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Sourced directly from the authorized manufacturer network to ensure authenticity and quality.
Ready to proceed? Start a request for Trastuzumab Botidotin 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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Trastuzumab botidotin is a targeted medicine for HER2-positive breast cancer that has spread or cannot be removed by surgery. It was developed in China by Sichuan Kelun-Biotech Biopharmaceutical, where it is sold as 舒泰莱®, and it was known as A166 during research.
China's National Medical Products Administration (NMPA) approved it in October 2025 for adults with:
It is a prescription cancer medicine and should only be used under a medical oncologist.
This medicine is an antibody-drug conjugate, or ADC. Its antibody part locks on to HER2, a protein found in very large amounts on HER2-positive breast cancer cells. The cancer cell draws the medicine inside, where a cleavable linker releases its payload, Duo-5. Duo-5 is a strong cell poison (a derivative of MMAF) that stops the cell from dividing, so the cell dies. Each antibody carries two payload molecules. The antibody itself also blocks HER2 growth signals and helps the immune system attack the cancer cells.
The phase 3 KL166-III-06 trial, published in the Journal of Clinical Oncology in 2026, included 365 people in China whose HER2-positive breast cancer had already been treated with standard HER2 antibody therapy and taxane chemotherapy. They were given either this medicine or an established comparison HER2 medicine. The time before the cancer grew again was 11.1 months against 4.4 months, and at one year 46.0% had no progression compared with 15.3%. 76.9% of patients responded to treatment, against 53.0%. Survival data were still early, but the trend favoured trastuzumab botidotin.
The dose in the Chinese prescribing information (the same as in the phase 3 trial) is:
It comes as a 40 mg vial of powder, which the hospital pharmacy dissolves and dilutes before the infusion. Because the dose depends on body weight, the number of vials varies from patient to patient. Your oncologist sets the exact plan, and doses may be delayed or lowered if eye side effects appear.
This information is not a treatment plan. For personalized medical advice, consult your doctor and refer to the full prescribing information.
Eyes: eye problems are the main side effect and need regular attention. In the phase 3 trial, changes to the cornea (the clear front of the eye) were seen in 92.9% of patients and were severe in 37.9%. Dry eye affected 61.5% (severe in 30.2%) and blurred vision 28.6% (severe in 20.9%). None of these eye problems made anyone stop treatment, but some patients needed a dose change. Tell your care team quickly about eye pain, dryness or blurred vision, so the dose can be adjusted in time.
Overall: severe side effects of any cause happened in 69.8% of patients, compared with 63.7% on the comparison medicine. Only 1.1% stopped treatment because of side effects. 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S20250056, October 2025). 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. For another HER2-positive breast cancer medicine available through import, see our page on Nerlynx.
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 vials are stored and shipped as directed on the pack, using temperature-controlled shipping where the pack calls for it, and delivered to the treating hospital. Because treatment is given every three 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.
Breast cancer units in Delhi treat patients from across North India, and dispatch from New Delhi keeps delivery times short.
Each three-weekly supply is timed so the vials reach the hospital before the infusion day.
Oncologists in Bangalore can request the medicine for a named patient and receive a written quote before anything is ordered.
Patients treated in Chennai can have each cycle delivered to the hospital pharmacy, alongside the eye checks their team arranges.
We help the treating team work out how many vials each dose 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, HER2 report and treatment history with us to begin the import.
Hospitals in Vellore can receive supplies for patients who travel there for breast 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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