Immuno-Oncology ‘SC Formulations’ Attract Korean Biotech Interest

Global pharmaceutical companies are increasingly focusing on developing subcutaneous (SC) formulations of immuno-oncology drugs, a rising trend in the industry. Korean immuno-oncology drug developers are also embracing this challenge, aiming to enhance patient convenience and treatment efficacy.

Traditionally, anticancer drugs are administered via intravenous (IV) injections in hospitals, requiring patients to endure infusions lasting at least an hour. In contrast, SC formulations can be self-administered at home in under 10 minutes, significantly improving patient convenience. Industry experts agree that developing SC formulations for immuno-oncology drugs is an unstoppable global trend.

In February, Merck (MSD) signed an exclusive agreement with Alteogen to develop an SC formulation of Keytruda (pembrolizumab), the world’s top-selling immuno-oncology drug. With Keytruda’s U.S. and European patents expiring in 2028, MSD is proactively developing the SC formulation to extend its market presence. Alteogen granted MSD worldwide exclusive rights to ALT-B4, a human recombinant hyaluronidase enzyme, to develop and commercialize the SC formulation of Keytruda.

Last year, Roche received UK approval for the SC formulation of its immuno-oncology drug, Tecentriq (atezolizumab). At the American Society of Clinical Oncology (ASCO) meeting in Chicago last month, research on SC formulations of immuno-oncology drugs garnered significant industry attention.

Johnson & Johnson has also transitioned its immuno-oncology drug, Rybrevant (amivantamab), from an IV to an SC formulation. Clinical trial results, combining it with Yuhan Corporation’s Leclaza (lazertinib), showed increased patient survival rates from 51% to 65%.

Korean biotech company GI Innovation is joining the global push for SC formulations. In April, GI Innovation submitted an amended Investigational New Drug (IND) application to the Ministry of Food and Drug Safety (MFDS) for clinical phase 1/2 trials, including an SC formulation for its next-generation immuno-oncology drug, GI-102. The company has completed the development of the SC formulation for GI-102 using its proprietary process development expertise.

Industry insiders unanimously agree that the development of SC formulations for immuno-oncology drugs, with their numerous advantages, has become a global trend. An anonymous biotech investment reviewer remarked, "The SC formulation of immuno-oncology drugs offers several benefits, including ease of administration. It will be an important consideration in future immuno-oncology drug development and can be applied to various antibody therapies, solidifying its position as a global development trend."

A biotech venture representative noted, "If latecomer companies can develop SC formulations and prove their efficacy in clinical trials, SC formulations can be used in combination therapies and as adjuvant treatments for cancer patients before and after surgery."