‘Forxiga’ is a popular new bis-L-proline salt-modified drug for targeting niche markets.

Trudapajeong (Photo = Boryeong website)

(Health Korea News / Lee Chung-man) New improved drugs made by converting AstraZeneca Korea Pharmaceuticals’ diabetes treatment drug ‘Forxiga’ (ingredient name: dapagliflozin) to bis-L-proline are gaining popularity for targeting niche markets. there is.

‘Forxiga’, the original of ‘Dafa Jinjeong’, is a sodium-glucose co-transporter-2 (SGLT-2) inhibitor that selectively inhibits SGLT-2, an enzyme involved in the reabsorption of glucose and sodium in the kidneys, thereby preventing them from being excreted in the urine. It is a mechanism that promotes glucose and sodium excretion.

‘Forxiga’ has dominated the diabetes treatment market since its launch in 2014 and has risen to the ranks of blockbuster drugs. According to UBIST, a market research company, it earned a profit of about 90 billion won in 2022.

As if they had been waiting, domestic companies started targeting generic drugs for ‘Forxigar’. As soon as the substance patent for ‘Forxiga’ expired on April 7, 2023, about 60 generic products were launched simultaneously.

With the generic onslaught and pressure from the National Health Insurance Corporation to lower the price of the Farxiga drug, AstraZeneca finally made the decision to withdraw its blockbuster drug worth tens of billions of won from the Korean market in April of this year.

For reference, the National Health Insurance Corporation basically seeks to reduce costs, and when a cheap generic is released, it tries to reduce the cost of covering the entire drug by lowering the price of the original drug.

While generic products are filling this empty space, the new improved salt-modified drug ‘Bis-L-Proline’ is attracting attention as it is quietly showing results.

‘BisL-proline’ is a compound in which two L-prolines (L-proline, a type of amino acid) are combined with dapagliflozin. It is a form of prodrug (prodrug: active only under specific conditions) that increases the stability of the drug and improves solubility and absorption rate.

The existing dapagliflozin compound structure is always in an activated state, so it is absorbed quickly. As a result, the drug may directly irritate the gastrointestinal tract, causing symptoms of nausea and vomiting, or increase urine output, resulting in side effects such as dehydration.

On the other hand, the solubility and absorption rate of the new salt-modified drug ‘Bis-L-Proline’ have been improved so that it is gradually activated in the body. Since the drug is activated slowly, side effects caused by rapid changes in body concentration can be reduced.

In particular, considering that the generic version of ‘Forxiga’ is currently saturated, the salt-modified new drug for ‘Bis-L-Proline’ appears to be a skillful niche market strategy.

As of the 19th, there are a total of 462 ‘Forxiga’ generic or improved new drug items that have obtained approval from the Ministry of Food and Drug Safety. Among these, the amount of outpatient prescriptions for these items calculated by UBIST over the nine months since April last year was only 29.5 billion won. There are only a few drugs advertised on the market.

In contrast, Farxiga’s new improved salt-modified drug for ‘Bis L-proline’ contains 5 mg of ‘Dapagliflozin Bis L-proline’ from Kyungdong Pharmaceutical, which was approved by the Ministry of Food and Drug Safety on the 19th. It can only be a dog. It is approved as an adjunct to diet and exercise therapy to improve blood sugar control in patients with type 2 diabetes. As of 2023, the production performance of these items, excluding Dafa soothing, recorded a total of 16.7 billion won.

The development of new improved drugs by changing the salt of ‘bis-L-proline’ can be interpreted as a strategy for companies to gain an advantage in a niche market with less competition.

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Source: www.hkn24.com