Korea approves Keytruda SC, developed with Alteogen's technology

Has improved patient convenience compared with existing intravenous formulation product

Includes all previous indications after proving bioequivalence

Product photo of Keytruda

The subcutaneous (SC) formulation of 'Keytruda (pembrolizumab),' a global blockbuster immunotherapy for cancer treatment, is set to enter the Korean market after securing marketing authorization from the Ministry of Food and Drug Safety (MFDS). This approval is evaluated as a major achievement for the domestic biopharma industry, as the product integrates Alteogen's platform technology, and Samsung Biologics has been confirmed as part of the global contract manufacturing organization (CMO) lineup.

On the 19th, the MFDS granted official marketing authorization for MSD Korea's 'Keytruda SC Inj (recombinant).'

The newly approved Keytruda SC was developed using ALT-B4, a modified human hyaluronidase platform technology from the domestic biotech company Alteogen. It features a formulation combining the active ingredient, pembrolizumab, with 'berahyaluronidase alfa,' an enzyme that temporarily degrades the extracellular matrix of subcutaneous tissue. Using this technology, the existing intravenous (IV) formulation was converted into an SC formulation, enabling rapid dispersion and permeation of the drug into subcutaneous tissue.

The contribution of South Korean companies is also significant in the manufacturing sector. According to the MFDS approval details, Keytruda SC's global contract manufacturing network includes Samsung Biologics, Korea's largest CMO, alongside BSP Pilot, Boehringer Ingelheim, and MSD headquarters. This system has enabled an innovative new drug developed with Korean platform technology to be supplied globally through Korea's state-of-the-art manufacturing facilities.

Patient convenience is expected to improve dramatically. With the conventional Keytruda IV formulation, patients had to spend 30 minutes to an hour receiving an infusion in a hospital infusion center bed. In contrast, Keytruda SC can be administered by healthcare professionals into the thigh or abdomen in just one to two minutes. The dosing schedule can be selected based on the patient's condition, offering options for either a 3-week cycle (395 mg) or a 6-week cycle (790 mg). Patients currently receiving the IV formulation can also transition to the SC formulation starting with their next scheduled dose, which is expected to yield strong preference in clinical settings.

The approved indications include the extensive scope of the existing IV formulation. Keytruda SC secured approvals across a total of 18 cancer types, including ▲melanoma ▲non-small cell lung cancer (NSCLC) ▲malignant pleural mesothelioma ▲head and neck cancer, classical Hodgkin lymphoma ▲urothelial carcinoma, gastric cancer ▲esophageal cancer ▲renal cell carcinoma, endometrial carcinoma ▲triple-negative breast cancer (TNBC) ▲cervical cancer ▲biliary tract cancer ▲hepatocellular carcinoma ▲microsatellite instability-high (MSI-H) solid tumors. This approval is based on data from a large-scale global bioequivalence clinical trial (MK-3475A-D77), which demonstrated comparable pharmacokinetic (PK) properties, efficacy, and safety profiles to the IV formulation.

A pharmaceutical industry employee stated, "Keytruda is a mega-blockbuster competing for the top spot in global sales," and added, "The fact that Alteogen's technological advancement and Samsung Biologics' manufacturing capabilities have been integrated into global pharma giant MSD's core pipeline is a major milestone, demonstrating that the standing of the Korean pharma and biotech industry has taken a significant leap forward." Keytruda is a mega blockbuster that recorded global sales of KRW 46 trillion last year. In South Korea, Keytruda's sales have surpassed KRW 500 billion, ranking as the highest-performing pharmaceutical in the country.