Five Oncology and Immunology Drugs Including Novartis' Trametinib Nominated for Priority Review in China

GBI learned from the Center for Drug Evaluation (CDE) of the National Medical Products Administration that five drug marketing applications were included in the proposed priority review list this week:Novartisdabrafenib capsules and trametinib tablets, Innovent Bio's adalimumab injection, Mundipharma (China)'s pralatrexate injection, and Roche's pertuzumab injection.

Dabrafenib and Trametinib——MelanomaGood News for Patients

Dabrafenib and trametinib are byGlaxoSmithKline(GSK)-developed anticancer drug. From 2014 to 2015, Novartis and GSK conducted a business swap, acquiring GSK's anti-Tumorproducts, the aforementioned two drugs were alsoNovartisrecruited under its banner.

Dabrafenib is a BRAF inhibitor that was approved by the U.S. FDA in May 2013 for the treatment of patients with metastatic melanoma and unresectable melanoma. Trametinib is a MEK inhibitor (note: while the source text mentions KRAS/MEK, trametinib is clinically a MEK inhibitor) that was also approved by the U.S. FDA in May 2013 as a monotherapy for patients with advanced melanoma harboring BRAF V600E/K mutations. The dabrafenib-trametinib combination therapy was first approved by the FDA in June 2017 for the treatment of metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutations, and subsequently in April 2018 receivedFDAApproved for BRAF V600 Mutation in Phase IIIMelanomaPostoperative Adjuvant Therapy for Patients.

Information on the ClinicalTrials.gov website indicates that Novartis has completed a study in China targetingMelanomaPatient's Phase IIClinical Trial. Thus,NovartisThe indication being applied for in China is most likely melanoma. According to reports,MelanomaIt has the highest degree of malignancy and the most rapidly increasing incidence rate.Tumorone of them. Currently, there are approximately 20,000 new cases annually in China.

“Blockbuster” Humira’s Dominance in China May Not Last Long

Adalimumab is an anti-TumorTumor Necrosis Factor Monoclonal Antibody Injection. This drug was developed and launched by AbbVie Inc. in the United States under the brand name Humira. Humira is AbbVie’s flagship product and has topped the global pharmaceutical sales rankings for six consecutive years, earning it the industry title of “World’s Best-Selling Drug.”

Humira was first approved for marketing in China in 2010. To date, it has received approval for three indications in China: rheumatoid arthritis, ankylosing spondylitis, and plaque psoriasis. No adalimumab biosimilars have yet been approved for marketing in China. However, in addition to Innovent Bio, Hisun Pharmaceutical, Henlius Biopharma, and Bio-Thera Solutions have all submitted marketing applications for adalimumab biosimilars, while more than 20 other manufacturers are conducting clinical studies on adalimumab biosimilars. Among these, Bio-Thera Solutions’ application has been included in the priority review program, and Hisun Pharmaceutical’s application was added to the proposed priority review list on February 14.

Pralatrexate Injection—Orphan Drug

Pralatrexate is an orphan drug developed by Allos Therapeutics. Pralatrexate is a folate analog metabolic inhibitor that competitively inhibits dihydrofolate synthase and also competitively inhibits the polyglutamation activity of folylpolyglutamate synthetase. Pralatrexate was approved in the United States in 2009FDAApproved for the treatment of peripheral T-cell lymphoma (PTCL).

Pertuzumab——Breast CancerMedicine

Pertuzumab injection is a novel anti-HER2 agent developed by Roche, which exerts its anti-HER2 effect by inhibiting HER2 heterodimerization and homodimerization. Pertuzumab (brand name: Perjeta®) was approved for marketing in China in December 2018, in combination with trastuzumab and chemotherapy, for the adjuvant treatment of patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer at high risk of recurrence.Bio ValleyBioon.com）