-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
- Cosmetic Ingredient
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
Shanghai- Takeda China announces on October 15, 2020 that its innovative drug Mobocertinib (TAK-788) has been approved by the Drug Review Center (CDE) of the State Drug Administration for inclusion in the "Breakthrough Treatment" Drug Variety" is used to treat patients with local late stage or metastasis non-small cell lung cancer (NSCLC) who have received at least one systemic chemotherapy in the past with exon 20 exon insertion mutations.
for this particular type of NSCLC, there are currently no approved treatment options worldwide.
Since July 2020, when the State Drug Administration issued the Breakthrough Therapeutic Drug Review Procedure (Trial), Takeda China submitted a breakthrough treatment application for Mobocertinib on the first day of the opening of the channel.
Mobocertinib is the first innovative drug from a foreign company to be recognized as a "breakthrough therapeutic drug variety" in China.
"In the field of lung cancer, compared to EGFR common mutations, T790M resistance, " said Professor Zhou Caissing, Director of oncology Department of Shanghai Lung Hospital affiliated with Tongji University, Director of the Lung Oncology Research Institute of Tongji University School of Medicine and lead of the Mobocertinib clinical trial. Mutations or rare mutations, EGFR 20 exon insertion mutation of NSCLC patients with poor prognostication, and there is currently no global approval of drugs for this target, so there is a very urgent clinical need in Chinese patients.
Based on Mobocertinib's current research data, it is expected to bring significant benefits to patients with EGFR 20 exon insertion mutation NSCLC, and we sincerely hope that the inclusion of breakthrough therapeutic drug varieties will help Mobocertinib benefit Chinese patients earlier.
" non-small cell lung cancer (NSCLC) is the most common type of lung cancer, according to the World Health Organization (WHO), about 1.8 million new cases of lung cancer each year, of which NSCLC accounts for about 85%.
EGFR 20 exon insertion mutation is a rare mutation of non-small cell lung cancer, accounting for about 2.1% of all NSCLCs.
in China, the occurrence of EGFR 20 exon insertion mutations accounts for about 2.3% of all NSCLCs.
At present, no therapeutic drugs have been approved worldwide for EGFR 20 exon targets, while existing EGFR-TKI, chemotherapy and immunotherapy have limited clinical benefits for patients with EGFR 20 exon insertion mutations, patients suffering from disease, with urgent clinical treatment needs.
Mobocertinib is a small molecule tyrosine kinase inhibitor (TKI) developed by Takeda that selectively targets the insertion of mutant microons in EGFR and human skin growth factor 2 (HER2) 20, and is the first drug to achieve China's participation in global simultaneous development, predicting that it will be able to bring breakthrough therapeutic benefits to patients with NSCLC who carry EGFR 20 exon insertion mutations.
preliminary efficacy and safety data from a Phase 1/2 clinical trial for Mobocertinib (AP32788-15-101) showed that the exon insertion in the refrive EGFR20 In patients with mutated NSCLC, the medium progression-free lifetime (mPFS) was up to 7.3 months after Mobocertinib treatment, the objective remission rate (ORR) was 43%, and the safety was controllable.
December 2019, Mobocertinib was qualified as an orphan drug by the U.S. Food and Drug Administration (FDA) and in April 2020 was awarded the FDA Breakthrough Therapy Designation.