Note: This article does not constitute any investment opinions or recommendations; please refer to official/company announcements for accuracy. This article only provides an introduction to drugs related to healthcare and is not a recommendation of treatment plans (if involved), and does not represent the platform's position. Authorization is required for the reprint of any article.November Global New Drug Monthly ReportClinical Approvals for New Drugs in China in November
NovemberA total of 174 new drugs were approved for clinical trials.(A total of 298 acceptance numbers)`, an increase of 29 products compared to last month.`；
NovemberThe new drug with the largest number of approved clinical application numbers is anti-tumor and immune function modulating drugs, with 142, accounting for 61%.；
NovemberThe approved dosage forms are mainly injections and tablets, with 137 and 100 respectively.。
Global Overview of Drugs Granted Orphan/Breakthrough/Fast Track Designation
Latest Updates on Positive/Failure Clinical Results of Innovative Drugs in Global Research
Lilly Announces Positive Topline Results from Phase 3 Clinical Trial of BTK Inhibitor Pirtobrutinib；
Innovent Bio and SANEGENEBIO Announce Phase 1 Clinical Trial Results of New Hypertension Drug IBI3016；
Merck's PCSK9 Oral Peptide Inhibitor Reaches Primary Endpoint in Phase 3 Trial；
AstraZeneca's Small Molecule New Drug Baxdrostat Phase 3 Clinical Results Announced, Targeting Resistant Hypertension。
Monthly RelatedLatest Policy Updates on Innovative Drugs, New Drug Registration and Submission in China, Global Orphan Drug/Breakthrough/Fast Track Designation Roundup, Top 20 Positive/Failure Clinical Results of Global Innovative Drugs in Development, Top 20 Global Innovative Drug R&D Progressetc., the Mox Entropy Consulting team, based on authentic and traceable global pharmaceutical data, will launch [a report] monthly."Global New Drug Monthly Report", in order to help industry insiders comprehensively grasp the new drug development situation worldwide each month and gain a thorough and in-depth understanding of global new drug development trends.November New Drug Approvals for Clinical Use/Market Launch in ChinaAccording to the statistics from摩熵医药database, a total of 174 new drugs were approved for clinical trials in November 2025.(A total of 298 acceptance numbers)，An increase of 29 products compared to last month, including 81 chemical drugs, 86 biologics, and 7 traditional Chinese medicines.Screenshot source: Mesentech Consulting Monthly Report
In November, the new drug with the highest number of clinical approvals was antineoplastic and immunomodulatory drugs, with 142 approvals, accounting for 61%. The number of approvals for digestive system and metabolic drugs was also relatively high, with 20 approvals. The main dosage forms approved were injections and tablets, with 137 and 100 approvals respectively.Source of screenshot: Mosun Consulting Monthly Report
In November, the pharmaceutical market in China welcomed7 ProductsApproval and Market Launch of Innovative DrugsInvolvedPegBioTheVipadacaine Injection，For the improvement of glycemic control in adult patients with type 2 diabetes。New Drugs Approved for Marketing in China in November 2025
Source of Screenshot:MaxEntropy Consulting MonthReport (Full data identification, scan the QR code at the end of the article to download and view.)
Global Overview of Drugs Granted Orphan Drug/Breakthrough/Fast Track DesignationNovember has a total of37A drug has been granted Orphan Drug/Breakthrough/Fast Track designation.November 2,Zhongshan Convida BioPharmaTheIvonescimabIncluded in the breakthrough therapy for the treatment of triple-negative breast cancer.List of Global Orphan Drug/Breakthrough/Fast Track Designated Products in November (Partial)
Note: Scan the QR code at the end of the document to download and view the complete data.
Top 20 Positive/Failure Clinical Results of Innovative Drugs Under Development WorldwideIn November Global Innovative Drug R&D Updates，November 10,Innovent BioAndSANEGENEBIOJointly announced, targeting angiotensinogen（AGT）Small interfering RNA（siRNA）DrugIBI3016（SANEGENEBIO R&D Code: SGB-3908The main results of the first-in-human (FIH) clinical Phase 1 study, presented at the 2025 American Heart Association（AHA）Digital Poster Session at Scientific Conferences.Source of Screenshot: Mesentech Global Drug R&D Database
This FIH study（NCT06501586/CTR20242500）A randomized, double-blind, placebo-controlled, single ascending dose trial conducted in healthy subjects and patients with mild hypertension to evaluate subcutaneous injection.IBI3016Post-dosing safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) characteristics. The results showed,IBI3016Single-dose administration achieves sustained and potent reduction in AGT levels along with preliminary blood pressure decrease. Following a single dose, serum AGT levels are significantly and durably reduced, with a maximum reduction of over 95%, remaining stable for six months. At three months,IBI3016All dose groups achieved a reduction in blood pressure. Safety and tolerability were good, with no unexpected safety signals.Top 20 Positive/Failure Clinical Results of Innovative Drugs Under Development Worldwide
Remarks:Scan the QR code at the end of the article to download and view the complete data.
Top 20 Global Innovative Drug R&D AdvancesIn the TOP20 list of global innovative drug R&D progress in November, there were many highlights.On November 4, the CDE website showed,Fosun PharmaSelf-developedLuwotinib(Former name: Fumatini, R&D code: FCN-159)The new indication is proposed to be included in the priority review, for use in patients aged 2 years and older with Langerhans Cell Histiocytosis (LCH).Pediatric patients.
Screenshot source: Mosentropy Medicine Global Drug R&D Database
LCH is a clonal hematologic neoplasm characterized primarily by the activation of the mitogen-activated protein kinase signaling pathway, which can affect various organs and systems throughout the body, with diverse clinical manifestations.LuwotinibYesFosun PharmaAn innovative small-molecule MEK1/2 selective inhibitor developed in-house, which inhibits tumor cell proliferation and induces apoptosis by blocking the abnormal activation of the MAPK signaling pathway. Previously,LuwotinibIt was approved for marketing in May this year for the treatment of LCH and histiocytic tumors in adult patients, as well as pediatric and adolescent patients aged 2 years and above with symptomatic, inoperable plexiform neurofibromas (PN) associated with Neurofibromatosis Type 1 (NF1).
TOP20 Global Innovative Drug R&D ProgressScreenshot source:MaxEntropy Consulting's "Global New Drug Monthly Report in Development - November 2025"
November 2025 Global New Drug Monthly ReportScan the QR code below to get the full"Global New Drug Monthly Report in Development as of November 2025" PDF VersionThis report is regularly released at the beginning of each month, so stay tuned.
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