Chinese pharmaceutical company Kexing Biopharm (SHA:688136) announced on Wednesday that China's National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for its independently developed innovative product, GB18.
It comes shortly after the US Food and Drug Administration (FDA) approved the IND application for GB18.
GB18 is an innovative biologic product developed for the treatment of cancer cachexia, a complication with a prevalence up to 40-70% among cancer patients. Currently, no specific biological therapies are available to address the condition, presenting vast market potential.
Last October, a research article of GB18's preclinical study was published in international academic journal mAbs. The study demonstrated that GB18 effectively alleviated weight loss in cancer cachexia models, demonstrating superior weight recovery and improved muscle fibres in both quantity and size compared to the comparator.
Innovent Biologics updates IBI343 data from Phase 1 clinical study in advanced pancreatic cancer
CirCode Biomed's IND application for HM2002 receives FDA clearance
Leads Biolabs reports LBL-024 clinical data in advanced EP-NEC at 2025 ASCO
Clarity Pharmaceuticals images first patient in 64Cu-SAR-bisPSMA PET/CT Phase III AMPLIFY trial
Kexing Biopharm's IND application for GB18 approved by US and Chinese regulators
CARsgen's Satri-cel granted Chinese Priority Review
RemeGen secures approval in China for Telitacicept in treating generalised myasthenia gravis