SKB BIO-B(06990.HK): TROP2 ADC Combined with Immunotherapy Gets Breakthrough Designation, Accumulating Five Relevant Qualifications
On January 5, 2026, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (referred to as "Kelun-Biotech", Stock Code: 6990) issued a voluntary announcement, stating that the company's core product — sacituzumab govitecan (sac-TMT, also known as SKB264/MK-2870, trade name: Jitalai®), a trophoblast cell surface antigen 2 (TROP2)-targeting antibody-drug conjugate (ADC), in combination with pembrolizumab (trade name: Keytruda®), an anti-programmed cell death protein 1 (PD-1) monoclonal antibody owned by Merck Sharp & Dohme LLC (MSD), has been granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of the People's Republic of China for the first-line treatment of specific non-small cell lung cancer (NSCLC).
The announcement clarifies that the target population of this combination therapy is patients with locally advanced or metastatic non-small cell lung cancer who have a programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥ 1%, are epidermal growth factor receptor (EGFR) mutation-negative, and anaplastic lymphoma kinase (ALK)-negative. According to relevant rules, Breakthrough Therapy Designation is mainly granted to therapeutic regimens that can provide effective prevention and treatment for diseases without existing effective therapeutic means or have significant clinical advantages compared with current treatments. For drugs included in the breakthrough therapy program, under relevant conditions, conditional approval applications and priority review and approval applications may be submitted when applying for drug marketing authorization, which will help accelerate the review and launch process of sacituzumab govitecan for this indication.
Previously, Kelun-Biotech had announced the results of the Phase 3 OptiTROP-Lung05 clinical trial of this combination therapy for the first-line treatment of PD-L1-positive NSCLC. The primary endpoint of progression-free survival (PFS) showed statistically and clinically significant improvements, and a beneficial trend was observed in overall survival (OS). This study is also the first Phase 3 clinical study of immunotherapy combined with ADC that reached the primary endpoint in the first-line treatment of NSCLC. Notably, as of the announcement date, sacituzumab govitecan has accumulated five Breakthrough Therapy Designations, covering multiple solid tumor indications including triple-negative breast cancer (TNBC) and non-small cell lung cancer.
As a novel TROP2 ADC with independent intellectual property rights owned by Kelun-Biotech, sacituzumab govitecan targets advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), and gynecological tumors. Developed with a novel linker, it has a drug-antibody ratio (DAR) of 7.4 and possesses advantages such as the bystander effect. Currently, the product has obtained marketing approval for three indications in China, two of which have been included in the national medical insurance catalog; the supplementary new drug application for its indication as second-line or later treatment for hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer has been accepted by the CDE and included in the priority review and approval procedure.
In terms of cooperation, in May 2022, Kelun-Biotech granted MSD exclusive rights to develop, use, manufacture, and commercialize sacituzumab govitecan in all regions outside the Greater China (including Mainland China, Hong Kong, Macau, and Taiwan). As of now, Kelun-Biotech has launched 9 registrative clinical studies in China, and MSD has initiated 15 ongoing global Phase 3 clinical studies exploring the drug as a monotherapy or combination therapy for the treatment of various types of cancer.
The announcement also includes a risk warning: sacituzumab govitecan, which has not yet been approved for other indications, may not ultimately be successfully developed and commercialized. Shareholders and potential investors of the company are advised to exercise caution when trading the company's securities.
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