A combination drug designed to treat both premature ejaculation and erectile dysfunction is set to enter the market, garnering significant interest regarding its potential impact.

DongKoo Bio and CTC Bio have announced the release of their jointly developed clomipramine/sildenafil combination drug on July 30th. Although both products will be manufactured by CTC Bio, DongKoo Bio will market it under the name 'GuSeJeong,' while CTC Bio will sell it as 'WonTuJeong.'

Since 2022, the two companies have collaborated on developing this combination drug, which merges clomipramine, used for premature ejaculation treatment, and sildenafil, an erectile dysfunction treatment. This combination drug was first approved by the Ministry of Food and Drug Safety (MFDS) in May 2024, nearly 11 months after its application was submitted in June 2023, drawing considerable attention within the industry.

In clinical settings, many patients with sexual dysfunction experience both premature ejaculation and erectile dysfunction. However, there has been a lack of medications addressing both conditions simultaneously, leading to the perception that these were separate markets. With market demand analysis driving their development efforts, DongKoo Bio and CTC Bio aim to unify these two markets, which could be a significant development in the pharmaceutical industry.

DongKoo Bio, known for its strengths in urological pharmaceuticals, expects to continue its growth trajectory with the release of GuSeJeong. DongKoo Bio, known for its leading urological drugs such as the prostate treatment Euro-F CR (tamsulosin) and Euro-Reed (finasteride), plans to leverage the launch of GuSeJeong to create synergies and expand its sales capabilities.

A representative from DongKoo Bio stated, "GuSeJeong is significant not just as a co-promotion effort, but as a joint development project undertaken by both companies, despite potential risks." They added, "We are currently considering various sales strategies, including CSO and in-house sales teams."

They further explained, "In the past, our urological sales were ranked in the top 10, but with our entry into the top 5, we now need a new growth driver. We see the launch of GuSeJeong as an opportunity to grow through internal synergies."

DongKoo Bio aims to become the leading player in the urological treatment market through this opportunity. One advantage noted by both companies is that the new combination drug will not face market competition for a certain period. As improved new drugs, GuSeJeong and WonTuJeong are listed for a six-year post-marketing surveillance (PMS) period, during which new generics are restricted from entering the market. Consequently, both companies are focused on avoiding internal competition and maximizing their respective strengths.

Industry analysts predict that DongKoo Bio, which possesses considerable sales capabilities, will focus on clinic-level sales, which account for the majority of revenues in the male "happy drug" market. A representative from DongKoo Bio commented, "Since this is a jointly developed product, we do not see it as a competitive relationship. We are concentrating our sales efforts on symposiums and academic conferences." They added, "While I cannot provide specific details, I understand that there have been discussions between the companies to avoid unnecessary competition."

Additionally, both companies plan to dominate the South Korean market over the next six years and expand into Southeast Asian countries such as Thailand, Vietnam, and the Philippines. This expansion strategy is reinforced by CTC Bio's recent implementation of an authenticity certification solution for WonTuJeong. In response to the growing global concern over counterfeit medicines, CTC Bio has introduced a digital watermark technology, known as HiddenTag, to provide an authenticity certification solution, effectively creating a preemptive measure against counterfeit products.

The representative from DongKoo Bio added, "With the successful joint development with CTC Bio, we have created the world’s first combination drug, establishing a foothold for future expansion into both South Korean and international markets. There is indeed an expectation of long-term positive performance."