US EditionKexing Biopharm's GB18 project received clearance of IND application from NMPA and FDA
- Kexing Biopharm announced on May 28, 2025, from Shenzhen, China, that NMPA approved its IND application for GB18 after earlier FDA clearance on May 21.
- This approval follows the company's independent development of GB18, an innovative biologic aimed at treating cancer cachexia, which affects 40% to 70% of cancer patients.
- GB18 targets GDF-15 through a unique nanobody-Fc fusion structure and demonstrated superior stability, bioavailability, and efficacy in preclinical studies published in the journal mAbs.
- The FDA approval marks a significant milestone amid the unmet clinical need for cancer cachexia treatments, with millions of advanced patients worldwide potentially benefiting from GB18.
- Kexing Biopharm is dedicated to advancing scientific research and maintaining high standards in its offerings to support effective treatments and enhance patient well-being on a global scale.
68 Articles
68 Articles
The Conway Daily Sun
Kexing Biopharm's GB18 project received clearance of IND application from NMPA and FDA
SHENZHEN, China, May 28, 2025 /PRNewswire/ -- On May 26th, Kexing Biopharm (688136.SH) announced that the National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for its independently developed innovative product, GB18. Moreover, GB18 has previously…
Kexing Biopharm's GB18 project received clearance of IND application from NMPA and FDA - PressReach
SHENZHEN, China, May 28, 2025 /PRNewswire/ — On May 26th, Kexing Biopharm (688136.SH) announced that the National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for its independently developed innovative product, GB18. Moreover, GB18 has previously received the clearance from U.S. Food and Drug Administration (FDA) for IND application on May 21st. GB18 is an innovative biologic product develope…
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