Sacituzumab Tirumotecan Injection

Sacituzumab tirumotecan, jointly developed by Kelun-Biotech and Merck, is an antibody-drug conjugate approved in China for advanced solid tumors, including certain types of non-small cell lung cancer and breast cancer, and continues to be studied in global clinical trials for additional indications.

It is a TROP2-directed antibody-drug conjugate: the antibody targets TROP2, a protein overexpressed on many tumor cells, delivering a topoisomerase-1 inhibitor payload directly into cancer cells to induce cell death while limiting exposure to healthy tissue.

• As an antibody-drug conjugate, may cause myelosuppression (low blood counts), including neutropenia and anemia — regular monitoring is required.
• Gastrointestinal toxicities such as nausea, vomiting, and diarrhea have been reported.
• Interstitial lung disease/pneumonitis is a class risk with topoisomerase-1-inhibitor ADCs; monitor for respiratory symptoms.
• This product is not FDA-approved and remains under clinical investigation/regional approval — treatment should only be undertaken under close oncologist supervision with full awareness of its regulatory status.

What documents are required to import Sacituzumab tirumotecan to India?

As a product not yet FDA-approved, it may only be imported in the patient’s name based on a treating oncologist’s recommendation, with full documentation of its overseas regulatory status. Required documents include:

• A valid prescription/recommendation from a registered oncologist, referencing the drug’s approval status in its country of origin
• Diagnostic/pathology report confirming the applicable cancer diagnosis
• Patient ID proof (issued by the Government of India)

How is the order confirmed?

The order is confirmed only after receipt and verification of a valid prescription and confirmation of sourcing feasibility given its limited regulatory approval.

Is Sacituzumab tirumotecan available in India?

It is not commercially marketed in India or the United States. Availability through the Named Patient Program (NPP) depends on sourcing feasibility from markets where it holds regulatory approval.

Indian Pharma Network (IPN) will assess sourcing feasibility for Sacituzumab tirumotecan on a case-by-case basis, given its current regulatory status, and facilitate supply where legally and logistically possible.

For enquiries, contact IPN at Phone: +91-9310090915 or email info@indianpharmanetwork.in.

Global Approval Status:

• China: Approved by the NMPA.
• United States: Not FDA-approved; under clinical investigation.

What is Sacituzumab tirumotecan used for?

It is used (where approved) for advanced solid tumors, including certain lung and breast cancers.

Who manufactures Sacituzumab tirumotecan?

It is jointly developed by Kelun-Biotech and Merck.

Is Sacituzumab tirumotecan FDA-approved?

No — it is approved by China’s NMPA and remains under clinical investigation in other markets, including the United States.

How much does Sacituzumab tirumotecan cost in India?

Cost and sourcing feasibility depend on the patient’s specific case — contact IPN to discuss.