Sichuan Kelun-Biotech Announces Positive Final Overall Survival Data for Core Product Sacituzumab Tirumotecan (sac-TMT) at 2026 ELCC

Hong Kong, March 18, 2026 – Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (Stock Code: 6990) has delivered a significant update that could have major implications for investors and the company’s future growth. The company announced that the final overall survival (OS) analysis from its pivotal OptiTROP-Lung03 study for its core product sacituzumab tirumotecan (sac-TMT, 佳泰萊®), a TROP2-directed antibody-drug conjugate (ADC), will be presented at the prestigious 2026 European Lung Cancer Congress (ELCC) in Copenhagen, Denmark.

Key Highlights from the Announcement

• Sac-TMT Achieves Breakthrough Results: The pivotal study compared sac-TMT to docetaxel in patients with locally advanced or metastatic EGFR-mutant non-small-cell lung cancer (NSCLC) who had failed prior EGFR-TKI and platinum-based chemotherapy. Sac-TMT demonstrated statistically significant and clinically meaningful improvements in both progression-free survival (PFS) and overall survival (OS).
• Study Results:
  • Hazard ratio (HR) for blinded independent central review (BICR)-assessed PFS was 0.30 (95% CI: 0.20–0.46, p<0.001).
  • HR for OS was 0.49 (95% CI: 0.27–0.88, p=0.007).
  • Based on these results, sac-TMT received regulatory approval from China’s National Medical Products Administration (NMPA) and was added to the National Reimbursement Drug List (NRDL), expanding patient access and potential market share.
• Final Data Presented at 2026 ELCC:
  • Median follow-up: 23.8 months.
  • 41.3% of patients in the control group crossed over to sac-TMT after disease progression.
  • Using the RPSFT model to adjust for crossover, median OS was 20.0 months for sac-TMT vs. 11.2 months for docetaxel (HR 0.45, 95% CI: 0.28–0.73).
  • 18-month OS rate: 54.7% (sac-TMT) vs. 9.1% (docetaxel).
  • Without adjustment, median OS was 20.0 months vs. 13.5 months (HR 0.63, 95% CI: 0.40–0.98).
  • Median PFS (investigator-assessed): 7.9 months (sac-TMT) vs. 2.8 months (docetaxel) (HR 0.23, 95% CI: 0.15–0.35).
• Reinforced Credibility with Multiple Studies: Sac-TMT’s efficacy and survival benefit was confirmed in the OptiTROP-Lung04 study, with results published in the New England Journal of Medicine, showing a median OS of 20 months for patients with EGFR-mutant NSCLC who progressed after both EGFR-TKI and platinum-based chemotherapy.

Product and Pipeline Details

• Innovative Mechanism: Sac-TMT is a novel human TROP2 ADC with a proprietary linker and a belotecan-derivative topoisomerase I inhibitor payload (KL610023), with a high drug-to-antibody ratio (DAR 7.4). The drug targets TROP2 on tumor cells, leading to DNA damage, cell-cycle arrest, apoptosis, and a bystander killing effect in the tumor microenvironment.
• Broad Indication Portfolio: Sac-TMT has secured approvals in China for four indications:
  • EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI and platinum-based chemotherapy.
  • Unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) post at least two systemic therapies.
  • EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC after EGFR-TKI therapy.
  • Unresectable or metastatic hormone receptor-positive, HER2-negative breast cancer after prior endocrine therapy and at least one chemotherapy line in the advanced setting.
• Market Access: The first two indications are included in China’s NRDL, which is likely to drive market penetration and revenue growth.
• Regulatory Recognition: Sac-TMT has received six Breakthrough Therapy Designations (BTDs) from the NMPA.
• Global Collaboration: In May 2022, Merck & Co. (MSD) licensed exclusive rights to develop and commercialize sac-TMT outside of Greater China. MSD is currently conducting 17 global Phase 3 studies for various cancer types, while Kelun-Biotech is running 9 registrational studies in China.
• First-in-Class Status: Sac-TMT is the world’s first TROP2 ADC approved for lung cancer, reinforcing the company’s leadership in ADC innovation and oncology.

Shareholder-Relevant and Price-Sensitive Information

• Significant Clinical Success: The robust survival data, regulatory approvals, and inclusion in the NRDL could significantly boost the company’s revenues and market position.
• Global Expansion Potential: The partnership with MSD opens the door for international market penetration, potentially driving long-term growth and value creation.
• Pipeline Strength and Indication Expansion: The ongoing global and domestic clinical studies may result in further label expansions, providing additional catalysts for share price appreciation.
• Risk Factors: Sac-TMT is still under clinical development for other indications, and these may not ultimately be approved or commercialized successfully. Shareholders are advised to exercise caution as future results are not guaranteed.

Conclusion

Sac-TMT’s positive final OS results, regulatory milestones, and strong clinical pipeline represent a material development for Sichuan Kelun-Biotech. The data reinforces sac-TMT’s potential as a new standard of care for pre-treated EGFR-mutant NSCLC and other solid tumors. These achievements, combined with global commercialization efforts, could materially impact the company’s future growth prospects and share value.

Disclaimer: This article is for informational purposes only and does not constitute investment advice. Investors are advised to conduct their own due diligence and consult professional financial advisors before making investment decisions. The development and commercialization of pharmaceutical products are subject to significant risks, and future clinical or regulatory outcomes may differ from current expectations.

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