suzhou, china, august 17, 2021 - alphamab oncology (stock code:9966.hk), announced that recently, the company received the "notice of approval of supplementary application for drug clinical trials" from the national medical products administration (nmpa), which approved the supplementary application for the pharmaceutical change of kn026, a recombinant humanized anti-her2 bispecific antibody, to use a liquid formulation for clinical research. this is the world's first her2 bispecific antibody approved for clinical research in liquid formulations.
kn026 is an anti-her2 bispecific antibody developed by alphamab oncology using the proprietary fc-based heterodimer bispecific platform technology called crib (charge repulsion induced bispecific). it can bind two non-overlapping epitopes of her2 simultaneously, leading to a dual her2 signal blockade. in pre-clinical studies, kn026 has demonstrated equivalent efficacy compared with the combinaton of trastuzumab and pertuzumab and was superior to either single agent in her2-positive tumor cell lines. in terms of production, the molecular size and shape of kn026 are the same as those of native igg antibodies. under current antibody production process, the product yield and quality have reached the world's leading level.
kn026 received ind approval from the national medical products administration (nmpa) of china and u.s. food and drug administration (fda) in 2018, and several phase i/ii clinical studies are undergoing, including her2 low expression or positive breast cancer, advanced her2 positive gastric and gastroesophageal junction cancer, her2-positive solid tumors, etc., showing good safety and significant anti-tumor activity.
dr. ting xu, chairman and ceo of alphamab oncology, commented, “kn026 has a unique competitive advantage among global her2 targeted agents. the approval of this liquid formulation for clinical research will provide more convenience to patients and medical staff for administration,and lay a good foundation for the development of subcutaneous injection administration in the future. this is in line with our mission to make cancer manageable and curable. we will continue to improve the quality of life of patients through innovation.”
kn026 is an anti-her2 bispecific antibody developed by alphamab oncology using the proprietary fc-based heterodimer bispecific platform technology called crib (charge repulsion induced bispecific). kn026 can bind two non-overlapping epitopes of her2 simultaneously, leading to a dual her2 signal blockade. kn026 has demonstrated potentially equivalent efficacy compared with trastuzumab and pertuzumab in combination, and was superior to either single agent, such as increased binding affinity, as well as better tumor inhibition in her2-positive tumor cell lines. additionally, kn026 has also shown inhibitory effect on tumor cells with medium or low her2 expression or trastuzumab-resistant cell lines.
kn026 received ind approval from the national medical products administration (nmpa) of china and u.s. food and drug administration (fda) in 2018. currently, it is in multiple phase i/ii clinical trials in china and phase i clinical trial in the united states. the results of phase i clinical trials show kn026 has good safety, tolerance and potentially superior anti-tumor activity in her2-positive breast cancer patients who progressed after multiple lines of anti-her2 treatment.
about alphamab oncology
alphamab oncology is focusing on innovation, production and commercialization of anti-tumor drugs. on december 12, 2019, the company was listed in the mainboard of hong kong stock exchange with stock code 9966.
alphamab has fully integrated proprietary biologics platforms in bi-specifics and protein engineering. its highly differentiated in-house pipeline includes fifteen tumor monoclonal antibodies and bispecific antibodies and a covid-19 bispecific antibody. four products have advanced into phase i-iii clinical trials or pre-marketing stage in china, the united states, japan and australia. the bla for envafolimab (kn035) has been accepted and granted priority review by the national medical products administration (nmpa).
the company also has state-of-the-art manufacturing capabilities designed and built to meet nmpa and eu/fda’s cgmp standards and a complete quality system which has passed the on-site inspection of a european union qualified person. alphamab oncology is committed to building a global leading, multi-dimensional drug development and commercialization platform, focusing on multifunctional biological innovative drugs, and to benefit patients in china and around the world.
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