Luye Pharma : VOLUNTARY ANNOUNCEMENT - CDE GRANTED PRIORITY REVIEW STATUS TO NEW DRUG APPLICATION FOR LY03004

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LUYE PHARMA GROUP LTD.

綠 葉 製 藥 集 團 有 限 公 司

(Incorporated in Bermuda with limited liability)

(Stock Code: 02186)

VOLUNTARY ANNOUNCEMENT

CDE GRANTED PRIORITY REVIEW

STATUS TO NEW DRUG APPLICATION FOR LY03004

The board of directors (the ''Board'') of Luye Pharma Group Ltd. (the ''Company'', together with its subsidiaries, the ''Group'') is pleased to announce that the Center for Drug Evaluation (the ''CDE'') under the National Medical Products Administration (''NMPA'') of the People's Republic of China (''China'') granted priority review status to the New Drug Application (''NDA'') for Risperidone Extended-release Microspheres for Injection (LY03004), an extended-release microspheres product for injection administered bi-weekly for the treatment of schizophrenia.

Previously, key clinical trials have been completed in China and the United States (''US'') in relation to LY03004. In May 2019, the FDA completed filing review and determined to accept the filing of the NDA for LY03004. In November 2019, the manufacturing facility of the Group located in Yantai, China successfully passed the FDA's Pre-Approval Inspection (''PAI'') with no FDA483 Inspection Observation.

The Company believes that LY03004, as a long-acting injectable drug administered bi-weekly, can help improve medication compliance issues which are common among patients with schizophrenia in relation to oral antipsychotic drugs, and simplify the treatment regimen. Furthermore, LY03004 has several advantages over the marketed reference drug. For example, there is no need to administer oral formulation for three weeks after the first injection of LY03004 unlike with the reference drug, and steady plasma drug level can be reached much faster with LY03004 than with the reference product.

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Schizophrenia is a severe mental disorder, characterized by profound disruptions in thinking, affecting language, perception and the sense of self. According to the World Health Organization (WHO), schizophrenia affects more than 21 million people worldwide, and one in every two persons suffering from schizophrenia does not receive care for the condition.

The Group has launched several products for the central nervous system therapeutic area, including Seroquel, Seroquel XR, Rivastigmine patches, Fentanyl patches and Buprenorphine patches, covering over 80 countries and regions around the world, including large pharmaceutical markets in China, the U.S., Europe and Japan, as well as fast growing emerging markets.

In addition to LY03004, the Group has a number of other pipeline projects focusing on the central nervous system for the concurrent development of China and overseas markets, including projects such as LY03003 for Parkinson's disease, LY03005 for the treatment of major depressive disorder, LY03010 for schizophrenia and schizoaffective disorder, LY30410 for mild to moderate Alzheimer's disease and LY03012 for chronic pain. The registration work in relation to the above pipeline products has been progressing well in strategic 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.

By Order of the Board

LUYE PHARMA GROUP LTD.

Liu Dian Bo

Chairman

Hong Kong, 30 December 2019

As at the date of this announcement, the executive directors of the Company are Mr. LIU Dian Bo, Mr. YANG Rong Bing, Mr. YUAN Hui Xian and Ms. ZHU Yuan Yuan; the non-executive director of the Company is Mr. SONG Rui Lin; and the independent non-executive directors of the Company are Mr. ZHANG Hua Qiao, Professor LO Yuk Lam, Mr. LEUNG Man Kit and Mr. CHOY Sze Chung Jojo.

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