吉贝尔：抗抑郁新药完成III期临床试验并拟申报NDA

Core Viewpoint - The company has successfully completed Phase III clinical trials for its new antidepressant drug JJH201501, showing significant efficacy compared to placebo and comparable to a standard treatment, with good safety and tolerability [1] Group 1: Clinical Trials and Drug Development - JJH201501 has demonstrated significant efficacy in both 10mg and 15mg dosage groups compared to placebo, and is on par with the 20mg group of hydrobromide vortioxetine [1] - The company is preparing to submit a new drug application for JJH201501 [1] - The anticancer drug JJH201601 is currently undergoing a Phase IIa clinical trial for cholangiocarcinoma, with 21 patients enrolled, and results are expected in the first half of 2026 [1] - Plans are in place to expand JJH201601's application to head and neck squamous cell carcinoma combination therapy [1] Group 2: Financial Performance - For the first three quarters of 2025, the company achieved sales revenue of 704.43 million yuan, representing a year-on-year growth of 9.52% [1] - Revenue from Niquilol tablets reached 135.29 million yuan, showing a significant year-on-year increase of 47.09% [1] - Research and development expenses totaled 52.33 million yuan, with the majority allocated to ongoing projects like JJH201601, while capitalized costs were focused on JJH201501 [1] Group 3: Market Strategy - The company is strengthening its OTC channel layout, indicating that the outpatient market will become an important component of future growth [1]