According to the data statistics from PharmaYun,May 20 to May 26During the period, a total of 52 innovative drugs / improved new drugs clinical applications / marketing applications were accepted by the CDE.(By application number, excluding supplementary applications)Among them, there are 41 acceptance numbers for domestically produced drugs and 11 acceptance numbers for imported drugs.

This week, a total of 50 innovative drugs / improved new drugs received "tacit approval" for clinical trial applications, including 21 chemical drugs and 26 biologics.3 TCM products.

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

Quick Overview of Innovative Drugs Approved for Marketing This Week

According to the data from PharmaCloud, a total of 93 generic drug applications for marketing approval/clinical trials were accepted by the CDE this week, including 68 new registration classification marketing applications.(Including Category 3 and Category 4 chemical drugs), 3 clinical application acceptance numbers under the new registration classification(Including Chemical Drug Category 3), 22 applications for consistency evaluation; a total of 6 varieties passed the consistency evaluation.(Counted by 12 acceptance numbers)This week, 39 varieties are deemed to have passed the consistency evaluation.(Counted by acceptance number, 53 items)This week, there are four regulatory updates on biosimilars, namely Anke Bio's Trastuzumab for Injection, SinoCellTech's Adalimumab Injection, and Betta Pharmaceuticals' Semaglutide Injection.(There are 2 items in the acceptance number)。

This week's approved/tentatively approved varieties are mainly drugs for the digestive system and metabolism, with the approved/tentatively approved product dosage forms primarily being tablets; this week also includes injectables.Cefoxitin Sodium has the highest number of approved/considered-approved applications with 5, while this week Famotidine Injection has the highest number of approved/considered-approved companies with 4.The industry, with the remaining varieties following closely behind.

At the enterprise level,This week, Guilin South Pharmaceutical Co., Ltd., Hainan Meikangda Pharmaceutical Co., Ltd., and Chenxin Pharmaceutical Co., Ltd.Multiple companies, including Hengrui Pharma, have 2 varieties that passed the evaluation/or are considered to have passed the evaluation. The number of varieties that passed the evaluation for other enterprises follows closely. This week, companies that passed the evaluation/or are considered to have passed the evaluation include:Guilin Nanyao Co., Ltd., Hainan Meikangda Pharmaceutical Co., Ltd., and Chenxin Pharmaceutical Co., Ltd. among 46 enterprises.

This WeekGranisetron Hydrochloride Tablets, Metoprolol Succinate Extended-Release Capsules, Acipimox CapsulesThree varieties welcome the first approval.

Varieties that passed the evaluation for the first time this week / Deemed to have passed the evaluation

Screenshot source:PharmCube Weekly Report

This Week's Approved/Deemed Approved Products from 5 Companies

Screenshot source:PharmCube Consulting Weekly

This week, there were 65 financing and investment events in the global pharmaceuticals and healthcare industry, compared toThe number remained unchanged from last time, with a total of 27 financing events in innovative drugs. Investment热度 in medical/pharmaceutical technology was also high, accounting for 23% this week, with 15 events.

There were 12 financing and investment events in China's pharmaceuticals and healthcare industry, a decrease of 7 compared to last week. These events mainly involved medical/pharmaceutical technology, medical services, and other medical-related fields.There were 2 financing events for medical device consumables, 1 for pharmaceutical manufacturing/services, 2 for another category, and 1 for the last category.Among them, Abundant Bio, Yanming Bio, and Blue Sail柏Sheng and Pufang Bio raised more than 100 million RMB.

This week, in China's innovative drug categories, anti-tumor drug research and development is a hotspot.For more industry information, please subscribe to Pharma.Integrated Consulting Weekly Report.