
Developer of Next-Generation Cytokine Anti-Tumor Immunotherapy

Developer of Biomedical Optical Imaging Systems

This week, there are a total ofClinical Trials of 39 Innovative Drugs/Improved New DrugsApplication for implied consent, covering18 Chemical DrugsAnd21 Biologics, No new additions in the field of traditional Chinese medicine. According to the data from PharmaCloud, during the period from March 4 to March 10, 2024, there were a total of 63 financing and investment events in the global pharmaceuticals and healthcare industry, which is a decrease of 7 events compared to the previous period.
Among them, there were 14 financing events for innovative drugs, and investment enthusiasm for medical device consumables continued to rise, accounting for 37%, with a total of 23 events. Meanwhile, there were 8 investment and financing events in China, a decrease of 8 compared to the previous period, involving fields such as medical device consumables, innovative drugs, and medical services. The financing amounts of Proviva Therapeutics and Vivolight both exceeded 100 million RMB. In the field of innovative drugs, anti-tumor drug research and development became the focus of this week.

PharmCube Consulting Weekly Report on Pharmaceutical Industry Insights, bringing you the best of this week(2024.03.04-2024.03.10)Latest Developments in the Pharmaceutical Field, IncludingCore Data of the Pharmaceutical Industry, Global R&D Progress of Innovative Drugs, Global Positive/Negative Clinical Results, Global Pharma Companies’ BD Deals/Strategic Collaboration Events...and other important information, helping you quickly grasp the industry trends and providing strong support for corporate decision-making.
Analysis of Registration and Application of Innovative Drugs/Modified New Drugs in China This Week
According to the data from PharmaCube, during the period of 2024.03.04-2024.03.10, a total of 61 innovative drugs/improved new drug registration applications were accepted by the CDE.(Statistics by acceptance number, excluding supplementary applications)Among them, there are 38 acceptance numbers for domestically produced drugs and 23 acceptance numbers for imported drugs.
This week, a total of 39 innovative drugs/improved new drugs received "tacit approval" for clinical trial applications, including 18 chemical drugs and 21 biologics.No Chinese herbal medicine.
Overview of Approved Clinical Innovative Drugs/Improved New Drugs
(Excluding supplementary applications)





Remarks:(1) Supplementary applications are not included here.Situation;(2) The innovative drugs/improved new drugs listed here mainly refer to those accepted and approved by the CDE.Category 1, Category 2, Category 5.1, and Biological Products Category 3.1 and 3.2.(3) More approved clinical information and R&D progress details and related target global distributionAnalysis, etc., can be obtained and downloaded as an EXCEL table through the PharmaLight China Drug Evaluation Database and/or by contacting PharmaLight customer service.
Generic Drugs/Biosimilars Registration and Submission Analysis
According to the statistics from PharmaCloud, this week(2024.03.04-2024.03.10)A total of 84 generic drug registration/clinical applications have been accepted by the CDE, including newRegistration Classification Marketing Application Acceptance Number: 57 Items(Including Category 3 and Category 4 chemical drugs), 7 clinical application acceptance numbers for new registration classifications(Including Category 3 chemical drugs,Class 4), 20 applications for consistency evaluation; a total of 7 varieties of generic drugs passed the consistency evaluation.(Counted by acceptance number, 9 items), No varieties are deemed as passed this week.Passed the consistency evaluation.No updates on biosimilar registration applications this week.
This week's approved varieties are mainly systemic anti-infective drugs, and the approved product dosage forms are mainly injections.Fluconazole and Sodium Chloride InjectionThe number of approval applications is the highest, with 2 in total, and at the same timeFluconazole and Sodium Chloride InjectionIt is also the variety with the highest number of enterprises passing the evaluation this week, with 2 enterprises passing the evaluation, namely Hubei Jin Yao Pharmaceutical Co., Ltd. and Sichuan Pacific Pharmaceutical Co., Ltd.; a total of 8 enterprises passed the evaluation this week, including Anhui Xianfeng Pharmaceutical Co., Ltd., Suzhou Pharmaceutical Factory of Jiangsu Wu Zhong Pharmaceutical Group Co., Ltd., and Heilongjiang Zhonggui Pharmaceutical Co., Ltd.


Global Medical and Health Industry Investment and Financing Events Recap
According to the data statistics from Pharma Intelligence, during the period of 2024.03.04-2024.03.10, there were a total of 63 financing and investment events in the global pharmaceuticals and healthcare industry, which is relativelyLast time, the number decreased by 7, including 14 financings in innovative drugs. The investment热度 in medical device consumables was also high, accounting for 37% this week, with a total of 23.Start.China's pharmaceuticals and healthcare industry saw a total of 8 financing and investment events, a decrease of 8 compared to last week. These events involved medical device consumables, innovative drugs, and healthcare.Service financing events occurred 5 times, 2 times, and 1 time respectively;Among them, the financing amount of Proviva Therapeutics and Vivolight exceeds 100 million RMB.This Week in ChinaIn the category of innovative drugs in China, the development of anti-tumor drugs is a hotspot.


Overview of Investment and Financing in China's Pharmaceutical and Healthcare Industry
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