Luye Pharma : VOLUNTARY ANNOUNCEMENT - APPROVAL FOR CLINICAL TRIAL FOR LURBINECTEDIN (LY01017) 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 CLINICAL TRIAL FOR

LURBINECTEDIN (LY01017) 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 Lurbinectedin for injection (LY01017), a product of the Group licensed in from Pharma Mar, S.A. (''PharmaMar''), has obtained the approval from the Centre for Drug Evaluation (''CDE'') of the People's Republic of China (''China'') to initiate clinical trials.

Lurbinectedin indicated for Small Cell Lung Cancer (''SCLC'') is an inhibitor of RNA polymerase II. RNA polymerase II is an enzyme that is essential for the transcription process that is over-activated in tumors with transcriptional addiction.

In June 2020, the U.S. Food and Drug Administration (FDA) has approved Lurbinectedin (brand name: ZepzelcaTM) for the treatment of adult patients with metastatic Small Cell Lung Cancer (SCLC) who suffered from relapse, after platinum-based chemotherapy. Lurbinectedin was approved under ''Accelerated Approval'' based on monotherapy clinical data from an open-label,multi-center, single- arm study in 105 adult platinum-sensitive and platinum-resistant patients with relapsed SCLC. The data showed that in relapsed SCLC, Lurbinectedin demonstrated an Overall Response Rate (ORR) of 35 percent and a median Duration of Response (DoR) of 5.3 months as measured by investigator assessment (30 percent and 5.1 months respectively, as measured by an independent review committee (IRC)).

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In addition to receiving the accelerated approval by the FDA, Lurbinectedin is currently available to patients in Australia and Singapore via the Special Access Scheme and submitted New Drug Applications (''NDA'') in Switzerland, Canada and Israel. Lurbinectedin has also been granted Orphan Drug Designation in the U.S., the European Union, Switzerland and Australia for the treatment of patients with SCLC.

In April 2019, the Group and PharmaMar entered into a license development and commercialization agreement with respect to Lurbinectedin (the ''Agreement''). Pursuant to the terms of the Agreement, the Company was granted the exclusive rights to develop and commercialize Lurbinectedin for Small Cell Lung Cancer and all other indications in China. In addition, the Company will also have the right to request the transfer of the technology with respect to the manufacturing of Zepzelca™ to the Company in China during the term of the Agreement.

According to the World Health Organization, the number of new lung cancer cases and deaths from lung cancer in China was about 774,000, and 690,000 in 2018 respectively.

Based on the Group's knowledge, there is very limited number of drugs effective for SCLC on the market. Backed by the solid data from the U.S. clinical trials, the Board believes that the drug will bring more possibilities for the patients suffering from SCLC.

By Order of the Board

LUYE PHARMA GROUP LTD.

Liu Dian Bo

Chairman

Hong Kong, 26 August 2020

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 director of the Company is Mr. SONG Rui Lin; 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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