"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 anticancer drug candidate, BAL0891.

According to industry sources on December 11, ShinlaGen's consolidated sales for the third quarter of this year reached approximately 2.8 billion won, marking an increase of about 114% compared to the same period last year (approximately 1.3 billion won). Cumulative sales for the first to third quarters amounted to 6.3 billion won, up more than 160% from 2.4 billion won during the same period last year. The company also succeeded in narrowing its losses. In the third quarter, ShinlaGen's operating loss was 6.1 billion won, a reduction of about 1.5 billion won from 7.6 billion won a year earlier. 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 decisive factor behind this improved performance was the effect of the merger with Woosung Pharmaceutical. After completing the absorption-type merger with Woosung Pharmaceutical on July 1, ShinlaGen included Woosung Pharmaceutical’s pharmaceutical division results in its consolidated earnings for the first time in the third quarter. Even though only partial results were reflected for part of the period, the addition of meaningful new revenue has already begun to change the company’s financial structure. Next year, with the full-year performance of Woosung Pharmaceutical to be reflected, the transformation in the sales structure is expected to become even more pronounced.

ShinlaGen is also working to expand the pharmaceutical division’s presence in overseas markets, leveraging its global partnerships and experience with international regulatory approvals. As a result, the division’s growth rate could accelerate further. Although the year-end results have not yet been finalized, Woosung Pharmaceutical is expected to achieve sales of up to 10 billion won for the first time since its founding. The company also plans to reorganize Woosung Pharmaceutical’s existing portfolio to strengthen revenue contributions from infusion products, while simultaneously improving production efficiency and distribution channels to establish a more stable sales base starting next year.

Positive momentum is also continuing in research and development. In particular, ShinlaGen’s core pipeline candidate, the anticancer drug BAL0891, is rapidly gaining recognition in the global oncology field based on its unique mechanism of action, potential for combination therapy, and consistent preclinical results. BAL0891 simultaneously inhibits TTK (threonine tyrosine kinase, a mitotic checkpoint regulator) and PLK1 (polo-like kinase 1), which are crucial phosphorylation enzymes for cancer cell division. This inhibition prevents normal cell division in cancer cells, inducing either "mitotic arrest" or "abnormal division leading to cell death." If commercialized, BAL0891 could become the first-in-class dual TTK/PLK1 inhibitor in its category. The possibility of synergy when used in combination with immune checkpoint inhibitors has been suggested, and ShinlaGen is now 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), two of the most influential conferences in the fields of immunotherapy and hematology worldwide.

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

BAL0891 is the world’s first drug to receive FDA approval for a combination trial using organoid (artificial organ) models. Beyond the results of the three aforementioned clinical trials, the final combination trial with an immuno-oncology drug is also drawing significant attention from global industry stakeholders. As the FDA has announced a phased abolition of animal testing, ShinlaGen, which has actively adopted organoid technology, is expected to be one of the beneficiaries.

A ShinlaGen representative stated, "If this year was a time to build up the company's value, from next year onward, we expect to respond with tangible results and achievements. The next-generation oncolytic virus platform, SJ-600, is also progressing smoothly through the CDMO (contract development and manufacturing organization) process, so we are steadily preparing for the post-BAL0891 era as well."