Shanghai, October 31, 2023 -- Luye Pharma Group today announced that its exclusive new drug, Rivastigmine Twice Weekly Transdermal Patch, has been approved by China's National Medical Products Administration (NMPA), for the symptomatic treatment of mild to moderate Alzheimer's disease (AD). The drug was developed by Luye Pharma on its proprietary transdermal patch platform in Europe, with commercialization in China is managed via collaboration between Luye Pharma and Changchun GeneScience Pharmaceutical Co., Ltd. (GenSci).
Yang Rongbing, President of Luye Pharma Group, said: "It's encouraging to see Rivastigmine Twice Weekly Transdermal Patch being widely accepted by doctors and patients in Europe following its launch. Thanks the collaborative efforts of our R&D teams in China and Europe, we have been able to bring the drug to China. We hope this innovative therapy can help more patients and address their unmet AD treatment needs. In the meantime, we'll focus further on the central nervous system (CNS) therapeutic area, leveraging our core strengths in this field to accelerate our global development."
Upgrading the formulation to address unmet needs in AD treatment
AD has become a major public healthcare challenge worldwide. In addition to being regarded as one of the most difficult diseases to treat, the development of new drugs is relatively slow, and existing drugs are limited. Moreover, the treatment of older patients is often challenging due to the prevalence of AD-associated conditions such as dysmnesia and cognitive disorders. In clinical practice, patient outcomes are significantly compromised due to issues such as poor patient compliance, high drug withdrawal rates as a result of adverse events, and difficulties with medication management. This has created a heavy burden for caregivers and AD patients, physically and financially. According to statistics, there are around 9.83 million AD patients in China, and the number is still growing.1
Rivastigmine is currently a first-line treatment for mild to moderate AD. Rivastigmine Twice Weekly Transdermal Patch adopts an innovative drug delivery system, and simplifies the dosage regimen, improving on the disadvantages of the oral formulation of Rivastigmine while relieving difficulties in administration for patients and their caregivers. Compared with the oral formulation, patch medication is administered transdermally, reducing adverse gastrointestinal reactions such as nausea and vomiting. Plasma concentration achieved through use of patches is more stable than that of oral formulation, allowing patients to receive stable treatment at the sufficient dosage. Patches are also more convenient than oral formulation for patients who have difficulty swallowing. In addition to these benefits, compared with the once-daily Rivastigmine transdermal patch, the twice weekly patch is administered less frequently, simplifies the dosage regimen, improves patient compliance, and provides a new option to patients for long-term disease management.
The Rivastigmine Twice Weekly Transdermal Patch, being the world’s first patch formulation of Rivastigmine to be administered twice weekly, has been approved for marketing in several European countries prior to China. The product and its formulation methods have been granted several international patents. In December 2021, Luye Pharma reached an agreement with GenSci, granting the latter commercialization rights to Rivastigmine Twice Weekly Transdermal and another product on the Chinese mainland.
In addition to China, Luye Pharma is also collaborating with local partners about this drug in multiple European countries, as well as Japan and Mexico.
Focusing on CNS to build a strong portfolio as an industry leader
New drug development in the CNS therapeutic area has been relatively slow for a number of years for a variety of reasons, including the complicated mechanisms of CNS disease, the difficulty in developing drugs which reach their targets, and the associated high-risk R&D required for a breakthrough. Furthermore, among the new CNS drugs currently available globally, few of them originate from China. Several innovative drugs and formulations of Luye Pharma are now available in China, the United States, and Europe, covering CNS diseases including AD, depression, schizophrenia, and bipolar disorder. These offerings demonstrate the value and potential of Luye Pharma to become a global-leading innovative pharmaceutical company with a focus on CNS in the future.
The company has already built a strong CNS portfolio. In January 2023, Rykindo® (Risperidone for Extended-release Injectable Suspension) was approved for marketing in the United States, making it the first new CNS drug developed by a Chinese pharmaceutical company to be approved for use in the United States. In November 2022, Ruoxinlin® (Toludesvenlafaxine Hydrochloride Sustained-release Tablets) was approved for marketing in China as the first "Class 1 Chemical Drug" for the treatment of Major Depression Disorder developed by a Chinese company. Other products in the portfolio such as Seroquel® (Quetiapine Fumarate) and its extended-release tablets, and once-daily Rivastigmine Transdermal Patches, are sold in China and abroad, in addition to Rivastigmine Twice Weekly Transdermal Patches, which are available in major European markets.
Currently in the company's drug development pipeline, LY03010 (Paliperidone Palmitate Extended-release Injectable Suspension) is at the Marketing Authorization Application (MAA) stage in China and the United States. LY03003 (Rotigotine Extended-release Microspheres for Injection), currently being developed in China and abroad, has been granted priority review for its New Drug Application (NDA) in China. Several other new products, such as LY03015, a VMAT2 inhibitor, are undergoing clinical trials in China and abroad. Internationally, the company has developed competitive capabilities in R&D, regulatory affairs, clinical trials, supply chain, and commercial activities, and has laid a solid foundation for commercializing new products around the world in the future.
1. Rujing Ren.et al. The China Alzheimer Report 2022. General Psychiatry. 2022; 35(1): e100751.