According to the announcement of the National Healthcare Security Administration of China on November 28, 2024, Kolupin® (tunlametinib), the world's first Class 1 innovative drug targeting NRAS-mutant melanoma developed by Kechow Pharma, has been officially included in China's new National Reimbursement Drug List.

About Tunlametinib:

Kolupin® (tunlametinib) is the first and only drug globally approved as a precisely targeted therapy for advanced NRAS-mutant melanoma patients who fail anti-PD-1/PD-L1 treatment. It is also the first mitogen-activated protein kinase kinase 1/2 (MEK1/2) inhibitor independently developed in China, filling in a gap in clinical practice. The drug exerts its anti-tumor effects by selectively inhibiting the activity of MEK1/2. It precisely matches the target protein's binding pocket, increasing MEK affinity and thereby enhancing tumor inhibition. Additionally, the drug demonstrates a favorable pharmacokinetic profile and significantly reduced cumulative toxicity.

The drug is approved for marketing based on the results of a single-arm, multicenter pivotal Phase II clinical registration study. The study evaluated the efficacy and safety of tunlametinib in patients with NRAS-mutant advanced melanoma. Based on the clinical data as of October 31, 2023, the median progression-free survival (mPFS) was 4.2 months, the median overall survival (mOS) was 13.7 months, the objective response rate (ORR) was 35.8%, the disease control rate (DCR) was 72.6% and the ORR in patients with prior immunotherapy reached 40.6%, as assessed by the Independent Radiological Review Committee (IRRC). Besides, the adverse reactions of tunlametinib were generally controllable and manageable. The recommended dose is 12 mg twice daily orally, either under fasting conditions or with meals, approximately 12 hours apart between doses.

Dr. Hongqi Tian, founder and chairman of Kechow Pharma, said that our company prioritizes innovation and fosters a "science-driven" corporate culture. We are dedicated to developing effective medications that truly address patients' clinical needs! Tunlametinib was included in the National Reimbursement Drug List in the same year it was approved for its first indication, reflecting China's support for high-value innovative drugs and highlighting our commitment to "enhancing the accessibility of innovative drugs to benefit patients". Tunlametinib will benefit a wider range of patients in the future, including those with RAS-mutant and RAF-mutant solid tumors. Indications such as BRAF-mutant non-small cell lung cancer (NSCLC) and BRAF-mutant colorectal cancer (mCRC) are currently undergoing clinical registration studies. The efficacy and safety data available so far are promising and expected to bring hope to even more patients. Looking ahead, Kechow Pharma is committed to benefiting a wider range of patients by developing more innovative drugs with high clinical value.

About Kechow Pharma

Kechow Pharma prioritizes innovation and fosters a "science-driven" corporate culture. The company boasts a robust product pipeline, featuring Kolupin® (tunlametinib), an MEK inhibitor already approved for marketing in China. Furthermore, the company is developing several other products to address unmet clinical needs in China and even worldwide. It is also engaged in the development of novel original small-molecule drugs with the potential to be "Best-in-Class" on a global scale. Kechow Pharma is dedicated to addressing the unmet clinical needs and enhancing the health and well-being of humans around the world!

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