According to the statistics from PharmaCloud, from June 3 to June 9, a total of 58 innovative drugs / improved new drug registration applications were approved by the Center for Drug Evaluation of the National Medical Products Administration.（CDE）Undertake(Statistics by acceptance number, excluding supplementary applications)Among them, there are 40 acceptance numbers for domestically produced drugs and 18 acceptance numbers for imported drugs.

This week, a total of 22 innovative drugs/improved new drugs received "tacit approval" for clinical trial applications, including 14 chemical drugs and 8 biological drugs, with no traditional Chinese medicine.

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

According to the data statistics from PharmaCloud, this week a total of 97 generic drug applications for marketing approval/clinical trials were accepted by the CDE, including 90 acceptance numbers for new registration classification marketing applications.(Including Category 3 and Category 4 chemical drugs), 2 new clinical application acceptance numbers under the new registration classification(Including Category 3 chemical drugs), Five applications for consistency evaluation; a total of seven varieties passed the consistency evaluation.(Counting 12 items by acceptance number)This week, 42 varieties are deemed to have passed the consistency evaluation.(Counting 66 items by acceptance number)This week, there are 3 biosimilar registration application dynamics, respectively from Yichang Dongyangguang.Insulin Glargine Injection, Jiangsu Wanbang'sInsulin Lispro Injectionand Ningbo Kunpeng'sInsulin Aspart 30 Injection。

This week, the approved/equivalent-to-approved varieties are mainly systemic anti-infective drugs, and the approved/equivalent-to-approved product formulations are primarily injectables; this weekTelmisartan TabletsThe maximum number of acceptance numbers for passing/reviewing is 5.Phloroglucinol InjectionThere are four companies with the highest number of approvals/regarded as approved enterprises.

At the enterprise level, Beijing Baimet Biopharmaceutical Co., Ltd. and Shijiazhuang No. 4 Pharmaceutical Co., Ltd. had the highest number of products passing or deemed to have passed evaluations this week with two products each. All other enterprises had one product passing or deemed to have passed evaluations. The total number of enterprises passing or deemed to have passed evaluations this week includes 58 companies such as Beijing Baimet Biopharmaceutical Co., Ltd., Shijiazhuang No. 4 Pharmaceutical Co., Ltd., and Qilu Pharmaceutical Co., Ltd.

This week hasAmoxicillin Sodium for Injection, Potassium Magnesium Aspartate Injection, Loxoprofen Sodium Granules, Fluocinonide/Hydroquinone/Tretinoin CreamFour varieties have received their first approval.

This Week's Approved/Evaluated as Approved Reached 5 Enterprise Varieties

Screenshot source:Pharmaceutical Consulting Weekly

This WeekThe global pharmaceuticals and healthcare industry witnessed a total of 65 financing and investment events, compared toLast time, the number increased by 16 cases, including 21 financing cases for innovative drugs. The investment热度 in medical device consumables was also relatively high, accounting for 29% this week.19 cases.

There were 16 financing and investment events in China's pharmaceuticals and healthcare industry, a decrease of one event compared to last week. Among them were medical/pharmaceutical technology and healthcare.There were 2, 9, and 1 financing events in the fields of equipment consumables, pharmaceutical manufacturing/services, respectively;Among them, Episun, Pukang Weixin Bio, Zhiwei Bio,Laiweilai Technology's financing amount exceeds 100 million RMB.

This week, in China, the development of biotechnological drugs is a hotspot in the category of innovative medicines.For more industry information, please subscribe to Pharma.CHIGENOVO Weekly Report.