Luye Pharma : VOLUNTARY ANNOUNCEMENT - NEUTRALIZING ANTIBODY AGAINST SARS-CoV-2 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

NEUTRALIZING ANTIBODY AGAINST SARS-CoV-2 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 LY-CovMab, an innovative product indicated for the coronavirus disease 2019 (''COVID-19''), developed by Shandong Boan Biotechnology Co. Ltd. 山東博安生物技術股份有限公司 (''Boan Biotech'', a subsidiary of the Company) completed phase I clinical trial in the People's Republic of China (''China'').

The clinical study completed in China is a phase I clinical study evaluating the safety, tolerability, pharmacokinetic characteristics and immunogenicity of LY-CovMab injection in a single dose. The clinical trial involved a total of 42 healthy Chinese subjects. The results show that LY-CovMab has a good safety and tolerability profile. It provides a clear reference for later clinical trials.

The COVID-19 pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) poses a tremendous threat to human health and the global economy. LY-CovMab is a human monoclonal neutralizing antibody that binds specifically to the receptor-binding domain in SARS-CoV-2 spike protein with high affinity, and can effectively block the attachment of the virus to the host cell surface receptor ACE2. The results of preclinical pharmacodynamics study show that LY-CovMab has good effects for both therapeutic and prophylactic venues against SARS-CoV-2 infection. LY-CovMab shows efficient neutralizing ability and could effectively cope with viral mutations. In addition, the FALA mutation introduced to LY-CovMab abrogates the binding with Fc receptors or complement receptors, reducing the antibody-dependent enhancement (ADE) risk.

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LY-CovMab was developed using Boan Biotech's Human Antibody Transgenic Mouse and Phage Display Technology. Antibodies derived from BA-huMab™, Boan Biotech's own human antibody transgenic mice, do not require the antibody humanization process. Through this platform Boan Biotech was able to obtain the lead antibody against SARS-CoV-2 in less than 50 days. This represents a significant acceleration of overall antibody development process.

COVID-19 is spreading across the world and LY-CovMab shows high potential therapeutic effect. Its related research has been published in ''Communications Biology'', a sub-journal of international authoritative journal ''Nature''. It is expected that phase II clinical trial of LY-CovMab will be carried out simultaneously in China, the United States and the Europe in the near future. The Group will push forward the launch of LY-CovMab in global markets and offer a potential effective therapeutic option for the patients.

LY-CovMab was included in the ''COVID-19 Neutralizing Antibody Emergency Project'' 《( 新型冠狀 病毒中和抗體產品研發應急項目》) by the Ministry of Science and Technology of China. This will speed up the research and development process and future launch of LY-CovMab in China.

ABOUT BOAN BIOTECH

Boan Biotech is a subsidiary of the Company. It is a fully integrated biopharmaceutical company established in 2013. It specialises in therapeutic antibody development with a focus on oncology, autoimmune, pain and endocrine diseases. Boan Biotech's antibody discovery activities are organised around three platforms, namely Human Antibody Transgenic Mouse and Phage Display Technology, Bispecific T-cell Engager Technology and ADC Technology Platform. It covers the whole process of target verification, antibody discovery and development, CMC. Boan Biotech has developed extensive experience in areas of antibody discovery, cell line stablization, upstream and downstream process, development of analytical methods, technology transfer, pilot scale test and commercial production. Boan Biotech's comprehensive and systematic research & development and manufacturing capabilities help ensure the high quality of antibodies, high development speed and low outsourcing services dependence. Boan Biotech has developed more than 10 innovative antibody products with international intellectual property protection and 8 biosimilar products. In relation to biosimilar products, LY01008 (Avastin® biosimilar) is expected to be approved to marketed in China soon; LY06006 (Prolia® biosimilar) and LY01011 (Xgeva® biosimilar) are under phase III clinical trial in China and phase I clinical trial in Europe as well as the United States; LY09004 (Eylea® biosimilar) is under phase III clinical trial in China. In addition, several innovative antibodies are expected to enter into the clinical stage within this year.

In addition, Boan Biotech possesses cell therapy technology that uses non-viral vectors for CAR-T for late stage solid tumors. Boan Biotech plans to develop new generation of universal CAR-T and switchable CAR-T, to develop safer, effective and affordable products for patients.

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The Group will continue to increase its investment in the research and development of biopharmaceuticals, in order to expedite the development of innovative biological products, to provide patients around the world with better treatment options and improved drug accessibility.

By Order of the Board

LUYE PHARMA GROUP LTD.

Liu Dian Bo

Chairman

Hong Kong, 6 May 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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