Qilu Pharmaceutical Announces NDA Approval of Nilotinib Capsules and Nintedanib Esilate Soft Capsules in China

On July 5, Qilu Pharmaceutical's targeted tumor treatment drug Nilotinib Capsules and pulmonary fibrosis treatment drug Nintedanib Ethanesulfonate Soft Capsules were successively approved for marketing by the National Medical Products Administration (NMPA) and deemed to have passed the consistency evaluation. To date, Qilu Pharmaceutical has a total of 132 products that have passed the consistency evaluation, 51 of which are the first in China.

NilotinibIt is a BCR-ABL kinase inhibitor that binds to and stabilizes the inactive conformation of the ABL protein kinase domain. Clinically, it is mainly used to treat Philadelphia chromosome-positive chronic myeloid leukemia that is resistant or intolerant to prior treatments, including imatinib. Nilotinib effectively inhibits the proliferation of murine leukemia cell lines and cell lines derived from Ph+ CML patients mediated by BCR-ABL kinase. It selectively suppresses the proliferation of BCR-ABL cell lines in CML patients and Philadelphia chromosome-positive primary leukemia cells, inducing apoptosis. Among 33 mutations studied, nilotinib overcomes imatinib resistance caused by 32 BCR-ABL kinase mutations, demonstrating significant clinical therapeutic advantages.

Qilu Pharmaceutical's Nilotinib Capsules applied for proprietary intellectual property rights in formulation patents during the R&D process and successfully passed the human bioequivalence study in one go. The launch of this product will reduce the economic burden on patients and improve the accessibility of medication.

Nintedanib Ethanesulfonate Soft CapsulesApproved for marketing in the United States in October 2014, it is the first targeted drug for the treatment of idiopathic pulmonary fibrosis. The "IPF Clinical Treatment Guidelines" jointly released by the American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association in 2015 and the "Chinese Expert Consensus on IPF Diagnosis and Treatment" in 2016 listed Nintedanib Ethanesulfonate as a recommended medication for the treatment of idiopathic pulmonary fibrosis. Currently approved indications include: idiopathic pulmonary fibrosis, non-small cell lung cancer, systemic sclerosis-associated interstitial lung disease, and progressive fibrosing interstitial lung disease, etc., and it has been included in the Class B National Medical Insurance Catalog.

Nintedanib ethanesulfonate is a multi-target triple angiokinase inhibitor that can inhibit various receptor tyrosine kinases (RTKs), competitively binding to the adenosine triphosphate (ATP) binding site on the intracellular receptor kinase domains, blocking intracellular signal transduction, and inhibiting the proliferation, migration, and transformation of fibroblasts. In addition, nintedanib ethanesulfonate can also inhibit the following non-receptor tyrosine kinases (nRTKs): Lck, Lyn, and Src kinases, effectively improving patients' pulmonary symptoms and signs while also having anti-inflammatory effects and suppressing cytokine production. The advantages of nintedanib ethanesulfonate in treating pulmonary fibrosis are very evident, as it can effectively inhibit the generation and degradation of collagenase, thereby preventing the formation of collagen, and can also effectively eliminate pulmonary toxins and waste, enhance the body's immunity, significantly reduce the annual decline rate of FVC in patients with idiopathic pulmonary fibrosis, delay disease progression, and improve patients' quality of life.

Editor: Muyan

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