Luye Pharma : VOLUNTARY ANNOUNCEMENT - APPROVAL FOR CLINICAL TRIAL FOR LPM4870108 TABLETS IN CHINA

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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

APPROVAL FOR CLINICAL TRIAL FOR

LPM4870108 TABLETS IN CHINA

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 Group's synthetic class one new drug with independent intellectual property right LPM4870108 tablets (LY01018) has obtained the approval from the Centre for Drug Evaluation (''CDE'') of the People's Republic of China (''China'') to initiate clinical trials. This drug is designed for the treatment of cancer patients with different tumor types harboring the NTRK fusion and patients with drug resistance to the first generation NTRK inhibitor.

NTRK gene fusion is a carcinogenic agent, which is discovered in over 20 types of solid tumors in adults and children, including lung cancer, colorectal cancer, thyroid tumor, and fibrosarcoma. The first-generation NTRK inhibitor with the same target has already been launched, however, most patients are observed with acquired resistance mutation after a period of treatment, including NTRK1-G595R,NTRK2-G639R,NTRK3-G623R. Currently, no second-generation inhibitor targeting abovementioned mutations has obtained approval for launch.

LPM4870108 is the Group's synthetic and highly selective second-generation NTRK inhibitor, which is effective to wild type and acquired resistance type mutant, and is intended to be used in the treatment of ''solid tumor patients with NTRK gene fusion and positive resistance mutations''. It is expected to cover all related indications of the currently available first-generation inhibitors with the same target; and also cover the inherent resistance of the first-generation inhibitors as well as the treatment of patients with resistance, i.e. including first-line and second-line treatments of patients with NTRK gene fusion solid tumors and therefore is expected to have a wider range of indications.

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The Board believes that LPM4870108 will enrich the Group's oncology product portfolio. The Group would be able to leverage on its experienced oncology marketing team to bring positive syneries in the introduction of the product to the market when the product is launched in the future.

By Order of the Board

LUYE PHARMA GROUP LTD.

Liu Dian Bo

Chairman

Hong Kong, 27 August 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.

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