Korean eye drops made by Huons, Sam Chun Dang Pharm, and Hanlim Pharm are increasingly winning orders in the global market.
Huons recently signed a deal with DMI Pharmaceutical, a pharmaceutical distribution firm for the Commonwealth of Independent States, to export its dry eye treatment Clacier.
In January, the company obtained approval from China Food and Drug Administration (CFDA) for a phase-3 study on Clacier. It also inked an exclusive deal with Chinese drug firm Interlims to supply the products for five years.
Huons estimates that the Chinese dry eye treatment market is worth 1.4 trillion won ($1.24 billion). The company plans to introduce its eye drops and stable drugs to the Saudi Arabian market through a partnership with local pharmaceutical firm Salehiya.
Huons is mainly focusing on specializing in eye drops for ophthalmology. The company won a patent for nanocomposite eye drop HU-007 not only in Korea but the U.S. In Korea, the drugmaker gained the nod for a phase-3 study on the nanocomposite eye drop in October last year. Huons said HU-007 proved its non-inferiority to Allergan’s Restasis, the popular dry eye treatment. The company aims to release HU-007 as a product in 2019.
To spur the drug development, Huons plans to introduce nine advanced facilities including BFS(Blow-Fill-Seal) system and an impurity inspector. From October, the company will also expand facilities to be able to make 300 million tubes of eye drop products.
Sam Chun Dang, which focuses on ophthalmic products, has won export deals as well.
In February, Sam Chun Dang agreed with a U.S. pharmaceutical company to ship six products including a glaucoma treatment, an anti-allergic agent, and an anti-inflammatory agent to the U.S. In the same month, the firm also won an order from a German drugmaker to export four glaucoma therapies.
In February 2016, the company concluded a contract with a U.S. pharmaceutical company to export seven ophthalmic generics, with the contract fee amounting to 7.8 billion won.
Sam Chung Dang is seeking a CGMP (Current Good Manufacturing Practice) certification because it is a prerequisite for exports to the U.S. The company is also boosting investment to sell more products overseas.
The company is expected to obtain a CGMP certification smoothly because it already has the EU-GMP certification. If the plan goes as scheduled, the company will be able to market products in the U.S. in 2020.
Hanlim Pharm is also preparing to expand the business into the global market. Although the U.S. Food and Drug Administration notified the company of the suspension of the eye drop facilities inspection last year, the company recently requested a re-assessment. Hanlim also secured the local retail channels in the U.S.
Pharmaceutical experts attribute the robust sales growth of Korean eye drops overseas to their low prices and sound quality.
Korean eye drops are 10-20 percent cheaper overseas than in Korea. As the companies have GMP-certified facilities at a similar level to those in Europe and the U.S., they keep receiving export orders from their partner firms.
Particularly in the U.S., the demand for Korean-made eye drops is high because other rivals find it difficult to develop products that comply with the U.S. registration regulations. Also, the supply of U.S. GMP-certified production facilities is in shortage.
“The Korean drugmakers seem to be applying their expertise in manufacturing generic drugs to the global business. Their analysis on the overseas market and long-term investments have led to winning deals,” a pharmaceutical source said. “As foreign rivals maintained prices of eye drops at high levels, Korean firms could sell their products well overseas with low prices, high-quality production facilities, and mass production.”