Antibody New Drug Developer

Developer of finished drugs and active pharmaceutical ingredients

Biopharmaceutical Manufacturer

High-end Biologics Developer

This Week, CDE Accepted 54 Registration Applications for Innovative Drugs/Modified New Drugs(By application number, excluding supplementary applications), of which 35 are domestically produced in China and 19 are imported. During the same period, 23 innovative drugs / improved new drug clinical trial applications received tacit approval, including 13 chemical drugs and 10 biological drugs. There were no traditional Chinese medicine applications this week.
In terms of global innovative drug development progress, CSPC Pharmaceutical Group Limited's Semaglutide weight loss indication has been approved for clinical trials, and Phanes Therapeutics' Claudin 18.2 × CD47 bispecific antibody has even received the FDA's Fast Track designation. Additionally, AstraZeneca's long-acting complement C5 protein inhibitor has also successfully gained FDA approval. Notably, Innovent Bio’s anti-CTLA-4 monoclonal antibody combined with anti-PD-1 monoclonal antibody is proposed to be included as a breakthrough therapy, showcasing its strong capabilities and potential in innovative drug development.
According to the data from Pharma Intelligence, during the period of 2024.03.25-2024.03.31, a total of 54 innovative drugs / improved new drug registration applications were approved by the Center for Drug Evaluation of the National Medical Products Administration.(CDE)Undertake(By application number, excluding supplementary applications)Among them, there are 35 acceptance numbers for domestically produced drugs and 19 acceptance numbers for imported drugs.
This week, a total of 23 innovative drugs/improved new drugs received "tacit approval" for clinical trial applications, including 13 chemical drugs and 10 biological drugs. There were no traditional Chinese medicines this week.
Overview of Approved Innovative Drugs/Modified New Drugs for Clinical Use (Excluding Supplementary Applications)


Note: Complete data can be obtained by replying "Weekly Report 5" on the PharmaCloud WeChat Official Account.
According to the latest data statistics from PharmaCloud, during the period from March 25 to March 31, 2024, the CDE accepted a total of 92 generic drug registration and clinical applications. Among them, the number of new registration classification marketing applications reached 76.(Including chemical drugs Class 3, Class 4, and Class 5.2), there are 4 new registration categories for clinical trial applications.(Including Category 3 chemical drugs); A total of 12 applications for consistency evaluation. During this period, a total of 8 varieties passed the generic drug consistency evaluation.(Counted by 10 acceptance numbers), no varieties were deemed to have passed the consistency evaluation this week. Additionally, there were no updates on the registration of biosimilars this week.

Source of screenshot: PharmaConsult Weekly Report
This week's approved varieties are mainly systemic anti-infective drugs, and the approved product dosage forms are mainly tablets; this weekCefixime DispersibleTabletThe number of approval applications is the highest, with 3 this week. The number of companies receiving approval for each product is the same this week; each company received approval for only 1 product this week. The companies receiving approval this week include Zhejiang Shapuaisi Pharmaceutical Co., Ltd., Shandong Zhongjiankangqiao Pharmaceutical Co., Ltd., and CSPC Zhongnuo Pharmaceutical.(Shijiazhuang)Eight companies including CO LTD。

Screenshot source:Pharma Intelligence Weekly
This week, no varieties passed the consistency evaluation. Among themAluminum Magnesium Picolinic Acid Tablets (Ⅱ)Is the first variety to pass the evaluation this week.
This Week's First-Time Passed/Deemed Passed Varieties
Source of screenshot:Pharma Intelligence Weekly
This week, no products from 5 companies were rated/approved.
Screenshot source:Pharma Intelligence Weekly
The global pharmaceuticals and healthcare industry witnessed a total of 51 financing and investment events, compared toLast week, the number decreased by 21 cases, including 15 financing cases in innovative drugs. The investment热度 in medical device consumables was also high, accounting for 29% this week.15 cases.

Screenshot source:Pharma Intelligence Weekly
There were 14 financing and investment events in China's pharmaceuticals and healthcare industry, a decrease of 3 compared to last week, including medical/pharmaceutical technology and medical devices.Medical consumables financing events occurred 3 times and 8 times, respectively;Among them, the financing amount of Microclear Medical and Meili Weiye exceeded 100 million RMB.

Screenshot source:Pharma Intelligence Weekly
This week, in the category of innovative drugs in China, biologics R&D is a hot spot. For more industry information, please subscribe to the Pharma Intelligence Weekly.

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