A subcutaneous injection that can administer an immunotherapy in 1–2 minutes using domestic technology has been developed and approved in the United States. Immunotherapies are usually given intravenously by medical staff in hospitals, but subcutaneous injections are more convenient than IV because the administration time is short.
Alteogen said on the 20th that its partner, U.S. Merck (MSD), received U.S. Food and Drug Administration (FDA) approval for the product "Keytruda Qurex."
Keytruda Qurex converts IV Keytruda into a subcutaneous formulation. Keytruda is an immunotherapy that Merck launched in 2014. It treats cancer by prompting human immune cells to attack cancer cells. Keytruda recorded $29.5 billion (41 trillion won) in sales last year.
◇Administration time drastically shortened with Alteogen technology
Keytruda Qurex was approved for 38 indications, including melanoma, non-small cell lung cancer, head and neck cancer, urothelial carcinoma, cervical cancer, and cholangiocarcinoma. Keytruda Qurex incorporates Alteogen's "ALT-B4" technology. This technology converts IV drugs into subcutaneous formulations. It breaks down the hyaluronan layer in subcutaneous tissue to allow rapid absorption of the drug.
Earlier, Merck said the subcutaneous Keytruda is equivalent in efficacy to the IV form. Merck conducted a phase 3 trial of Keytruda Qurex in patients with non-small cell lung cancer and said the pharmacokinetic results for the subcutaneous and IV Keytruda were similar.
IV Keytruda takes 30 minutes. Subcutaneous Keytruda is administered for 1 minute once every 3 weeks and 2 minutes once every 6 weeks. The company said that in the United States, patients may be able to receive it at clinic-level hospitals as early as the end of this month.
Alteogen signed its first technology transfer agreement with Merck in Jun. 2020, granting rights to use the ALT-B4 technology. After partially amending the contract in Feb. last year, the company became able to receive additional milestones by development stage and a portion of sales as royalties.
Park Sun-jae, chief executive officer of Alteogen, said, "A product utilizing ALT-B4 technology has received approval in the United States," adding, "We will work to develop and commercialize our partner's products and provide convenience to more patients."
◇An era when patients administer anticancer injections themselves
The medical community says an era is opening in which patients receive cancer treatment at home via subcutaneous injection. As subcutaneous injections become common, patients will be able to inject into the abdomen or thigh as easily as with insulin pens without medical staff having to place an IV. Merck said, "For patients for whom IV is difficult, treatment can be simplified by administering a subcutaneous injection in areas excluding 5 cm around the navel."
Developing an IV drug as a subcutaneous injection can improve patient convenience and expand the market accordingly. Original drug developers are also seeking patent extension effects using the same technology. The Keytruda patent expires in 2028. Once the patent ends, biosimilars of Keytruda are expected to launch, eroding its market influence. Merck's strategy is to create new demand with subcutaneous Keytruda.
Celltrion, a domestic biosimilar specialist, also boosted the added value of its medicines using the same approach. After receiving approval in 2016 for Remsima IV (intravenous), a biosimilar of the autoimmune disease treatment Remicade, the company developed a subcutaneous formulation, Remsima SC (subcutaneous), which won U.S. FDA approval as a new drug in 2023.
Remicade is a blockbuster drug developed by Janssen, the pharmaceutical subsidiary of U.S. Johnson & Johnson (J&J). Celltrion was the first to develop a Remicade biosimilar and then the first to develop a subcutaneous formulation. Remsima SC has been sold in the United States under the brand name Zymfentra since last year.
As subcutaneous injectables expanded the market based on patient convenience and turned generics into new drugs, the value of subcutaneous injection technology also rose. Alteogen signed a technology transfer agreement for subcutaneous injection technology with the United Kingdom's AstraZeneca in Mar., worth more than 1.8 trillion won.
Earlier, in Feb. last year, it signed an exclusive 636 billion won deal with U.S. Merck to use the subcutaneous injection technology for the immunotherapy Keytruda. In Nov., it signed an agreement to develop a subcutaneous formulation of Enhertu, an ADC (antibody-drug conjugate) breast cancer treatment new drug from Japan's Daiichi Sankyo. The deal is reportedly worth 440 billion won.