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.
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
FDA approves Bio-Thera and Hikma's biosimilar STARJEMZA for US market
Innate Pharma reports sustained efficacy of lacutamab in Sézary syndrome and mycosis fungoides
Moderna withdraws application for flu-COVID combination vaccine pending additional efficacy data
Promontory Therapeutics reports successful FDA meeting after Phase 2 study of PT-112
Life Molecular Imaging and SOFIE announce Neuraceq distribution in Albany, NY