Jiqun Pharmaceutical: GP-21401, a new insomnia drug, obtained phase II and III clinical trial approval


Release time:

2019-12-18

The new product GP-21401 ( GP401 ) applied by Nanjing Jiqun Pharmaceutical Technology Co., Ltd. as a marketing authorization holder has recently obtained the "Clinical Trial Notification" (hereinafter referred to as "NMPA") issued by the National Medical Products Administration (hereinafter referred to as "NMPA" ). CYHS1900169 ), Phase II clinical trials will be launched soon!

The new product GP-21401 ( GP401 ) applied by Nanjing Jiqun Pharmaceutical Technology Co., Ltd. as a marketing authorization holder has recently obtained the "Clinical Trial Notification" (hereinafter referred to as "NMPA") issued by the National Medical Products Administration (hereinafter referred to as "NMPA" ). CYHS1900169 ), Phase II clinical trials will be launched soon!

With the development of society, people's work pressure continues to increase, and the number of people with sleep disorders increases year by year. Sleep disorders have become a global public health problem. 43.4% of people in China have experienced varying degrees of insomnia ( AIS score ≥ 4 points) in the past year, 10 % of people suffer from insomnia ( DSM-IV standard), and as many as 57% of adults in mainland China have insomnia symptoms. % , far exceeding that of developed countries such as Europe and the United States, and is still growing at an annual rate of 30% ! The market potential is huge!

GP-21401 is a new drug under development by Jiqun Pharmaceutical. It can inhibit the action of histamine and H1 receptors by competitively binding to H1 receptors. The release of histamine is positively correlated with the awakening phase. This new drug easily penetrates the blood-brain barrier. It has the characteristics of high CNS penetration and is used to treat different degrees of insomnia.

Drug key information

GP-21401 can inhibit the interaction between histamine and H1 receptors by competitively binding to H1 receptors. The release of histamine is positively correlated with the awakening phase. This new drug easily penetrates the blood-brain barrier and has high CNS penetration characteristics. , compared with Avastin, GP-21401 is about 20 times higher ! After oral administration, GP-21401 is well absorbed and takes effect quickly. Metabolites can be almost completely eliminated. The drug has no accumulation effect in the body, and pregnancy does not affect its pharmacokinetics. This product has a good hypnotic effect and is better than ordinary antihistamines! This product is highly safe and can be used by pregnant women and children without restrictive prescriptions.

 

This product fills the domestic gap. It does not fall under the management of psychotropic drugs, is classified as a non-controlled drug, and is very safe. This product is expected to become China's first antihistamine target OTC new drug for the treatment of difficulty falling asleep, easy awakening and short-term sleep phase shortening!

About Jiqun Pharmaceutical

Founded in 2013 , Jiqun Pharmaceutical is a high-growth innovative biopharmaceutical enterprise specializing in new drug research and development, technology transfer, technical services and industrialization of new pharmaceutical products. It was listed on the New Third Board in 2017 . It is a national high-tech enterprise, a science and technology small and medium-sized enterprise in Jiangsu Province, and a gazelle enterprise in Nanjing. In 2019 , it was approved as the "Nanjing Generic Drug Quality and Efficacy Consistency Evaluation Engineering Research Center." Obtaining this clinical trial approval will help increase the company's R&D enthusiasm and optimize the company's core competitiveness!

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