The board of directors of Luye Pharma Group Ltd. announced that the new central nervous system (CNS) exclusive drug Rivastigmine Twice Weekly Transdermal Patch developed by the Group has been approved by the National Medical Products Administration of China for the symptomatic treatment of mild to moderate Alzheimer's disease (AD). The commercialization of the product in China is managed via collaboration between the Group and Changchun GeneScience Pharmaceutical Co. Ltd. (GENSCI').

AD has become a major challenge to public healthcare worldwide. It is regarded as one of the most difficult diseases to treat, and 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.

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. The product and its formulation methods are protected globally under a number of patents. Rivastigmine Twice Weekly Transdermal Patch was developed by the research and development platform for transdermal patch of Luye Pharma AG, a subsidiary of the Company in Germany, which is one of the largest independent transdermal drug delivery system manufacturers in Europe.

Luye Pharma AG possesses transdermal drug delivery system manufacturing facilities with highly complex production processes and technologies with high technical barrier, and such facilities have passed GMP inspections of the Food and Drug Administration of the United States (U.S.), EU GMP inspections, and Japanese GMP inspections.