Luye Pharma : VOLUNTARY ANNOUNCEMENT - LUYE PHARMA RECEIVED A COMPLETE RESPONSE LETTER FROM THE U.S. FDA REGARDING ITS NDA FOR LY03004

Hong Kong Exchanges and Clearing Limited and The Stock Exchange of Hong Kong Limited take no responsibility for the contents of this announcement, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this announcement.

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

LUYE PHARMA RECEIVED A COMPLETE RESPONSE LETTER

FROM THE U.S. FDA REGARDING ITS NDA FOR LY03004

The board of directors (the ''Board'') of Luye Pharma Group Ltd. (the ''Company'', together with its subsidiaries, the ''Group'') announces that the Company received a complete response letter (the ''CRL'') from the U.S. Food and Drug Administration (the ''FDA'') regarding its New Drug Application (''NDA'') for LY03004, an Extended-Release Microspheres for Injection administered biweekly for the treatment of schizophrenia and bipolar I disorder. The CRL requested additional information and the satisfactory resolution of inspection issues of the active pharmaceutical ingredient (''API'') manufacturing facility before this application may be approved. The Company will work closely with its API partners and the FDA to address the issues raised in the letter and move forward the approval process of this NDA promptly. The directors of the Company are confident in pushing forward the approval process of LY03004 by the FDA in a timely manner.

The Company has submitted its first NDA for LY03004 to the U.S. FDA on March 28, 2019 and the filing was successfully accepted by the FDA on May 31, 2019. The manufacturing facility of the Company located in Yantai, China has successfully passed the Pre-Approval inspection (''PAI''), its first on-site inspection by U.S. FDA, with no FDA 483 in July 2019. In China, the NDA of this product has been accepted by the Center for Drug Evaluation (''CDE'') of National Medical Products Administration (''NMPA'') on November 26, 2019 and the NDA has been granted priority review status by CDE on December 30, 2019.

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 two people suffering from schizophrenia does not receive care for the condition.

- 1 -

Bipolar I disorder, also known as manic-depressive illness, is a brain disorder that causes unusual shifts in mood, energy, activity levels, and the ability to carry out day-to-day tasks.

The Group has simultaneously 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 in 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, 31 January 2020

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.

- 2 -