[Song Young Doo, Edaily Reporter] shares surged for a second consecutive day setting a new 52 week high. The rally is attributed to the U.S. Food and Drug Administration(FDA) approval of Yuvezzi a presbyopia treatment for which the company holds Korean rights.

As an application has already been submitted to Korea’s Ministry of Food and Drug Safety(MFDS) expectations are growing that FDA approval could accelerate commercialization in Korea. How much the drug will contribute to earnings remains a key question.

Biotoxtech shares also jumped on the day, following news that its subsidiary secured a non human primate study contract from a Nasdaq-listed overseas company.

Kwangdong Pharmaceutical stock trend.(Source=KG Zeroin MP Doctor)

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Yuvezzi May Gain First-Mover Advantage in Korea

According to KG Zeroin’s MP DOCTOR, Kwangdong shares rose 30%(won 2,400) to close at won 10,400. The company had already hit the upper price limit the previous day, rising 29.87% to a new 52week high.

The strong momentum over two days was driven by Yuvezzi, a presbyopia treatment licensed from overseas. Developed by UK based Tenpoint Therapeutics Yuvezzi recently received FDA approval. Kwangdong announced the news through a press release on the 19th.

Several presbyopia treatments have already been launched globally, most of them single-agent products. Yuvezzi however is the world’s first dual combination therapy containing carbachol and brimonidine tartrate.

It works by improving near vision and depth of focus. Although it does not cure presbyopia it provides temporary symptom relief. While existing products offer around six hours of effect with once daily dosing Yuvezzi is reported to provide up to 10 hours of duration which is viewed as a competitive advantage.

Vuity developed by AbbVie/Allergan, VIZZ developed by Lenz Therapeutics, and Qlosi developed by Orasis have already received FDA approval and are being marketed globally. Yuvezzi is expected to compete with these products in international markets.

Kwangdong filed for MFDS approval in September last year. Currently, no eye drops have been approved in Korea specifically for presbyopia. VIZZ filed for approval in December last year. Optus Pharmaceutical signed a domestic exclusive sales agreement with Orasis for Qlosi in September 2024 and announced plans for launch this year, but no approval application has yet been disclosed.

As a result analysts suggest Kwangdong may secure an early lead in Korea’s presbyopia treatment market. Korea’s presbyopic population is estimated at around 17 million, but the drug market remains at an early stage.

According to Grand View Research the combined myopia and presbyopia treatment market in Korea was approximately won 600 billion in 2023, with presbyopia accounting for roughly won 112 billion.

Industry observers expect accelerated aging and reluctance toward surgery to support market growth. However, Yuvezzi’s limitation as a temporary solution is noted. Presbyopia occurs when the lens loses elasticity, causing blurred near vision. Yuvezzi works by constricting the pupil to improve clarity similar to tightening a camera aperture to sharpen focus.

Presbyopia correction methods include surgery, glasses or contact lenses, and medication. Yuvezzi must compete not only with other drug therapies but also with various alternative correction methods.

Ultimately pricing and insurance coverage will be key competitive factors after MFDS approval. However since presbyopia is categorized as a functional decline rather than a severe disease, reimbursement under the national health insurance system is considered unlikely. For Yuvezzi to become a sustainable revenue source for Kwangdong, pricing competitiveness and marketing capabilities will be crucial.

Kwangdong plans to expand its ophthalmology business starting with Yuvezzi. A company official stated that it is strengthening its portfolio by securing domestic rights to innovative ophthalmic drugs including Raxone, OCU400, and NVK002.

Biotoxtech Secures Largest-Ever Primate Study Order

Biotoxtech shares also rose sharply climbing 20.83%(won 550) to close at won 3,190. The company attributed the rally to improved investor sentiment after its subsidiary KeyPrime Research secured a non human primate study contract.

The company announced that KeyPrime Research signed a USD 2.45 million(approximately won 3.5 billion) contract with a Nasdaq-listed U.S. company. The contract amounts to roughly 25% of last year’s revenue and represents the largest order in the company’s history. It is particularly meaningful as the first GLP(Good Laboratory Practice) study secured from an overseas client.

According to the company continuous efforts to visit overseas clients participate in academic conferences and symposiums and promote its strict GLP compliant management system contributed to winning the contract.

KeyPrime Research established a global-standard non human primate testing facility in Osong in 2022. It subsequently obtained GLP certification for repeated dose toxicity studies in 2023 and GLP certification for cardiovascular safety pharmacology studies in 2025.

The company has diversified its non clinical portfolio by offering liver and cardiac biopsy services specialized ophthalmic administration and immunoassay services.

CEO Kim Dong il said “Since obtaining Korea’s first GLP certification for non human primate cardiovascular safety pharmacology studies late last year, our technical capabilities and study execution capacity have begun to gain recognition in the market. This contract is meaningful as it represents a direct breakthrough into the U.S. market which sets the global standard for drug approvals.”

The company aims to secure more than won 30 billion in orders this year with overseas contracts accounting for more than 50%.