According to MoEntropy data statistics, during the period from February 10, 2025, to February 16, 2025, a total of 55 innovative drugs / improved new drugs clinical applications / marketing 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 37 acceptance numbers for domestically produced drugs and 18 acceptance numbers for imported drugs.

This week, a total of 33 innovative drugs / modified new drugs received "tacit approval" for clinical trial applications, including 16 chemical drugs, 15 biological drugs, and 2 traditional Chinese medicines.

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

Note:Full data can be accessed by scanning the QR code at the end of the article.

According to Mose Data statistics, during February 10 to February 16, 2025, a total of 86 generic drug applications for marketing/clinical trials were accepted by the CDE, including 66 new registration classification marketing application acceptance numbers.(Including Category 3 and Category 4 chemical drugs), 7 clinical application acceptance numbers for new registration categories(Including Chemical Drug Class 3, Class 4), 13 consistency evaluation applications. This week, 2 varieties passed the consistency evaluation.(Counted as 3 items by acceptance number)This week, 34 varieties are deemed to have passed the consistency evaluation.(49 items by acceptance number)This week, there are four registration application dynamics for biosimilars, respectively from Taiji Group.Semaglutide Injection(Counted as 2 items by acceptance number)And Hangzhou China-AmericaUstekinumab Injection(Counted as 2 items by acceptance number)。

This week, the approved/viewed as approved varieties are mainly digestive system and metabolic drugs, with the approved/viewed as approved product forms primarily being tablets; this week, lactulose oral solution has the highest number of approved/viewed as approved application numbers, reaching 7, and lactulose oral solution is also the variety with the most approved/viewed as approved companies this week, reaching 4.

Screenshot source:MaxEntropy Consulting Weekly Report

At the enterprise level,This week, Qilu Pharmaceutical Co., Ltd. has obtained approval or deemed approval for as many as two varieties, while the number of approved or deemed approved varieties for other companies is one each. The total number of enterprises obtaining approval or deemed approval this week includes 39 companies such as Jinan Kangqiao Pharmaceutical Technology Co., Ltd., Jiangsu Yong'an Pharmaceutical Co., Ltd., and Qilu Pharmaceutical Co., Ltd.

Screenshot source:MaxEntropy Consulting Weekly Report

This week hasIlaprazole Enteric-Coated Tablets, Vitamin B12 Eye DropsTwo more productsFirst evaluation/pass of varieties.

This week hasTafluprost Eye Drops1PaymentProducts from five companies that have passed the review or are considered to have passed the review.

Screenshot source:MaxEntropy Consulting Weekly Report

In addition,Among the TOP 10 global clinical outcomes，February10Day,InFlectis BioScience Company Announces Completion of Phase 2a Clinical Trial —— P288ALS TRIAL.The trial perimeterThe oral small-molecule therapy IFB-088 developed by the company aims to explore its preliminary therapeutic effects on bulbar-onset amyotrophic lateral sclerosis.The results and safety profile are of significant clinical importance and research value.

Screenshot source:MaxEntropy Consulting Weekly Report

The next day,Regeneron Pharmaceuticals announced positive results from the QUASAR Phase 3 clinical trial. Data analysis shows that, in targeting the retina,In the treatment of patients with secondary macular edema following retinal vein occlusion (RVO), Eylea HD (aflibercept, 8 mg) is administered every 8 weeks.Compared with Eylea (Aflibercept, 2 mg) administered every 4 weeks, the non-inferiority criteria were met.After completing the initial 5 monthly dosesIn the patient population, 93% of patients were able to maintain a dosing regimen of once every 8 weeks.The results showed that the QUASAR trial was successful at 36 weeks.Achieved the primary endpoint: patients receiving Eylea HD dosed every 8 weeks showed non-inferiority in vision improvement compared to those dosed every 4 weeks.Patients treated with Eylea.Eylea HD has demonstrated stability in patients with branch retinal vein occlusion as well as central or hemicentral retinal vein occlusion.Consistent efficacy.Moreover, among patients receiving Eylea HD treatment for 36 weeks, 88% were able to maintain after the initial three monthly doses.Enough to maintain a dosing regimen of once every 8 weeks;After completing the initial five monthly doses, this proportion increased to 93%.