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Finishingrainbow
On July 12, the latest announcement by CDE showed that Pfizer's third-generation ALK inhibitor lorlatinib tablets and Cinda Bio's FGFR inhibitor pemigatinib tablets are planned to be included in the priority review
Screenshot from CDE official website
Pfizer lorlatinib
Pfizer lorlatinibThe CDE announcement showed that two applications of Pfizer's lorlatinib tablets (loratinib) have been included in the proposed priority review, and the proposed indications are: for the treatment of one or more ALK tyrosine kinase inhibitors in the past Of ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) patients
Screenshot from CDE official website
In NSCLC, anaplastic lymphoma kinase (ALK)-positive patients account for about 3%-5%
Lorlatinib (Lorbrena) is a third-generation ALK inhibitor that has shown high activity in preclinical lung cancer models carrying ALK rearrangement
It is reported that in the Phase II clinical trial of lorlatinib in the treatment of ALK+ or ROS1+ advanced NSCLC patients, for newly treated ALK-positive non-small cell lung cancer patients, the objective remission rate reached 90%, and the disease control rate reached 97%; Lorlatinib second-line or third-line treatment 59 For patients who have used crizotinib or crizotinib + chemotherapy, the objective response rate was as high as 69%
Lorlatinib is to Pfizer, just like osimertinib is to AstraZeneca, it is used as a second-line therapy to provide a solution for patients to develop resistance to the first-generation drug, and then promoted to a first-line therapy to cover more patients The crowd
Cinda Bio-pemigatinib
Cinda Bio-pemigatinibCDE publicity shows that Cinda Bio FGFR 1/2/3 inhibitor pemigatinib tablets are planned to be included in the priority review.
Screenshot from CDE official website
Cholangiocarcinoma (CCA) is a malignant tumor that originates from bile duct epithelial cells.
Innovent's pemigatinib is a selective fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor
It is reported that pemigatinib is jointly developed by Incyte and Cinda Bio, and Cinda Bio is responsible for the commercialization of China, Hong Kong, Macau and Taiwan
It is worth mentioning that, not long ago, Innovent has announced that the China Food and Drug Administration has accepted the marketing application of pemigatinib for this bile duct cancer indication
A total of 108 patients with cholangiocarcinoma were enrolled in the FIGHT-202 study and received pemigatinib 13.
Reference source: Medical Rubik's Cube, Insight database, Cinda Bio's official website