Luye Pharma : VOLUNTARY ANNOUNCEMENT - CLINICAL TRIAL APPLICATION OF LY03014 WAS FORMALLY ACCEPTED BY CDE

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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

CLINICAL TRIAL APPLICATION OF LY03014

WAS FORMALLY ACCEPTED BY CDE

The board of directors of Luye Pharma Group Ltd. (''the Company'', together with its subsidiaries, the ''Group'') is pleased to announce that the clinical trial application of the Group's Class 1 new drug LPM3480392 injection product (''LY03014'') has received formal acceptance from the Centre for Drug Evaluation (''CDE'') of the People's Republic of China (''China'').

LY03014 is a small molecule Gi protein biased at mu-opioid receptor agonist, LY03014 is indicated for the treatment of postoperative moderate-to-severe acute pain and breakthrough cancer pain. Completed pharmacodynamic and pharmacokinetic studies have shown that the product is able to significantly reduce pain and reduce the occurrence of respiratory depression, constipation, and opioid tolerance. Completed toxicology studies and cardiovascular safety by long-term telemetry monitoring have shown that the product has not caused liver toxicity and changes in cardiac QT interval (an important parameter of cardiac safety).

There are 300 million surgical patients worldwide each year, more than 80% of whom experience postoperative pain, and about 75% of these patients experience acute postoperative pain. Opioids are the most common medication for moderate to severe pain and the gold standard for postoperative pain medication. There is no concern on addiction to the extent that the postoperative pain medication does not exceed 72 hours. According to the data from IQVIA, the size of the analgesics market in China in 2019 reached RMB 15.82 billion, with a compound annual growth rate (CAGR) of 17.4% from 2017 to 2019.

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The Group has launched several analgesic products globally, such as Buprenorphine transdermal patches and Fentanyl transdermal patches. Besides, the Group also has innovative small molecule pain relief oral drug LY03012 and other innovative products under research and development.

The board of directors believes that LY03014 will enrich the Group's product portfolio in the field of analgesia and will accordingly continue to promote the Group's development in such field.

By Order of the Board

LUYE PHARMA GROUP LTD.

Liu Dian Bo

Chairman

Hong Kong, 9 March 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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