The board of directors of Shanghai Henlius Biotech, Inc. announced that, recently, clinical trial application for anti-HER2 domain II humanised monoclonal antibody injection ("HLX11") developed by the Company (for the treatment of metastatic breast cancer and early breast cancer), has been approved by the National Medical Products Administration. Details of the study on the product: HLX11 is a biosimilar of pertuzumab independently developed by the Company, which can be primarily used for the following indications: metastatic breast cancer (in combination with trastuzumab and docetaxel, for the treatment of patients with HER2-positive, metastatic, or unresectable locally recurrent breast cancer who have not received prior anti-HER2 therapy or chemotherapy) and early breast cancer (neoadjuvant therapy in combination with trastuzumab and chemotherapy for the patients with HER2-positive, locally advanced, inflammatory, or early breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer; adjuvant therapy for patients with HER2-positive early breast cancer with high risk of recurrence). On 31 October 2019, the application for clinical trial for HLX11 for metastatic breast cancer and early breast cancer treatment was accepted by the NMPA. Market condition: As at the date of this announcement, the anti-HER2 Humanised Monoclonal Antibody sold in the PRC included Herceptin@ (trastuzumab injection) and Perjeta@ (pertuzumab injection). According to IQVIA CHPA's information (provided by IQVIA, a leading provider of professional medical and health information and strategic consultation), domestic sales of anti-HER2 Humanised Monoclonal Antibody in the PRC in 2018 and the first three quarters of 2019 were approximately RMB 2.73 billion and RMB 3.44 billion, respectively.