Drug Update | Global New Drug Approvals (Sep 1–5, 2025)

DengYueMed reports the latest developments in global new drug approvals and submissions for early September 2025.

Newly Approved Drugs

1. Lecanemab Subcutaneous Auto-Injector (IQLIK™)

• Manufacturer: Eisai & Biogen
• Approval Date / Region: Sep 1, 2025, USA
• Indication: Maintenance treatment for early Alzheimer’s disease (mild cognitive impairment and mild dementia)
• Clinical Highlights:
  • Subcutaneous auto-injector delivers dose in ~15 seconds, enabling at-home self-administration.
  • Comparable clinical and biomarker efficacy to intravenous infusion.
  • Lower systemic reaction rate (<1% vs. 26% with IV).
  • Monthly 360 mg injection improves adherence and reduces caregiver burden.

2. Inebilizumab Injection (XinYue®)

• Manufacturer: Changzhou Hengbang Pharma (Hansoh Pharma subsidiary)
• Approval Date / Region: Sep 1, 2025, China
• Indication: Adult IgG4-related disease (IgG4-RD)
• Clinical Highlights:
  • MITIGATE Phase III trial: 87% reduction in relapse risk (HR 0.13, P<0.001).
  • 57.4% achieved complete remission without treatment (vs. 22.4% placebo).
  • Rapid depletion of peripheral B cells, reducing disease biomarkers.
  • 89.7% avoided corticosteroid use.

3. Denosumab Injection (HLX14)

• Manufacturer: Fosun Pharma (subsidiary Fuhong Hanlin)
• Approval Date / Region: Sep 2, 2025, USA
• Indication: Biosimilar for multiple denosumab indications (osteoporosis, giant cell tumor, etc.)
• Clinical Highlights:
  • Provides cost-effective alternative to the reference drug, which generated $7.252B globally in 2024.
  • Regulatory filings progressing in Europe (EMA) and Canada.

4. Teplizumab Injection

• Manufacturer: Sanofi
• Approval Date / Region: Sep 5, 2025, China
• Indication: Children ≥8 years and adults with Stage 2 type 1 diabetes, delaying progression to Stage 3
• Clinical Highlights:
  • CD3-targeting monoclonal antibody protects pancreatic function.
  • TN-10 study showed nearly 3-year delay in disease progression; case reports suggest up to 10 years.

5. Enarodustat Tablets (Ennaro®)

• Manufacturer: Shinlitai
• Approval Date / Region: Sep 5, 2025, China
• Indication: Anemia treatment in CKD patients on dialysis
• Clinical Highlights:
  • Oral HIF-PHI therapy offers an alternative to injections.
  • Previously approved for non-dialysis CKD patients in 2023.

6. Fexuprazan Hydrochloride Tablets

• Manufacturer: Yangtze River Pharmaceutical & Daewoong Pharmaceutical
• Approval Date / Region: Sep 5, 2025, China
• Indication: Presumed for reflux esophagitis
• Clinical Highlights:
  • New potassium-competitive acid blocker (P-CAB), reversible proton pump inhibition.
  • May provide faster, longer-lasting effect compared to traditional PPIs.

Drug Submissions / Filings

1. Bemosumab Injection + Anlotinib Capsules

• Manufacturer: Chia Tai Tianqing
• Submission Date / Region: Sep 2, 2025, China
• Indication: Advanced or unresectable alveolar soft part sarcoma (ASPS)
• Clinical Highlights:
  • TQB2450-Ib-02 study: ORR 72.41%, CR 10.34%
  • Median PFS not reached; combination therapy superior to anlotinib monotherapy
  • Granted breakthrough therapy designation by CDE

2. Benralizumab

• Manufacturer: AstraZeneca
• Submission Date / Region: Sep 2, 2025, China
• Indication: Adults & adolescents ≥12 years with eosinophilic disorders
• Clinical Highlights:
  • Anti-IL-5R biologic for precise eosinophil targeting
  • Expansion of indications beyond severe eosinophilic asthma

3. HRS9531 Injection

• Manufacturer: Hengrui Pharma
• Submission Date / Region: Sep 2, 2025, China
• Indication: Adult overweight/obesity management (BMI≥28 kg/m² or ≥24 kg/m² with comorbidities)
• Clinical Highlights:
  • GLP-1/GIP dual receptor agonist; 3rd phase trial: 6 mg group lost 19.2% body weight on average
  • 44.4% patients lost ≥20% body weight
  • Safety and tolerability profile similar to other GLP-1 agents

4. Madderoxavir Granules

• Manufacturer: CSPC & Antigen Bio
• Submission Date / Region: Sep 2, 2025, China
• Indication: Children 2–11 years with uncomplicated influenza A/B
• Clinical Highlights:
  • Cap-dependent endonuclease inhibitor
  • Single granular dose suitable for children; faster symptom relief, low resistance risk

5. Lecanemab Weekly Subcutaneous Dose (sBLA)

• Manufacturer: Eisai & Biogen
• Submission Date / Region: Sep 4, 2025, USA
• Indication: Early Alzheimer’s disease
• Clinical Highlights:
  • Weekly 500 mg subcutaneous dose as alternative to biweekly IV
  • Simplifies treatment from initiation to maintenance at home

6. Vosoritide Injection

• Manufacturer: BioMarin Pharmaceutical
• Submission Date / Region: Sep 5, 2025, China
• Indication: Pediatric achondroplasia
• Clinical Highlights:
  • First globally approved treatment for children with achondroplasia
  • Phase III: 1.57 cm/year growth increase vs. placebo

7. DB-1303/BNT323 (HER2 ADC)

• Manufacturer: Yingen Biotech
• Submission Date / Region: Sep 5, 2025, China
• Indication: HER2-positive unresectable or metastatic breast cancer
• Clinical Highlights:
  • Phase III PFS primary endpoint achieved
  • Uses stable cleavable linker and topo inhibitor payload to enhance anti-tumor effect and reduce off-target toxicity

References: Company websites, NMPA, FDA

This information is for reference only and is not a substitute for professional medical advice. For specific disease treatment, please consult a licensed healthcare professional.