Source: Biopharmaceutical Era
On January 16, Novatim Immune Therapeutics (Zhejiang) Co., Ltd. (hereinafter referred to as "Novatim") announced itsThe World's First Nano Bispecific ADC Developed Entirely In-House—KY-0301Following the FDA clinical trial approval obtained in December 2024, it has now received the tacit approval for clinical trials from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China.
KY-0301 is Novatim's nano bispecific ADC platform based on independent innovation.The world's first nano bispecific ADC developed by "TPEBEN"。By simultaneously targeting c-MET (cellular-mesenchymal epithelial transition factor) and EGFR (epidermal growth factor receptor), the development of bispecific nanobody-drug conjugates (BsNb-ADC) can deliver drugs to tumor tissues more effectively, address toxicity caused by prolonged drug retention in the bloodstream, and incorporate innovative safety designs.Thereby making the drug safety much higher than that of similar bispecific ADC products currently on the market.At the same time, systematically optimize the nano bispecific ADC process to address the issue of product uniformity.Increase the purity of DAR4 products to the highest level in the industry (98%).In preclinical studies, KY-0301 demonstrated more effective tumor tissue penetration, higher anti-tumor activity, and better safety compared to traditional bispecific antibody-drug conjugates (ADCs).Experimental results from four CDX animal models and two PDX animal models showed that KY-0301 rapidly inhibited the growth of various solid tumors, almost all reaching a state of complete regression, with drug delivery capacity nearly doubled compared to traditional bispecific ADCs within the same timeframe.Its toxicological data also demonstrated better safety results compared to traditional bispecific ADCs, laying a solid foundation for its clinical research.Novatim Immune Therapeutics (Zhejiang) Co., Ltd.Founded in 2018, focusedTumor ImmunotherapyA biopharmaceutical technology enterprise focused on the research and development of innovative drugs and clinical applications, based on clinical needs and differentiation, is committed to efficient and breakthrough R&D innovation by establishing three major R&D platforms:Bifunctional Antibody Platform, Nano Bispecific ADC Platform, Enhanced Dual-Target CAR-T Platform.Independently developed from scratch more than 10 novel, differentiated potential FIC/BIC pipelines.Based on a bispecific antibody platform, the company has independently developed China's first βγ-biased PD1/IL2 fusion protein, which is currently in Phase Ⅰb clinical trials in China as a monotherapy or in combination with PD-L1 monoclonal antibody, and has also received IND approval in the United States.Based on the nano bispecific antibody ADC platform, the company independently developed the world's first nano bispecific antibody ADC, obtaining IND approval in both China and the United States;Based on the enhanced dual-target CAR-T platform, the company has independently developed the world's first parallel-enhanced structure dual-target CAR-T, which is currently in clinical PhaseⅠ/Ⅱa.
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