GSK plc has staked the fate of its flagship immuno-oncology drug Jemperli on Korea's biotech corporations Alteogen. It decided to introduce Alteogen's ALT-B4 technology to switch the existing intravenous (IV) administration to a subcutaneous (SC) injection.
Alteogen said on the 20th that it signed a licensing-out (L/O) agreement with a GSK subsidiary to apply its SC formulation-conversion technology ALT-B4 to the immuno-oncology drug (PD-1 inhibitor) Jemperli. ALT-B4 is a technology that enables high-dose antibody drugs to be administered subcutaneously.
Why did Jemperli, which entered the blockbuster ranks last year by surpassing 1 trillion won in sales, pull out the card of a formulation change? Behind it lies big pharma's calculated move to survive in the saturated PD-1 inhibitor market and the survival instinct of "patent defense."
◇ PD-1 market turns into a "red ocean"… GSK's breakthrough is "convenience"
Jemperli is the heart of GSK's oncology business. It is especially dominant in endometrial cancer treatment. It is the only therapy that has proven in clinical trials to extend overall survival (OS, the time from the start of treatment to death).
In fact, the median survival in the Jemperli treatment arm was 44.6 months, overwhelming the existing standard of care (28.2 months. Leveraging this efficacy, Jemperli swept the U.S. and European markets, posting cumulative sales of 600 million pounds (about 1.19 trillion won) through the third quarter last year.
The problem is market conditions. With powerful rivals such as Keytruda (MSD) and Opdivo (BMS) already entrenched, there are limits to expanding share on efficacy alone. In the so-called "mature" PD-1 market, GSK's differentiation strategy is "dosing convenience."
With traditional IV infusion, patients must lie in a hospital bed and receive a drip for more than 30 minutes. In contrast, a subcutaneous injection using Alteogen's technology takes just 1–2 minutes. It is a groundbreaking change that can reduce patient discomfort and increase hospital throughput. It is a structure that will inevitably shift preferences in clinical settings.
◇ "Evergreening" strategy to extend patent life… Korean technology is the key
The more decisive reason is patents. For drugmakers, changing the formulation is the most effective way to extend a product's life. Even if the original drug's patent expires, obtaining new drug approval for a new formulation (SC) can extend the exclusive sales period. The industry calls this the "evergreening" strategy.
GSK's choice of Alteogen among many partners suggests an intent to take the "safe route." Alteogen's ALT-B4 technology has already been used to develop the SC formulation of MSD's Keytruda, the world's No. 1 cancer drug, and has passed reviews by U.S. and European regulators.
The deal is seen as heralding a full-fledged push by global big pharma to pursue oncology formulation strategies. Alteogen's global partners for ALT-B4 have increased to five, adding GSK's subsidiary Tesaro to MSD (Merck in the U.S.), Sandoz, Daiichi Sankyo, and AstraZeneca (AZ).
Jeon Tae-yeon, CEO of Alteogen, said, "There is only one drug, but our technology is a platform, so it can be applied simultaneously to multiple blockbuster medicines," and added, "Through our collaboration with Tesaro (a GSK subsidiary), we have once again proven the versatility of our technology."