Kelun-Biotech Showcases Breakthrough TROP2 ADC Sacituzumab Tirumotecan Clinical Results at 2025 CCHIO Congress in Kunming
Monday, November 10, 2025
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., a leading innovator in China’s bio-pharmaceutical sector, has announced substantial clinical milestones during the 2025 Chinese Congress on Holistic Integrative Oncology (CCHIO) held from November 6 to 9 in Kunming, Yunnan. This major scientific event, featuring collaboration from the Chinese Anti-Cancer Association, World Association for Integrative Oncology, and top integrative medicine institutions, united academicians, oncology experts, and researchers from across the country to examine the latest cutting-edge approaches in cancer diagnosis and therapeutic innovation.
Kelun-Biotech’s highlight during the Congress was the oral presentation of several new data sets from ongoing and completed clinical studies of its TROP2 antibody-drug conjugate (ADC), sacituzumab tirumotecan (sac-TMT). Most notably, Professor Sheng Jindong of Tianjin Cancer Hospital detailed results from a Phase II study focusing on sac-TMT monotherapy for patients with locally advanced or metastatic endometrial cancer (EC). In this pivotal trial, 158 patients were enrolled and stratified into two dosage groups—4 mg/kg and 5 mg/kg—yielding new efficacy and safety insights. The study underscores Kelun-Biotech’s commitment to addressing serious unmet needs in gynecological malignancies.
Additional sessions spotlighted the robust clinical activity of sac-TMT in combination with the anti-PD-1 antibody tagitanlimab in treatment-naive advanced non-squamous non-small cell lung cancer (NSCLC). Prominent features included sustained antitumor responses, therapeutic benefit across PD-L1 expression levels, and a tolerable safety profile with no emergent safety signals. These findings reinforce sac-TMT’s broad potential in solid tumors beyond breast and lung cancer, and highlight Kelun-Biotech’s further expansion into combination immunotherapies in Asia’s oncology landscape.
Currently, Kelun-Biotech is advancing two Phase 3 registrational trials in China evaluating sac-TMT with pembrolizumab as first-line therapy for metastatic NSCLC (including both PD-L1 positive and negative patients). Beyond NSCLC, other development programs involve over 30 clinical studies in lung cancer, breast cancer, and gynecological tumors, leveraging the company’s proprietary antibody-drug conjugate (ADC) and novel drug conjugate (DC) technology platforms, notably OptiDC™. Notably, three indications for sac-TMT are now approved and marketed in China, namely for triple negative breast cancer (TNBC), EGFR mutation-positive advanced non-squamous NSCLC post-EGFR TKI and platinum chemotherapy, and in metastatic settings after prior targeted therapies. The drug is the world’s first TROP2 ADC approved for lung cancer, showcasing significant clinical innovation from China’s domestic pipeline to global markets.
Strategically, Kelun-Biotech’s rapid advancement reflects the growing scientific infrastructure and R&D capabilities emerging in Asia’s biopharma sector. MSD (Merck & Co.), an international partner, is jointly sponsoring 15 ongoing Phase III global clinical studies of sac-TMT as a mono- or combination therapy for a spectrum of cancers. This global partnership underlines Kelun-Biotech’s transformative role within Asia’s innovation ecosystem and the international recognition of its antibody-drug conjugate technologies.
As China’s regulatory environment increasingly prioritizes innovative biologics and fast-tracks approvals for high-impact therapies, Kelun-Biotech’s developments take on critical importance for pharma executives monitoring Asia’s R&D trajectory. The company’s clinical progress, built upon a strong pipeline of over 30 proprietary projects (4 approved, 1 NDA, more than 10 in the clinic), not only elevates standards in oncology care domestically but also sets the stage for cross-border technology licensing and partnerships. Overall, these announcements signal Asia’s advancing leadership in cancer drug discovery, translational research, and global biopharma collaborations.
