Luye Pharma's Rykindo® NDA Filing Accepted by the U.S. FDA

SHANGHAI,May 30,2019 -- Rykindo® (LY03004),Luye Pharma'sinnovative,independently developedExtended-Release Microspheres formulationfor injection,is one step closer to going on the U.S. market. The US Food and Drug Administration (FDA) has completed the filing review and accepted the filing of Rykindo®'s new drug application (NDA).

Rykindo® is the first innovative formulation from China to have an NDA accepted by the FDA. This also indicates that China's first independently-developed microsphere products will be ableto enter the U.S. market in the near future. Meanwhile,Rykindo®'s registration process in Europe and emerging markets is making good progress. The news once again demonstrates that Luye Pharma has reached an advanced international standard in the research of novel drug delivery technologies,such as microspheres; it also highlights the success of the company's strategy,to achieve globalized development through long-term,in-depth product pipeline planning.

Rykindo®'s dosage strengths intended for market are 12.5 mg,25 mg,37.5 mg,and 50 mg of risperidone per vial. The drug is administered once every two weeks by intramuscular injection to treat schizophrenia and bi-polar disorder. According to the World Health Organization,there are approximately 23 million patients worldwide suffering from schizophrenia and 60 million patients suffering from bi-polar disorder,with the global number of patients suffering from mental illness constantly on the rise. By simplifying the treatment regimen due to the need for an injection only once every two weeks,Rykindo® as an injectable drug can improve patient compliance,a common issue with oral antipsychotic drugs. In addition,Rykindo® has several advantages over the reference drug. One example is there is no need to administer an oral formulation for three weeks after the first injection of Rykindo®,unlike with the reference drug. Another example would be the shorter time required for steady plasma drug levels to be achieved by Rykindo®,when compared to the reference product.

The global number of patients in the central nervous system (CNS) therapeutic area,where Rykindo® 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 Rykindo®,Luye Pharma has a number of other pipeline candidates at home and abroad. These include Rotigotine Extended-Release Microspheres for Injection (LY03003) for the treatment of Parkinson's disease,which has entered Phase III studies in China and the U.S. and Phase I studies in Japan; Ansofaxine Hydrochloride Extended-Release Tablets (LY03005),a new compound for the treatment of depression,which has entered phase III clinical trials in China and a pivotal clinical phase in the United States; a pivotal study for Rivastigamine Multi-Day Transdermal Patch (LY30410),for the treatment of Alzheimer's disease,has been completed in Germany and Paliperidone Extended-Release Suspension Injection (LY03010) for the treatment of schizophrenia and schizoaffective disorders,is being developed simultaneously in China and abroad.

Luye Pharma also boasts a number of established brands in the CNS field,such as Seroquel and Seroquel XR,Fentanyl Patch and Buprenorphine 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.