BA1302 / Luye Group, Shandong Boan Biotechnology - LARVOL DELTA

Shandong Boan Biotechnology…announces that BA1302, a novel CD228-directed antibody-drug conjugate ('ADC') independently developed by the Company, has completed the monotherapy dose-escalation phase of the phase I clinical trial ('Phase Ia') in China (HKEXnews) - "As of 1 August 2026, the Phase Ia trial had evaluated seven dose levels ranging from 0.2 mg/kg to 3.6 mg/kg. A total of 36 subjects with different types of advanced solid tumors were enrolled in the trial....Preliminary anti-tumor activity was observed in multiple types of solid tumors. Partial responses ('PR') were observed in subjects with triple-negative breast cancer, esophageal carcinoma, melanoma, and cervical cancer. Specifically, one of the two subjects with triple-negative breast cancer achieved a PR, one of the three subjects with CD228-positive esophageal cancer achieved a PR, one of the twelve subjects with melanoma treated at a dose of 2.0 mg/kg or higher achieved a PR, and the only subject with cervical cancer achieved a PR."

P1 data • Trial completion • Cervical Cancer • Esophageal Cancer • Melanoma • Triple Negative Breast Cancer

APPROVAL OBTAINED FOR INITIATING CLINICAL TRIALS FOR BA1302 IN THE U.S. (HKEXnews) - "The board of directors (the 'Board') of Shandong Boan Biotechnology Co., Ltd. (the 'Company') announces that the United States (the 'U.S.') Food and Drug Administration ('FDA') has approved the initiation of clinical trials of the novel antibody-drug conjugate ('ADC') targeting CD228 (BA1302) independently developed by the Company. BA1302 is intended for the treatment of various solid tumors....The Phase 1 clinical trial of BA1302 is ongoing in the People’s Republic of China ('China'), with its development progress leading similar projects globally."

IND • Trial status • Breast Cancer • Melanoma • Non Small Cell Lung Cancer • Pancreatic Adenocarcinoma

Safety and Efficacy of BA1302 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=167 | Recruiting | Sponsor: Shandong Boan Biotechnology Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Lung Adenocarcinoma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor

BA1302 GRANTED ODD FOR SQNSCLC AND PANCREATIC CANCER BY U.S. FDA (HKEXnews) - "The board of directors (the 'Board') of Shandong Boan Biotechnology Co., Ltd. (the 'Company') announces that its BA1302, a novel CD228-directed antibody drug conjugate ('ADC'), has recently been granted the Orphan Drug Designations ('ODD') by the United States (the 'U.S.') Food and Drug Administration ('FDA') for the treatment of squamous non-small-cell lung cancer ('sqNSCLC') and pancreatic cancer respectively. Intended for treatment of various solid tumors, BA1302 is the first CD228 ADC to enter the clinical stage in China and the only one undergoing clinical development worldwide."

Orphan drug • Lung Non-Small Cell Squamous Cancer • Pancreatic Cancer

Safety and Efficacy of BA1302 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=167 | Not yet recruiting | Sponsor: Shandong Boan Biotechnology Co., Ltd

Metastases • New P1 trial • Breast Cancer • Gastrointestinal Cancer • Hepatology • Lung Adenocarcinoma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Boan Biopharma’s new ADC drug approved for clinical use in advanced solid tumors [Google translation] (Eastmoney.com) - "On July 25, the official website of the Drug Review Center of the National Medical Products Administration announced that the Class 1 new drug BA1302 for injection applied by Boan Bio was approved for clinical trials and is intended to be developed for the treatment of advanced solid tumors...Preclinical studies have shown that BA1302 has excellent tumor inhibition effects in tumor models such as lung cancer, gastric cancer and melanoma, and has good safety and tolerance in cynomolgus monkey toxicology pre-experiments."

New trial • Gastric Cancer • Lung Cancer • Melanoma • Oncology • Skin Cancer • Solid Tumor