This year, significant clinical trial results and the outcomes of U.S. Food and Drug Administration (FDA) approval applications that can gauge the competitiveness of domestic corporations are expected to be announced.
According to the industry on the 2nd, the subcutaneous injection formulation of the cancer treatment Keytruda, developed using the technology of Alteogen, is set to undergo the U.S. Food and Drug Administration (FDA) approval application process this month.
Alteogen possesses technology that converts intravenous (IV) formulations to subcutaneous (SC) formulations. Last year, Alteogen proved its competitiveness by signing technology transfer agreements with global pharmaceutical companies such as MSD, Japan's Daiichi Sankyo, and Switzerland's Sandoz. As a result, it gained attention in the securities market, increasing its market capitalization by over 11 trillion won in just one year. Its current market cap stands at around 16 trillion won.
This year, attention is focused on whether the Keytruda SC formulation will finally pass the FDA approval gateway. Generally, the FDA approval review period is 10 months, but if prioritized for review, a decision on approval may be made within 6 months. MSD's Keytruda is the world's top-selling pharmaceutical product, with annual global sales of about 33 trillion won, making it highly influential in the market. Although Alteogen has domestically approved products, it has yet to succeed in commercialization under FDA approval standards. Once approved, the technology fees (milestones) that Alteogen receives will also increase, contributing to growth in performance.
There are also a considerable number of corporations preparing to announce significant clinical trial results that can assess their medium- to long-term growth potential. Clinical trials generally proceed through preclinical (animal testing) and human clinical phases 1 to 3 before leading to final approval, and each advancement in the clinical stages can multiply the value many times over. This is because they are moving closer to successful commercialization.
Results of clinical trials for new drug candidates that domestic corporations previously exported technology for are also expected to be released soon. The results may lead to milestone payments and impact corporate valuations.
Yuhan Corporation, which received technology transfer from Ensol Biosciences in 2009 and developed the degenerative disc treatment new drug candidate YH14618 (SB-01), exported the technology to U.S. partner SpineBioPharma in 2018. The phase 3 trial results are set to be announced in the second quarter of this year. This product has been conducting phase 3 trials after receiving a waiver from the FDA for phase 2 trials. There is currently no fundamental treatment for degenerative discs. YH14618 works by injecting it into the spine to induce disc regeneration without surgery. The total scale of the technology transfer agreement at the time in 2018 was $218.15 million (about 320.1 billion won). It is reported that Yuhan Corporation and Ensol Biosciences agreed to share milestone fees in a 3:1 ratio.
LigaChem Biosciences has exported technology to Chinese Posun Pharma and U.K. Xsuda Therapeutics for the cancer drug candidate LCB14, which is currently in phase 1 trials for breast cancer and phase 3 trials for stomach cancer in China, and in phase 1 trials in Australia. Posun Pharma plans to apply for conditional approval of LCB14 as a third-line treatment for breast cancer in China in the first half of this year. Hanall Biopharma is expected to release the phase 3 primary endpoint results for HL161BKN (substance name batoclimab) aimed at patients with severe myasthenia gravis, as well as initial data for phase 2b trials targeting chronic inflammatory demyelinating polyneuropathy (CIDP), within the first quarter of this year.
Global pharmaceutical giants are increasingly acquiring technologies and patents based on early clinical data from small biotech companies developing their substances, sometimes even merging or acquiring the companies altogether. Attention is now on whether domestic corporations will continue to achieve technology export successes this year.
Bridge Biotherapeutics is set to announce phase 2 clinical trial results for the idiopathic pulmonary fibrosis candidate BBT-877 within the year. Chaperone will disclose the phase 2b part 1 clinical results for its atopic dermatitis treatment candidate NuGel during the BFC Global Healthcare Conference in San Francisco, USA, on the 12th.
ABL Bio's phase 1 results for the Parkinson's disease candidate ABL-301 are also expected to be released in the first half of the year. D&D Pharmatech plans to unveil initial clinical results for its oral glucagon-like peptide (GLP)-1 class obesity treatment DD02S, currently being developed with U.S. partner Metzler, in the first half of this year. It is also set to announce primary endpoint results for phase 2 trials of metabolic dysfunction-related hepatic steatosis (MASH) treatment candidate DD01.
Geunhee Seo, head of the healthcare team at Samsung Securities' Research Center, noted, "This year, global pharmaceutical companies could expand mergers and acquisitions (M&A) in anticipation of a 'patent cliff' where they will lose exclusivity due to patent expirations by 2030."
Huh Hyemin, a researcher at Kiwoom Securities, said, "Active M&A is expected during the JP Morgan Healthcare Conference, which will be held in San Francisco, USA, from Jan. 13 to 16," and added, "The domestic market requires momentum from interest rate environments, technology transfers, and expanded penetration into the U.S. market."