Deregulate to foster new modalities like ADC, gene therapy

KoreaBio holds a seminar on the ‘Bio-industry Trends and Outlook’ on the 28th

Obesity drugs, ADCs, and gene therapies suddenly rise as new R&D trends

"Government role is critical, including funding, deregulation, and creation of small funds”

Seung-Kyou Lee, Vice President of KoreaBio

New modalities (therapeutic approaches) such as antibody-drug conjugates (ADCs), obesity drugs, and gene-editing technologies need dramatic regulatory relief to settle in Korea, said experts.

 

On the 14th, KoreaBio held a seminar on trends and prospects of the bio-industry at the El Tower in Seocho-gu, Seoul.

 

At the event, Seung-Kyou Lee, Vice President of KoreaBio, presented his assessment of the bio-industry this year and its prospects.

 

Lee cited gene therapy drugs, obesity and diabetes drugs, and ADCs as new modalities that the Korean pharma-bio industry is interested in and developing.

 

With the recent commercialization of gene therapy drugs such as Exa-cel, and Lyfgenia overseas, domestic companies with genetic scissors technology have also started busily developing new drugs.

 

Genetic scissors are molecular biological tools that recognize and cut specific areas in the DNA to edit genes.

 

Currently, domestic biotech companies such as ToolGen, Organoid Sciences, and GeneKOre have entered the market and started developing products.

 

Lee said that the LMO Act should be revised to vitalize the domestic gene therapy market.

 

Recently, the LMO Act was proposed to distinguish between genetically engineered organisms (GEOs) and genetically modified organisms (GMOs) to exempt them from regulations.

 

The LMO Act aims to separate GEOs from GMOs and exempt them from the regulations that apply GMOs, ultimately to foster Korea’s GEO industry.

 

"Gene therapy is rapidly emerging as a global industry trend.

 

If Korea’s regulations are not eased, it will be difficult for domestic companies to grow," he said, adding, "GMO exemptions or ease of regulations for gene-edited crops/seeds is necessary." Diabetes, obesity drugs, ADCs also on the rise..."Need more government R&D support for biotechs" Treatments for obesity and diabetes have also emerged as a major R&D trend in the Korean biotech industry.

 

The use of glucagon-like peptide (GLP-1) injectables has grown dramatically due to their ability to achieve effective weight loss.

 

As GLP-1-based obesity drugs such as Saxenda, Wegovy, and Zepbound have shown dramatic weight loss effects in clinical trials, newcomers are mostly targeting GPL-1.

 

Currently, various domestic pharmaceutical biotech companies such as Hanmi Pharmaceutical, Peptron, Inventage Lab, Dong-A ST, and Progen have entered the market.

 

Lee explained, "The number of companies developing drugs for diabetes and obesity will continue to grow.

 

However, investment sentiment in biotech companies is weak.

 

This is why it is time to expand government R&D support for biotech companies." He pointed to "ADC" as one of the modalities that will emerge as an R&D trend this year and beyond.

 

ADCs are anticancer drugs made by linking antibodies that bind to specific target antigens on the surface of cancer cells with drugs that have cell-killing properties.

 

ADCs have the advantage of using the selectivity of the antibody to its target, and the killing activity of the drug that selectively acts on cancer cells, thus increasing the therapeutic effect while minimizing side effects.

 

LigaChem Biosciences, Pinotbio, and Orum Therapeutics have succeeded in exporting ADC technology to multinational pharmaceutical companies and are being recognized for their technology.

 

"It's time for a different level of effort to be invested compared to what we've been doing so far," said Lee, adding that securing funding is essential for biotechs to focus more on drug development.

 

"I hope a small fund of KRW 30 billion to 50 billion can be created to be invested in the biotech sector." "We need to improve the conditions for maintaining the special listing in bio technology, such as relaxing the legal loss requirement and the threshold of KRW 3 billion in sales, and we would like to see support and incentives established for the self-reliance of Materials, Components, and Equipment businesses and stabilization of the supply chain of raw materials and pharmaceuticals."