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Kelun-Biotech Interim Results Unveiled

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., commonly referred to as Kelun-Biotech, has announced its unaudited consolidated results for the first half of 2026, reporting significant financial and operational achievements. With total revenue reaching approximately RMB 978 million, the company has seen its pharmaceutical product sales soar to RMB 657 million, which marks an impressive 112% increase compared to the same period last year.

The driving forces behind this remarkable growth include the recognition of the high-quality clinical data that Kelun-Biotech has produced, alongside a noticeable shift in treatment paradigms and enhanced accessibility to its pharmaceuticals. The company has successfully established a robust operational model within China that integrates research and development, manufacturing, quality management, and commercialization capabilities. It aims to broaden its footprint internationally through strategic collaborations, harnessing partnerships to gain valuable global clinical development insights and commercial experience.

Advancements in Oncology Treatment

A focal point for Kelun-Biotech lies in Antibody-Drug Conjugate (ADC) and novel drug conjugation (DC) therapies. Notably, the company boasts two ADC products that have already received marketing approval. Furthermore, its product pipeline remains diversified and complementary, featuring innovative solutions in both indications and safety profiles. By facilitating the flexible combination of various drug components with a range of targeting conjugates—which include antibodies and small molecules—the firm continues to advance its novel drug conjugation assets.

In its pursuit of progress, Kelun-Biotech is committed to enhancing ADC therapies in conjunction with Immuno-Oncology (IO) treatments, integrating various agents to develop drug candidates that exhibit synergistic mechanisms of action. Beyond oncology, the company seeks to tackle significant therapeutic areas, expanding its research to cover autoimmune and metabolic diseases. Clinical trials for conditions such as asthma, chronic obstructive pulmonary disease (COPD), and atopic dermatitis are already underway.

Strengthening the Clinical Pipeline

The efficiency of Kelun-Biotech's developmental process is evident in its progressively expanding clinical pipeline. The company has adopted a tiered strategy targeting high-prevalence cancers like lung and breast cancer. This pipeline encompasses various drug modalities, including ADCs, immunotherapies, and small-molecule targeted therapies. Key milestones achieved during this reporting period include:

• - Sac-TMT: This version of the TROP2 ADC has garnered approvals for four cancer indications and continues to show promising results in ongoing clinical studies, including a recent pivotal trial evaluating its effectiveness as a first-line treatment for advanced conditions.
• - HER2 ADC (trastuzumab botidotin): Currently approved for 2L+ HER2-positive breast cancer with an ongoing Phase 2 study focusing on patients previously treated with other ADCs.

Additional innovative assets include SKB315 (CLDN18.2 ADC), SKB410 (Nectin-4 ADC), and other ground-breaking dual-payload ADCs still under development.

Commercial Expansion and Market Recognition

Three of Kelun-Biotech's products have successfully been included in the National Reimbursement Drug List (NRDL), enhancing their accessibility across healthcare institutions in China. The company's strategic outreach has expanded over 30 provinces, ensuring wider access to drugs, which is critical for fiscal growth. Complemented by a 800+ strong commercial team, Kelun-Biotech’s initiatives are setting the stage for sustained market success.

Outlook for Future Growth

Looking ahead, Kelun-Biotech emphasizes its commitment to innovation and enhancing operational efficacy, aspiring to position itself as a world-class biopharmaceutical player. This includes optimizing its drug development pipelines, enhancing collaborations abroad, and broadening its global reach. With ongoing clinical studies and collaborations with international entities like Merck Sharp & Dohme, the company is well on its way to fulfilling its vision of addressing global healthcare needs with innovative treatment solutions.

Overall, Kelun-Biotech's interim results portray a dynamic organization poised for continued success in the biopharmaceutical landscape, underscoring its relentless commitment to pioneering therapeutic advancements and meeting critical medical demands.