Luye Pharma : VOLUNTARY ANNOUNCEMENT - FDA AGREES TO WAIVE PEDIATRIC CLINICAL TRIALS OF LY03004

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LUYE PHARMA GROUP LTD.

綠 葉 製 藥 集 團 有 限 公 司

(Incorporated in the Bermuda with limited liability)

(Stock Code: 02186)

VOLUNTARY ANNOUNCEMENT

FDA AGREES TO WAIVE PEDIATRIC CLINICAL TRIALS OF 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 Food and Drug Administration (''FDA'') of the United States of America (the ''U. S.'') has agreed to waive pediatric clinical trials at the submission of a New Drug Application (''NDA'') in the U.S. for the Group's innovative drug, Risperidone Extended Release Microspheres for injection (''LY03004'').

On 9 July 2012, President Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law. The legislation permanently reauthorizes Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act (PREA). In accordance with BPCA and PREA, FDA requires the sponsors who will be submitting a NDA must submit a agreed Pediatric Study Plan (''PSP''), and carry out the clinical study according to PSP after the product approval, even if the drug product is intended only for adults.

The Group submitted an initial PSP to FDA to request a full waiver of the pediatric studies based on the prevalence of pediatric schizophrenia in the relevant international databases and the guideline for the treatment of children with schizophrenia issued by the American Academy of Child and Adolescent Psychiatry (AACAP). Through numerous communications with FDA, the FDA has agreed to waive all pediatric clinical studies for LY03004. FDA's decision will significantly reduce the research and development cost, and timely benefit a large number of patients with schizophrenia.

The Group owns patents related to the formulation of LY03004. The patents have been acquired in countries such as the U.S., China, Europe, Japan and Korea and are valid until year 2032. LY03004 has already completed its registration required clinical trials both in China and the U.S. Apart from China and the U.S., the Group also plans to register and launch LY03004 in Europe and Japan.

Besides LY03004, the Group has numerous central nervous system pipeline projects concurrently being developed in China and overseas markets, such as rotigotine Extended Release Microspheres for injection (LY03003) for Parkinson's disease, ansofaxine hydrochloride extended release tablets (LY03005) for depression, and rivastigmine transdermal patch for mild to moderate Alzheimer's disease. The registrations 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, 21 February 2018

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.