Luye Pharma : VOLUNTARY ANNOUNCEMENT - TRIPTORELIN ACETATE EXTENDED-RELEASE MICROSPHERES FOR INJECTION (LY01007) COMPLETED PHASE I CLINICAL TRIAL 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

TRIPTORELIN ACETATE EXTENDED-RELEASE MICROSPHERES FOR INJECTION (LY01007) COMPLETED PHASE I CLINICAL TRIAL 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 has completed phase I clinical trial for Triptorelin acetate extended-release microspheres for injection (''LY01007'') in the People's Republic of China (''China''). This clinical trial was designed to assess the pharmacokinetic (PK), pharmacodynamics (PD), and safety profiles of a single dose of LY01007 and compare it to Diphereline®. An experienced clinical study site in China recruited 24 prostate cancer patients for this trial with 12 subjects each in the LY01007 and Diphereline® groups.

In this clinical trial, subjects in the LY01007 group received a single intramuscular injection of 3.75 mg of LY01007, and the Diphereline® group received a single intramuscular injection of 3.75 mg of the commercial formulation Diphereline®. The results showed that LY01007 had higher bioavailability, and the relative bioavailability (AUC0-t relative to the control group) was 133.21%. There was no statistical difference in the main pharmacodynamic evaluation parameters (TES, LH and FSH). It met the pharmacokinetic and pharmacodynamic characteristics of this kind of long-acting preparation. LY01007 was considered safe and well tolerated, and there was no occurrence of any serious adverse events (SAEs) or adverse event leading to withdrawal or death.

LY01007 is the Group's monthly extended release microspheres product for intramuscular formulation of triptorelin acetate, a gonadotropin-releasing hormone agonist, applying the Group's microspheres injection technology. It is an oncology product candidate for the treatment of certain cancers, including prostate cancer, breast cancer and so on.

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LY01007 use a unique formulation and preparation process. Compared to other marketed products in China, LY01007 has higher drug loading efficiency, with less injection amount of microspheres, and uses new container closure system, such that clinical operation is more convenient.

The Company has filed a Patent Cooperation Treaty application for its Triptorelin Microspheres pharmaceutical composition and such application entered into China, the United States (''U.S.'') and Europe in 2014.

According to IQVIA, the market size for gonadotropin-releasing hormone agonist products in China in 2018 was approximately RMB4.95 billion, and grew at a compound annual growth rate of 19.7% from 2016 to 2018. The market size for triptorelin in China in 2018 was approximately RMB1.03 billion, with a compound annual growth rate of 5.2% from 2016 to 2018.

The Company believes that LY01007 has a good marketing potential and will provide an impetus to the Group's development in the oncology therapeutic area. In addition to this drug, the Company has another gonadotropin-releasing hormone agonist product, Goserelin Acetate Extended Release Microspheres for Injection, which has commenced phase III clinical trial in China and completed phase I clinical trial in the U.S..

By Order of the Board

LUYE PHARMA GROUP LTD.

Liu Dian Bo

Chairman

Hong Kong, 5 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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