Yahong Pharmaceuticals: A performance briefing was held on September 2, with participation from Caitong Securities, Shenwan Pharmaceuticals and other institutions
Q: How is APL-1702 progressing? When will it be approved?
Answer: In May 2024, the company announced that the application for the listing of the product PL-1702 (generic name aminolevulinic acid hexyl hydrochloride ointment photodynamic therapy system) was accepted for the treatment of patients aged 18 years and above with histologically confirmed high-grade squamous intraepithelial lesions (HSIL) of the cervix who have excluded carcinoma in situ. In addition, in the first half of 2024, the Womenâs Health Division conducted an in-depth analysis of the needs of doctors and patients and the industry commercialization environment through extensive market and industry research, and had a clearer understanding of each link of the successful listing of the product. The formulation of the key listing strategy for PL-1702 has been completed. The commercial supply of the product is also being actively planned to ensure that the product is brought to domestic doctors and patients as soon as possible after the product is approved.
Regarding the follow-up progress, the company will strictly fulfill its information disclosure obligations in accordance with the âShanghai Stock Exchange Science and Technology Innovation Board Stock Listing Rulesâ and other relevant regulations.
Q: What is the progress of APL-1706âs launch?
Answer: The marketing application of PL-1706 was accepted by the National Medical Products Administration in November 2023. The company is actively promoting its marketing review and approval work, and has successfully passed the CFDI (Food and Drug Review and Inspection Center of the National Medical Products Administration) inspection, and expects to obtain marketing approval in the first half of 2025.
PL-1706 is currently the only approved contrast agent in the world to assist in the diagnosis or surgery of bladder cancer. When used in combination with a blue light cystoscope, it can effectively improve the detection rate of bladder cancer (especially the detection rate of carcinoma in situ (CIS)), make surgical resection more complete, and thus reduce the tumor recurrence rate.