Luye Pharma : VOLUNTARY ANNOUNCEMENT - A PHASE III CLINICAL TRIAL IN CHINA OF CLASS 1 NEW DRUG ANSHUFAXINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS (LY03005) IN THE TREATMENT OF MDD MET THE PREDEFINED ENDPOINTS

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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

A PHASE III CLINICAL TRIAL IN CHINA OF CLASS 1 NEW DRUG ANSHUFAXINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS (LY03005)

IN THE TREATMENT OF MDD

MET THE PREDEFINED ENDPOINTS

The board of directors (the ''Board'') of Luye Pharma Group Ltd. (the ''Company'', together with its subsidiaries, the ''Group'') is pleased to announce that a phase III clinical trial of the Group's Class 1 new chemical entity (NCE) product Anshufaxine Hydrochloride Extended-release Tablets (LY03005) in the treatment of Major Depressive Disorder (MDD) in China met the predefined endpoints.

LY03005 is a new antidepressant agent developed by the new therapeutic entity/new chemical entity (NTE/NCE) technology platform of Luye Pharma Group.

Studies reveals that Anshufaxine is a serotonin (5-HT)-norepinephrine (NE)-dopamine (DA) reuptake inhibitor (SNDRIs).

Phase Ⅲ clinical trial of LY03005 is a multi-center, randomized, double-blind and placebo-controlled study aiming to verify the efficacy and safety of LY03005 in the treatment of MDD. A total of 558 Chinese adult depressive disorder patients who met the DSM-5 diagnostic criteria was enrolled and randomized into LY03005 80 mg, 160 mg and placebo groups in a 1:1:1 ratio for 8-week double-blind treatment. Statistically significant improvements in both primary and secondary endpoints were observed in the LY03005 groups with oral administration of 80 mg and 160 mg once daily compared with placebo group.

Primary efficacy endpoint data demonstrated a statistically significant improvement (P＜0.0001) in changes of Montgomery-Asperger Depression Scale (MADRS) total score at the end of week-8 (vs baseline) in the 80 mg and 160 mg LY03005 groups in comparison with placebo group respectively.

Secondary efficacy endpoint data showed statistically significant improvements (P＜0.0001 or P＜0.05) in changes of 17-item Hamilton Depression Scale (HAM-D17), Clinical Global Impression (CGI), Hamilton Anxiety Scale (HAM-A), HAM-D17 Anxiety/Somatization Factor, HAM-D17 Cognitive

Impairment Factor, HAM-D17 Blocking Factor, MADRS Anhedonia Factor Score and Sheehan Disability Scale (SDS) total score at the end of week-8 (vs. baseline) in the 80 mg and 160 mg LY03005 groups in comparison with placebo group respectively.

Safety data showed that LY03005 was safe and well tolerated. Most of the adverse events (AEs) were mild and moderate with rare treatment termination. No related Serious Adverse Events (SAEs) occurred. Common AEs (incidence>5%, more than twice as much as placebo) observed in LY03005 groups included nausea, vomiting, headache, drowsiness, etc. There was no difference between

LY03005 and placebo in Arizona Sexual Experience Scale (ASEX) score and no patient developed Treatment Emergent Sexual Dysfunction (TESD) in the study.

The abovementioned Phase Ⅲ result suggests that LY03005 is safe and effective in the treatment of MDD and has a triple reuptake inhibitor profile with a comprehensive improvement of depressive symptoms, especially in the relief of anhedonia, improvement in cognitive function, and no impact on sexual function.

The Group had obtained patents covering the chemical compound, crystal form and formulation of

LY03005. The patents in relation to the chemical compound and crystal form had been granted in target markets such as China, the United States of America (the ''U.S.''), Europe, Japan and Korea.

According to the data from IQVIA, the size of the anti-depressants market in China in 2020 was RMB6.31 billion. In addition to China, the registration and clinical trials works in relation to LY03005 have been carried out simultaneously in the U.S. and Japan, and entered into NDA and phase I clinical stages respectively.

The Group has launched several products for the central nervous system therapeutic area, including Seroquel, Seroquel XR, Rivastigmine patches, Fentanyl patches and Buprenorphine patches, covering over 80 countries and regions around the world, including large pharmaceutical markets in China, the U.S., Europe and Japan, as well as fast growing emerging markets.

The Group's central nervous system division has set up a marketing and sales team of 110 members in relation to five major sales regions in China, covering all regions of the country.

Apart from LY03005, the Group has a number of other pipeline projects relating to the central nervous system which are under concurrent development in China and overseas markets, with projects such as LY03004 (Rykindo®, approved for marketing in China on 14 January 2021) for schizophrenia and bipolar disorder, LY03003 for Parkinson's disease, LY03010 for schizophrenia and schizoaffective disorder and LY30410 for mild to moderate Alzheimer's disease and LY03012 for chronic pain. The registration processes 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, 25 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.