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Hangzhou, China – Novatim Immune Therapeutics (Zhejiang) Co., Ltd. (Novatim), a pioneering biopharmaceutical company focused on innovative cancer immunotherapies, has achieved a historic milestone with its nanobody-based bispecific antibody-drug conjugate (BsNb-ADC), KY-0301. With the support of SDM Bioservices, KY-0301 has received green light for clinical trial applications from both the U.S. FDA and China NMPA.
SDM Bioservices provided comprehensive medical and regulatory support for Novatim’ U.S. and China Investigational New Drug (IND) submissions. SDM team completed all necessary work and submitted the FDA IND application within just 68 days from start to finish, securing the FDA nod three days ahead of schedule. Additionally, SDM supported the preparation of clinical trial application materials for China NMPA, enabling Novatim to obtain clearance 14 working days earlier than anticipated.
This achievement represents SDM Bioservices’ dedication to client interest, SDM expertise in navigating complex regulatory landscapes and delivering efficient, high-quality solutions for biopharmaceutical companies.
About KY-0301
KY-0301 is the world’s first nanobody-based bispecific ADC, developed using Novatim Immune Therapeutics’s proprietary TPEBEN platform. By simultaneously targeting c-MET and EGFR, KY-0301 is designed to enhance drug delivery to tumor tissues while minimizing systemic toxicity. Its innovative safety profile and optimized manufacturing process, which achieves a drug-to-antibody ratio (DAR) purity of 98%, set it apart from traditional bispecific ADCs.
Preclinical studies have demonstrated KY-0301’s superior tumor penetration, potent antitumor activity, and improved safety compared to conventional ADCs. In four CDX and two PDX animal models, KY-0301 exhibited rapid tumor suppression, often achieving complete regression. Additionally, it delivered nearly twice the drug payload of traditional bispecific ADCs within the same timeframe, with a favorable toxicology profile that underscores its potential as a transformative cancer therapy.
About Novatim Immune Therapeutics
Established in 2018, Novatim Immune Therapeutics (Zhejiang) Co., Ltd. operates with Tinova (Shanghai) as its wholly-owned subsidiary, Focusing on pioneering advancements in cancer treatment, Novatim is dedicated to the research and clinical application of innovative cancer immunotherapy.
Grounded in clinical needs, Novatim strives to achieve innovative breakthroughs in discovering both first-in-class and best-in-class drugs. Specializing in cancer immunotherapy research, Novatim harnesses three key platforms: the Bifunctional Antibody Platform, the Nano Dual Antibody ADC Platform, and the Enhanced Dual Target CAR-T Platform. 10 FIC/BIC products were developed based on Novatim’s technological breakthroughs.
KY-0301 is the world's first nano-dual-anti-ADC developed by Novatim based on its own innovative nano-dual-anti-ADC platform “TPEBEN”.
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