Luye Pharma issued the following announcement on Nov. 4.
LY03004, Luye Pharma's innovative, independently developed Extended-Release Microspheres for Injection has taken another step closer to going on the U.S. market. The company has announced that it has received the Establishment Inspection Report from the U.S. Food and Drug Administration (FDA), indicating that the company's manufacturing facility located in Yantai, China, where LY03004 is manufactured, successfully passed the Pre-Approval Inspection (PAI), with no FDA-483 Inspectional Observation.
LY03004 is the first microsphere product independently developed by a Chinese pharmaceutical company, and is also the first innovative formulation from China that has filed a New Drug Application (NDA) in the U.S., receiving wide attention from the industry. The seven-day PAI inspection is Luye Pharma's first on-site inspection by the U.S. FDA and is a critical step in the review process of the company's NDA of LY03004. Passing the first U.S. FDA's PAI with zero observation demonstrates the company's strong commitment and extensive expertise in ensuring compliance with the highest global quality standards, including the U.S. FDA cGMP regulations.
"Successful passing the PAI is an important milestone in the NDA process for LY03004. We are fully prepared for the global launch of LY03004 and other innovative formulations, and will continue to strengthen our quality standards to ensure that the company's products are manufactured at the highest quality for patients worldwide," said a Luye Pharma Group management representative.
LY03004 is administered once every two weeks by intramuscular injection to treat schizophrenia and bi-polar I disorder. According to the World Health Organization, there are more than 21 million people worldwide suffering from schizophrenia, and 60 million people suffering from bi-polar disorder, with the global number of patients suffering from mental illness constantly on the rise. LY03004 can improve medication compliance in patients with schizophrenia. Compliance is a common issue with oral antipsychotic drugs and LY03004 would simplify the treatment regimen. Furthermore, LY03004 has several advantages over the reference drug, for example, LY03004 has a shorter period of oral supplementation after the first injection than the reference drug and the steady plasma drug levels of LY03004 can be achieved much faster than the reference product.
The global number of patients in the central nervous system (CNS) therapeutic area, where LY03004 is applied is extremely large. Luye Pharma initiated a strategy of long-term planning for this area more than a decade ago, with the company's strategic approach to this treatment area setting the tone for the next stage of its business growth. In addition to LY03004, Luye Pharma has a number of other pipeline projects focusing on the CNS for the concurrent development of China and other countries, with projects such as Rotigotine Extended-Release Microspheres for Injection (LY03003) for Parkinson's disease, Ansofaxine Hydrochloride Extended-Release Tablets (LY03005) for depression, Paliperidone Palmitate Injectable Suspension (LY03010) for schizophrenia and schizoaffective disorder and Rivastigmine Multi-Day Transdermal Patch (LY30410) for Alzheimer's disease. The registrations of the above pipeline products are progressing well in major pharmaceutical markets such as China, the U.S., Europe and Japan, and the products are expected to be launched in these countries and further expanded into the global markets.
Luye Pharma also boasts a number of established brands in the CNS field, such as Seroquel, Seroquel XR and Rivastigamine Once-A-Day Transdermal Patch, among others. These products, covering more than 80 countries and regions including China, the U.S., Europe, Japan and other major pharmaceutical markets, as well as fast-growing international emerging markets, will form a competitive product portfolio together with the upcoming pipeline drugs, generating synergy which will help to accelerate the company's pace of expansion in CNS therapy in the future.
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