Luye Pharma Well Positioned for CNS Market with the Approval of A New Indication for Seroquel XR in China

SHANGHAI,July 22,2018 --Luye Pharma Group has announced that its Central Nervous System (CNS) drug,Seroquel XR (Quetiapine Fumarate XR),has received approval from the official Chinese medical authorities for a new indication in the treatment of depression arising from bipolar disorder. The approval of this new indication will not only help to benefit a great number of people living with mental illness,but will also boost sales of the drug.

Seroquel XR is an atypical antipsychotic (APP) drug with anti-depressant properties. It is mainly used for the treatment of schizophrenia and bipolar disorder,and is approved in some markets for the treatment of depression and generalized anxiety disorder. The drug has been marketed in more than 80 countries and regions around the world and is widely recognized by doctors and patients. In the first half of this year,Luye Pharma acquired the rights for Seroquel (Quetiapine Fumarate) and Seroquel XR from AstraZeneca in 51 countries and regions,including China,with the acquisition finalized in June 2018.

"Depression arising from bipolar disorder" is another indication for Seroquel approved in China,in addition to schizophrenia. Bipolar disorder is a common psychiatric disease that not only has a huge impact on patients' lives,work and study,but also puts a heavy burden on their families and society. Quetiapine has been recommended by the China Guidelines for the Prevention and Treatment of Bipolar Disorders as the only first-line treatment for depressive episodes associated with type II bipolar disorder. Administered once daily,Seroquel XR has a rapid onset of action,good tolerance,and sees high levels of patient compliance.

According to IQVIA data,sales of the Seroquel series in China have increased by 26% and 17% in the past two years,respectively. Further to this,following negotiations in July last year,Seroquel XR was added to the National Drug Reimbursement List,significantly enhancing its accessibility while reducing the economic burden for patients.

"We remain very optimistic about Seroquel's long-term prospects,and in particular,its strong growth momentum in China going forward. We will continue to increase our investment in Seroquel at home and abroad,driving synergistic development of our CNS product pipeline," a senior management spokesperson commented.

CNS is one of Luye Pharma's four core therapeutic areas. Apart from marketed products,several other CNS products are being concurrently developed in China and overseas markets. Risperidone Extended Release Microspheres (LY03004) for the treatment of schizophrenia and bipolar disorder has reached the NDA (new drug application) stage in the United States and China. Rotigotine Extended Release Microspheres (LY03003) indicated for Parkinson's disease and Ansofaxine Hydrochloride Extended Release Tablet (LY03005) indicated for depression have begun Phase III clinical trials. Multi-day Rivastigmine Transdermal Patches for the treatment of mild to moderate Alzheimer's disease has also entered into a key stage of clinical trials. Other new drug development projects such as LY03012,an investigational drug for analgesia,are also in progress. The registration procedures for all of the above-mentioned new drugs are going as planned in the major international markets such as China,the U.S.,Europe and Japan. The new products will launch first in these regions before expanding into additional international markets at a later date. With comprehensive,forward looking planning,Luye Pharma is poised for a glittering future in the field of CNS treatments.

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