[Edaily Reporter Na Eun-kyung] The domestic livestock industry is on the verge of achieving the localization of foot-and-mouth disease (FMD) vaccines, a product it has relied on imports for decades. With #OptiPharm recently receiving approval for its FMD vaccine clinical trial plan and commencing full-scale clinical trials, there is speculation that Korea’s first domestically produced FMD vaccine could be commercialized as early as next year.

In particular, the development of a Korean-specific vaccine tailored to domestic strains and a production process compatible with standard manufacturing facilities are cited as key strengths. Attention is focused not only on the domestic market, valued at 100 billion won annually, but also on the potential for future expansion into overseas markets.

'Korean-style vaccine' containing Andong and Boeun strains… Countdown to commercialization

According to OptiPharm on the 7th, the company received approval for a clinical trial plan for its FMDV-VLP vaccine candidate from the Animal and Plant Quarantine Agency last April and has been conducting on-farm clinical trials since last month. OptiPharm plans to apply for marketing authorization by the end of this year or early next year after completing the clinical trials this year, and then begin sales.

Foot-and-mouth disease (FMD) is a Class 1 notifiable livestock disease that affects cloven-hoofed animals such as cattle and pigs. In South Korea, FMD vaccination has been mandatory since 2011. However, as there are currently no domestically produced vaccines, the country relies on imports for the majority of its vaccine supply. The biotech industry estimates the size of the domestic FMD vaccine market to be approximately 100 billion won annually.

A key feature of the vaccine being developed by OptiPharm is that it is designed based on FMD virus strains that have actually circulated in South Korea. OptiPharm has been working to develop a vaccine better suited to the domestic disease control environment by incorporating the Yeoncheon strain (Type A), the Andong strain (Type O), and the Boeun strain.

While existing imported vaccines were developed based on global epidemic strains, OptiPharm explains that it aims to create a Korean-specific vaccine that reflects domestic outbreak cases. OptiPharm expects this to enhance the efficiency of domestic disease control and contribute to securing vaccine sovereignty in the future.

Passed Over 10 Rounds of Validation… Final Stage Before Approval

OptiPharm also secured meaningful results during the pre-commercial validation process. An OptiPharm official explained, “In collaboration with the Foot-and-Mouth Disease Vaccine Research Center, we conducted over 10 preliminary experiments in a Biosafety Level 3 (BSL-3) facility,” adding, “Through this, we obtained data demonstrating excellent protective efficacy.” At the end of last year, the company also conducted a challenge test to verify the vaccine’s protective efficacy by exposing it to the actual foot-and-mouth disease virus.

Since the foot-and-mouth disease vaccine is a veterinary drug, its development process is relatively simpler compared to human pharmaceuticals. Once the safety and efficacy of the foot-and-mouth disease vaccine are confirmed in clinical trials, it can be commercialized after obtaining marketing authorization. For this reason, the biotech industry interprets OptiPharm’s entry into the clinical phase as a sign that the development of a domestically produced foot-and-mouth disease vaccine has effectively reached its final hurdle.

In particular, concerns have persistently been raised regarding so-called “abnormal meat” issues—specifically, the formation of granulomas or abscesses at the injection site—with vaccines currently used in Korea. For livestock farmers, this is a sensitive issue as it reduces the market value of the meat during the slaughter process.

OptiPharm is developing a vaccine that utilizes various combinations of adjuvants instead of the conventional oil-based adjuvant, with the aim of reducing the likelihood of abnormal meat formation.

Aiming Beyond the 100 Billion Won Domestic Market to Target Overseas Markets

The localization of the foot-and-mouth disease vaccine goes beyond simply replacing imports. It is also significant in terms of establishing a stable vaccine supply system during emergency disease control situations and strengthening the nation’s disease control capabilities.

OptiPharm’s vaccine is being developed using virus-like particle (VLP) technology. Since it does not require the cultivation of live viruses like conventional vaccines, it can be manufactured in standard veterinary vaccine production facilities. The company expects this approach to lower production costs and facilitate increased production capacity in the event of an emergency.

If foot-and-mouth disease spreads on a large scale, the damage to farms is estimated to reach hundreds of billions of won. In fact, during the 2010–2011 foot-and-mouth disease outbreak, approximately 3.9 million animals were culled nationwide, and the financial losses to farms exceeded 3 trillion won.

OptiPharm plans to first verify the product’s competitiveness through domestic sales before expanding into overseas markets. The global foot-and-mouth disease vaccine market is estimated to be worth trillions of won, with sustained demand centered in East and Southeast Asia.

An OptiPharm official stated, “We are currently conducting clinical trials for the foot-and-mouth disease vaccine,” adding, “Our goal is to focus on clinical trials this year and proceed with the marketing authorization process by the end of this year or early next year to begin sales.”

The official added, “We plan to finalize our strategy for entering overseas markets after confirming the results of domestic sales.”