Sunshine Guojian Pharmaceutical: Projects 608 and 613 have both submitted new drug marketing applications to the CDE and have been accepted

Zhitong
2025.06.19 09:18

An investor asked Sunshine Guojian Pharmaceutical on the interactive platform: Noticing that the company is laying out in the field of self-immune diseases, focusing on autoimmune diseases, with pipelines such as IL-17A monoclonal antibody and IL-5 monoclonal antibody entering Phase III or NDA stages, can we expect gradual commercialization in the second half of 2025? Sunshine Guojian Pharmaceutical stated that the company's 608 project and 613 project have both submitted new drug marketing applications to the CDE and have been accepted. Since the new drug marketing application still needs to go through review, clinical trial site inspections, drug production site inspections, and approval processes, there is uncertainty regarding whether the products can be successfully marketed and the timing of the market launch. The company will fulfill its information disclosure obligations in a timely manner regarding subsequent progress in accordance with relevant regulations