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Marketing Authorization Application Accepted by CDE for Luye Pharma’s Antidepressant Anshufaxine Hydrochloride Extended-Release Tablets

2021 / 06 / 10 Publisher:Luye Life Sciences Group

Luye Pharma Group announced that the marketing authorization application for the company’s in-house developed Class 1 new drug Anshufaxine Hydrochloride Extended-Release Tablets (LY03005) has been accepted by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration.

LY03005 is used for the treatment of major depressive disorder (MDD) and was developed by Luye Pharma on its new therapeutic entity/new chemical entity (NTE/NCE) R&D platform. It is the world’s only serotonin (5-HT)-norepinephrine (NE)-dopamine (DA) reuptake inhibitor (SNDRIs) with proven mode of action and clinical efficacy, making it a first-in-class product. 

The application for marketing authorization is based on clinical data generated from 6 clinical studies in China. The phase III clinical trial is a multi-center, randomized, double-blind and placebo-controlled study designed to verify the efficacy and safety of LY03005 in the treatment of MDD. A total of 558 Chinese adult depressive disorder patients who met the DSM-5 diagnostic criteria were enrolled and randomized into LY03005 80 mg, 160 mg and placebo groups in a 1:1:1 ratio. They received eight weeks of double-blind treatment. The results suggest that LY03005 achieves a comprehensive and stable improvement of depressive symptoms, in particular rapidly reducing anxiety, significantly relieving anhedonia, and improving cognitive function. It does not cause drowsiness, and has no impact on sexual function, body weight and lipid metabolism. These clinical features of LY03005 are the keys to helping patients suffering from MDD to reintegrate into society.

LY03005 Expected to Fill a Lengthy Gap in First-line Antidepressant Launches

According to the World Health Organization, MDD is one of the most common mental disorders, with approximately 350 million sufferers around the world. The disease has a high rate of incidence and recurrence, and is severely incapacitating. It is the leading cause of incapacity worldwide and a major contributor to the overall global burden of disease. Global Health Estimates: Depression and Other Common Mental Disorders, published by the World Health Organization in 2017, stated that the prevalence of depressive disorders in China was about 4.2%. IQVIA data shows that the market for anti-depressants in China grew to RMB 6.31 billion in 2020.

Despite the enormous clinical demand, the research and development of new antidepressant drugs has been relatively slow for a long time. Worldwide, dozens of antidepressants are currently under development, but very few have been approved for marketing as first-line treatment in recent years, with the most recent approval by the U.S. FDA dating back to 2013.

In the history of antidepressants, the first generation of uptake inhibitors were selective 5-HT reuptake inhibitors (SSRIs), which improve depression but fail to improve patients’ slow movement and cause weight gain. The second generation of uptake inhibitors, the selective 5-HT–NE reuptake inhibitors (SNRIs), improve the slow movement and cause less weight gain. These two classes of drugs are currently the mainstays in the treatment of depression, but they have deficiencies, such as slow onset of action and failure to improve patients’ anhedonia (reward-related) and cognitive functions, as well as causing sexual dysfunction. 

As a SNDRIs, LY03005 increases the reuptake inhibition of DA compared with SNRIs. This is associated with the reward mechanism and helps to relieve anhedonia in patients and activates brain-derived nerve growth factor (BDNF) in the cerebral cortex, which helps improve patients’ cognition function. It also activates the hypothalamic-gonadal axis, which alleviates sexual dysfunction.

In addition to China, LY03005 has entered the new drug application stage in the U.S. and completed phase I clinical studies in Japan. Luye Pharma plans to register and launch the drug in the U.S., Japan, China, Europe and other markets, and has obtained patents covering the chemical compound, crystal form and formulation. Patents in relation to the chemical compound and crystal form have been granted in target markets such as China, the U.S., Europe, Japan and South Korea.

Robust CNS Portfolio with Breakthroughs in High-potential Pipeline Products 

The central nervous system (CNS) therapeutic area including MDD is one of the core strategic areas for Luye Pharma. The company has developed a product pipeline containing a series of differentiated innovative drugs and formulations on its NCE and novel drug delivery technology platforms, with constant breakthroughs in high-potential products in the pipeline.

In May of this year, Rivastigmine Multi-Day Transdermal Patch, an innovative formulation for the treatment of Alzheimer’s disease, became eligible for marketing authorization in multiple countries in the European Union. This January, Rykindo® (Risperidone Microspheres for Injection (II)) for the treatment of schizophrenia was granted marketing authorization in China, making it the first innovative microsphere formulation developed independently by a Chinese company. Rivastigmine Once-Daily Transdermal Patch (Brand Name: 金斯明®) for the treatment of Alzheimer’s disease, also made its appearance on the shelves of hospitals and pharmacies in nearly 50 cities across China. Luye Pharma has set up a professional marketing and sales team in relations to five major sales regions in China, covering all regions of the country. 

In addition, Luye Pharma currently has multiple new drugs under development, targeting various CNS diseases including Parkinson's disease and bipolar disorder. These drugs have entered the late clinical development stages or new drug application stage in China, the U.S. and Europe, as well as other countries and regions. The company is accelerating the execution of its global strategy and strengthening its core competitive strengths in this area by continuously adding new products, to build a rich product portfolio and enhance the business.

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