Group 1 - The company Qianhong Pharmaceutical (002550.SZ) is actively communicating with the CDE regarding its innovative drugs QHRD106 and QHRD107, which are in the process of applying for the next stage of clinical research [1] - The company aims to advance the drug development progress in accordance with CDE requirements and is committed to regulatory compliance in its disclosures [1] Group 2 - An investor inquired about the core content of the CDE's feedback on drugs 106 and 107, questioning whether it pertains to technical details, clinical trial data, or procedural inquiries, and if it involves significant issues affecting drug safety and efficacy [3] - The investor also asked if the company needs to submit supplementary materials in response to the feedback and the expected timeline for such submissions [3]
千红制药:公司创新药物QHRD106、QHRD107处于与CDE沟通申请进入下一阶段临床研究过程中