China’s Generic Drug R&D Weekly Progress
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China’s Generic Drug R&D Weekly Progress

Key Highlights and Insights (Sept 7-13, 2024)

China’s pharmaceutical landscape continues to witness rapid advancements in generic drug development. The latest report from Pharmacodia Global (Sept 7-13, 2024) sheds light on key developments, approvals, and applications in the generic drug R&D sector. This weekly insight covers significant approvals, consistency evaluations, and emerging trends in the generic drug market, reflecting China’s strategic focus on fostering domestic pharmaceutical innovation.

Let’s dive into the highlights and key trends from this week's report.

1. New Generic Drug Approvals

This week, 69 new generic drug approvals were granted, encompassing a wide range of formulations, including 21 tablets, 14 injections, and 5 oral solutions. This indicates a diverse portfolio of drug development aimed at addressing multiple therapeutic areas.

  • Sodium Fluoride F-18 Injection by HTA Co Ltd (Approval Date: Sept 3, 2024)
  • Exenatide Injection by Hybio Pharmaceutical Co Ltd (Approval Date: Sept 10, 2024)
  • Nicotinic Acid Sustained Release Tablets by Yichang Humanwell Pharmaceutical (Approval Date: Sept 10, 2024)

2. Consistency Evaluations: A Critical Metric

Consistency evaluations play a pivotal role in ensuring that generic drugs match the quality and performance of original brand drugs. This week saw 5 new consistency evaluation approvals for drugs like Nefopam Hydrochloride Injection (Shijiazhuang No. 4 Pharmaceutical Co Ltd) and Cefuroxime Sodium Injection (Suzhou Erye Pharmaceutical Co Ltd), both vital in pain management and antibiotic therapy.


3. Generic Drug Applications Surge

An impressive 157 new registration applications were submitted this week, covering 107 varieties. This includes:

  • 39 tablets
  • 33 injections
  • 12 oral solutions

Notable submissions include:

  • Brexpiprazole Tablets by Zhejiang Huahai Pharmaceutical Co Ltd (Sept 13, 2024)
  • Vortioxetine Hydrobromide Tablets by Zhejiang Siwei Medical Technology Co Ltd (Sept 13, 2024)


4. Supplementary Applications: Expanding Drug Indications

In addition to new drug registrations, supplementary applications were also a key focus, with numerous eye drops, capsules, and creams seeing updates. Some notable examples include:

  • Norfloxacin Eye Drops
  • Naproxen Capsules
  • Terbinafine Hydrochloride Cream

These supplementary applications are critical as they reflect ongoing efforts to enhance existing drug formulations, improve patient safety, and expand indications.


For companies and stakeholders in the pharmaceutical industry, staying updated on these trends is crucial for strategic decision-making and future investments.

Visit our website to download the full report and gain deeper insights into the evolving landscape of generic drug R&D in China.

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