Pipeline-Leads Biolabs

Expanded Access

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Expanded Access Policy

What is Expanded Access?

Expanded access, sometimes also referred to as “compassionate use”, is a regulatory pathway by which patients with serious or life-threatening diseases or conditions may obtain investigational medicinal products (IMPs) outside of clinical trials when no comparable or satisfactory alternative therapy options exist.

Company Position

Nanjing Leads Biolabs Co., Ltd. (hereinafter referred to as “the Company”) conducts clinical trials to evaluate the safety and efficacy of its investigational products. The Company believes that participation in well-designed clinical trials is the most appropriate way for patients to access our investigational medicinal products prior to regulatory approval.

Based on the current stage of clinical development and the ongoing assessment of safety profile of IMPs, our IMPs will not be provided for expanded access at this time.

Policy Scope and Limitations

This policy applies to all IMPs that are not approved for any use by regulatory authorities. The posting of this policy does not guarantee any particular patient will be able to access to any specific investigational product, nor should it be construed as such a guarantee.

Policy Review

The Company recognizes that expanded access may be important for certain patients under appropriate circumstances. We will regularly review this policy in light of accumulating clinical data and regulatory requirements, and may revise this policy at any time. If changes are made, this webpage will be updated to reflect the revised policy.