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Kelun-Biotech Wins Fourth China Indication for Core TROP2 ADC in Advanced Breast Cancer

Story Highlights
  • Kelun-Biotech’s TROP2 ADC sacituzumab tirumotecan gained NMPA approval for a fourth indication in pretreated HR-positive, HER2-negative metastatic breast cancer.
  • Phase 3 data showed sacituzumab tirumotecan significantly improved progression-free survival and response rates versus chemotherapy, reinforcing its role and future potential in Kelun-Biotech’s oncology portfolio.
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Kelun-Biotech Wins Fourth China Indication for Core TROP2 ADC in Advanced Breast Cancer

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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Class H ( (HK:6990) ) has provided an announcement.

Sichuan Kelun-Biotech Biopharmaceutical announced that its core TROP2-directed antibody-drug conjugate sacituzumab tirumotecan (sac-TMT) has received approval from China’s National Medical Products Administration for a fourth indication, specifically for adult patients with unresectable or metastatic HR-positive/HER2-negative breast cancer who have previously received endocrine therapy and at least one line of chemotherapy in the advanced setting. The approval, grounded in positive Phase 3 OptiTROP-Breast02 data showing a statistically significant and clinically meaningful improvement in progression-free survival and higher objective response rates versus chemotherapy across key subgroups, further entrenches sac-TMT as a major oncology asset for Kelun-Biotech and strengthens its competitive position in the fast-growing ADC market, with additional global and China-based Phase 3 trials underway in earlier-line HR+/HER2- disease that may broaden its future commercial potential.

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 antibody-drug conjugates and other innovative therapies for advanced solid tumors, including breast cancer, non-small cell lung cancer, gastric cancer and gynecological malignancies. Its core product, the TROP2-directed ADC sacituzumab tirumotecan (sac-TMT), is supported by proprietary intellectual property and has been licensed to Merck & Co. for development and commercialization outside Greater China, underscoring the company’s global ambitions in oncology.

Average Trading Volume: 569,906

Technical Sentiment Signal: Buy

Current Market Cap: HK$98.59B

See more insights into 6990 stock on TipRanks’ Stock Analysis page.

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