"Build-Up Is Over"... Next Year Is ShinlaGen's Time to Strike Back

Merger with Woosung Pharmaceutical and Clinical Results for Key Pipeline
Multiple Catalysts for Business Rebound Next Year... Technology Transfer Expectations Rising

ShinlaGen is preparing for a "time to strike back" next year, leveraging the effects of its merger with Woosung Pharmaceutical and the announcement of clinical results for its key oncology pipeline drug, BAL0891.

According to industry sources on December 11, ShinlaGen’s consolidated revenue for the third quarter of this year was approximately 2.8 billion won, up about 114% from the same period last year (approximately 1.3 billion won). Cumulative revenue for the first to third quarters reached 6.3 billion won, more than 160% higher than the 2.4 billion won recorded during the same period last year. The company also narrowed its losses. ShinlaGen’s operating loss for the third quarter was 6.1 billion won, a reduction of about 1.5 billion won compared to 7.6 billion won in the same period last year. Net loss for the period also shrank by about 2 billion won, from 7.9 billion won last year to 5.9 billion won this year.

The improvement in performance was decisively driven by the effects of the merger with Woosung Pharmaceutical. After completing its absorption-type merger with Woosung Pharmaceutical on July 1, ShinlaGen included the results of Woosung Pharmaceutical’s pharmaceutical business division in its consolidated revenue for the first time in the third quarter. Even though only a partial period was reflected, the addition of meaningful new revenue has begun to bring real changes to the company’s financial structure. Next year, with Woosung Pharmaceutical’s full-year performance included, the shift in revenue structure is expected to become even more pronounced.

Additionally, ShinlaGen is working to expand the pharmaceutical business division into overseas markets, leveraging its experience with global partnerships and international regulatory approvals. This is expected to accelerate the division’s external growth. While full-year results for this year have not yet been finalized, Woosung Pharmaceutical is expected to achieve annual revenue of 10 billion won for the first time since its founding. The company plans to further strengthen the contribution of infusion products by reorganizing Woosung Pharmaceutical’s existing portfolio, while simultaneously improving production efficiency and distribution channels to establish a more stable revenue base starting next year.

Positive momentum is also continuing in the research and development sector. In particular, ShinlaGen’s core pipeline candidate, the anti-cancer agent BAL0891, is rapidly gaining presence in the global oncology field based on its unique mechanism of action, combinatorial potential, and consistent preclinical results. BAL0891 simultaneously inhibits TTK (mitotic checkpoint kinase) and PLK1 (polo-like kinase 1), both of which are critical phosphorylation enzymes for cancer cell division. This inhibition prevents cancer cells from dividing normally, inducing either "mitotic arrest" or "abnormal division leading to cell death." If commercialized, BAL0891 could become the "first-in-class" anti-cancer agent among TTK/PLK1 dual inhibitors. There is also potential for synergistic effects when used in combination with immune checkpoint inhibitors, and ShinlaGen is actively pursuing combination strategies with immuno-oncology drugs. This year, the company was invited to present the clinical overview of this candidate at both the Society for Immunotherapy of Cancer (SITC 2025) and the European Hematology Association (EHA 2025), which are globally influential in the fields of immuno-oncology and hematologic malignancies, respectively.

Notably, three out of four clinical cohorts are expected to be completed next year. BAL0891 is undergoing a large-scale Phase 1 clinical trial involving 260 participants, with four cohorts: three for solid tumors and one for hematologic malignancies. At least two to three sets of clinical data are scheduled for release next year. Several major global pharmaceutical companies have already received the clinical overview for BAL0891 and are awaiting the Phase 1 results to be released next year, raising expectations for full-scale technology transfer (license-out) deals.

BAL0891 is the world’s first drug to receive FDA approval for a combination clinical trial using organoid (artificial organ) models. In addition to the three clinical results mentioned above, the final combination trial with an immuno-oncology drug is attracting significant attention from global industry stakeholders. With the FDA announcing a phased abolition of animal testing, ShinlaGen, which has proactively adopted organoid technology, is expected to be one of the beneficiaries.

A ShinlaGen representative stated, "If this year was about building up the company’s value, we expect next year to be a time of delivering results and achievements. The next-generation oncolytic virus platform, SJ-600, is also progressing smoothly in the CDMO (contract development and manufacturing organization) process, so we are steadily preparing for what comes after BAL0891."