Kelun-Biotech’s TROP2 ADC Sacituzumab Tirumotecan Gets China NMPA Marketing Approval

Kelun-Biotech’s TROP2 ADC Sacituzumab Tirumotecan Gets China NMPA Marketing Approval

By, Admin 28 November 2024

Kelun-Biotech’s TROP2 ADC sacituzumab tirumotecan receives China NMPA marketing approval for 2L+ advanced or metastatic TNBC

Overview

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., a holding subsidiary of Kelun Pharmaceutical, which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs, announced that the company received marketing authorization in China from National Medical Products Administration (NMPA) for the first domestically developed trophoblast cell-surface antigen 2 (TROP2)-directed antibody–drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, formerly SKB264/MK-2870) for adult patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting). This is the first domestically developed TROP2 ADC approved for marketing in China and the first domestically developed ADC fully approved for marketing in China.

Behind the Approval

  • The approval is based on the positive results from a randomized, controlled, phase 3 OptiTROP-Breast01 study in adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting). 
  • Sac-TMT demonstrated statistically significant and clinically meaningful improvement in both progression-free survival (PFS) and overall survival (OS) compared to chemotherapy.
  • The results were presented at the special clinical science symposium for next-generation ADCs at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in May 2024.

Previous sNDA Approvals

Previously, NMPA has accepted two supplemental new drug applications (sNDA) seeking the approvals of sac-TMT monotherapy for the treatment of patients with locally advanced or metastatic EGFR-mutant non-small cell lung cancer (NSCLC) following progression on EGFR-TKI therapy only, or both EGFR-TKI and platinum-based chemotherapy, respectively.

Words from the CEO: Kelun-Biotech

  • Dr Micheal Ge, CEO of Kelun-Biotech said, “It is a great pleasure to share with you the important milestone moment of the successful approval and launch of sacituzumab tirumotecan in China, which is a significant achievement of Kelun-Biotech's years of deep-rooted source innovation. As the company's first proprietary TROP2 ADC innovative drug, the successful launch of sacituzumab tirumotecan officially opens up a new pattern for the treatment of patients with 2L+ advanced TNBC.”
  • We expect that its excellent clinical efficacy and safety results will significantly enhance the clinical benefits and improve the quality of life of patients with advanced TNBC. In the future, we will continue to explore the clinical value of sacituzumab tirumotecan in other indications, maximize the market potential of sacituzumab tirumotecan, and satisfy the clinical needs of patients nationwide.”

About Breast Cancer

  • Breast cancer is a threat to women's lives and health. Among them, triple-negative breast cancer has unique biological behavioural characteristics, and is also known as the “most toxic” breast cancer. 
  • 2022 analysis of China's malignant tumour epidemiology data shows that there are 357,000 new cases of breast cancer and 75,000 deaths in Chinese women annually. 
  • In the absence of effective therapeutic targets for triple-negative breast cancer, chemotherapy is the most important systemic treatment in the clinic, but it often has poor efficacy and high toxicity and side effects, and the prognosis is different from other subtypes of breast cancer, it is vital to explore more therapeutic means to improve the clinical benefit.

About the Main Product: Sac-TMT

  • Sac-TMT, a core product of the company, is a novel human TROP2 ADC in which the company has proprietary intellectual property rights, targeting advanced solid tumours such as NSCLC, breast cancer (BC), gastric cancer (GC), gynaecological tumours, among others. 
  • Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. 
  • Sac-TMT specifically recognizes TROP2 on the surface of tumour cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumour cells and releases KL610023 intracellularly. 
  • KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumour cells, which in turn leads to cell-cycle arrest and apoptosis. 
  • In addition, it also releases KL610023 in the tumour microenvironment. 
  • Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumour cells.

License for Exclusive Rights

In May 2022, the company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (includes Mainland China, Hong Kong, Macao, and Taiwan).

The Kelun-Biotech

Kelun-Biotech is a holding subsidiary of Kelun Pharmaceutical, which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs.

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