Luye Pharma : VOLUNTARY ANNOUNCEMENT - ANSOFAXINE HYDROCHLORIDE EXTENDED RELEASE TABLETS (LY03005) COMMENCED PHASE I HEALTHY VOLUNTEER STUDY IN JAPAN

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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

ANSOFAXINE HYDROCHLORIDE EXTENDED RELEASE TABLETS (LY03005)

COMMENCED PHASE I HEALTHY VOLUNTEER STUDY IN JAPAN

The board of directors (the ''Board'') of Luye Pharma Group Ltd. (the ''Company'', together with its subsidiaries, the ''Group'') is pleased to announce that Ansofaxine Hydrochloride Extended Release Tablets (''LY03005''), a New Chemical Drug for the treatment of major depressive disorder has begun Phase I Clinical Study in Japan.

ABOUT LY03005

LY03005 is a central nervous system product candidate being developed within new compounds platform. It is a serotonin-norepinephrine-dopamine triple reuptake inhibitor (SNDRI) in extended release tablet form for the treatment of major depressive disorder.

Traditional anti-depressants such as selective serotonin reuptake inhibitors (SSRIs) and serotonin- norepinephrine 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.

The Group had obtained patents covering the chemical composition, crystal form and formulation of extended release tablets. The patents relating to the chemical composition and crystal form had been granted in the target countries/regions such as China, United States, Europe, Japan, Korea, etc.

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The Group plans to register and launch LY03005 in the U.S., Japan, China, Europe and other countries/ regions. Apart from Japan, the Group is carrying out LY03005 phase 3 clinical trials in China, as well as series clinical trials in the U.S.

ABOUT DEPRESSION

Depression is a common disorder worldwide, with more than 300 million people affected according to data of the World Health Organization. This disorder brings pain and hardship to patients, particularly suffering in their social lives.

The total National Healthcare Insurance (NHI) sales for anti-depressants in Japan in 2018 was approximately JPY157 billion (approximately USD1.45 billion), and this market grew at a compound annual growth rate (CAGR) of 9.9% 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 regarding the central nervous system 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, Rotigotine Extended Release Microspheres for injection (LY03003) for Parkinson's disease, Paliperidone Palmitate injectable suspension (LY03010) for schizophrenia and schizoaffective disorder and Rivastigmine Multi-day Transdermal Patch (LY30410) for mild to moderate Alzheimer's disease. 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, 12 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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