#China #Chengdu #oncology #Kelun-Biotech #Sacituzumab

Kelun-Biotech Reports Impressive 2025 Interim Results

On August 18, 2025, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKEX: 6990) announced its unaudited interim results for the first six months ending June 30, 2025. The company reported robust revenue of approximately RMB950.4 million, reflecting a strong market position despite broader industry challenges.

Financial Highlights

The total commercial sales reached RMB309.8 million, demonstrating a significant increase aligned with the company's strategic focus on innovation and comprehensive commercialization infrastructure. However, the company recorded a loss of RMB145.2 million during this period, which can be attributed to increased investments in research and development, approximately RMB611.5 million, aimed at enhancing its drug development capabilities.

Despite the loss, the company's cash reserves remain strong at approximately RMB4527.8 million, providing a solid foundation for future growth and investments.

Strategic Positioning in Biopharmaceuticals

The first half of 2025 marked a pivotal moment for China's biopharmaceutical industry, characterized by accelerated drug development innovation and favorable policy advancements. Kelun-Biotech has seized these opportunities through its proprietary technology platforms and a commitment to delivering innovative therapies for significant unmet medical needs in both oncology and non-oncology fields.

The company has developed a pipeline of over 30 drug candidates, with more than 10 already in clinical stages, focusing primarily on various types of cancer including breast cancer, non-small cell lung cancer, and gastrointestinal cancers. Kelun-Biotech aims to continuously evolve its offerings to improve global health outcomes.

Pipeline Highlights

Kelun-Biotech's leading product, sacituzumab tirumotecan (branded as sac-TMT), received considerable attention as it is a first-in-class TROP2 antibody-drug conjugate (ADC). The drug has been approved by the National Medical Products Administration (NMPA) in China for treating patients with triple-negative breast cancer (TNBC) who have previously undergone systemic therapies. The company is currently conducting a Phase 3 study for sac-TMT to compare its efficacy against chemotherapy in the management of advanced TNBC.

In addition to the TNBC indication, Kelun-Biotech is advancing various other assets within its oncology portfolio. For instance, the NMPA accepted a new drug application (NDA) for sac-TMT aimed at patients with HR+/HER2- breast cancer and has initiated a Phase 3 study for its application.

Another vital product, trastuzumab botidotin, for HER2+ breast cancers has also gained traction, with an NDA submitted to NMPA following positive Phase 2 trial results. The company aims to build upon its ADC success by exploring various other innovative drug candidates, enhancing its therapeutic reach.

Expanding Market Access

Kelun-Biotech has made significant strides in commercializing its offerings, as sac-TMT, tagitanlimab, and Cetuximab N01 are now accessible to numerous provinces and cities across China. The sales of sac-TMT alone account for around 97.6% of total commercial revenue during the reporting period, highlighting the drug's pivotal role in the company's commercial strategy.

To enhance market presence, Kelun-Biotech has built an extensive marketing team and established partnerships with key distribution groups, ensuring efficient product delivery and facilitating interactions with healthcare professionals. The company's marketing campaigns aim to engage various segments of the healthcare sector, enhancing awareness regarding innovative therapies among physicians and patients alike.

Global Collaborations

Kelun-Biotech continues to expand its global collaboration network, partnering with industry leaders like MSD to advance clinical research worldwide. The ongoing Phase 3 global clinical studies for sac-TMT reflect the company's commitment to maximizing the value of its pipeline while providing robust solutions for patients globally.

The company is deepening its collaboration with other partners in ADC research, focusing on broadening its innovative pipeline. This approach is integral to Kelun-Biotech's mission, emphasizing the pursuit of high-quality therapies to meet diverse medical needs.

Looking Ahead

As Kelun-Biotech moves forward into the second half of 2025, it will pursue innovation by optimizing payload-linker strategies and developing differentiated pipelines targeting significant medical needs. Its future endeavors are focused on enhancing commercialization efforts and expanding its global footprint. With ongoing strategic partnerships, the company is poised to unlock the full potential of its drug candidates and establish itself as a predominant player in the global biopharmaceutical market.

For further inquiries and detailed information about ongoing projects, visit Kelun-Biotech's official website.