Luye Pharma : VOLUNTARY ANNOUNCEMENT - SUBMISSION OF NDA FOR LY03005 TO THE U.S. FDA

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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

SUBMISSION OF NDA FOR

LY03005

TO THE U.S. FDA

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 Company has successfully submitted the New Drug Application (''NDA'') to the Food and Drug Administration (''FDA'') of the United States of America for LY03005, a new chemical drug for the treatment of major depressive disorder.

The application was based on the consensus reached with the FDA under End-Of-Phase2-CMC (EOP2- CMC) meeting and Pre-NDA (PNDA) meeting.

ABOUT LY03005

LY03005 is a serotonin-norepinephrine-dopamine triple reuptake inhibitor (SNDRI), and one of the active metabolites is a serotonin-norepinephrine reuptake inhibitor (SNRI). LY03005 is an exclusive central nervous system product for major depressive disorder developed under the Group's new chemical/therapeutic entities (NCE/NTE) R&D platform.

The Group had obtained patents covering the chemical compound, crystal form and formulation of LY03005. The patents in relation to the chemical compound and crystal form had been granted in target markets such as China, United States, Europe, Japan and Korea.

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ABOUT DEPRESSION

Depression is a common disorder worldwide, with more than 300 million people affected according to data from the World Health Organization, and this disorder bring pain and hardship to patients and, in particular, cause patients to suffer in their social life.

Traditional anti-depressants such as selective serotonin reuptake inhibitors (SSRIs) and serotoninnorepinephrine reuptake inhibitors (SNRIs) drugs are typically associated with disadvantages such as anhedonia, sexual dysfunction and inability to improve cognitive impairment. Compared with traditional anti-depressant drugs, LY03005 is expected to be relatively beneficial in helping preserve patients' sexual function, have a better safety profile and produce more rapid onset as well as better efficacy.

According to the data from IQVIA, the market size for anti-depressants in the United States in 2018 was USD4.74 billion, with a compound annual growth rate (CAGR) of 7.3% from 2016 to 2018.

ABOUT THE GROUP'S CENTRAL NERVOUS SYSTEM PIPELINE PROJECTS

Apart from LY03005, the Group has a number of other pipeline projects relating to the central nervous system which are under concurrent development in China and overseas markets, with projects such as Rykindo® (LY03004) (Risperidone Extended Release Microsphere for Injection for schizophrenia and bipolar disorder, which has filed NDA with FDA and passed Pre-Approval Inspection (PAI) in the U.S.), LY03003 for Parkinson's disease, LY03010 for schizophrenia and schizoaffective disorder and LY30410 for mild to moderate Alzheimer's disease and LY03012 for chronic pain. The registration processes of the above pipeline products are 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 market.

By Order of the Board

LUYE PHARMA GROUP LTD.

Liu Dian Bo

Chairman

Hong Kong, 26 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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