Recently, Hengrui Medicine received the Drug Registration Approval issued by the State Drug Administration, approving the company's Class 1 innovative drug Remazolam Toluenesulfonate for injection (trade name: Rebinin®).
Remazolam tosylate for injection belongs to benzodiazepines, and it is a new type of short-acting GABA a receptor agonist. It is metabolized by systemic plasma esterase, and its metabolites are inactive. It has the advantages of quick awakening, small influence on cardiovascular and respiratory system, and sedative reversal agent. The sedative indications for gastroscopy approved for marketing this time were declared for production in March 2018 and were included in the priority review by the State Drug Administration. In addition, the product is also undergoing clinical research in the fields of colonoscopy sedation, general anesthesia, etc. Among them, the colonoscopy sedation indication was declared for production in August this year, and has been given priority by the State Drug Administration because of its obvious therapeutic advantages. Review procedures, general anesthesia indications are undergoing phase III clinical trials.
Gastroscopy is one of the most widely used methods of digestive endoscopy in clinical practice, but conscious gastroscopy often brings different degrees of pain and discomfort to the patient, and sedation with gastroscopy can eliminate or alleviate patients during the gastroscopy. Subjective pain and discomfort such as pain, nausea and vomiting can especially eliminate the patient's fear of re-examination, improve the patient's acceptance of gastroscopy, and create better conditions for endoscopic physicians.
Gathering Wisdom and Sweating Sweat
Hengrui Pharmaceutical Remazolam project was established in 2010. After ten years of exploration and hard work, the R & D team devoted a lot of hard work, and after a large number of preliminary screening and research work, it developed the tosylate salt of Remazolam. "Twenty-five" major new drug creation project.
Remazolam free base is unstable, and salt formation is needed to improve its physicochemical properties. Hengrui Pharmaceuticals fully considered safety based on the existing literature and selected a less toxic toluenesulfonic acid during the salt screening process. As a salt, remazolam tosylate has better optical purity and safety. The salt can obtain a stable form I in water, which reduces the risk of residual organic solvents in the finished product. However, because of the easy hydrolysis of remazolam, the formulation is a big challenge. During the prescription screening process, the research and development team conducted various investigations, brainstormed ideas, and creatively designed experiments to solve the problems of solvents, freeze-dried formulas, and processes. It abandoned the animal-derived excipients and chose safer small-molecule amino acids commonly used in injections. As an excipient, the excipients ensure the reconstitution characteristics and stability of the preparation, and also ensure the safety of the preparation.
New drug projects have long research cycles. For the smooth development of the project, members of the research and development team often work overtime around the clock to ensure the smooth development of research and development.
The strictest requirements require the highest standards to successfully pass the strictest inspections
Remazolol tosylate for injection is a domestic chemical innovation drug that has been declared and produced in accordance with the centralized acceptance procedure of the State Drug Administration. 2019 年 3 季度接受了甲苯磺酸瑞马唑仑原料和制剂的注册研制现场核查和生产现场检查。 In accordance with the "four strictest" spirits and requirements, Hengrui Medicine accepted the registration and development site inspection and production site inspection of remazolam tosylate in the third quarter of 2019 . Thanks to the company's research and development team for many years, in accordance with the most stringent requirements, to carry out various research and development work to the highest standards, through efficient collaboration, close cooperation, and finally passed the most stringent on-site inspection.
Sharpen a sword in ten years-the epitome of Hengrui people's innovation
1 — 2 个能获批上市，不仅过程漫长，而且投入巨大。 Pharmaceutical innovation is a high-input, high-risk, long-term project. R & D personnel have screened 10,000 compounds, and fewer than ten can enter the clinic. Finally, only 1-2 can be approved for marketing. Not only is the process lengthy, but also Great investment. Seeking success in failure requires courage, wisdom, concentration, and focus. It also requires adherence to the patient as the center, service to health as its duty, and persistent and unswerving exploration and practice. This is what Hengrui is committed to. Motive power.
Grinding a sword in ten years, it is plum blossom. The successful development of Remazolam tosylate for injection is another true portrayal of Hengrui Pharmaceutical's innovation. During the research and development process, team members and the project grew together. In their own words, "this child has finally grown up!", "Although the research and development of innovative drugs is difficult, time will eventually give us the best feedback with the best results. ! "
Remazolol tosylate for injection is the sixth innovative drug approved by Hengrui Medicine and the company's first innovative drug in the field of patient comfort diagnosis and treatment. It is another major achievement of the company's scientific and technological innovation strategy. The listing of this product will further enrich the company's surgical drug product line, consolidate the company's advantageous position in the field of surgical drugs, bring the gospel to domestic patients, and meet patients' needs for comfortable diagnosis and treatment.