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Sourced directly from the authorized manufacturer network to ensure authenticity and quality.
Ready to proceed? Start a request for Sacituzumab Tirumotecan on our secure patient portal to submit your prescription, upload documents and track your approval status.
Supplied with complete CDSCO-approved import and customs documentation, including Form 12A & 12B, CDEC, GST Bill of Entry, Commercial Invoice, and Packing List.
Manufacturer / Innovator:
China
Regulatory Approval:
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Sacituzumab tirumotecan, often shortened to sac-TMT, is a targeted cancer medicine developed in China by Sichuan Kelun-Biotech Biopharmaceutical. It is sold there under the brand name 佳泰莱® and was first approved for triple-negative breast cancer, one of the hardest breast cancers to treat once it has spread.
China's National Medical Products Administration (NMPA) has approved it for four groups of adults:
It is a prescription cancer medicine and should only be used under a medical oncologist.
This medicine is an antibody-drug conjugate, or ADC. The antibody part finds TROP2, a protein found in large amounts on the surface of many breast and lung cancer cells. Once the cancer cell pulls the medicine inside, it releases its payload, a chemotherapy-type drug called KL610023 that damages the cell's DNA so it cannot divide. Each antibody carries about 7.4 payload molecules, and because the payload can pass through cell membranes it can also reach nearby cancer cells. The idea is to deliver strong treatment to the tumour while sparing more of the healthy body.
In the phase 3 OptiTROP-Breast01 trial, published in Nature Medicine in 2025, 263 people with metastatic triple-negative breast cancer who had already had at least two treatments were given either this medicine or standard chemotherapy. The time before the cancer grew again was 6.7 months against 2.5 months, and the risk of death was cut by nearly half (hazard ratio 0.53). Median survival had not yet been reached in the sac-TMT group, against 9.4 months with chemotherapy. 45.4% of patients responded to treatment, compared with 12.0% on chemotherapy.
For HR-positive, HER2-negative breast cancer, the phase 3 OptiTROP-Breast02 trial found that the time before the cancer grew again was 8.3 months against 4.1 months with chemotherapy chosen by the doctor, and 41.5% responded compared with 24.1%.
The dose in the Chinese prescribing information is:
The first four infusions run for about 90 minutes, and the patient is watched for at least 90 minutes afterwards; later infusions can be shorter if there has been no reaction. Medicines to prevent infusion reactions are given before every dose (an antihistamine and a fever and pain reliever, plus a steroid and a stomach-acid blocker for the first four doses). The medicine comes as a freeze-dried powder in 200 mg and 100 mg vials, which the hospital pharmacy dissolves and dilutes. Because the dose depends on body weight, the number of vials changes from patient to patient. Your oncologist sets the exact plan and may lower the dose if side effects appear.
This information is not a treatment plan. For personalized medical advice, consult your doctor and refer to the full prescribing information.
Blood counts: the main side effects are on the blood. In the OptiTROP-Breast01 trial, anaemia affected 82.3% of patients (severe in 29.2%), low neutrophils 78.5% (severe in 34.6%) and low platelets 40.8% (severe in 13.1%). Fever with low neutrophils was uncommon (1.5%). Most severe drops happened in the first two cycles and usually recovered within about two weeks. Blood counts are checked every week for the first two months and then before each cycle.
Overall: about 3 in 10 patients (30.8%) needed a lower dose, but only 1.5% stopped treatment because of side effects. One patient died from a treatment-related cause (multiple organ failure). Safety in pregnancy, breastfeeding and children has not been established.
Step 1 – Search & request your medicine: The patient or treating doctor submits a request with basic details to initiate the access process.
Step 2 – Verification & eligibility review: The team verifies availability and reviews eligibility against regulatory and clinical requirements to ensure a compliant pathway.
Step 3 – Receive quote & delivery timeline: A transparent quotation is shared, covering medicine cost, logistics, and a clear delivery timeline.
Step 4 – Regulatory approval process: Assistance is provided to secure the approvals and documentation required for legal cross-border access.
Step 5 – Temperature-controlled import & handling: The medicine is sourced and transported under strict GDP-compliant, cold-chain conditions to maintain product integrity.
Step 6 – Secure delivery: The medicine is delivered to the patient or treating hospital, with updates provided at each stage.
Note: From request to delivery, every step is designed to ensure your treatment reaches you safely, compliantly, and without unnecessary delays.
The injection can be imported only in the patient's name, by the patient or a government hospital, in line with India's import regulations for unapproved medicines. You will need:
Once we have received and checked a valid prescription and, where needed, an import permit.
No. It is approved only in China (approval number 国药准字S20240052). It has no CDSCO approval, it is not sold in Indian pharmacies, and the US FDA and European Medicines Agency have not approved it either.
Patients can still get it legally through the Named Patient Program (NPP), which allows a medicine not registered in India to be imported for one specific patient on a prescription. It should not be confused with Trodelvy (sacituzumab govitecan), which is a different TROP2-targeted medicine from another company. For another TROP2 antibody-drug conjugate available through import, see our page on Datroway.
It can be made available to patients, doctors, and hospitals across major cities in India, including Gurgaon, Delhi, Bangalore, Mumbai, Navi Mumbai, Thane, Hyderabad, Mysore, Kerala, Chennai, Coimbatore, Madurai, Kolkata, Ahmedabad, Surat, Vadodara, Pune, Nagpur, Nashik, Jaipur, Udaipur, Lucknow, Kanpur, Gorakhpur, Chandigarh, Mohali, Faridabad, Noida, Ghaziabad, Kochi, Trivandrum, Kozhikode, Thrissur, Kannur, Mangalore, Bhubaneswar, Patna, Ranchi, Raipur, Guwahati, Visakhapatnam, Vijayawada, Goa, Jammu, Srinagar, Dehradun, Bhopal, Indore, Ludhiana, Amritsar, and others — and can facilitate delivery to the patient's treating hospital. Orders are confirmed only after receipt of a valid doctor's prescription and an import permit, where applicable.
NamedPatientProgram.com (NPP) sources this medicine through the manufacturer's authorised supply channels in China and arranges supply to patients, doctors, and hospitals under applicable legal provisions. The Chinese label describes taking the vial out of the refrigerator before it is prepared, so the vials are kept cold and shipped with cold-chain, temperature-controlled shipping, following the exact temperature printed on the pack, and delivered to the treating hospital. Because treatment is given every two weeks and the dose depends on weight, we plan quantities ahead for each cycle. All prescriptions are dispensed and checked by registered pharmacists and dispatched from New Delhi, India, after legal requirements are fulfilled.
For the current cost in India and availability, contact NPP via WhatsApp at +91 98104 69557 | Toll-Free: 1800-1200-365 or email info@namedpatientprogram.com.
Patients across India can access this medicine through regulated import pathways, with delivery arranged to the treating hospital on a valid specialist's prescription.
Large oncology centres here see many women with advanced breast cancer, and dispatch from New Delhi keeps the journey to the hospital short.
Supply is timed to the two-weekly infusion schedule, so the vials reach the day-care unit before each dose.
Oncologists in Bangalore can request this medicine for a named patient and receive a written quote before anything is ordered.
Patients from across Tamil Nadu treated in Chennai can have each cycle delivered straight to the hospital pharmacy.
We help treating teams plan how many vials each cycle needs, based on the patient's weight.
Shipments to Kolkata and the eastern states are tracked from dispatch to delivery.
Patients in Pune can use the same documented import route, with an update at every stage.
The oncologist can share the prescription, pathology and earlier treatment details with us to start the import.
Hospitals in Vellore can receive supplies for patients who travel there for breast or lung cancer care.
Serves patients from Punjab, Haryana and Himachal Pradesh, with delivery to the treating hospital.
We coordinate delivery to cancer hospitals across Uttar Pradesh, planned around each patient's treatment dates.
Patients across Kerala can receive the medicine at their hospital in Kochi and nearby cities.
Access can also be coordinated for patients in other Indian cities, subject to a valid prescription and regulatory requirements.
Written By
Nitin GoswamiDeputy Manager – Content & Social Media, Ikris Pharma Network
Sources: NMPA • CDSCO
Last Updated: 19 October 2026
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