Kelun-Biotech Achieves Breakthrough in First-Line NSCLC Treatment with World's First Successful ADC-Immunotherapy Combination
Key Insights
Kelun-Biotech (search)'s SKB264 (sac-TMT) combined with pembrolizumab achieved primary endpoint in Phase III trial for first-line PD-L1 (search) positive NSCLC, marking the world's first successful ADC-immunotherapy combination in this setting.
The company reported strong 2025 performance with revenue of RMB2.06 billion and four approved products, including three core assets entering China's National Reimbursement Drug List in January 2026.
SKB264 received FDA Commissioner Priority Review Voucher, reducing regulatory review time from 10-12 months to 1-2 months, with Merck (search) planning first marketing application by 2026.
Kelun-Biotech (search) has achieved a significant milestone in oncology treatment with its antibody-drug conjugate (ADC) SKB264 becoming the first ADC to successfully combine with an immune checkpoint inhibitor in first-line non-small cell lung cancer (NSCLC) treatment. The Chinese Phase III clinical trial comparing SKB264 (sac-TMT) combined with Keytruda (pembrolizumab) to Keytruda monotherapy for first-line treatment of PD-L1 (search) positive NSCLC met its primary endpoint of progression-free survival, with overall survival also showing a positive trend.
This breakthrough represents a potential paradigm shift in NSCLC treatment, as it marks the world's first Phase III clinical trial to demonstrate the success of an ADC combined with an immune checkpoint inhibitor in first-line NSCLC. Complete data from this pivotal study will be presented at the American Society of Clinical Oncology Annual Meeting in June 2025.
Regulatory Acceleration and Global Development
The therapeutic potential of SKB264 has gained significant regulatory recognition. In January 2025, the compound was granted a "Commissioner Priority Review Voucher" by the US FDA, dramatically reducing the regulatory review period from the standard 10 to 12 months to just 1 to 2 months. This designation underscores the FDA's recognition of the drug's potential to address unmet medical needs.
Partner Merck (search) is expected to submit the first marketing application for SKB264 in second-line and above endometrial cancer by 2026, with approval anticipated by late 2026 or early 2027. The global development program is extensive, with Merck having initiated 17 global Phase III clinical trials for SKB264, covering areas such as breast cancer, lung cancer, gynecological cancers, and gastric cancer.
Strong Commercial Performance and Market Access
Kelun-Biotech (search) reported robust financial performance for 2025, with revenue reaching approximately RMB2.06 billion and gross profit of approximately RMB1.48 billion, representing year-on-year increases. Despite R&D expenses of approximately RMB1.32 billion and a net loss of RMB382 million, the company maintains a strong financial position with cash and financial assets totaling approximately RMB4.56 billion.
The company has successfully transitioned into a commercial biopharmaceutical entity with four products and eight indications approved for marketing in China. These include Sacituzumab Tirumotecan (佳泰莱®), Trastuzumab Botidotin (舒泰莱®), Tagitanlimab (科泰莱®), and Cetuximab N01 (达泰莱®).
A major commercial milestone was achieved with the inclusion of three core products—SKB264 (sac-TMT), A167, and A140—in China's National Reimbursement Drug List starting January 2026. This inclusion is expected to significantly expand patient access and drive sales growth.
Expanding Pipeline and Clinical Achievements
Beyond SKB264, Kelun-Biotech (search) has built a robust pipeline of more than 30 drug candidates, with over 10 in clinical development. The company is expanding beyond oncology into autoimmune diseases and metabolic disorders, leveraging its proprietary OptiDC™ technology platform.
Key clinical achievements include multiple approvals for sac-TMT across different cancer types. In March 2025, the company received marketing authorization for sac-TMT in EGFR (search) mutant-positive NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy, making it the first TROP2 (search) ADC approved for lung cancer globally. In October 2025, another approval was granted for EGFR mutant-positive NSCLC patients who progressed after EGFR-TKI therapy alone.
Strategic Partnerships and Global Expansion
The company has established multiple strategic partnerships to accelerate global development. The collaboration with MSD encompasses 17 ongoing Phase III global clinical studies of sac-TMT. Additionally, partnerships with Ellipses Pharma for RET (search) inhibitor development and Windward Bio (search) for TSLP antibody development demonstrate the company's commitment to expanding its global footprint.
In December 2025, Kelun-Biotech (search) entered into a strategic collaboration with Crescent Biopharma for SKB105/CR-003 and SKB118, with Crescent receiving exclusive rights outside Greater China while Kelun-Biotech retains rights in Greater China.
Financial Outlook and Market Position
CMBI analysts have raised their target price for Kelun-Biotech (search) from HKD498.55 to HKD507.11, maintaining a "Buy" rating. The firm projects that 2025 will be pivotal as the company transitions into full commercialization, with four products expected to be approved and product sales revenue reaching RMB543 million.
The company's debt-to-asset ratio has further declined to 18.7%, indicating improved financial health. With ample cash reserves of RMB4.6 billion, Kelun-Biotech (search) is well-positioned to fund domestic commercialization and pipeline development through the anticipated expansion phase.