suzhou, january 9 2024- alphamab oncology (stock code: 9966.hk) announced an application for clinical trial of jskn016, a new generation of bispecific antibody adc drug, was officially accepted by cde and will carry out clinical research on the treatment of advanced malignant solid tumors.
jskn016 can simultaneously target her3 (human epidermal growth factor receptor 3) and trop2 (trophoblast cell surface antigen 2, human trophoblastic surface antigen 2). after binding with trop2 or her3 on the surface of tumor cells, jskn016 enters the lysosome through target-mediated endocytosis, releasing cytotoxic topoisomerase i inhibitor (topii), and then inducing tumor cell apoptosis. in addition, the inhibitor can penetrate the cell membrane and enter the antigen-negative tumor cells to exert bystander effect.these effects can effectively inhibit the growth of tumor cells.
this is the first global clinical study of jskn016 to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics, and antitumor activity of jskn016 in chinese subjects with advanced malignant solid tumors.
about jskn016
jskn016 is a bispecific antibody conjugated drug (adc) targeting her3 and trop2, which is developed inhouse with proprietary glycan-specific conjugation platform. jskn003 can induce apoptosis of trop2 or her3 positive tumor cells, and penetrate the cell membrane into antigen-negative tumor cells to exert bystander effect, thus effectively inhibiting the growth of tumor cells. the clinical study of jskn016 for the treatment of advanced malignant solid tumors has been accepted by the cde.
about alphamab oncology
alphamab oncology is a biopharmaceutical company dedicated to the discovery, development manufacturing and commercialization of world-class innovative biotherapeutics for cancer treatment. on december 12, 2019, alphamab oncology was listed on the main board of hong kong stock exchange, with the stock code:9966.
to make cancer manageable and curable，alphamab oncology has always been guided by clinical value and patient needs, and focuses on the development of innovative, safe and affordable anti-tumor drugs to benefit patients in china and around the world.
we have created a biological macromolecule drug discovery, research and development, manufactured technology platform with independent intellectual property rights such as protein/antibody engineering, antibody screening, multi-module/multi-functional antibody modification.
with multiple in-house proprietary technology platforms, alphamab oncology has established a globally competitive and differentiated pipeline which consists of tumor single domain antibody/monoclonal antibodies, multi-functional antibodies, and antibody-drug conjugates. among them, the world's first subcutaneous pd-l1 inhibitor injection (envafolimab) has been obtained the market approval by the chinese national medical products administration, several varieties have entered the critical clinical stage in china and the united states, 2 varieties were selected into the national special project of " new drug development", and 3 varieties were granted 4 orphan drug qualifications by fda.
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