Recently, Jilemei® (soximerexyl sulfate tablets), a Class 1 innovative drug supported by Fangda Pharmaceutical (Suzhou) Co., Ltd. in the clinical stage, has been granted priority review and approval by the National Medical Products Administration and conditionally approved for marketing .

Developed by Zhejiang Hangyu Pharmaceutical, a subsidiary of Jiming Kexin , this drug is intended to treat adult patients with advanced non-small cell lung cancer ( NSCLC ) with murine sarcoma virus oncogene ( KRAS ) G12C mutation who have received at least one systemic therapy , providing a new treatment option for this lung cancer subtype with a well-defined molecular target.
As a partner, Fangda's team completed the production , quality release, and stability studies of Phase I and Phase II clinical samples , and provided integrated services such as clinical double-blind labeling , sample storage management , clinical drug delivery, and international transportation . With its efficient, professional, and flexible production and supply capabilities, Fangda helped the project's clinical research proceed smoothly and ultimately achieve market launch.
This assistance is a significant demonstration of Fangda Pharma's CDMO service capabilities . Fangda's clinical sample manufacturing workshop is built according to international cGMP standards .Under the "One World, One System" global unified quality system , the relevant production and testing systems can meet the audit requirements of regulatory agencies such as NMPA and FDA , providing quality assurance that meets international registration standards for innovative drug clinical research.
In the future, Fangda Pharma will continue to deepen its one-stop R&D service capabilities, covering everything from molecular discovery to commercial CDMO production , as well as from preclinical evaluation to biomarker-driven early clinical research and companion diagnostic development. This will provide key laboratory data and scientific decision support for innovative drug development, helping more original Chinese achievements to accelerate their entry into the global market.

https://bydrug.pharmcube.com/news/detail/40cb738fe91b12d14547040a00b4d000