Alphamab Oncology (stock code: 9966.HK) announced that a clinical trial (Study ID: JSKN033-102) of JSKN033, a high-concentration subcutaneous co-formulation consisting of anti-HER2 bispecific antibody-drug conjugate (ADC) and PD-L1 immune checkpoint inhibitor, meets the requirements of the "Pilot Program for Optimizing the Review and Approval of Clinical Trials for Innovative Drugs", and has been included in the pilot project by the Shanghai Municipal Drug Administration with the consent of the Center for Drug Evaluation (CDE).

The IND application will be submitted to CDE accordingly and is expected to undergo accelerated review and approval process, while expediting the initiation of the phase I/II clinical trial for advanced malignant tumors. The National Medical Products Administration (NMPA) of China issued the "Pilot Program for Optimizing the Review and Approval of Clinical Trials for Innovative Drugs" on July 31, 2024, which clearly proposed to explore the establishment of working system and mechanism to comprehensively improve the quality and efficiency of clinical trials, aiming to complete the review and approval of innovative drug clinical trial applications within 30 working days, thereby shortening the time required to initiate clinical trials.

JSKN033-102 is an open-label, multicenter, Phase Ⅰ/Ⅱ clinical study designed to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics and anti-tumor activity of JSKN033 in patients with advanced metastatic malignant tumors, and to determine the maximum tolerated dose (MTD) and/or the recommended phase II dose (RP2D). The pilot leading site of this study is Fudan University Shanghai Cancer Center.

With the incidence and mortality rates rising year by year, malignant tumors have become the leading cause of death globally and in China. According to relevant research statistics, there were 19.3 million new cancer cases worldwide in 2020, and nearly 10 million people died from malignant tumors. The incidence rates of breast cancer, lung cancer, colorectal cancer, prostate cancer, and gastric cancer rank the top five among all tumor types. Despite significant advancements in immunotherapy and molecular targeted therapies in recent years, the demand for innovative drugs and new treatment options continues to grow among clinicians and patients. Alphamab Oncology has long focused on unmet clinical needs, dedicated to developing differentiated, clinically valuable, and globally competitive new drugs to help cancer patients extend survival and improve the quality of life.

JSKN033 is the global first high-concentration subcutaneous co-formulation consisting of ADC and PD-L1 immune checkpoint inhibitor in first-in-human clinical trials. Developed on top of the superior solubility and stability of the world's first subcutaneously injectable PD-L1 inhibitor Envaforlimab, JSKN033 combines immunotherapy (KN035) and ADC (JSKN003), makes ADC subcutaneous injectable and leads to improved safety and convenience. The first-in-human phase I/II clinical study of JSKN033 conducted in Australia (JSKN033-101, NCT06226766) demonstrated favorable safety profile and encouraging anti-cancer activity in heavily treated patients. Detailed clinical data were recently presented at the Annual Meeting of the Society for Immunotherapy of Cancer in 2024 (SITC 2024). The inclusion of JSKN033 in the pilot program for optimizing the review and approval of clinical trials for innovative drugs is a recognition of Alphamab's differentiated innovative pipeline products, which will also accelerate the clinical development of JSKN033 in China and is anticipated to offer a safe, effective and more compliant treatment option for patients sooner.