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LUYE PHARMA GROUP LTD.

(Incorporated in Bermuda with limited liability)

(Stock Code: 02186)

VOLUNTARY ANNOUNCEMENT

CLASS 1 NEW DRUG LY03014 COMMENCED ENROLMENT OF SUBJECTS IN

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'') announces that enrolment of subjects in phase I clinical trial in the People's Republic of China (''China'') has commenced in relation to the Group's Class 1 new drug LPM3480392 injection (''LY03014'').

LY03014 is a small molecule Gi protein biased at mu-opioid receptor agonist, and is indicated for the treatment of postoperative moderate-to-severe acute pain and breakthrough cancer pain. Completed non-clinical 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).

The first phase I clinical trial of LY03014 is a randomized, double-blind, placebo-controlled, dose-escalation clinical study in Chinese healthy subjects to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics characteristics of a single intravenous infusion of LPM3480392 in humans.

There are 300 million surgical patients worldwide each year, more than 80% of whom experience postoperative pain, and approximately 75% of these patients experience acute postoperative pain. Opioids are the most common medication for moderate to severe pain and the golden standard for postoperative pain medication. There is no concern on addiction to the extent that the postoperativepain medication does not exceed 72 hours. According to the data from IQVIA, the size of the analgesics market in China in 2019 reached RMB15.82 billion, with a compound annual growth rate (CAGR) of 17.4% from 2017 to 2019.

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, 18 March 2021

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 directors of the Company are Mr. SONG Rui Lin and Mr. Sun Xin; 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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Luye Pharma Group Ltd. published this content on 18 March 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 18 March 2021 04:05:00 UTC.