Luye Pharma : VOLUNTARY ANNOUNCEMENT - APPROVAL FOR INITIATING CLINICAL TRIAL FOR NIVOLUMAB INJECTION ("LY01015") 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

APPROVAL FOR INITIATING CLINICAL TRIAL FOR NIVOLUMAB

INJECTION (''LY01015'') 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 Nivolumab injection (''LY01015'') 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) has obtained the approval from the National Medical Products Administration (''NMPA'') of the People's Republic of China (''China'') to initiate clinical trials.

As the first biosimilar to OPDIVO® approved for clinical trials according to Registration Classification

3.3 of Biological Product, LY01015, is indicated for the treatment of patients with Melanoma, Non- Small Cell Lung Cancer (NSCLC), Malignant Pleural Mesothelioma, Renal Cell Carcinoma (RCC), Classical Hodgkin Lymphoma (cHL), Squamous Cell Carcinoma of the Head and Neck (SCCHN), Urothelial Carcinoma, Colorectal Cancer, Hepatocellular Carcinoma (HCC), Esophageal Squamous Cell Carcinoma (ESCC) and Advanced Gastric or Gastroesophageal Junction Cancer (GC/GEJC).

In addition to the market in China, Boan Biotech is also planning to register LY1015 in other countries and regions.

PD-1 is a negative immune regulatory molecule. Interacting with its ligands, PD-L1 or PD-L2,PD-1 can downregulate the activity levels of T-cells, leading to tumor cells escaping from the recognition and killing by the immune system. Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, which can contribute to the inhibition of tumors through immune response mediated by T-cells.

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According to public financial reports, sales of OPDIVO® (the reference drug for LY01015) amounted to US$7.20 billion in 2019 globally with an annual growth rate of 7.0%. OPDIVO® obtained the Biologics License Application (''BLA'') approval in China in June 2018.

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 stabilization, 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, apart from LY01015, 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, one of its innovative antibody products, LY-CovMab for neutralizing SARS-CoV-2 completed phase I clinical trial in China. 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.

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.

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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