Kelun-Biotech Achieves Major Milestone with Sacituzumab Tirumotecan for HR+/HER2- Breast Cancer
On February 6, 2026, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. made an announcement that has implications for breast cancer treatment. The company's latest product, sacituzumab tirumotecan (sac-TMT), was awarded a new indication approval by the National Medical Products Administration (NMPA) of China. This approval is specifically for the treatment of adult patients diagnosed with unresectable or metastatic HR+/HER2- breast cancer, particularly for those who have undergone prior endocrine therapy and at least one line of chemotherapy.
This new designation marks the fourth approved indication for sac-TMT in China, following successful results from the Phase III OptiTROP-Breast02 trial. This pivotal study demonstrated the drug's efficacy and safety as a monotherapy compared to standard chemotherapy options. Remarkably, the trial included participants with significant health challenges; 95.7% of enrolled subjects exhibited visceral metastases, with a considerable percentage also having liver metastases.
The results of this study were notable, revealing that sac-TMT led to a statistically significant enhancement in progression-free survival (PFS) when assessed by a Blinded Independent Central Review. Specifically, patients treated with sac-TMT experienced a PFS of 8.3 months, compared to just 4.1 months for those receiving standard chemotherapy. The hazard ratio, a measure of the risk of an event happening in the treatment group compared to the control group, was an impressive 0.35, indicating a clear advantage for sac-TMT. Furthermore, consistent benefits were observed across various patient subgroups, underscoring the treatment's broad applicability.
In addition to PFS, a trend toward improved overall survival (OS) was noted, alongside a higher objective response rate (ORR) of 41.5% in the sac-TMT group versus 24.1% in the control group. These findings suggest not only that sac-TMT could extend patient longevity but also that it might offer a more effective treatment response than traditional chemotherapy, especially for patients with HR+/HER2- breast cancer.
For context, breast cancer is a major global health concern, with HR+/HER2- being the most prevalent subtype, accounting for about 70% of all cases. Patients suffering from advanced HR+/HER2- breast cancer have historically encountered a grim prognosis, and treatment with chemotherapy often yields low response rates and limited survival benefits. The introduction of sac-TMT could revolutionize current therapeutic strategies for these patients, providing an innovative approach in an area of significant unmet need.
Sac-TMT functions as a TROP2-directed antibody-drug conjugate (ADC), specifically designed to target and eliminate cancer cells. This product, which the company developed with proprietary technology, is structured to deliver an anticancer payload directly into tumor cells. This payload is a topoisomerase I inhibitor, known for its potency against various solid tumors, including breast cancer and non-small cell lung cancer (NSCLC).
The approval of sac-TMT is not just a singular achievement for Kelun-Biotech; it also positions the company as a leader in the advancement of ADC therapies. To date, four indications for sac-TMT have been authorized for marketing within China, covering a range of challenging cancers, including specific types of lung cancer and triple-negative breast cancer (TNBC).
To further complement its drug development efforts, Kelun-Biotech has secured an exclusive licensing agreement with MSD (Merck) for the commercialization of sac-TMT outside of Greater China, a strategic move that could expand the drug's reach and availability to patients globally.
The landscape of breast cancer treatment is continuously evolving, and with Kelun-Biotech's commitment to innovative drug development and the recent approvals of sac-TMT, patients with HR+/HER2- breast cancer may soon have access to more effective, targeted treatment options that can profoundly improve their quality of life and survival rates. As the company continues its ambitious clinical research agenda, it is poised to significantly contribute to combatting this prevalent form of cancer on a global scale.
This new designation marks the fourth approved indication for sac-TMT in China, following successful results from the Phase III OptiTROP-Breast02 trial. This pivotal study demonstrated the drug's efficacy and safety as a monotherapy compared to standard chemotherapy options. Remarkably, the trial included participants with significant health challenges; 95.7% of enrolled subjects exhibited visceral metastases, with a considerable percentage also having liver metastases.
The results of this study were notable, revealing that sac-TMT led to a statistically significant enhancement in progression-free survival (PFS) when assessed by a Blinded Independent Central Review. Specifically, patients treated with sac-TMT experienced a PFS of 8.3 months, compared to just 4.1 months for those receiving standard chemotherapy. The hazard ratio, a measure of the risk of an event happening in the treatment group compared to the control group, was an impressive 0.35, indicating a clear advantage for sac-TMT. Furthermore, consistent benefits were observed across various patient subgroups, underscoring the treatment's broad applicability.
In addition to PFS, a trend toward improved overall survival (OS) was noted, alongside a higher objective response rate (ORR) of 41.5% in the sac-TMT group versus 24.1% in the control group. These findings suggest not only that sac-TMT could extend patient longevity but also that it might offer a more effective treatment response than traditional chemotherapy, especially for patients with HR+/HER2- breast cancer.
For context, breast cancer is a major global health concern, with HR+/HER2- being the most prevalent subtype, accounting for about 70% of all cases. Patients suffering from advanced HR+/HER2- breast cancer have historically encountered a grim prognosis, and treatment with chemotherapy often yields low response rates and limited survival benefits. The introduction of sac-TMT could revolutionize current therapeutic strategies for these patients, providing an innovative approach in an area of significant unmet need.
Sac-TMT functions as a TROP2-directed antibody-drug conjugate (ADC), specifically designed to target and eliminate cancer cells. This product, which the company developed with proprietary technology, is structured to deliver an anticancer payload directly into tumor cells. This payload is a topoisomerase I inhibitor, known for its potency against various solid tumors, including breast cancer and non-small cell lung cancer (NSCLC).
The approval of sac-TMT is not just a singular achievement for Kelun-Biotech; it also positions the company as a leader in the advancement of ADC therapies. To date, four indications for sac-TMT have been authorized for marketing within China, covering a range of challenging cancers, including specific types of lung cancer and triple-negative breast cancer (TNBC).
To further complement its drug development efforts, Kelun-Biotech has secured an exclusive licensing agreement with MSD (Merck) for the commercialization of sac-TMT outside of Greater China, a strategic move that could expand the drug's reach and availability to patients globally.
The landscape of breast cancer treatment is continuously evolving, and with Kelun-Biotech's commitment to innovative drug development and the recent approvals of sac-TMT, patients with HR+/HER2- breast cancer may soon have access to more effective, targeted treatment options that can profoundly improve their quality of life and survival rates. As the company continues its ambitious clinical research agenda, it is poised to significantly contribute to combatting this prevalent form of cancer on a global scale.
Topics Health）
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