Kelun Pharmaceutical's oral disintegrating film for sildenafil citrate (50mg/25mg), submitted as a Class 3 chemical drug, has been officially approved for marketing. This not only means that the first company in China to launch this new dosage form of the drug, but also that Kelun Pharmaceutical has become the "first generic manufacturer of sildenafil citrate oral disintegrating film in China" with this approval, and is regarded as the first company to pass the consistency evaluation.
In the fiercely competitive market of andrology drugs, sildenafil, a "super product" with its own built-in traffic, has always been a battleground for companies. According to data from PharmNet, the domestic sildenafil market has maintained a high scale in recent years, with total sales reaching 6.6 billion yuan in 2023 and remaining at a massive 6.3 billion yuan in 2024. Faced with such a huge market worth tens of billions of yuan for treating erectile dysfunction, traditional tablets have long been a red ocean, and "new dosage forms" have undoubtedly become the sharpest weapon for companies to break through and seek differentiated competition.
Compared to traditional tablets, orally disintegrating films are a natural fit for the use of anti-ED medications. Firstly, they don't require water; they dissolve and are quickly absorbed when placed on the tongue, greatly alleviating the awkwardness of patients having to search for warm water in certain situations, improving concealment and compliance. Secondly, orally disintegrating films are absorbed through the oral mucosa, resulting in faster onset of action and effectively avoiding the first-pass effect of the liver. This superior user experience is expected to quickly translate into strong purchasing power in the retail market. Currently, although there are numerous sildenafil tablet approvals in China, Kelun Pharmaceutical is the only company in this niche innovative dosage form, orally disintegrating films, to have received formal approval for market launch, giving it a significant first-mover advantage. Of course, facing this tempting market, other entrants are rapidly joining the fray. According to data from PharmData, eight companies in China are currently applying for approval for this dosage form, including well-known and powerful pharmaceutical companies such as Guangzhou Baiyunshan, Zhejiang Lepu, and Hainan Huluwa. It is foreseeable that with Kelun Pharmaceutical crossing the finish line first, the starting gun for the anti-ED oral dissolving film market has officially been fired.
Through this single-product approval, we can clearly see Kelun Pharmaceutical's systematic approach in the andrology market. Prior to this, Kelun Pharmaceutical had already secured approvals for several blockbuster andrology products, including vardenafil hydrochloride tablets and dapoxetine hydrochloride tablets. Now, with the strong addition of sildenafil citrate oral disintegrating film, Kelun Pharmaceutical has not only achieved "multi-target, multi-mechanism" coverage in the andrology drug field, but has also formed a rich product portfolio encompassing both tablets and high-end formulations.
This series of combined moves has undoubtedly given Kelun Pharmaceutical stronger bargaining power and brand synergy in the out-of-hospital OTC market and online e-commerce channels. In this men's health market worth over 6 billion yuan, Kelun Pharmaceutical, holding the first generic drug with a new dosage form, has clearly seized the leading position in the next cycle.