Luye Pharma : Jinyouping (Rotigotine Microspheres for Injection) Approved for Marketing in China

- The world's first long-acting microsphere formulation for treating Parkinson's disease is another CNS product of the company approved in the fast track process -

Shanghai, June 20, 2024 - Luye Pharma Group today announced that its Jinyouping (rotigotine microspheres for injection) has been approved for marketing by China's National Medical Products Administration (NMPA) with a priority review designation for the treatment of Parkinson's disease (PD).

Developed on the company's industry-leading microsphere platform, this weekly medication is the world's first long-acting, extended-release microsphere formulation for the treatment of PD through continuous dopaminergic stimulation (CDS). It is another innovative product from the microsphere platform, which will further enhance the company's leading edge in the Central Nervous System (CNS) therapeutic area.

A breakthrough weekly formulation improving the prognosis of PD via CDS

PD is a common neurodegenerative disease affecting older adults. It significantly compromises patients' quality of life with motor symptoms like tremor and non-motor symptoms like autonomic disorders. China alone has over 3 million PD patients , and this number is expected to reach 5 million by 2030 . Existing treatments only improve symptoms without stopping disease progression. Along with disease progression, patients will develop motor complications, which may be accelerated by the chronic, non-physiological, intermittent or pulsatile stimulation of striatal dopaminergic receptors. This is a major challenge in treating the disease, affecting up to 90% of the patients .

"PD patients will experience a narrowing therapeutic window along with disease progression, and at the same time, their motor and non-motor symptoms will become worse, and their 'off' time will become longer," said Professor Chen Biao, Head of Neurology at the Xuanwu Hospital of the Capital Medical University. "This is a significant burden to patients and their caregivers. CDS is a key mechanism in PD treatment, as it can improve motor symptoms and reduce the risk of motor complications. Jinyouping is a long-acting weekly medication that provides CDS, and we believe it will be a better treatment option for PD patients throughout the disease course."

Jinyouping works via CDS. It delivers rotigotine, a dopamine receptor agonist, as a long-acting weekly formulation. Compared with the currently available short-acting daily dopamine receptor agonists, Jinyouping does not produce the non-physiological and pulsatile stimulation. This makes it an extended-release medication that can stably release rotigotine for seven days. As a result, the concentration of rotigotine in the blood remains stable for seven days, and its therapeutic effect also sustains during that period. This is CDS in a real sense, which can minimize symptom fluctuations and adverse reactions associated with the fluctuating concentration of the drug in the blood. Besides, as a weekly medication, Jinyouping also helps to improve patient compliance and facilitate the long-term management of this disease.

A randomized, double-blind, placebo-controlled Phase 3 clinical study conducted in China shows that Jinyouping is safe and well-tolerated, and it can comprehensively and sustainably improve the motor symptoms of patients. In this study, the subjects treated with Jinyouping responded to the treatment significantly better and enjoyed a higher quality of life versus the control group.

The globally leading microsphere platform helps Luye Pharma build a robust CNS portfolio

The CNS therapeutic area, which includes Parkinson's disease, is one of the strategic areas for Luye Pharma. To address the unmet medical needs, the company has built a differentiated portfolio of innovative CNS drugs and formulations leveraging its platforms for Novel Drug Delivery Systems (NDDS), which include microspheres, and New Molecular Entities (NME). This is a competitive edge for Luye Pharma.

Take the microsphere formulation used by Jinyouping for example. Microspheres are complex formulations that release active ingredients at the required speed and within the required period ranging from one week to several months, so as to improve efficacy, safety and patient compliance, a significant advantage in clinical practice. But they are difficult to develop and produce, and few Chinese companies are able to produce them on an industrial scale. Luye Pharma has ended many years of monopoly by foreign companies in this field to become a global leader in developing and producing microspheres.

In addition to China, the CNS drugs of Luye Pharma have also reached overseas markets including the U.S. and Europe. Among them, Rykindo®(risperidone) for extended-release injectable suspension, is China's first new CNS drug approved for marketing in the U.S., and Ruoxinlin® (Toludesvenlafaxine Hydrochloride Sustained-release Tablets), which has been approved for marketing in China, is the first proprietary Class 1 innovative chemical drug developed in China for the treatment of Major Depressive Disorder.

Yang Rongbing, President of Luye Pharma Group, said: "Globally, the demand for treating CNS diseases is growing. This is a focused area for us where we have built an internationally competitive portfolio covering multiple psychiatric and neurological disorders. The launch of these new drugs will further enhance our competitiveness in the CNS therapeutic area and allow us to be better-positioned to address the unmet needs of patients."

About Luye Pharma Group

Luye Pharma Group is an international pharmaceutical company dedicated to the R&D, manufacturing and sale of innovative medications. The company has established R&D centers in China, the U.S. and Europe, with a robust pipeline of over 30 drug candidates in China and more than 10 drug candidates in other international markets. Luye Pharma maintains high-level international standards in novel drug delivery technologies including microspheres, liposomes, and transdermal drug delivery systems. The company has also achieved multiple innovations in new chemical entities and antibodies, and is actively making strategic developments in the fields of cell therapies and gene therapies.

Luye Pharma is developing a global supply chain of 8 manufacturing sites built up around the world, with GMP quality management and control systems established in line with international standards. With more than 30 products covering the central nervous system, oncology, cardiovascular, metabolism and other therapeutic areas, business is conducted in over 80 countries and regions around the world, including the largest pharmaceutical markets - China, the U.S., Europe and Japan, as well as in fast growing emerging markets.