March is expected to be a testing ground to gauge the potential of South Korea's pharmaceutical and bioindustry. Domestic pharmaceutical and bio corporations are set to release significant clinical trial results one after another. Depending on the follow-up results of the new drugs each corporation is focusing on, success could lead to enhanced competitiveness in the global market, but failure may result in losing overseas partners and making it difficult to recover.
According to the industry on the 12th, major pharmaceutical and bio corporations such as SK Biopharm, Yuhan Corporation, the top revenue traditional pharmaceutical company, and Alteogen, the top KOSDAQ market capitalization corporation, will successively announce their clinical trial results.
SK Biopharm is expected to announce the phase 3 clinical trial results of its self-developed sleep disorder treatment 'SUNOSI' (ingredient name solriamfetol) related to attention deficit hyperactivity disorder (ADHD) and major depressive disorder (MDD) this month. SUNOSI is a treatment that increases levels of the neurotransmitters dopamine and norepinephrine to induce attention and arousal effects.
SK Biopharm exported the technology for SUNOSI to Aerial Biopharma in the United States in 2011, and since then, rights transfers have followed with several changes in the development entity. The rights for SUNOSI went from Jazz Pharmaceuticals to Axovant Gene Therapies. Currently, Axovant holds global rights except for 12 Asian countries, for which SK Biopharm retains the rights.
SUNOSI was launched in the United States in 2019 and in Canada in 2021. Last year, it generated over 130 billion won in sales, continuing its growth trend. If the phase 3 results expand the target diseases to ADHD and MDD, the royalty amount received by SK Biopharm is expected to increase significantly. Currently, SK Biopharm is estimated to receive about 7% of SUNOSI's sales as royalties. The phase 3 results are expected to be announced by Axovant.
Mirae Asset Securities Research Center noted, 'If this phase 3 trial is successful, SUNOSI's annual maximum sales could expand by about nine times,' adding, 'Accordingly, SK Biopharm's royalty size will also increase.'
Yuhan Corporation and Alteogen will publicly share the results of their major technology's clinical trials at the European Lung Cancer Conference (ELCC 2025) in Paris, France, starting on the 26th.
Yuhan Corporation and Oscotec will announce the final efficacy of the non-small cell lung cancer (NSCLC) new drug 'Lecaresta.' Lung cancer is classified into small cell lung cancer if the cancer cells are small and non-small cell lung cancer if they are large. Non-small cell cancer accounts for 70-80% of all lung cancers.
Lecaresta will publicly share the overall survival (OS) study results of the last phase 3 trial conducted in combination with Johnson & Johnson's Rybrevant (ingredient name amivantamab). Among several indicators indicating the effects of cancer drugs, the most critical indicator is OS, which shows the time it takes from the start of treatment until death. The duration of how much it extends a patient's lifespan is an important measure for patients and healthcare professionals when selecting cancer drugs.
In January, Johnson & Johnson anticipated that the OS of the Lecaresta-Rybrevant combination therapy would increase by more than a year compared to Tagrisso monotherapy. The OS of Tagrisso, updated in September, was 37.3 months. If improved by over a year, the OS of the Lecaresta combination therapy is expected to be just over 50 months. This is close to the period typically considered 'cured,' which is five years. Mirae Asset Securities Research Center analyzed that 'the announcement of this OS result increases the likelihood that Lecaresta combination therapy will become the standard treatment in the first-line market for EGFR mutation non-small cell lung cancer.'
Alteogen will also be evaluated for its technical capabilities at the same conference. The company is poised to announce phase 3 results applying its platform technology to change the administration method of the world’s number one immune cancer drug, Keytruda by Merck, from intravenous (IV) to subcutaneous (SC).
Merck is expected to disclose the phase 3 results of Keytruda SC targeting metastatic non-small cell lung cancer by applying Alteogen's formulation change platform 'ALT-B4.' The phase 3 study was conducted by comparing the efficacy of chemotherapy with Keytruda IV and chemotherapy with Keytruda SC (subcutaneous). Previously, Merck stated that Keytruda SC proved to be equally effective to the IV formulation in adult patients with non-small cell lung cancer.
Alteogen's formulation change platform was also applied to the formulation change of Daiichi Sankyo's antibody-drug conjugate (ADC) Enhertu (ingredient name trastuzumab deruxtecan). Enhertu approached nearly 4 trillion won in sales last year and gained significant attention in the global industry due to successive big deals, with evaluations suggesting that this result will have considerable implications for Alteogen's future partnerships.
Additionally, HANALL BIOPHARMA will announce the phase 3 results of its myasthenia gravis new drug Batoclimab technology exported to Immunovant in the United States at the end of this month. Batoclimab is a new drug developed to eliminate antibodies that cause autoimmune diseases and is being developed in a subcutaneous formulation. ABL Bio is on the verge of revealing global phase 2 and 3 data for its solid tumor dual antibody 'ABL001.' Previously, rights for domestic and global development were transferred to HANDOK and the American company Compass Therapeutics, respectively.