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China’s NMPA Accepts and Grants Priority Review Designation to the New Drug Application for Luye Pharma’s Rotigotine Extended-Release Microspheres

2023 / 08 / 02 Publisher:Luye Life Sciences Group

August 1, 2023 – Luye Pharma Group today announced that the New Drug Application (NDA) of its weekly-dosed Rotigotine Extended-Release Microspheres for Injection (LY03003) for the treatment of Parkinson’s disease (PD) has been accepted and granted priority review by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). Developed on the company’s industry-leading microsphere platform, LY03003 is the world's first long-acting extended-release microsphere formulation for the treatment of PD. This drug is also being developed in the U.S. and Japan. 


LY03003 is expected to help numerous PD patients through CDS

PD is a neurodegenerative disease common in middle-aged and older people, which significantly impact the patients' quality of life. Non-ergot dopamine agonists (DAs) including rotigotine are the preferred medications for patients in the early stage of young-onset PD. Non-ergot DAs that produce continuous dopaminergic stimulation (CDS) can also treat motor complications of PD patients in the middle or advanced stage and slow down their progression.

LY03003 is the world's first weekly dopamine agonist formulation that produces CDS. Unlike other short-acting DAs that are already commercially available, LY03003 does not produce non-physiological, pulsatile stimulation. Injected intramuscularly, it exhibits distinct properties of an extended-release formulation. LY03003 maintains a stable release of rotigotine over seven days, to really produce CDS. It also maintains a stable concentration of the active ingredient in the blood, to produce sustained therapeutic effects over several days in a row and reduce adverse reactions arising from concentration fluctuation. Additionally, the once-a-week dosing frequency improves patient compliance and makes long-term management of the disease easier.

The NDA for LY03003 is made based on several Phase I clinical trials and one Phase III clinical trial. The results of those trials show that LY03003 is safe and effective in treating PD and can comprehensively improve the patients’ motor symptoms in a sustained manner and improve their quality of life.

According to statistics, approximately 10 million people worldwide are living with PD. The number of PD patients in China is expected to increase from 1.99 million in 2005 to nearly 5 million by 2030, which will be almost half of all the PD patients in the world. LY03003 will be a new option for treating the disease.


Accelerate the commercialization of innovative microsphere formulations for clinical applications

Microsphere formulations are complex. They can be designed to release active ingredients at the required speed and duration (e.g. from one week to several months) in clinical practice. This is a significant advantage in clinical applications, as it improves efficacy, safety, and patient compliance. However, the development and production of microsphere formulations are technically challenging and demanding. Within the domestic industry, companies rarely produce microsphere formulations on an industrial scale. Luye Pharma stands out in this field to become a leading player in the world thanks to its years of hard work.

On its innovative microsphere platform, Luye Pharma has developed a series of microsphere formulations with promising clinical applications targeting major therapeutic areas such as the central nervous system and oncology. In addition to LY03003, the company is also developing LY03009, a monthly rotigotine microsphere formulation. Furthermore, the NDA for the company's in-house developed Goserelin Microspheres for Injection (Baituowei) was just approved in China on June 30, making it the world's first and only microsphere formulation of goserelin approved for launch. In January this year, the company’s long-acting Risperidone Microspheres for Injection ( Rykindo®) had its NDA approved in the U.S., making it the first complex formulation developed by a pharmaceutical company from the Chinese mainland to receive approval from the U.S. Food and Drug Administration under the provisions of Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.

While accelerating the commercialization of innovative formulations from its microsphere platform, the company is leveraging its leading edge in this field and its existing resources to speed up its strategic expansion in key therapeutic areas around the world.

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