LNC Pharma Pte. Ltd. (hereinafter referred to as “LNC Pharma”), a wholly-owned subsidiary of Yantai Lannacheng Biotechnology Co., Ltd. (hereinafter referred to as LNC), manages international affairs. LNC was co-founded in 2021 by Yantai Dongcheng Pharmaceutical Group Co., Ltd., a leading nuclear medicine enterprise in China, and Professor Xiaoyuan (Shawn) Chen, a renowned expert in molecular imaging and nanomedicine. LNC is committed to global R&D and the regulatory registration of radiotheranostics. More information about our pipeline and ongoing clinical trials is available on our website: https://en.dc-lnc.com/pro1.
LNC’s investigational product, 177Lu-LNC1004 Injection, is a FAP-targeted radionuclide therapeutic currently in Phase 1 clinical trial for patients with advanced FAP-positive solid tumors (More details can be found at https://www.clinicaltrials.gov/study/NCT05723640?intr=177Lu-LNC1004&rank=1). Clinical trials are an essential means for patients to access 177Lu-LNC1004 Injection.
In compliance with the 21st Century Cures Act (2016), manufacturers of investigational drugs intended to treat serious diseases or conditions must make policy publicly available for evaluating and responding to expanded access requests.
We fully acknowledge and endorse the importance of Expanded Access Programs (EAPs) under certain circumstances and evaluate requests in accordance with local health authority regulations and available scientific and clinical evidence. When considering a request, the following medical criteria must be met:
• The patient has a serious or immediately life-threatening disease or condition.
• There are no comparable or satisfactory alternative therapies available for diagnosis, monitoring, or treatment.
• The patient is not eligible for enrollment in a clinical trial.
• The potential benefit to the patient justifies the potential treatment risks.
• Providing the investigational medical product will not interfere with ongoing investigational trials supporting the medical product’s development or potential market approval for the indication.
LNC reverses the right to update this policy in accordance with the 21st Century Cures Act.
If you do not qualify for the clinical trials for 177Lu-LNC1004 Injection, and your treating physician determines that this investigational drug may be the best and only treatment option for you, your physician may contact us on your behalf at j.zhang@nus.edu.sg. We strive to respond to compassionate use requests within five business days of receipt.
