Archives: Agenda

From Scale to Strategy: How China’s Local Ecosystem Fuels Global Clinical Innovation 从规模到战略：中国本土生态如何推动全球临床创新

  • Leveraging China’s integrated research, healthcare, and technology networks to accelerate development
  • How scale, speed, and digital innovation are reshaping global clinical trial execution
  • Translating local operational excellence into global study success
  • Less on drug supply multinational sponsors can apply from China’s evolving clinical ecosystem

 

  • 借助中国一体化的科研、医疗和技术网络加速开发。
  • 规模、速度与数字化创新如何重塑全球临床试验执行。
  • 将本土运营卓越转化为全球研究成功。
  • 跨国申办方可从中国不断演进的临床生态中借鉴的经验。

Comparator Sourcing: Navigating Global Supply for China Registration Trials 对照药采购：为中国注册临床试验驾驭全球供应

Securing the right comparator drug is often the most critical yet daunting hurdle in planning a registration trial in China. Unlike other supplies, a comparator is not merely a commodity; it is a regulatory benchmark, a clinical necessity, and a potential bottleneck that can derail timelines and compromise data integrity.

确保合适的对照药，往往是规划中国注册临床试验中最关键、也最具挑战性的环节。与其他物资不同，对照药并非普通商品；它既是法规基准，也是临床必需品，还可能成为影响时间线和数据完整性的瓶颈。

  • Why Compliance is Non-Negotiable
  • From Global Market to Local Solutions
  • Mastering the Logistics & Regulatory Journey
  • How to ensure Supply Continuity
  • What is the Evolving Landscape in the Future
  • 为什么合规不可妥协
  • 从全球市场到本地解决方案
  • 掌握物流与法规旅程
  • 如何确保供应连续性
  • 未来格局将如何演变

CASE STUDY 案例研究 Inner-Ear Gene Therapy — From Target to IND: How China’s Integrated CRO/CDMO Ecosystem Accelerates CGT Translation 内耳基因疗法 – 从靶点到 IND：中国CRO/CDMO 生态如何加速 CGT 转化

  • Proof of concept established: 2.5-year follow-up data for OTOF gene therapy demonstrate that inner-ear gene therapy is safe, effective, and delivers predictable therapeutic outcomes.
  • The target-to-IND pathway is mature: parallel workflows + a dense CRO/CDMO ecosystem + an integrated CRDMO model enable China to move from discovery to IND 50–70% faster than the global norm.
  • Supply chain readiness determines successful delivery: cold-chain logistics, potency testing, and end-to-end regulatory compliance systems (NMPA/QMS) are critical to the scaled delivery of cell and gene therapies (CGT).
  • Structural advantage: national strategic tailwinds + partners’ end-to-end delivery capabilities help Chinese companies such as Euhearing Therapeutics accelerate CGT implementation.

 

  • 概念验证已成立: OTOF 基因治疗 2.5 年随访数据证明内耳基因治疗安全、有效且疗效可预测。
  • 从靶点到 IND 已成熟: 并行化工作流 + 密集 CRO/CDMO 生态 + CRDMO 一体化,使中国「发现→IND」周期比全球快 50–70%。
  • 供应链就绪决定落地: 细胞与基因治疗(CGT)的冷链、效价与全程监管链(NMPA/QMS)是规模化交付的关键。
  • 结构性优势:国家战略红利 + 合作伙伴端到端交付，有助于以佑音医药等为代表的中国企业加速 CGT 落地。