Nearly $1.2 billion: Chinese-developed nano bispecific antibody ADC licensed for overseas markets

Source: Antibody Circle

On August 29, Novatim Immune Therapeutics (Zhejiang) Co., Ltd. announced an exclusive licensing agreement with Radiance Biopharma, granting Radiance the overseas development, regulatory, and commercialization rights for KY-0301, the world’s first nano bispecific antibody ADC. The total deal value reaches as high as $1.165 billion.

According to the terms of the agreement, Novatim will obtain $15 million initial payment, as well as the highest $150 million R&D registration milestone payment, and $1 billion commercialization milestone payment. It will also receive tiered sales royalties based on the annual net sales in the licensed territory.

KY-0301 is a globally first-in-class nano bispecific antibody ADC independently developed by Novatim. It received U.S. IND approval in 2024 and is currently undergoing Phase I dose-escalation clinical trials in China. The first subject was dosed in May, and the trial is expected to be completed by the end of 2017.

Compared to traditional bispecific ADC, KY-0301 demonstrates more effective tumor tissue penetration, higher anti-tumor activity, and superior safety. Moreover, based on the broad overexpression of MET and EGFR in tumors and innovative differential design, KY-0301 has the potential to bring new breakthroughs in the treatment of non-small cell lung cancer, colorectal cancer, head and neck squamous cell carcinoma, and other indications.

In preclinical studies, experiments using four CDX animal models and two PDX animal models consistently showed that KY-0301 rapidly inhibited the growth of various solid tumors, achieving near-complete regression, and demonstrated almost double the drug delivery capacity compared to conventional bispecific ADCs within the same timeframe.