ANKE BIO(300009)2022-11-22 03:06Group 1: Production and Sales Progress - The annual production capacity of the recombinant human growth hormone production line is 20 million units, with the expansion project completed last year and currently undergoing verification with the National Medical Products Administration [2] - The sales volume of recombinant human growth hormone injection exceeded the total sales of the previous year in Q1 2021, indicating a positive market outlook [3] - The company is planning to build new production lines for recombinant human growth hormone to meet market demand [2] Group 2: Regulatory and Approval Status - The application for new specifications of recombinant human growth hormone injection is currently in the sample inspection phase, with expected approval around mid-year [3] - The HER-2 monoclonal antibody clinical trial is being conducted according to the national biosimilar standards, aiming for production approval as the second HER-2 biosimilar in China [4] Group 3: Strategic Development and Marketing - The company has adjusted its strategic direction since 2020, focusing on gene-engineered drugs and enhancing brand influence to increase market share [3] - The marketing strategy will combine online and offline promotion, with an expected increase in sales expenses compared to 2020 due to more offline activities [4] Group 4: Research and Development Initiatives - The company is actively involved in the development of CAR-T cell therapy, with ongoing clinical research and preparations for regulatory submissions in both China and the U.S. [4] - The company is also preparing to launch a new injection device for growth hormone that alleviates injection fears and enhances user convenience [5]