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Novartis Submits New Indication for Dabrafenib/Trametinib Combination Therapy in China; BeiGene Holds Partial Commercial Rights

Sep 12, 2025 14:19 CST Updated 14:19
Novartis

Drug Development and Manufacturing

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On September 12, the CDE website showed that NovartisDabrafenib Mesylate Capsules Marketing Application Accepted. Based on publicly available information and clinical trial progress, the Insight database speculates that the indication for this application isIn combination with trametinib for the treatment of patients with locally advanced or metastatic disease who have been previously treated,Radioactive Iodine-Refractory BRAF V600E Mutation-Positive Differentiated Thyroid Cancer. AndThe marketing application for Trametinib was accepted by the CDE on September 4.
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Screenshot source: CDE official website
Dabrafenib is a potent and selective inhibitor of BRAF kinase activity, and trametinib is a reversible, highly selective allosteric inhibitor of MEK1 and MEK2 kinase activity.
May 2013,Dabrafenib was first approved by the FDA for marketing in 2014.DabrafenibThe combination therapy with trametinib was approved for the first time in the United States. Since the approval of the combination therapy,Global sales continue to rise. According to Novartis' financial report, the global sales of this combination therapy exceeded in 2024.$20 billion。
In China,DabrafenibThe combination therapy with trametinib has been approved for three indications: 1)For the treatment of unresectable or metastatic BRAF V600 mutation-positiveMelanoma；2）Used for treatmentBRAF V600 Mutation-Positive Stage IIIAdjuvant Treatment for Patients with Completely Resected Melanoma；3）Used for treatmentBRAF V600 Mutation-Positive MetastaticNon-Small Cell Lung Cancer。
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Screenshot source: Insight database
In June 2021, Novartis launched aRandomized, Double-blind, Placebo-controlled Phase III Study Aimed at EvaluatingEfficacy and Safety of Dabrafenib in Combination with Trametinib in Previously Treated Locally Advanced or Metastatic, Radioactive Iodine-Refractory BRAF V600E Mutation-Positive Differentiated Thyroid Cancer. Results have not yet been disclosed.
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Screenshot source: Insight database
It is worth mentioning that, in 2021, BeiGene and Novartis reached a strategic cooperation, with NovartisGrant BeiGene marketing, promotion, and sales rights in designated regions within ChinaDabrafenib, Trametinib, and 5 other productsRights to approved anti-tumor drugs.
Insight Database Compiled the 2025 Global New Drug Submission and Market Launch List，Scan the QR code below ?, reply with the keywordNew Drug Application for Market LaunchCan be obtained for free(Updated once at the beginning of each month, currently updated to August)。
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Disclaimer:This article is for information sharing only and does not represent the position or viewpoint of Insight. It does not recommend or introduce any treatment plans. If needed, please consult and contact正规医疗机构.

Editor：ccai
PR Article Coordination: WeChat insightxb
SubmissionWeChat: insightxb; Email: insight@dxy.cn
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