GC Cell(144510)'s cell therapy pipelines that have been prepared for years will enter a full-fledged validation phase in the second half. With profitability improvements for the existing clinical testing business also signaled by the health insurance fee restructuring, attention is on whether GC녹십자 can shed its image as the group's "sore finger" and reemerge as a growth pillar.
◇ GC Biopharma's results hampered by GC Cell… signs of recovery in the existing business
GC Cell was launched in 2011 as GC Labcell and acquired GC Cell in 2021 to form its current business structure. It aims to build a value chain spanning research and development (R&D), manufacturing, commercialization, and distribution of cell therapies, and the clinical testing business currently supports this.
Of last year's consolidated sales of 165.5 billion won, clinical testing services accounted for the largest share at 48.7%. They were followed by the hepatocellular carcinoma adjuvant therapy Immuncell-LC injection (22.3%) and biologistics (18.9%).
The issue is profitability. GC Cell posted a consolidated operating loss of 13.8 billion won last year, marking a second straight year of losses. The net loss surged 241.9% year over year to 258.9 billion won. In the first quarter, consolidated sales were 37.4 billion won, down 5.5% from a year earlier, and the operating loss was 5.1 billion won.
In fact, although GC Biopharma improved sales and operating profit last year, consolidated net income was in the red. The securities market assesses that GC Cell's large net loss weighed on consolidated results.
The surge in net loss was largely due to accounting factors. Of the 378.2 billion won in goodwill recognized at the time of the 2021 merger, about 180 billion won was impaired last year, reflecting a book loss. No actual cash outflow occurred. The company says it has no plan for additional goodwill impairment.
Changes have been flagged in the institutional environment surrounding the existing business. Under the health insurance fee restructuring, from Dec., claims for commissioned clinical test fees will be filed directly with the National Health Insurance Service without going through hospitals. The commissioned test fee rate will also be raised from 40% to 45%.
However, the actual magnitude of profitability improvement has not yet been finalized. A company official said, "An additional conditional compensation system is also set to be introduced," and noted, "We will be able to calculate the specific impact on profit and loss after the final fee revision is confirmed."
◇ CAR-NK faces commercialization test… year-end data in focus
The key that will determine whether results recover is ultimately research and development (R&D) performance. GC Cell has built a next-generation cell therapy pipeline, including the commercial product Immuncell-LC injection, its own CAR-NK platform, the NK cell therapy of its U.S. affiliate Artiva Biotherapeutics, and BCMA CAR-T from China's IASO Biotherapeutics.
The asset drawing the most market attention is the in-house CAR-NK platform. Since no NK cell therapy has been approved worldwide, development risk is high, but if commercialization succeeds, it could secure a competitive edge in the early market.
GC Cell is conducting a clinical trial of "GCC2005," discovered through this platform. GCC2005 targets patients with NK/T-cell lymphoma, a hematologic cancer that occurs in both NK cells and T cells, who do not respond to existing treatments. Even in third-line therapy, response rates remain at 20%–30%, making it a hard-to-treat area.
In the phase 1 preliminary results (eight evaluable patients) released at the American Society of Hematology (ASH) in Dec. last year, the objective response rate (ORR) was 62.5% and the complete remission (CR) rate was 37.5%. There were no serious adverse events or treatment discontinuations. Based on these data, it was selected for an oral presentation session at ASH despite being an early-stage trial.
The company aims to enter phase 1b within the year, start a global phase 2 in the second half of next year, and file for marketing approval in 2030.
The market believes that if high-dose cohort data are disclosed at year-end, it will serve as the first test bed to gauge the competitiveness of the CAR-NK platform. Heo Hye-min of Kiwoom Securities said, "If efficacy and safety are confirmed even at high doses, the competitiveness of the CAR-NK pipeline—which can be manufactured in advance and stored for immediate administration without patient-specific production—could stand out and lead to a re-rating of corporate value."
However, the company said, "The schedule for additional data disclosure has not yet been finalized," adding, "Whether there will be an ASH presentation at year-end is also undecided at this point."
◇ "AB-101" to enter phase 3 within the year… expectations for rights and royalties
If GCC2005 is a long-term growth driver, a more visible short-term momentum comes from "AB-101." It is an umbilical cord blood–derived NK cell therapy out-licensed by GC Cell to Artiva, which initially confirmed safety and efficacy in diffuse large B-cell lymphoma (DLBCL) and then expanded the indication to autoimmune diseases.
The current target indication is refractory rheumatoid arthritis. In phase 2a results (in combination with rituximab) presented at the European Alliance of Associations for Rheumatology (EULAR) this year, 71% of patients who completed at least six months of follow-up achieved ACR50 (50% or greater improvement in symptoms). This far exceeds the 20%–30% response rate of standard treatments. Complete depletion of B cells that cause disease was also confirmed in all 28 analyzable patients.
Phase 3 is expected to begin as early as the third quarter. Artiva targets key data readouts in the second half of 2028 and a biologics license application (BLA) in 2029. To that end, in May it raised $300 million (about 440 billion won) by issuing common stock and pre-funded warrants.
GC Cell holds rights to AB-101 in the Asia-Pacific region and the right to receive double-digit royalties. If clinical development proceeds smoothly, royalties and the value of commercialization rights could grow together, making it a potential mid- to long-term revenue source for the company. If phase 3 starts, this year's milestone receipt is estimated at about 1.5 billion won.
◇ "Fucaso" nears domestic approval… "new sales source next year"
The pipeline expected to boost short-term sales is "Fucaso." GC Cell has brought in the domestic rights and is only going through the approval process.
Fucaso is currently sold in China as a fourth-line therapy for multiple myeloma. In a local study of 116 patients, it recorded an ORR of 96%, a minimal residual disease (MRD) negativity rate of 95%, and a 12-month progression-free survival rate of 78.8%. The price in China is about 200 million won, cheaper than the competing therapy "Carvykti" from Johnson & Johnson (about 600 million won based on the U.S. list price).
GC Cell applied to the Ministery of Food and Drug Safety in Feb. this year for an import license for Fucaso. Since it was designated as an orphan drug and for expedited review in Aug. last year, there is speculation that the approval process could be shortened.
The industry also raises the possibility that GC Cell could directly manufacture Fucaso in Korea in the future by using its cell therapy GMP facility (Cell Center). The company said it is "under review," withholding further comment.
Kim Seung-jun, a researcher at the Korea IR Association, predicted, "If approval proceeds as planned, new sales contributions could begin in earnest from next year."
The company said, "In the short term, we will strengthen the profitability of the existing business and CAR-NK research and development capabilities, and in the mid- to long-term, we plan to foster AB-101 and Fucaso as new growth pillars." However, the prevailing view in the industry is that for this to lead to a re-rating of corporate value, clinical performance and approvals, as well as a recovery in the profitability of the existing business, must be demonstrated together.