Luye Pharma Further Bolsters Global CNS Portfolio with Approval to Start LY03010 U.S. Clinical Trials

SHANGHAI,Sept. 27,2018 -- Luye Pharma Group has announced that the company's new drug candidate for the treatment of schizophrenia and schizoaffective disorders,Paliperidone Palmitate Injectable Suspension for Intramuscular Use (LY03010),has obtained approval from the U.S. Food and Drug Administration (FDA) to conduct clinical trials in the United States. The FDA has confirmed acceptable demonstration of stable bioequivalence after multiple doses,satisfying the 505(b)(2) NDA submission requirements for LY03010 in the Pre-IND meeting minutes.

Luye Pharma is dedicated to building a globally competitive product portfolio in the central nervous system therapeutic field,including oral tablets,transdermal patches and injection formulations covering multiple indications. Some of the signature products include Seroquel (Quetiapine Fumarate,immediate release,IR) and Seroquel XR (extended release formulation),and Rivastigmine Transdermal Patches. New drug candidates include Risperidone Extended Release Microspheres (LY03004),which have reached the final stage of the NDA process in the United States,among several others currently in the late stage of clinical development. Diversification of the CNS portfolio will further strengthen Luye Pharma's leading position in this field and lay a solid foundation for the company's ongoing global market penetration.

LY03010 is administered once a week,by intramuscular injection,for the treatment of schizophrenia and schizoaffective disorders. As a severe mental illness,schizophrenia is characterized by high and repeated recurrence due to poor treatment compliance,a major barrier to successful treatment of the disease. Non-compliance or partial compliance with treatment has been reported by doctors and clinicians to be one of the leading causes of relapse and re-hospitalization; the greater the number of relapses,the higher the degree of disease progression and the longer the required maintenance treatment period. LY03010 is able to improve this compliance issue common among patients using oral antipsychotic drugs. Moreover,compared with the market alternative,LY03010 optimizes the initial dosing regimen,potentially bringing greater convenience to patients,hence increasing patient compliance.

Schizophrenia not only causes serious harm to patients,but also places a heavy burden on their families and society. According to the World Health Organization,more than 21 million people worldwide are affected by schizophrenia,with one out of every two patients left untreated. According to a 2005 American National Comorbidity Survey,approximately 2.4 million American adults,or about 1.1 percent of the population age 18 and older,have schizophrenia. Driven by this huge unmet need,sales performance of similar drugs has been very good. For instance,global sales of INVEGA SUSTENNA / XEPLION / TRINZA / TREVICTA in 2017 was USD 2.569 billion,an increase of 16% y-o-y; in the first half of 2018,global sales for this product reached USD 1.416 billion,an increase of 14.8% y-o-y.

"LY03010 can effectively improve drug compliance,thus helping address the considerable unmet medical needs of patients,their families and society,so,we are very optimistic about LY03010's prospects. Receiving approval for LY03010's clinical trials in U.S. is further impetus for the company to continue expanding its CNS product pipeline and strengthen its leading position in this therapeutic field",a senior managing representative at Luye Pharma said.

CNS is considered one of the four core therapeutic fields for Luye Pharma's long-term development. A number of drugs in this field are being developed in parallel,both in Chinese and overseas markets. Several drugs have entered the late stages of clinical trials and will soon be launched in major markets around the world; examples include: Risperidone Extended Release Microspheres for Injection (LY03004),for the treatment of schizophrenia and bipolar disorder,which have reached the final stage of the NDA process with submissions planned for China and the United States. Rotigotine Extended Release Microspheres for Injection (LY03003) for the treatment of Parkinson's disease and Ansofaxine Hydrochloride Extended Release Tablets (LY03005) for the treatment of depression,which have both entered Phase III clinical trials in China and the United States respectively. Meanwhile,Rivastigmine multi-day patch products for the treatment of Alzheimer's disease are also under clinical development and analgesic drug Buprenorphine patches have entered the pre-clinical phase in China.

In addition to CNS,Luye Pharma has a wealth of pipeline products at home and abroad in the fields of oncology,metabolism,and cardiovascular diseases. Driven by a "global R&D" focused strategy,Luye Pharma has established a global R&D network,with R&D centers covering China,the United States and Europe. Currently,30 drugs are being developed in China,with more than 10 drugs being developed in overseas markets. Luye Pharma has reached a high level international standard in advanced drug delivery technologies such as microspheres,liposomes and transdermal drug delivery systems,with the company making active efforts to develop innovative compounds and antibodies,cells and gene therapies,as well as smart formulations.

To enable patients to benefit the most from these excellent R&D results,Luye Pharma has established 7 manufacturing sites with more than 30 production lines around the world,also maintaining a GMP quality management and control system of the highest international standards. The company has more than 30 marketed products,with a business presence in more than 80 countries and regions around the world,including China,the United States,Europe,Japan and other major global pharmaceutical markets,as well as high-growth emerging markets. The high standard of the global quality management system coupled with resourceful global market operations capability helps Luye Pharma better provide patients worldwide with high quality,innovative drugs.

View original content:/news-releases/luye-pharma-further-bolsters-global-cns-portfolio-with-approval-to-start-ly03010-us-clinical-trials-300720157.html