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Kelun-Biotech’s ADC-PD-1 Combo Wins Breakthrough Therapy Status in First-Line Lung Cancer

Story Highlights
  • Kelun-Biotech’s TROP2 ADC sac-TMT plus pembrolizumab gained Breakthrough Therapy status in China for first-line PD-L1-positive advanced NSCLC.
  • Backed by positive Phase 3 data, this fifth Breakthrough Therapy designation for sac-TMT could speed approval and reinforce Kelun-Biotech’s oncology position.
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Kelun-Biotech’s ADC-PD-1 Combo Wins Breakthrough Therapy Status in First-Line Lung Cancer

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An announcement from Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Class H ( (HK:6990) ) is now available.

Sichuan Kelun-Biotech announced that its core TROP2-directed ADC, sacituzumab tirumotecan (sac-TMT), in combination with MSD’s PD-1 inhibitor pembrolizumab, has been granted Breakthrough Therapy Designation by China’s National Medical Products Administration for first-line treatment of PD-L1-positive, EGFR- and ALK-negative locally advanced or metastatic non-small cell lung cancer. The designation, supported by Phase 3 OptiTROP-Lung05 data showing a statistically significant and clinically meaningful progression-free survival benefit and a positive trend in overall survival, is expected to accelerate regulatory review and potential approval, further strengthening Kelun-Biotech’s positioning in the ADC and lung cancer treatment landscape; this latest recognition marks the fifth Breakthrough Therapy Designation for sac-TMT across multiple solid-tumor indications, underscoring its strategic importance and potential value for patients and the company’s oncology portfolio.

The most recent analyst rating on (HK:6990) stock is a Buy with a HK$545.00 price target. To see the full list of analyst forecasts on Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Class H stock, see the HK:6990 Stock Forecast page.

More about Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Class H

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. is a China-based biopharmaceutical company focused on developing innovative antibody-drug conjugates (ADCs) and other targeted therapies for advanced solid tumors, including non-small cell lung cancer, breast cancer, gastric cancer and gynecological malignancies. Its core product sacituzumab tirumotecan (sac-TMT) is a proprietary TROP2-directed ADC designed to deliver a novel topoisomerase I inhibitor payload to tumor cells, aiming to improve outcomes in difficult-to-treat cancers across multiple indications.

Average Trading Volume: 615,330

Technical Sentiment Signal: Buy

Current Market Cap: HK$93.41B

For detailed information about 6990 stock, go to TipRanks’ Stock Analysis page.

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