As global big pharma reorganize their core research and development (R&D) pipelines, the fortunes of Korea's pharmaceutical and biotech corporations are diverging.
In the past, signing technology export deals worth trillions of won was regarded as a success indicator for Korean biotech corporations, but now whether the asset remains a core development asset at a global drugmaker and advances to real-world clinical trials and commercialization is emerging as the new standard that separates corporate competitiveness.
On the 4th (local time), Merck (MSD) and Pfizer each unveiled research and development (R&D) strategies to drive future growth through their second-quarter earnings announcements.
Through this announcement, the development direction and assessments of the out-licensed candidates from domestic corporations Alteogen(196170), Hanmi Pharmaceutical(128940), Ingenia Therapeutics, and D&D Pharmatech(347850) also diverged.
Earnings announcements by global big pharma are more than a disclosure of business performance; they show which technologies and candidates will receive focused development resources going forward.
As technology exports by Korean biotech corporations have become more active, big pharma's investor events such as conference calls are increasingly seen as a "report card" that gauges domestic corporations' development status and competitiveness after the out-licensing.
◇ Alteogen platform succeeds in commercialization; Hanmi and Ingenia also included as core assets
In its earnings materials, MSD listed "Keytruda QLEX," which uses Alteogen's platform technology, and candidates secured from Hanmi Pharmaceutical and Ingenia Therapeutics as key growth assets.
The most notable case is Alteogen.
MSD presented the immuno-oncology drug "Keytruda QLEX," which applies Alteogen's human hyaluronidase platform technology, as a next-generation growth engine. Keytruda QLEX converts Keytruda from the existing intravenous (IV) administration to a subcutaneous (SC) formulation.
Keytruda QLEX posted $463 million (about 660 billion won) in sales in the second quarter of this year, far exceeding market expectations. MSD said adoption by clinicians and patients has expanded after securing a permanent U.S. reimbursement J-code (a code used by medical institutions to claim drug expenses), and expressed confidence in its future growth potential.
It is evaluated as a representative success case of technology export, as a domestic biotech corporation's platform technology was applied to a global blockbuster drug and subsequently led to actual commercialization and revenue growth.
Hanmi Pharmaceutical also made MSD's core pipeline. "MK-6024 (epinopegdutide)," a GLP-1/glucagon (GCG) dual agonist that Hanmi Pharmaceutical out-licensed to MSD in 2020, was included as one of MSD's key late-stage development candidates.
MK-6024 is a dual agonist that simultaneously targets the GLP-1 receptor and the glucagon receptor, and is being developed as a treatment for obesity and metabolic diseases.
Earlier this year, MK-6024 was excluded from materials presented at the J.P. Morgan Healthcare Conference, prompting some in the market to raise the possibility of a reprioritization and causing the stock price to swing. However, with MSD including it again in this announcement, the view is that development is continuing.
Ingenia Therapeutics' ophthalmic disease candidate "MK-8748" was also presented as a core late-stage pipeline asset for MSD.
MK-8748 is an asset that Ingenia Therapeutics transferred to EyeBio, which MSD secured by acquiring EyeBio in 2024. A global phase 3 trial is underway for wet age-related macular degeneration (wAMD) and diabetic macular edema (DME).
◇ Pfizer adjusts D&D Pharmatech candidate; "Oralink development will continue"
On the same day as MSD, Pfizer announced adjustments to the development strategy for some oral obesity drug candidates. Through this, Pfizer disclosed the discontinuation of development for the oral obesity candidate "MET-224o."
MET-224o is a candidate that D&D Pharmatech transferred to the U.S. biotech Metsera, and it applies D&D Pharmatech's oral absorption platform technology "ORALINK." Oralink is an oral delivery platform that helps peptide drugs be absorbed stably in the body.
In 2023 and 2024, D&D Pharmatech transferred six Oralink-based oral obesity candidates to Metsera in deals totaling $803.5 million. After Metsera was acquired by Pfizer last year, the technology came to be assessed within the global big pharma's obesity drug development strategy.
However, D&D Pharmatech explained that this decision stemmed not from limitations of Oralink but from Pfizer's reorganization of its obesity drug development strategy.
The company said Pfizer has been focusing on differentiated obesity treatments since acquiring Metsera, and continues to develop oral peptide-based GLP-1 candidates.
Pfizer also said, "We will continue to search for GLP-1 substances through oral peptides and small molecules," indicating that, separate from adjustments to individual candidates, research and development in oral obesity treatments will continue.
◇ Sanofi to continue cooperation with Adel and SK bioscience; ABL301 reprioritized
French drugmaker Sanofi has made its "selection and concentration" approach in research and development (R&D) strategy more pronounced.
Sanofi has in-licensed "ADEL-Y01 (Sanofi development code SAR449548)," an Alzheimer's disease candidate co-developed by domestic biotech venture Adel and Oscotec(039200), and is leading global clinical development.
ADEL-Y01 is an antibody therapy candidate that targets abnormal tau protein involved in the onset of Alzheimer's disease. A phase 1a/1b trial is underway. Late last year, Sanofi signed a technology transfer deal with Adel worth up to $1.04 billion (about 1.5 trillion won), and this announcement is seen as showing that ADEL-Y01 is being developed as a major external innovation asset in the central nervous system (CNS) field.
Cooperation is also continuing on the next-generation vaccine candidate "GBP410," which is being co-developed with SK bioscience(302440). GBP410 is a 21-valent pneumococcal conjugate vaccine candidate, and Sanofi is expanding the scope of collaboration beyond joint development to include next-generation pneumococcal vaccines for children and adults.
By contrast, "ABL301 (Sanofi development code SAR446159)," a Parkinson's disease candidate out-licensed by ABL Bio(298380), was affected by changes in development strategy.
ABL301 is a bispecific antibody-based therapy candidate that ABL Bio out-licensed to Sanofi in 2022; after its development priority was downgraded early this year, it was excluded from Sanofi's second-quarter research and development (R&D) pipeline.
However, a change in development priority does not necessarily mean termination of the licensing deal or a halt to development. ABL Bio said its contract with Sanofi remains in place and that follow-up development strategies are under review.
Industry officials see these shifts as a sign that technology exports by Korean biotech corporations have entered a new phase. In the past, the size of a deal itself determined corporate value; now, whether the asset remains a core development asset at a global drugmaker and proceeds to clinical trials and commercialization is becoming the key criterion that defines a corporation's competitiveness.
Lee Seung-gyu, vice chairman of the Korea Biotechnology Industry Organization, said, "In the past, when a research paper related to a corporation appeared in an international journal like Nature Medicine, the stock would hit the upper price limit, and the out-licensing itself was sometimes taken as success in new drug development, but now technology transfer is just one step in the process, and there is a growing view that a sustainable business structure that extends through clinical trials and commercialization is important."