On November 3, Luye Pharma made a blockbuster announcement on its wechat official account:
Luye Pharma Group announced that its self-developed Class 1 innovative drug Torudivenlafaxine Hydrochloride Sustained-release tablets (trade name: Roxin Lin ®) has officially received marketing approval from the National Medical Products Administration for the treatment of depression. Roxinlin ® is China's first class 1 chemotherapeutic innovative drug with independent research and development and independent intellectual property rights for the treatment of depression. The listing of this variety is a major breakthrough in the treatment field of domestic innovative drugs.
Clinical studies have demonstrated that Roxylin ® can provide a comprehensive and stable treatment of depression, significantly improve anxiety, block/fatigue symptoms, anhedonia and cognitive ability, and promote the recovery of social function. It has good safety and tolerance, does not cause drowsiness, does not affect sexual function, body weight and fat metabolism.
"The approval of Raoxin Line ® is a solid step in the development of new antidepressant drugs by domestic pharmaceutical companies and an important milestone in the history of psychoactive drug development in China," said Prof. Hongyan Zhang of Peking University Sixth Hospital, principal investigator of the clinical trial of Raoxin Line ®. "The clinical pharmacodynamic characteristics of Roxylin ® can help patients to comprehensively relieve the multi-dimensional symptoms of depression, especially to meet patients' therapeutic needs for improving anxiety, anhedonia, fatigue, cognitive symptoms, and so on, providing clinicians with a new therapeutic weapon."
The cure rate is low and the relapse rate is high
New drugs are needed to treat depression
Depression has the characteristics of high prevalence, high disability rate and high recurrence rate. According to the data of the World Health Organization, about 3.8% of the global population suffers from depression. 1. The latest epidemiological survey results in China show that the prevalence rate of depression in China is 3.4%, and there are about 50 million patients who need standardized drug treatment. The recurrence rate of this disease is as high as 50%~85%, of which 50% patients will relapse within 2 years after the occurrence of the disease. 3. It has become an important factor affecting family life and social productivity.
Although existing antidepressants are generally effective, there is an obvious unmet clinical need for treatment: the cure rate is low, residual symptoms after treatment, mainly including anxiety, cognitive impairment, fatigue, anhedonia, etc., seriously impair social function, and significantly accelerate the recurrence of depression 4-7; In addition, it is easy to cause sexual dysfunction, weight gain, emotional retardation, lethargy and other adverse reactions, which affect patients' medication compliance and also become an important factor leading to poor prognosis 8,9.
At present, domestic and foreign authoritative guidelines emphasize that the goal of depression treatment is to "obtain clinical cure, reduce the risk of recurrence, improve functional impairment and improve the quality of life". This requires that the treatment of the disease focus on all symptom dimensions, including emotional, physical and cognitive. The development of Rosinlin ® following this therapeutic philosophy is expected to improve the current treatment status of this disease and promote the reintegration and integration of patients into society.
Multiple reuptake inhibition
Comprehensively improve the multi-dimensional symptoms of depression
The study on the mechanism of action of Rosinrin ® was published in Frontiers in Pharmacology 10,11, The Phase II clinical results have been published in the International Journal of Neuropsychopharmacology. 12. The results were also released at the 19th National Conference on Psychiatry of the Chinese Medical Association. The Phase III results were presented at the 2022 Annual meeting of the American Psychiatric Association (APA). Preclinical studies of its mechanism of action have demonstrated that it is a triple reuptake inhibitor (SNDRI) of serotonin (5-HT), norepinephrine (NE) and dopamine (DA). 5-HT, NE and Daergic nervous system play important roles in the pathogenesis of depression 13. Compared with the existing selective 5-HT reuptake inhibitors (SSRI) and 5-HT/NE dual reuptake inhibitors (SNRI), SNDRI increases the intervention of DA, which can achieve synergistic therapeutic effects and more comprehensively alleviate symptoms of different dimensions in patients with depression. At the same time antagonize the side effects caused by the decrease of DA energy caused by the increase of 5-HT level 14.
The approval was based on the completion of six clinical studies in China, including the Phase III trial, a multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of the drug in the treatment of depression. The results of the clinical study showed that: Changes in Montgomery-Asperger's Depression Scale (MADRS) total scores from baseline, 17-item Hamilton Depression Scale (HAM-D17) total scores from baseline, MADRS response rate and remission rate, HAM-D17 response rate and remission rate, and Hamilton Anxiety Scale (HAM-A) total scores from baseline after 8 weeks of treatment with Rohingin ® Significantly better than placebo, especially in the improvement of anhedonia, block, cognitive impairment, fatigue and other aspects of statistical difference compared with placebo, and compared with traditional antidepressant drugs obvious advantages; Raxylin ® is safe and well tolerated, does not induce drowsiness, and does not affect sexual function, body weight, and lipid metabolism.
Dr. Jingwei Tian, head of Rosinlin ® R&D Project, Vice President of Non-clinical Research and head of New Drug Discovery Research at Luye Pharma Group, said, "Depression has a complex and diversified symptom presentation, and better efficacy and safety can be achieved through multi-target intervention. Rosinrin ® is a SNDRI antidepressant that has been proven from basic research to confirmatory clinical trials. It can comprehensively improve patients' symptoms, promote the recovery of social functions, and provide strong support for patients to return to their families and society as soon as possible."
Prominent advantages in central nervous system field
Unmet demand for service to patients
Yang Rongbing, president of Luye Pharmaceutical Group, said, "Depression, as one of the most common mental disorders in China, imposes a heavy disease burden on patients, their families and even society. We are excited about the approval of Rosinin ® and are ready for commercialization ahead of schedule. We hope to leverage our accumulated strengths in central nervous system therapy to bring this new treatment option to patients as soon as possible and improve access to innovative medicines."
Central nervous therapeutic areas, including depression, is one of the core strategic areas leaves pharmaceutical, surrounding the disease area, the company for many years actively build innovative product portfolio, improve the self-management team, sinking channels and expand the market, is now pushing central nervous products cover nearly 3000 hospitals, domestic commercial advantage is highlighted. The approval of the listing of Rosinlin ® continues to expand the company's CNS product portfolio, further promoting the company's existing resources and advantages of the synergy and commercial operation capability.
About Rosin ®
Toludivenlafaxine hydrochloride Sustained release Tablets (Trade name: Roxinlin ®) is a class 1 innovative drug developed by Luye Pharmaceutical Group based on its new molecular entity/new Therapeutic entity technology platform (NCE/NTE). Preclinical studies have shown that it has the triple reuptake inhibition (SNDRI) effect of 5-hydroxytryptamine (5-HT), norepinephrine (NE) and dopamine (DA) for the treatment of depression. Clinically, Rohingin ® acts by inhibiting the uptake of a variety of monoamine neurotransmitters. In addition, phase III clinical trials are underway for the treatment of generalized anxiety disorder.
