Novatim Immune Therapeutics (Zhejiang) Co., Ltd. (hereinafter referred to as "Novatim") announced that its newly independently developed global first nano-bispecific ADC - KY-0301, having already received FDA clinical trial approval in December 2024, has now obtained the clinical trial implied approval from the Center For Drug Evaluation of the National Medical Products Administration (NMPA).
KY-0301 is the world's first nano bispecific antibody-drug conjugate (BsNb-ADC) developed by Novatim based on its independently innovated nano bispecific antibody ADC platform "TPEBEN". By simultaneously targeting the interstitial epithelial transformation factor (c-MET) and the epidermal growth factor receptor (EGFR), it develops a bispecific nano antibody-drug conjugate (BsNb-ADC), which can more effectively deliver the drug to tumor tissues and solve the toxicity caused by excessive drug retention in the blood system. Combined with the unique safety design, it makes the drug safety much higher than that of similar bispecific ADC products on the market currently. At the same time, it systematically optimizes the nano bispecific antibody ADC process to solve the problem of product homogeneity and increase the purity of the DAR4 product to the highest level in the industry (98%).
In preclinical studies, KY-0301 demonstrated superior tumor tissue penetration, higher anti-tumor activity, and better safety compared to traditional bispecific ADCs. The experimental results from four CDX animal models and two PDX animal models all indicated that KY-0301 could rapidly inhibit the growth of various solid tumors and almost all achieved complete regression. Moreover, within the same time frame, it was observed that its drug delivery capacity was nearly twice that of traditional bispecific ADCs. The toxicological data also demonstrated better safety results than traditional dual-antibody ADCs, laying a solid foundation for its clinical research.
Novatim
Novatim Immune Therapeutics (Zhejiang) Co., Ltd. was established in 2018. It is a biopharmaceutical technology enterprise specializing in the research and development of innovative drugs for tumor immunotherapy. Based on clinical needs and differentiation, it is committed to establishing three research and development platforms: dual-function antibody platform, nano-bispecific ADC platform, and enhanced dual-target CAR-T platform. It independently developed over 10 novel and differentiated potential FIC/BIC pipelines.
Based on the dual-functional antibody platform, Novatim independently developed the first βγ-biased PD1/IL2 fusion protein in China. Currently, the PD1/IL2 antibody is in Phase Ⅰb clinical trial in China, and has also obtained IND approval in the United States. Based on the nano-bispecific ADC platform, Novatim independently developed the world's first nano-bispecific ADC, and both China and the United States have obtained IND approval. Based on the enhanced dual-target CAR-T platform, Novatim independently developed the world's first parallel enhanced structure dual-target CAR-T, which is currently in clinical Phase Ⅰ/Ⅱa.
