Luye Pharma Group Limited — Regulatory Filings 2021

Jul 28, 2021

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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

NEW INDICATION APPROVED FOR BOYOUNUO (BEVACIZUMAB INJECTION) IN CHINA

The board of directors (the ‘‘Board’’) of Luye Pharma Group Ltd. (the ‘‘Company’’, together with its subsidiaries, the ‘‘Group’’) announces that the Bevacizumab injection (‘‘LY01008’’, or ‘‘Boyounuo’’) of 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 been approved by the National Medical Products Administration (‘‘NMPA’’) of the People’s Republic of China (‘‘China’’) for the treatment of recurrent glioblastoma (‘‘GBM’’), which is the third approved indication of Boyounuo in China. In April 2021, Boyounuo was approved by the NMPA for the treatment of advanced, metastatic or recurrent non-small cell lung cancer and metastatic colorectal cancer.

GBM is the most common malignant primary brain tumor, representing approximately 57% of all gliomas and 48% of all primary malignant central nervous system (‘‘CNS’’) tumors. GBM is regarded as one of the most difficult tumors to treat in the field of neurosurgery, characterized by high morbidity, high recurrence rate, high mortality rate and low cure rate. Current major treatment regimens for GBM include surgical resection, radiotherapy, and chemotherapy. The overall prognosis remains poor, and long-term survival is rare with a median survival of less than 2 years. Therefore, more new therapeutic methods are urgently needed for GBM patients.

Boyounuo is an anti-VEGF humanized monoclonal antibody injection and a biosimilar to Avastin[®] independently developed by Boan Biotech. Avastin[®] has been approved worldwide for the treatment of non-small cell lung cancer, metastatic colorectal cancer, glioblastoma, renal cell carcinoma, cervical cancer, ovarian cancer and other solid tumors. Its significant efficacy and well safety have been widely recognized. According to the ‘‘Guidelines on Similarity Evaluation and Indication Extrapolation of Biosimilars’’ 《( 生物類似藥相似性評價和適應症外推技術指導原則》), Boyounuo can be gradually

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applied and approved for all indications of Avastin approved in China. According to the data from IQVIA, global sales of Bevacizumab injection were USD6.09 billion, and sales in China were RMB3.63 billion in 2020.

ABOUT BOAN BIOTECH

Boan Biotech is a fully integrated biopharmaceutical company as a subsidiary of the Group. It specialises in therapeutic antibody development, manufacturing and commercialization with a focus on oncology, autoimmune, pain and endocrine diseases. Boan Biotech’s antibody discovery activities are organized around three platforms, namely Human Antibody Transgenic Mouse and Phage Display Technology, Bispecific T-cell Engager Technology and ADC Technology Platform. Boan Biotech has developed more than 10 innovative antibody products with international intellectual property protection and 8 biosimilar products.

Boan Biotech has developed extensive experience in areas of antibody discovery, cell line development, upstream and downstream process development, analytical development, technology transfer, pilot and commercial scale production. Boan Biotech is also actively exploring other cutting-edge technologies. Its cell therapy products use non-viral vectors for CAR-T for late stage solid tumors. Boan Biotech is also developing new generation of universal CAR-T and switchable CAR-T, to develop safer, effective and affordable products for patients.

In addition to China, Boan Biotech is also engaged in biopharmaceutical products development in markets in the United States and the European Union.

By Order of the Board LUYE PHARMA GROUP LTD. Liu Dian Bo Chairman

Hong Kong, 28 July 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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