140 New Drug Candidates Enter Clinical Trials in July; Five Innovative Drugs Approved for Market, Including XianLiTing from Sino-Mainland and Ropeginterferon alfa-2b from PharmaEssentia
Salubris
Pharmaceutical Product R&D Developer
Johnson & Johnson
Medical Device R&D and Manufacturer
In July, multiple innovative drugs were successively approved for marketing.
Salubris's Voglibose Benzoate Tablets Approved for Marketing
Novo Nordisk's Injectable Petrolatum Coagulase α Approved for Marketing
Daiichi Sankyo's Mirogabalin Besylate Tablets Approved for Marketing in China
AstraZeneca's Budesonide/Formoterol Fumarate Inhalation Aerosol Approved for Marketing
Global Orphan Drug/Breakthrough/Fast Track Designation Summary
July has 45Products granted Orphan Drug/Breakthrough/Fast Track designation.
Latest Updates on Positive/Failure Clinical Results of Innovative Drugs Under Development Worldwide
Eisai Announces Post-Hoc Analysis Results of Phase 3 REFLECT Trial for Small Molecule Therapy Lenvima
Johnson & Johnson/Legend Biotech Jointly Announce Positive Phase 3 Results of CAR-T Therapy
Gan & Lee Pharmaceuticals Announces Phase 1b/2a Clinical Trial Results for GLP-1 Receptor Agonist GZR18 Injection
Novo Nordisk's Next-Generation Weight Loss Therapy Shows Latest Results: Over 13% Weight Reduction in 12 Weeks
According to the data from PharmaYun, a total of 140 new drugs were approved for clinical trials in July 2024.(A total of 231 acceptance numbers), an increase of 32 products compared to last month, including 63 chemical drugs, 75 biologics, and 2 traditional Chinese medicines.
The new drug with the largest number of clinical approvals this month is antineoplastic and immunomodulatory drugs, with 98, accounting for 42%. The number of systemic anti-infective drugs approved is also relatively high, with 11. The main dosage forms approved are tablets and injections, with 78 and 95 respectively.
In July, China's pharmaceutical market welcomed the official approval and launch of five innovative drugs, involvingPHARMAESSENTIATheRopeginterferon alfa-2b (P1101) Injection，Used for the treatment of polycythemia vera.Daiichi SankyoTheMilnacipran Besylate Tablets, applicable to neuropathic pain.AstraZenecaTheBudesonide Formoterol Fumarate Inhalation Aerosol, applicable to chronic obstructive pulmonary disease, asthma.SalubrisTheBenzoic Acid Fuglitan Tablets, used for the treatment of type 2 diabetes.NovartisTheInjectable Petrolatum Coagulase α, applicable to adult and pediatric patients with Hemophilia A (congenital Factor VIII deficiency): on-demand treatment and control of bleeding episodes; perioperative management; routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
In July, a total of 45 drugs received Orphan Drug/Breakthrough/Fast Track designations.Vertex(Vertex Pharmaceuticals)Announces FDA Acceptance for ReviewNav1.8InhibitorVX-548（Suzetrigine）The marketing application has been granted priority review status for the treatment of moderate to severe acute pain. This represents a significant breakthrough in the field of analgesics and has the potential to disrupt the commercial competitive landscape of pain medications.
List of Global Orphan Drug/Breakthrough/Fast Track Designated Products in July (Partial)
Note: Scan the QR code at the end of the document to download and view the complete data.
In July Global Innovative Drug R&D Dynamics,Regulus TherapeuticsShared its novel oligonucleotide therapyRGLS8429Latest Progress in Phase 1b Clinical Trial for Autosomal Dominant Polycystic Kidney Disease, Particularly Positive Results from the Third Cohort, Demonstrates Good Patient Tolerance and No Safety Issues.
Screenshot source: PharmaYoo Global Drug R&D Database
Immediately following,Wave Life SciencesAnnounced on July 1st, its developed allele-selective antisense oligonucleotide therapyWVE-003In Huntington's disease（HD）Phase 1b/2a Clinical TrialSELECT-HDSignificant achievements have been made in China, effectively reducing mutant huntingtin protein.（mHTT）Expression, while maintaining wild-type protein（wtHTT）Excellent health levels, full-course safety, and tolerability with no serious adverse events recorded.
In addition,Eisai（Eisai）The company released information about small molecule drugsLenvima（lenvatinib）As a first-line treatment for unresectable hepatocellular carcinoma（uHCC）Stage 3 of the patientREFLECTPost-hoc analysis of the trial provided an in-depth examination of the characteristics of deep remission, offering a new perspective for clinical application.
It is worth mentioning that, on July 3,Johnson & Johnson（Johnson & Johnson）Join Hands with Legend Biotech（Legend Biotech）Jointly UnveiledCARTITUDE-4Optimistic Results from the Second Pre-scheduled Interim Analysis of the Study. The study focuses on the CAR-T therapy Carvykti, co-developed by both parties.(ciltacabtagene autoleucel, abbreviated as cilta-cel)，Compared with standard therapy, it is used for the treatment of relapsed or multiple myeloma.（MM）And for lenalidomide（lenalidomide）Demonstrated positive efficacy in patients with drug resistance, opening up new hope for the treatment of this refractory disease.
In the TOP20 list of global innovative drug R&D progress in July, there were many highlights. First,Hinova PharmaceuticalsOn July 1, it announced the good news of its self-developed Class 1 new drug - Protein Degradation Targeting ChimeraHP518 Tablets, successfully obtained the FDA Fast Track designation in the United States. This breakthrough marksHP518 TabletsIn the treatment of androgen receptors（AR）An important step has been taken in the field of triple-negative breast cancer.
Immediately following, on July 2,Eli LillyThe company announced the official launch of an international multicenter(Including China)The Phase 3 clinical study focuses onlepodisiran（LY3819469）. This study aims to evaluatelepodisiranIn confirmed atherosclerotic cardiovascular disease with elevated lipoprotein(a) levels（ASCVD）Efficacy in patients or high-risk adults for cardiovascular events, with a focus on reducing major adverse cardiovascular events（MACE）The ability to manage risks brings new hope for cardiovascular disease management.
Source of Screenshot:PharmaYun Global Drug R&D Database
On the same day,HenliusGood news also came in as the company announcedSulrelimab InjectionHas obtained the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan（PMDA）The approval to launch an international multicenter Phase 3 clinical trial. This study aims to further exploreSulrilimab InjectionUnitedBevacizumab InjectionAnd chemotherapy regimens, as first-line treatment for metastatic colorectal cancer, demonstrate efficacy and safety, offering a new therapeutic option for colorectal cancer patients worldwide.
This report is regularly released at the beginning of each month, so stay tuned.
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