The Ministry of Food and Drug Safety (MFDS) said Friday that it published a guideline regarding the clinical pharmacological considerations for antibody-drug conjugate (ADCs) to help Korean companies enter early-stage clinical trials.

ADCs have recently emerged as an essential platform for developing next-generation oncology drugs. They are targeted cancer therapies that combine antibodies that bind to specific antigens on the surface of cancer cells with cytotoxic drugs. 

For instance, LegoChem Biosciences, one of the most active in this area, signed a $1.25 billion licensing agreement with Amgen in Dember last year. More recently, it partnered with Swiss biotech Elthera to develop and commercialize a monoclonal antibody as a cancer target in several solid tumors. 

Biopharmaceutical giants, such as Celltrion and Lotte Biologics, also signed deals with Pinotbio, a company specializing in developing ADC platforms. In May, Pinotbio received 5 billion won ($3.8 million) in state funds to develop the manufacturing process for ADC’s GMP production.

This guideline is designed to support the commercialization of ADCs developed by domestic companies as part of the Regulatory Innovation 2.0 Project, which is being promoted to expand patient treatment opportunities.

Since ADC drugs have cytotoxic components, they can cause serious side effects even in small doses if they destroy normal cells rather than cancer cells. Thus, clinical pharmacological tests to understand their in vivo dynamics are very important. 

Consequently, the guideline provides detailed information on the considerations for bioassay, dose setting, drug interactions, and immunogenicity in ADC clinical trials.

“We hope that the guidelines will help reduce the trial and error in ADC development and speed up commercialization,” a ministry official said. “We will continue to actively support drug development using new technologies based on scientific evidence to expand patient treatment opportunities.”