Whether Hengrui, who is more than half a year ahead of humanwell's new drug rimazolen in NDA, can continue to have a good rest

Recently, Yichang humanwell's under development variety "rimazolom besylate" and its injection officially submitted NDA application to the state The product is a new drug of class 1, sedative and fully complies with the product layout of Yichang humanwell However, it is worth mentioning that in March this year, Hengrui's "ramazolam toluene sulfonate" (only changed the salt type of the variety) entered the NDA state earlier than humanwell; then, the two varieties are so similar, so it is interesting to compare, and the competition between humanwell and Hengrui in the future will be more interesting and worthy of attention! 1 First of all, ramazolam is a short acting GABAA receptor agonist developed by paion company in Germany, and it is a benzodiazepine type central nervous system drug In 2012, paion granted Renfu pharmaceutical the right to develop rimazazolam in China with a cooperation agreement of 3 million euros and subsequent sales share, and entered into NDA stage on 15th of this month Table 1: important registration information of rimazolom besylate 2 The great event of Renfu - rimazolom besylate - R & D · in May 2014, Yichang humanwell Pharmaceutical Co., Ltd submitted clinical trial application to CFDA (chemical medicine 1.1); · in June 2015, obtained the approval document of clinical trial; ·In October 2015, the phase I clinical study of single dose safety and pharmacokinetics / pharmacodynamics of rimazolum besylate for injection in healthy volunteers completed the first trial in China; ·In May 2017, the first two center, open and dose increasing clinical trial II of rimazazolam besylate for injection for sedation tolerance, effectiveness and safety of colonoscopy was completed in China; ·In April 2018, the multicenter, randomized, single blind, positive drug parallel control phase III clinical trial of rimazazolam besylate for injection for the effectiveness and safety of colonoscopy diagnosis and treatment completed the first trial in China, and the trial in China was completed in July 2018; ·In September 2018, it is planned to launch the phase II clinical trial to evaluate the effectiveness and safety of rimazazolam besylate for injection in the induction and maintenance of general anesthesia in selective surgery... 3 Synthesis information ~ brief introduction by querying patent wo2011032692a1 / us7473689b2, rimazazolam can be made by the following methods: 4 Patent information Paion company, the Chinese application number of the original research patent is cn201310166860, the public number is cn103288834b, the application date is 2007.07.10, and the public date is 2015.07.15 See the following table for details: Table 2: the original research patent of rimazazolam benzenesulfonate 5 Competitors: Hengrui - rimazazolam toluene sulfonate There is no doubt that Hengrui has found a loophole in this variety, developed toluene sulfonate rapidly, and obtained class 1.1 clinical approval document of Sinochem drugs in April 2013, and started phase I research rapidly in October of the same year; in May 2017, the project has been carried out to phase III clinical; in March 2018, rimazolen mesylate applied for production in China, and obtained priority review in April It is easy to find that Hengrui's R & D speed and progress are slightly better when comparing the clinical status of two varieties of the two companies The comparison is shown in the following table: Table 3: clinical progress of two "rimazoluns" 6 The conclusion is that there are absolutely many stories about the competition between humanwell and Hengrui The R & D personnel involved are lucky enough to be able to experience the speed competition process of such a class 1 new drug; however, the case is not highly repetitive for the industry, especially in today's increasingly important intellectual property rights, similar events are almost impossible OK, return to the theme, Renfu and Hengrui will have a good future in the future market share of this product What's your opinion? Welcome to leave a message.