西米普利单抗 cemiplimab

Drug Class

PD-1 blocking monoclonal antibody

Mechanism

Binds to the PD-1 receptor on T-cells, blocking its interaction with PD-L1 and PD-L2, thereby restoring T-cell mediated anti-tumor immune responses.

Approved Indication

Treatment of adult patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or radiation.

What This Means For Patients

西米普利单抗 is not distributed through mainland China's retail pharmacy network. Uwell Cloud can help arrange a purchase channel for this medicine, sourced and dispatched from Hong Kong; clinical administration support in China can be coordinated on request. Availability and eligibility for any specific patient are determined by clinical review.

Regulatory Approvals

• FDA — Approved (2018) — Sources
• EMA — Approved (2019) — Sources

Pivotal Clinical Evidence

• Study 1540 — Migden et al., N Engl J Med 2018 (NCT02760498) — Sources

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761097s000lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/libtayo