On February 25, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) announced on its website that KHN707 tablets, a Class 1 new chemical drug submitted by Chengdu Kanghong Pharmaceutical Group Co., Ltd., has been approved for clinical trials . This is an oral small-molecule selective orexin receptor (OX2R) antagonist independently developed by Kanghong Pharmaceutical . The approved indication for clinical trials is insomnia , and it has shown sleep-promoting effects in various insomnia efficacy models in preclinical studies.

Insomnia patients mainly experience difficulty falling asleep, sleep maintenance disorders, and reduced total sleep time. Persistent insomnia can cause symptoms such as low mood, poor memory, and difficulty concentrating, not only affecting daily life and work but also leading to other central nervous system disorders, such as varying degrees of depression. According to data from the "Guidelines for the Diagnosis and Treatment of Insomnia in Chinese Adults (2023 Edition)" published under the leadership of the Sleep Disorders Group of the Neurology Branch of the Chinese Medical Association, the clinically significant prevalence of insomnia in the general Chinese population is approximately 15%. Therefore, there is an unmet clinical need in the field of anti-insomnia treatment for effective, safe, and long-term-use novel drugs.

Orexin is a neurotransmitter found in specific areas of the brain that typically transmits various messages to the body to maintain wakefulness and is one of the main factors causing insomnia. Orexin receptor antagonists (DORAs) are a class of clinically tested, safe, and effective new anti-insomnia drugs.

Kanghong Pharmaceutical's further systematic research on orexin receptors revealed that OX1R and OX2R have different physiological functions. Drugs that selectively antagonize OX2R can eliminate the potential safety risks associated with OX1R antagonism while ensuring the efficacy of anti-insomnia treatment. KHN707 tablets improve sleep quality by selectively inhibiting OX2R, including accelerating sleep onset and prolonging sleep duration . Furthermore, preclinical research data shows that KHN707 tablets are well-tolerated, do not cause rebound effects after discontinuation, are non-addictive and non-dependent, and can be taken long-term, covering the entire insomnia population. With no expected residual effects the next day, it possesses broad clinical application prospects.

Kanghong Pharmaceutical possesses extensive experience and technological expertise in the research and development of new drugs for the mental and neurological fields. Clinical trials for its Class 1 new drug KH607 tablets, used to treat depression and postpartum depression, and its Class 1 new drug KHN702 tablets, used to treat acute pain, are progressing steadily. Looking ahead, Kanghong Pharmaceutical will continue to focus on unmet clinical needs, concentrating on its strengths in ophthalmology, mental/neurological medicine, and oncology, hoping to provide patients with more treatment options.

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