Kelun-Biotech's Sac-TMT Approved in China for Advanced Metastatic TNBC Treatment

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") has announced that it has obtained marketing approval in China from the National Medical Products Administration (NMPA) for sacituzumab tirumotecan (sac-TMT, previously known as SKB264/MK-2870). This antibody-drug conjugate (ADC) targets trophoblast cell-surface antigen 2 (TROP2) and is intended for adult patients suffering from unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have undergone at least two previous systemic treatments, including one for advanced or metastatic disease. This marks the first TROP2-directed ADC developed domestically to receive marketing approval in China, as well as the first fully approved ADC created within the country.

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The endorsement stems from favorable outcomes in the randomized, controlled, phase 3 OptiTROP-Breast01 trial involving adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who had previously undergone at least two systemic treatments (with a minimum of one for advanced or metastatic disease). Sac-TMT achieved statistically significant and clinically relevant advancements in both progression-free survival (PFS) and overall survival (OS) when compared to traditional chemotherapy. These findings were presented during the special clinical science symposium on next-generation antibody-drug conjugates (ADCs) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in May 2024.

Additionally, the National Medical Products Administration (NMPA) has received two supplemental new drug applications (sNDA) for the approval of sac-TMT monotherapy aimed at treating patients with locally advanced or metastatic EGFR-mutant non-small cell lung cancer (NSCLC) following disease progression solely on EGFR-TKI therapy, or on both EGFR-TKI and platinum-based chemotherapy.

Dr. Micheal Ge, the CEO of Kelun-Biotech, remarked, "We are thrilled to announce the significant milestone of sacituzumab tirumotecan’s successful approval and launch in China, which marks a major success for Kelun-Biotech's longstanding dedication to innovative sourcing. As the company's inaugural proprietary TROP2 ADC, the launch of sacituzumab tirumotecan heralds a new era in the management of patients with second-line or later advanced TNBC. We anticipate that its outstanding clinical efficacy and safety profile will greatly improve clinical outcomes and enhance the quality of life for patients suffering from advanced TNBC. Moving forward, we will continue to delve into the clinical applicability of sacituzumab tirumotecan for other indications, optimizing its market potential while addressing the needs of patients across the country."

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According to the data provided by the Synapse Database, As of November 28, 2024, there are 15 investigational drugs for the TOP1 x Trop-2 target, including 103 indications, 53 R&D institutions involved, with related clinical trials reaching 241 and as many as 198 patents.

Sacituzumab tirumotecan is an antibody drug conjugate (ADC) that targets TOP1 and Trop-2. It is utilized in the treatment of a wide range of neoplastic, skin and musculoskeletal diseases, digestive system disorders, respiratory diseases, urogenital diseases, other diseases, endocrinology, and metabolic diseases.