BA1301 / Luye Group - LARVOL DELTA

A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BA1301 in Advanced Solid Tumors. (clinicaltrials.gov) - P1 | N=70 | Recruiting | Sponsor: Shandong Boan Biotechnology Co., Ltd

New P1 trial • Solid Tumor

Boan Biotech's Two Innovative Drugs Targeting Claudin 18.2 Granted ODD by FDA (PRNewswire-Asia) - "Boan Biotech today announced that two of its Claudin18.2-targeted investigational drugs have been granted the Orphan Drug Designation (ODD) for the treatment of pancreatic cancer by the U.S. Food and Drug Administration (FDA): one is BA1105, an innovative antibody; and the other is BA1301, an innovative Antibody-Drug Conjugate (ADC)."

Orphan drug • Pancreatic Cancer

Anxin International: The performance of Boan Biological (06955) is expected to be greatly improved due to the heavy volume of various products and the imminent listing [Google translation] (Investing.com) - "BA2101 (long-acting IL4R monoclonal antibody) has entered Phase 1 clinical trials in China and is expected to complete Phase 1 clinical trials for SAD by the end of 2023; BA1106 (non-IL-2 blocking anti-CD25 monoclonal antibody) has entered Phase 1 clinical trials in China. It is expected to complete the Phase 1 SAD clinical trial in 2024; BA1105 (ADCC enhanced Claudin 18.2 monoclonal antibody) has entered the Phase 1 clinical trial in China, and is expected to complete the Phase 1 SAD clinical trial by the end of 2023; BA1301 (Claudin 18.2 ADC) has obtained IND approval is expected to start phase 1 clinical trial in the second quarter of 2023; BA1202 (CEA/CD3 double antibody) is expected to receive IND approval in the first half of 2023."

IND • New P1 trial • Gastrointestinal Cancer • Immunology • Oncology • Solid Tumor

Application Proof of Shandong Boan Biotechnology Co., Ltd (HKEXnews) - "'We received the IND approval for BA1105 from the NMPA in September 2021, and are currently conducting the Phase 1 clinical trial. We plan to complete the ongoing Phase 1 clinical trial in December 2023... We were conducting the pre-clinical study of BA1301 as of the Latest Practicable Date, and we plan to submit the IND application in the first half of 2023...We received the IND approval for BA1201 from the CDE in December 2021. We plan to initiate the Phase 1 clinical trial in China by the first half of 2022 and complete the Phase 1 clinical trial in December 2023'."

New P1 trial • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

More than 40 products into the clinical! Claudin18.2 Target, who will dominate? (Echemi.com) - "On October 22, the clinical trial application of the first ADC new drug BA1301 injection submitted by Boan Bio was accepted, which may add another fire to the ADC track. BA1301 is a new ADC drug targeting Claudin18.2, which is indicated for gastric cancer, pancreatic cancer and esophageal cancer...Claudin18.2-ADC has been laid out successively by 10 pharmaceutical companies such as Henrui Pharmaceutical, Shipharmaceutical, Xinda Biological, including LM-302, JS-107, CMG901 and other drugs under research...Among the five biosimilar drugs under development, BA6101 (besumumab injection, Proliximab biosimilar) in the field of metabolism was accepted by the China Food and Drug Administration on October 14, 2021, and is currently under review and approval (supplementary task review). It is expected to be approved for marketing in the second half of 2022."

New trial • Non-US regulatory • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor