[TIDE Reporter Minji Son ] Global big pharma companies leading the obesity treatment market are expanding their pipelines into cardiovascular diseases. This move stems from the assessment that while glucagon-like peptide-1 (GLP-1) class obesity treatments—which have long emphasized weight loss—have driven explosive growth, their future growth potential is limited. With the full-scale implementation of a strategy to reinvest funds secured from obesity treatments into building a cardiovascular, renal, and metabolic (CVRM) pipeline—alongside a simultaneous shift toward subcutaneous (SC) formulations—there are expectations that domestic companies in this sector, such as Alteogen Inc., could emerge as new beneficiaries.

Beyond “Obesity” to “Heart”… Big Pharma Shifts Investment Focus

According to ClinicalTrials.gov, the U.S. National Institutes of Health (NIH) clinical trial information portal, on the 25th, Novo Nordisk initiated a Phase 1 clinical trial in Germany involving 32 healthy adults to compare systemic exposure levels of the heart failure treatment candidate “CDR132L” following subcutaneous (SC) and intravenous (IV) administration.

Safety and efficacy testing for CDR132L has already progressed to a Phase 2 clinical trial involving heart failure patients. This trial focuses on comparing the pharmacokinetic (PK) characteristics of CDR132L based on its route of administration rather than verifying its therapeutic efficacy. This is interpreted as a strategy to enhance the drug’s competitiveness as a treatment for chronic diseases by validating the feasibility of the subcutaneous (SC) route, which offers greater convenience compared to the conventional intravenous (IV) route. Given the nature of chronic heart failure, which requires long-term treatment, the company is moving to secure a subcutaneous (SC) injection formulation that offers greater patient convenience, with an eye toward late-stage clinical trials and commercialization.

CDR132L is an RNA-based heart failure treatment that Novo Nordisk acquired in 2024 through its acquisition of the German pharmaceutical company Cardio Pharmaceuticals. It works by inhibiting the microRNA “miR-132,” a key factor in heart disease. Unlike GLP-1 agonists, which indirectly reduce cardiovascular risk through weight loss and improved blood glucose control, it differentiates itself by directly targeting the root cause of heart failure.

This clinical trial is seen as evidence that Novo Nordisk’s investment strategy is shifting beyond expanding its obesity indications toward cardiovascular diseases. In fact, other global pharmaceutical companies are following a similar trend. Last year, Eli Lilly strengthened its cardiovascular disease pipeline by acquiring Verb Therapeutics, a developer of gene-editing therapies for cardiovascular diseases, for $1.3 billion (approximately 1.9 trillion won). That same year, Roche also strengthened its presence in the cardiovascular, renal, and metabolic disease sectors by acquiring 89Bio, a U.S. biotech company developing “pegozaphermin,” a candidate treatment for metabolic dysfunction-associated steatohepatitis (MASH), for up to $3.5 billion (approximately 5 trillion won).

Cardiovascular Pipeline Must Also Shift to SC... Will Alteogen Inc. Seize Another Opportunity?

There is speculation that these changes could present opportunities for the domestic pharmaceutical and biotech industry. The fact that Novo Nordisk paid over 1 trillion won to acquire Cardio Pharmaceuticals is cited as an example demonstrating global demand in the cardiovascular field.

A biotech industry official stated, “As development has focused primarily on anticancer drugs—which can be tested in clinical trials with relatively small patient populations—cardiovascular therapies, which require long-term follow-up of large patient cohorts, have been a relatively neglected area.” The official added, “While global Big Pharma companies once concentrated on anticancer drugs and rare diseases, the strategic value of cardiovascular pipelines is rising again, and this trend warrants attention.”

However, in South Korea, where development is dominated by obesity treatments and anticancer drugs, innovative drug pipelines directly targeting cardiovascular diseases—such as heart failure—are relatively rare. Consequently, there is speculation that if cardiovascular drug development gains momentum, platform technology companies supporting such efforts could indirectly benefit.

Alteogen Inc.(196170)is a prime example. Just as Novo Nordisk has initiated a clinical trial to switch from an existing IV formulation to a subcutaneous (SC) formulation, the importance of SC formulation conversion technology—which enhances patient convenience—is growing for treatments of chronic diseases requiring long-term administration.

Alteogen Inc.’s subcutaneous formulation conversion platform, “ALT-B4,” is a recombinant human hyaluronidase that temporarily breaks down hyaluronic acid in subcutaneous tissue, enabling high-dose antibody and protein drugs—which were previously administered intravenously—to be delivered subcutaneously. By converting drugs that previously required intravenous administration to subcutaneous administration, the company can shorten treatment time and even explore the possibility of self-administration in the future. Alteogen Inc. is widely recognized for having demonstrated its technological capabilities by signing technology agreements with companies such as Merck (MSD), AstraZeneca, Daiichi Sankyo, GSK, and Biogen. There is also speculation that the recent decision by the U.S. Patent Trial and Appeal Board (PTAB) to invalidate competitor Halozyme’s MDASE patent could have a positive impact on future global technology transfers.

Olix Pharmaceuticals, Inc.(226950), a company developing RNA interference (RNAi) therapeutics, is also expected to benefit indirectly. Given that CDR132L is an RNA-based heart failure treatment, analysts suggest that RNA therapeutics could expand their scope beyond rare diseases to include chronic conditions such as cardiovascular diseases.

The key distinction between RNA therapeutics and existing treatments is that they directly regulate disease-related RNA before proteins are produced. While existing heart failure treatments generally focus on reducing the burden on the heart and delaying disease progression by regulating blood pressure and neurohormones, RNA therapeutics offer the advantage of directly suppressing the genetic signals that cause myocardial hypertrophy and fibrosis.

Of course, there are still significant challenges that must be overcome before RNA therapeutics can benefit patients. Not only is the technology for efficiently delivering the drug to the target tissue not yet fully established, but the nature of cardiovascular diseases also requires large-scale, long-term clinical trials, placing a heavy burden on development. Another biotech industry official explained, “As RNA delivery technologies are becoming increasingly sophisticated, and given that global big pharma companies—which have secured substantial cash reserves through obesity treatments—are actively investing in the cardiovascular field, the development of RNA-based treatments for chronic diseases is likely to accelerate further.”