NewTimeSpace News:SKB BIO-B(06990.HK) issued an announcement on February 6, 2026, disclosing that the new indication marketing application for its core product sacituzumab govitecan (sac-TMT, trade name: Jitalai®) has been approved by the National Medical Products Administration (NMPA) of China.

It is reported that the approved indication is for the treatment of adult patients with unresectable or metastatic HR+/HER2- breast cancer who have previously received endocrine therapy and at least one line of chemotherapy in the advanced disease stage. This marks the fourth indication of the product launched in China. The approval is based on the positive results of the OptiTROP-Breast02 Phase 3 clinical study, which was presented as a Late-Breaking Abstract (LBA) and oral presentation at the 2025 European Society for Medical Oncology (ESMO) Congress.

The announcement clarified that the global cooperation and clinical layout of sacituzumab govitecan are steadily advancing. Kelun-Biotech has granted Merck & Co., Inc. the exclusive development and commercialization rights outside the Greater China region. Currently, both parties are advancing multiple global Phase 3 clinical studies. The market potential of this product is expected to be further unleashed, providing long-term performance support for the company.

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