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[Kim Jiwan, Edaily Reporter] “It Costs About 3.5 Million won per Gram. Once Fully Operational, We Expect to Receive Orders Exceeding 50㎏.”

When asked about the future prospects of leuprorelin, Jae-Il Kim, CEO of AnyGen and Professor at Gwangju Institute of Science and Technology’s (GIST) Department of Life Sciences, responded with confidence.

Leuprorelin (Leuprorelin Acetate) is a drug used to treat prostate cancer, breast cancer, endometriosis, uterine fibroids, and precocious puberty. It works by suppressing estrogen and progesterone (female hormones) in the ovaries and testosterone (male hormone) in the testes. First Leuprorelin API Export to the U.S. Market

Jae-Il Kim, CEO of AnyGen and Professor at Gwangju Institute of Science and Technology’s (GIST), is having an exclusive interview with EDaily at GIST, located on Cheomdan-Gwagiro in Buk-gu, Gwangju, in September last year. (Photo by Jiwan Kim)

◇Another Generic? The Battle for Long-Acting Formulations

On February 24, AnyGen announced that it had received an order for leuprorelin active pharmaceutical ingredient (API) from a U.S. pharmaceutical company, marking the start of its exports. This initial shipment is for sample testing, and if it passes the tests, the contract will transition into a clinical trial phase followed by full-scale commercial supply.

This export deal is significant. Some critics dismiss leuprorelin as a generic drug, noting that over ten different leuprorelin products have already been approved by Korea’s Ministry of Food and Drug Safety (MFDS). In the U.S., even more generic versions are expected to be on the market. However, this perspective overlooks the reality of the leuprorelin market.

An AnyGen representative stated “It’s true that leuprorelin is a generic drug. However, the market has been shifting toward long-acting (sustained-release) formulations, which is the current development trend.”

For example, a three-month sustained-release formulation requires only one injection per quarter, significantly reducing the number of injections compared to the one-month formulation. This increased convenience makes long-acting leuprorelin the preferred option among patients.

The original leuprorelin has a half-life of three hours, necessitating daily subcutaneous injections. However, the market is now dominated by long-acting formulations lasting 1 month, 3 months, 6 months, and even 12 months.

Kim emphasized “Leuprorelin is a peptide-based drug. Manufacturing a long-acting version requires highly advanced peptide synthesis technology.” He further noted that the U.S. client specifically requested a long-acting formulation, and if the sample passes the tests, the deal will proceed to commercial-scale production.

Since generic drugs require only bioequivalence verification with the original, clinical trial failures are rare, making commercialization relatively straightforward.

High Potential for Additional Orders

Industry analysts believe that AnyGen has a high likelihood of securing additional orders.

An AnyGen representative stated “There are only about ten peptide manufacturers worldwide, including AnyGen, capable of producing long-acting leuprorelin.” If this long-acting product successfully enters the U.S. market and proves its competitiveness, other pharmaceutical companies currently selling short-acting leuprorelin may turn to AnyGen for their API supply.

Notably, this contract was facilitated through AnyGen’s U.S. partner, Interchem, which has played a key role in expanding its presence in the American market.

Founded in 1981 in New Jersey, Interchem is a mid-sized pharmaceutical company in the U.S. and serves as AnyGen’s client and agent.

Kim explained “The company we signed the deal with is a new U.S.-based generic pharmaceutical company. Interchem helped secure them as a client and is actively handling agency operations in the U.S. If we build a strong track record, additional orders will follow.”

FDA cGMP Certification in Progress AnyGen’s peptide manufacturing plant is currently undergoing the final review for FDA Current Good Manufacturing Practice (cGMP) certification. The company submitted its FDA cGMP application in October last year.

An AnyGen official noted “The significance of this export deal is that it was signed while the FDA cGMP certification is still in progress. Once we secure certification, interest in our products will increase even further.”

He added “The final review will be completed within six months. Since there were no issues during the preliminary review, we are confident about passing the final assessment.”

“won 3.5 Million per Gram ? A Market Worth Trillions”

This deal has also boosted market expectations for AnyGen’s future revenue.

Kim revealed “Leuprorelin API costs won 3.5 million per gram ($2,600). After FDA cGMP certification, we expect to sell around 50 kg per year.”

At this price point, 1 kg is worth won 3.5 billion ($2.6 million), and 50 kg would generate approximately won 175 billion ($130 million) in revenue.

The U.S. infertility treatment market alone is valued at $5.8 billion (won 7.7 trillion), followed by China at CNY 26 billion (won 4.7 trillion).

In fertility treatments, leuprorelin and ganirelix are typically used in sequence, with leuprorelin accounting for 70% of the total market. Even when limited to the U.S. market, the leuprorelin market size is estimated at won 5.39 trillion ($4 billion).

AnyGen also manufactures ganirelix API, supplying peptide ingredients to LG Chem, which recently submitted a ganirelix product application to the U.S. FDA.

The price of Ganirelix API is significantly higher at won 9 million ($6,700) per gram due to its complex structure containing numerous non-natural amino acids. This complexity makes ganirelix more technically challenging to manufacture and more expensive than leuprorelin.