• 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.

FORWARD-LOOKING STATEMENTS

This announcement contains forward-looking statements concerning future events, including the proposed offering and listing of Evotec’s securities. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “should,” “target,” “would” and variations of such words and similar expressions are intended to identify forward-looking statements. Such statements include comments regarding Evotec’s expectations for revenues, Group EBITDA and unpartnered R&D expenses. These forward-looking statements are based on the information available to, and the expectations and assumptions deemed reasonable by Evotec at the time these statements were made. No assurance can be given that such expectations will prove to have been correct. These statements involve known and unknown risks and are based upon a number of assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond the control of Evotec. Evotec expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Evotec’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.