Shanghai, December 3, 2022 - Luye Pharma Group today held an offline product launch conference in Shanghai, together with an online event, to announce the launch of Ruoxinlin® (Toludesvenlafaxine Hydrochloride Extended-Release Tablets) in China. Ruoxinlin® is China's first class 1 innovative chemical drug independently developed locally for the treatment of Major Depressive Disorder (MDD) and protected by intellectual property rights. The drug provides a powerful new option for patients, bringing the treatment of MDD to a new level.

The launch ceremony

Over one thousand healthcare professionals attended today's event, both online and offline in Shanghai, including academics Lu Lin from Peking University Sixth Hospital, Professor Li Lingjiang from the Second Xiangya Hospital of Central South University, Professor Yu Xin from Peking University Sixth Hospital, Professor Zhao Min from Shanghai Mental Health Center, Professor Jia Fujun from Guangdong Provincial People's Hospital, Professor Yang Fude from Beijing Huilongguan Hospital, Professor Fang Yiru from Shanghai Mental Health Center, and Professor Wang Xiaoping from the Second Xiangya Hospital of Central South University. Attendees witnessed the milestone moment together with corporate representatives of Luye Pharma Group, including Yang Rongbing, Group President, Li Li, Group Vice President and Head of Luye Pharma (China), Dr. Tian Jingwei, Group Vice President of Non-Clinical Research, and Chen Zhe, Head of the Central Nervous System Business Unit of Luye Pharma (China).

Professor Lu Lin, President of Peking University Sixth Hospital, congratulated the company on the launch of Ruoxinlin®, saying: "MDD affects nearly 300 million people worldwide. Since the outbreak of the COVID-19 pandemic, the prevalence of MDD has been on the rise, posing an increasingly serious challenge to patients and caregivers. Meanwhile, developing new drugs for the treatment of mental disorders has been difficult, with few innovative drugs in this therapeutic area. This is why we are so excited to see the launch of Ruoxinlin® as China's first ever Class 1 innovative antidepressant; it represents a breakthrough in China's innovative CNS drug development field."

Professor Li Lingjiang, President of the Chinese Society of Psychiatry, said: "Depressive disorder is a common mental disorder in China, with a prevalence rate of 6.8%, according to the China Mental Health Survey. There are many challenges to treating the disease; however, the launch of Ruoxinlin® has effectively broken the bottleneck in the research and development of domestically produced innovative antidepressant drugs, opening a new chapter in the treatment of depression in China. As clinicians, we are very much looking forward to the clinical application of this drug which will benefit a wider group of patients, with better efficacy and safety."

Ruoxinlin® is expected to change the landscape for MDD treatment

As one of the most common mental disorders, MDD has a low rate of remission, and many patients who have achieved clinical remission will still experience long-term residual symptoms which severely impair their social functioning, and precipitate further relapses. In addition, current treatments often cause adverse reactions, resulting in poor medical compliance, an important reason for poor prognosis. The relapse rate of MDD is as high as 50%-85%, and 50% of relapses occur within 2 years of the onset of the disease1.

Professor Zhao Min, President of Shanghai Mental Health Center, said: "The number of MDD patients is huge, but their clinical manifestations vary from one to another. Although generally effective, existing antidepressants are not satisfactory in terms of remission rates and are still incapable of reducing certain symptoms. How to improve efficacy and prognosis is an important area in the treatment of MDD. We have long been looking forward to the advent of new therapeutics to better satisfy the unmet needs of patients."

MDD has complex and multifaceted symptoms, which are affected by three neurotransmitters: serotonin (5-HT), norepinephrine (NE), and dopamine (DA). A concurrent increase of these neurotransmitters in synaptic gaps promises a greater synergy between the therapeutic agents and a more comprehensive improvement of MDD symptoms. Meanwhile, the additional benefit of elevating DA also helps alleviate the adverse reactions caused by the decrease in DA as a result of increased 5-HT levels2.

Ruoxinlin® is a new chemical entity developed by Luye Pharma. A preclinical study shows that the drug can inhibit the reuptake of 5-HT, NE and DA. Clinical studies have proven that Ruoxinlin® can comprehensively and stably improve symptoms of MDD, including significantly reducing anxiety and retardation/fatigue, relieving anhedonia, improving cognition, and facilitating the faster social recovery of patients. In addition, the drug does not cause somnolence and has no significant impact on sexual function, bodyweight or lipid metabolism, demonstrating a favorable safety profile and good tolerability. Ruoxinlin® also has fewer drug interactions, as it is not metabolized by hepatic CYP450 enzymes.

Dr. Tian Jingwei, R&D Project Leader of Ruoxinlin®, Vice President of Non-Clinical Research and Head of New Drug Discovery at Luye Pharma Group, said: "I am very excited to see the launch of Ruoxinlin® as a new treatment option for patients. Acting on multiple targets, the drug is safer and more effective, relieving multiple symptoms of MDD and helping patients' social recovery, allowing for a faster return to normal life."

Comprehensively improving depressive symptoms

Authoritative guidelines for the treatment of MDD both in China and internationally aim to "achieve full remission, reduce the risk of relapses, alleviate functional impairment, and improve quality of life", underscoring the improvement of emotional, somatic and cognitive symptoms.

Studies show that 30% to 50% of MDD patients will have residual symptoms3-4 after treatment. Common residual symptoms include anxiety, cognitive impairment, fatigue, and anhedonia5-6. The number of residual symptoms is closely related to patients' social functioning and quality of life; more residual symptoms often means more impaired social functioning and lower patient satisfaction for quality of life and treatment outcomes. In addition, in such cases the condition is more likely to become chronic, increasing patient risk of suicide7.

Professor Zhang Hongyan, a chief physician from the Psychiatry Department of Peking University Sixth Hospital, said: "Many patients experience remission of core symptoms after treatment with antidepressants, but still suffer impaired social functioning and even relapses caused by residual symptoms. Ruoxinlin® has the ability to reduce multiple MDD symptoms, especially anxiety, anhedonia, fatigue, and cognitive impairment, satisfying MDD patients' unmet needs. This ability helps to improve patient quality of life and restore social functioning, achieving a lasting clinical cure in the real sense."

Safer and more tolerable with better patient compliance

In addition to residual symptoms, patients receiving medications for the treatment of MDD also face distress and somatic comorbidities caused by adverse drug reactions, such as sexual dysfunction, weight gain, and somnolence, which are common in antidepressant treatment8. Studies show that over 80% of MDD patients will have at least one adverse reaction and on average, patients experience up to four separate adverse reactions9-10. Many patients stop taking medications of their own accord or even resist treatment due to intolerability. As a result, antidepressants only afford these patients marginal benefits.

Clinical studies show that Ruoxinlin® has a good safety profile and tolerability: patient treatment compliance was over 90%, with no impact on sexual function, nor any changes in weight or lipid metabolism observed. The drug's influence on blood pressure and sleep is limited. In addition, the risk for drug interactions is low, because Ruoxinlin® is not metabolized by hepatic CYP450 enzymes and thus does not interfere with liver function.

Experts attending today's event said that treating MDD should be a long process during which a standard treatment should be adopted from beginning to end, covering the acute phase, the consolidation phase, and the maintenance phase. Adverse reactions often hinder medical compliance and cause interruptions to treatment, increasing the risk of relapses. If an antidepressant has a good safety profile and tolerability, patients will display better medical compliance and therefore will be more likely to complete an entire treatment course, achieving a higher chance of full remission.

Accelerating the availability of Ruoxinlin® to serve patients

Just 27 days after Ruoxinlin® was approved for launch, Luye Pharma was able to make the drug available for clinical use by leveraging the Group's expertise and resources in the central nervous system (CNS) therapeutic area, including its in-house sales & marketing team and powerful commercial network, enabling patients to benefit from this innovative therapy as soon as possible. Ruoxinlin® is now available through various channels for the treatment of patients around China, including hospitals, pharmacies and online platforms.

Meanwhile, Luye Pharma is actively embracing opportunities for collaboration in innovation. The company is in strategic collaboration with partners in the CNS therapeutic area such as Jiangsu Nhwa Pharmaceutical and Haoxinqing.cn. Luye Pharma is also working with Mindfront Health, a mental health service provider under the Luye Life Sciences Group banner, to increase the availability of Ruoxinlin®.

Yang Rongbing, President of Luye Pharma Group, said: "MDD is a serious public health challenge and severely undermines patients' quality of life. The disease disrupts the normal lives and careers of patients, and exerts a heavy financial burden on their family and wider society. To address unmet needs, we are accelerating the commercial availability of Ruoxinlin® at various levels while increasing its accessibility to patients. We hope that this drug will help more patients make a full recovery and return to their normal lives."
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References:
  1. Guidelines for the Prevention and Treatment of Depressive Disorders in China (2nd ed.)
  2. Murugaiah A. M. J. Med. Chem. 2018, 61(6), 2133-2165.
  3. Rush AJ, Trivedi MH, Wisniewski SR, et al. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report [J]. Am J Psychiatry. 2006，163(11): 1905-1917.
  4. Xiao L, Feng L, Zhu X, et al. A survey of residual depressive symptoms after acute treatment in China [J]. Chinese Journal of Psychiatry, 2017,50 (03): 175-181
  5. Zhao R, et al. Journal of Psychiatry, 2020, 33 (5): 326-329.
  6. Hiranyatheb T, et al. Neuropsychiatric Disease and Treatment, 2016, 12: 3175.
  7. NIL R,LUTOLF S,SEIFRITZ E. Residual symptoms and functionality in depressed outpatients: A one-year observational study in Switzerland with escitalopram [Jl. J Affect Disord, 2016, 197: 245-250.
  8. Cartwright C, et al. Patient Prefer Adherence. 2016 Jul 28;10:1401-7.
  9. MGH Housestaff Manual. Department of Medicine, Massachusetts General Hospital June 2019.
  10. Managing the Adverse Effects of Antidepressants. Psychiatric Times, Vol 31 No 7, Volume 31, Issue 7

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Luye Pharma Group Ltd. published this content on 05 December 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 05 December 2022 15:11:01 UTC.