Newsletter0522e--Bydrug医药资源云-35页

Pharmcube Weekly Round-up Summary | May 13–19, 2023

1. Drug Application Updates

• Novel Drug Approvals (5)
  • Eisai: Perampanel oral suspension for epilepsy.
  • Bayer: Finerenone tablet for heart failure.
  • Nanjing Sanhome: SH229 tablet for hepatitis C.
  • Zhejiang Borui: Zuberitamab injection for lymphoma.
  • Jiangsu Ab&b: Quadrivalent influenza vaccine.
• CTA/Filing Updates (41/38)
  • GLP-1R agonists (e.g., HDM1002, azd9592) show clinical trial approval.
  • ADCs (e.g., datopotamab deruxtecan) and CAR-T therapies (e.g., GC012F) progress.
• Generic/Biosimilar Approvals (28/44)
  • Key approvals include ticagrelor, oseltamivir, and amlodipine + valsartan tablets.

2. Key Procurement Notes

• China's Inter-Provincial Procurement Alliance: Shanghai leads a 14-province collaboration, entering procurement data phase.
• Jiangxi Province: Announced results of 16-province alliance drug procurement, rejecting monosialotetrahexose ganglioside.

3. Key Policy Notes

• Medical Consumables Insurance: Draft guidelines for provincial record-keeping and standardized pricing.
• AI in Drug Development: FDA discussion paper on AI/ML integration in drug development.

4. Corporate & Investment News

• Major Deals:
  • Lanova Pharma licenses ADCs to AstraZeneca for $600M.
  • MEHECO re-lists on Swiss Exchange.
  • BioRx Therapeutics raises $44M for Treg therapies.
• Funding Rounds:
  • Red Cloud Biologics closes ~¥100M Series B+.
  • Hengrui Medicine secures ~¥300M for culture media.
• Pipeline Milestones:
  • Gracell Bio initiates SLE trial with GC012F CAR-T.
  • Astellas' non-hormonal VMS drug (Veozah) FDA-approved.
  • Roche's gene therapy for DMD near FDA approval.

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**注：本文仅提取`Pharmcube`提供的`MD`格式内容并作结构化处理，无额外添加内容。**