENT OF INSOMNIA
EVOTEC’S LICENCE PARTNER ZHEJIANG JINGXIN PHARMACEUTICAL CO., LTD (“JINGXIN”) WILL LEAD ALL COMMERCIALISATION EFFORTS FOR EVT201 IN CHINA AND SOUTH KOREA
Hamburg, Germany, 06 December 2023:Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) announced today that Zhejiang Jingxin Pharmaceutical Co., Ltd (“Jingxin”) has received the approval from the Chinese National Medical Products Administration (“NMPA”) for the novel insomnia treatment EVT201, also known as Dimdazenil in China.
Insomnia, the difficulty falling or staying asleep, affects an estimated 10-20% of the general population with a higher incidence in women, the elderly, and those with comorbid medical and psychiatric conditions. EVT201 is a novel partial positive allosteric modulator of the GABAA receptor with high affinity and moderate efficacy. This binding activity profile gives EVT201 an improved safety profile compared to full agonists.
From 2005 onwards, EVT201 was originally developed by Evotec as a treatment option for insomnia. The Company led clinical Phase II development for EVT201, yielding positive safety and efficacy results, before licensing the programme out to Jingxin for further development and commercialisation in China. After Jingxin reported positive results of its Phase III clinical trials for EVT201 in insomnia in 2021, the agreement was expanded to South Korea in 2022. Jingxin also retains an option to expand the licence globally.
Evotec is entitled to receive double-digit royalties of net sales as well as milestones based on commercial success and further sub-licensing.
Dr Werner Lanthaler, Chief Executive Officer of Evotec, commented: “We are excited to see Jingxin announce the approval of EVT201 as a novel short-term treatment of insomnia. EVT201 is an early example of Evotec’s ability to leverage neuroscience disease understanding to repurpose an in-licensed drug candidate and build a partnership to commercialise this asset. We have full confidence in our partner Jingxin for the commercialisation of EVT201 in China and South Korea to respond to the unmet medical need of insomnia patients.”
About EVT201
EVT201 is a new class 1 small molecule drug for the treatment of adult insomnia. It is a partial agonist of GABAA (γ-aminobutyric acid A) receptor, which selectively acts on the α1 subtype of the benzodiazepine receptor, with high affinity and moderate strength agonism, inducing rapid onset of sleep and maintenance of sleep. Compared with conventional benzodiazepine GABA receptor full agonists, it has significant advantages in terms of dyskinesia, after-effects, tolerance, ethanol interactions, physical dependence, memory impairment, and other adverse effects.