亚虹医药(688176) - 江苏亚虹医药科技股份有限公司投资者关系活动记录表

Group 1: Product Information - The company’s product, Dipaht (Pazopanib tablets), is a multi-targeted tyrosine kinase inhibitor (TKI) for first-line treatment of advanced renal cell carcinoma, with an estimated 431,000 new cases globally in 2020, and approximately 70,000 in China [3] - Dipaht was officially prescribed for the first time in Shanghai in October 2023 and has been included in medical insurance [3] - APL-1706 Phase III clinical trial demonstrated superior detection of bladder cancer compared to white light cystoscopy (WLC), with 43.3% of patients (42 out of 97) having additional lesions detected [4] Group 2: Clinical Trials and Results - APL-1706 Phase III trial confirmed its efficacy in detecting carcinoma in situ (CIS) with 84.6% of CIS patients (11 out of 13) having lesions detected that were not found by WLC [4] - APL-1202 is undergoing three key clinical trials, with the Phase II trial completed in September 2023 showing positive interim results [5] - The company is closely monitoring the follow-up of trial participants for APL-1202 and will disclose results according to regulations [6] Group 3: Financial Status - As of September 2023, the company had approximately CNY 2.386 billion in cash and financial assets, indicating a solid financial reserve for stable development [5] Group 4: Commercialization and Team Structure - The company has established a commercialization team that includes departments for medical affairs, market access, sales, and digital operations, aiming to create a professional team for future product launches [5] - The company has launched an online management platform "Hongyi Hui" to provide comprehensive services for urological diseases, enhancing its integrated treatment approach [6] Group 5: Regulatory and Approval Process - The company is actively preparing NDA applications for APL-1702 and APL-1706, ensuring compliance with relevant regulations for timely disclosure [6] - The company will continue to monitor the clinical trial progress of APL-1202 and will disclose information as required by regulations [7]