GB18 / Shenzhen Kexing Pharma - LARVOL DELTA

A Phase I Clinical Study to Evaluate the Efficacy and Safety of GB18 Injection in Patients With Tumor Cachexia (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Kexing Biopharm Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Biliary Tract Cancer • Breast Cancer • Cachexia • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • GDF15

A Phase I Clinical Study to Evaluate the PK, PD, Efficacy, and Safety of GB18 Injection in Patients With Tumor Cachexia (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Kexing Biopharm Co., Ltd.

First-in-human • New P1 trial • Biliary Tract Cancer • Breast Cancer • Cachexia • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • GDF15

Case Report: Electroacupuncture combined with transcutaneous auricular vagus nerve stimulation for treating antiseizure medication-resistant juvenile myoclonic epilepsy. (PubMed, Front Psychiatry) - "Despite treatment with sodium valproate and clonazepam, he continued to experience multiple seizures weekly and was unable to attend school due to anxiety...From the second session, electroacupuncture was intensified at GV20, GV24, and GB18 due to initial symptom worsening...The patient resumed school attendance, experienced reduced anxiety regarding seizures, and reported enhanced social engagement. This case suggests that combined electroacupuncture and taVNS may be a promising non-pharmacological adjunct in the treatment of ASM-resistant JME, contributing to improved seizure control and multidimensional QOL outcomes."

Journal • CNS Disorders • Epilepsy • Mood Disorders • Pain • Psychiatry

To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of GB18 Injection in Healthy Participants (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Shenzhen Kexing Pharmaceutical Co., Ltd.

New P1 trial • Cachexia • Oncology

Bidirectional Modification of a Galbulimima Alkaloid Identifies Selective Opioid Ligands. (PubMed, ACS Cent Sci) - "In an open-field activity assay, we demonstrate that by increasing G protein signaling preference, agonists display an increase in exploratory, anxiolytic-like behaviors with no signs of sedation. The brevity and success of this campaign, combined with in vitro and in vivo pharmacology, demonstrate GB18 and its analogs as tractable new opioid scaffolds that allow favorable properties to be dialed in and unwanted properties removed."

Journal • Anesthesia • ARRB1

Kexing Biopharm's GB18 project received clearance of IND application from NMPA and FDA (The Manila Times) - "On May 26th, Kexing Biopharm...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."

IND • New trial • Cachexia • Oncology

Kexing Biopharm Obtained IND Approval for Its Self-developed GB05 from U.S. FDA (PRNewswire) - "Kexing Biopharm Co., Ltd...recently announced that the Investigational New Drug Application (IND) of GB05, Human Interferon α1b Inhalation Solution, a self-developed product by the Company's wholly-owned subsidiary, Shenzhen Kexing Pharmaceutical Co., Ltd., has been approved by the United States Food and Drug Administration (FDA), and this approval allows Shenzhen Kexing to initiate its proposed clinical trials in the US. The proposed indications are pediatric lower respiratory tract infections caused by respiratory syncytial virus (RSV), such as pneumonia and bronchiolitis. This significant breakthrough in antiviral drug development brings new hope to the treatment of RSV infections in children globally...Meanwhile, the IND applications of GB18 indicated for cancer cachexia (a nanobody targeting GDF-15) are about to be submitted in both China and the US within this year."

IND • New trial • Metabolic Disorders • Pneumonia • Respiratory Syncytial Virus Infections