According to MoEntropy data statistics, from October 21 to October 27, a total of 55 innovative drugs / improved new drug clinical applications / marketing applications were accepted by the CDE.(Statistics by acceptance number, excluding supplementary applications)Among them, there are 43 acceptance numbers for domestically produced drugs and 12 acceptance numbers for imported drugs.

This week, a total of 26 innovative drugs / improved new drug clinical trial applications received "tacit approval," including 7 chemical drugs and 19 biologics, with no traditional Chinese medicine.

Quick Overview of Innovative Drugs/Modified New Drugs Approved for Clinical Trials This Week (Partial Information, Excluding Supplemental Applications)

Note:Full data can be identified by scanning the QR code at the "end of the article" for download and viewing.

According to MoEntropy data statistics, from October 21 to October 27, a total of 126 generic drug applications for marketing/clinical trials were accepted by the CDE, including 109 new registration classification marketing applications.(Including chemical drugs Class 3, Class 4, and Class 5.2), 6 clinical application acceptance numbers under the new registration classification(Including Category 3 chemical drugs), 11 applications for consistency evaluation; a total of 21 varieties passed the consistency evaluation.(Counted by acceptance number, 32 items)This week, 42 varieties are deemed to have passed the consistency evaluation.(A total of 59 items by acceptance number)This week, there is one regulatory filing update for biosimilars, which is Qilu Pharmaceutical's Trastuzumab for Injection.

This week, the approved/viewed as approved varieties are mainly systemic anti-infective drugs, with the approved/viewed as approved product formulations primarily being injections. This week, Pentoxifylline Injection had the highest number of approved/viewed as approved application numbers, totaling 4, and it was also the variety with the most approved/viewed as approved companies this week, reaching 4.

At the enterprise level,Nanjing Cavendish Bioengineering Technology Co., Ltd., Southwest Pharmaceutical Co., Ltd., and Fujian Baonuo Pharmaceutical Research and Development Co., Ltd. have been rated as having up to 2 varieties of products that meet the standards or are considered to meet the standards. The number of varieties meeting the standards or considered to meet the standards for other companies follows closely behind. This week, a total of 67 enterprises, including Nanjing Cavendish Bioengineering Technology Co., Ltd., Southwest Pharmaceutical Co., Ltd., and Fujian Baonuo Pharmaceutical Research and Development Co., Ltd., met the standards or are considered to have met the standards.

Varieties that passed the evaluation for the first time this week / Varieties deemed to have passed the evaluationScreenshot source:MaxEntropy Consulting Weekly Report

Screenshot source:MaxEntropy Consulting Weekly Report