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Trastuzumab Rezetecan

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Trastuzumab Rezetecan

Supplied with complete CDSCO-approved import and customs documentation, including Form 12A & 12B, CDEC, GST Bill of Entry, Commercial Invoice, and Packing List.

Medicine Name: Trastuzumab Rezetecan
Generic Name (API): Trastuzumab rezetecan
Dosage Form & Strength: 100 mg
Route: Intravenous (IV) infusion
Drug Class: HER2-directed antibody-drug conjugate

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
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What Is Trastuzumab Rezetecan Used For?

Trastuzumab rezetecan is a HER2-targeted cancer medicine developed in China by Jiangsu Hengrui Pharmaceuticals. It was known as SHR-A1811 during research and is sold in China as 艾维达®. It is used for several cancers that carry HER2 changes, in the lung, breast and bowel.

China's National Medical Products Administration (NMPA) has approved it, on its own, for adults with:

  • HER2-mutant non-small cell lung cancer (May 2025, conditional approval): unresectable locally advanced or metastatic disease with an activating HER2 (ERBB2) mutation, after at least one earlier systemic treatment
  • HER2-positive breast cancer (March 2026): locally advanced or metastatic disease after one or more earlier anti-HER2 treatments
  • HER2-positive colorectal cancer (August 2026): after the standard bowel cancer chemotherapy medicines have stopped working

It is a prescription cancer medicine and should only be used under a medical oncologist.

How It Works

This medicine is an antibody-drug conjugate, or ADC. The antibody part attaches to HER2 on the surface of cancer cells, and the cell then pulls the whole medicine inside. There, enzymes cut the link and release a cell-killing payload that stops the cell from dividing, so it dies. The released payload can pass easily through cell membranes, so it can also reach neighbouring cancer cells, which Hengrui calls a bystander effect.

What the Trials Showed

Breast cancer: in the phase 3 HORIZON-Breast01 trial, reported in The Lancet Oncology in 2026, 287 women in China with HER2-positive metastatic breast cancer that had already been treated were given either this medicine or a standard tablet-based HER2 combination. The time before the cancer grew again was 30.6 months against 8.3 months (hazard ratio 0.22). At one year, 84.7% were free of progression compared with 35.5%, and 81.7% responded to treatment against 55.9%.

Lung cancer: in the phase 2 HORIZON-Lung study (The Lancet Oncology, 2025), 94 people with HER2-mutant lung cancer were treated. About three in four responded (73%, rising to 74.5% with longer follow-up), and the time before the cancer grew again was a median of 11.5 months.

Recommended Dosage

In both trials the dose was:

  • 4.8 mg per kg of body weight, given as a drip into a vein
  • Once every 3 weeks
  • Continued until the cancer progresses or side effects become too difficult

Each vial holds 100 mg. As an example, a 60 kg patient needs 288 mg per dose, which means three vials. Your oncologist sets the exact plan and may delay or lower a 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.

Warnings and Precautions

Blood counts: the main side effects are on the blood. In the HORIZON-Lung study, severe falls were seen in neutrophils (40%), white cells (27%), red cells or anaemia (23%) and platelets (11%). In the breast cancer trial, the most common severe side effects were also low neutrophils, low white cells and low platelets. Regular blood tests are needed throughout treatment, and a dose may be delayed or reduced.

  • Lungs: interstitial lung disease (lung inflammation and scarring) occurred in 3% of patients in the breast cancer trial, mostly mild, with one severe case. In the lung cancer study it was reported as a serious side effect in 5%. Report a new cough, breathlessness or fever straight away.
  • Serious side effects: treatment-related serious side effects affected 13% of patients in the breast cancer trial (12% with the comparison treatment) and 23% in the lung cancer study.

Overall: severe treatment-related side effects happened in about 62% to 70% of patients across the two trials. Few people stopped because of them (1% in the lung cancer study), though in that study about 30% needed a pause and 17% a lower dose. Safety in pregnancy, breastfeeding and children has not been established.

How to Access Trastuzumab Rezetecan in India: A 6-Step Process

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.

Documentation & Availability

What documents are required to import Trastuzumab Rezetecan to India?

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:

  • A valid prescription from a qualified medical oncologist
  • Pathology and biomarker reports confirming the HER2 result (HER2-positive breast or bowel cancer, or a HER2 mutation in lung cancer), with details of earlier treatments
  • Patient ID proof (issued by the Government of India)

How is the order confirmed?

Once we have received and checked a valid prescription and, where needed, an import permit.

Is Trastuzumab Rezetecan available in India?

No. It is approved only in China. It has no CDSCO marketing approval and is not sold in Indian pharmacies; in India it is so far being tested only in a clinical trial. 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 other HER2-targeted medicines available through import, see our pages on Hernexeos for HER2-mutant lung cancer and Nerlynx for HER2-positive breast cancer.

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.

Sourcing & Delivery

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 100 mg 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 the dose depends on weight and is repeated every three weeks, we work out the vial count for each cycle in advance. 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.

Availability Across Major Cities in India

Patients across India can access this medicine through regulated import pathways, with delivery arranged to the treating hospital on a valid specialist's prescription.

Delhi

Lung and breast cancer specialists in Delhi see patients from across North India, and dispatch from New Delhi keeps delivery quick.

Mumbai

Each three-weekly supply is timed to reach the hospital before the infusion date.

Bangalore

Oncologists in Bangalore can request the medicine for a named patient and get a written quote before anything is ordered.

Chennai

Patients treated in Chennai can have the vials delivered straight to the hospital pharmacy for each cycle.

Hyderabad

We help the treating team calculate the number of 100 mg vials each dose needs.

Kolkata

Shipments to Kolkata and the eastern states are tracked from dispatch to delivery.

Pune

Patients in Pune can use the same documented import route, with an update at every stage.

Ahmedabad

The oncologist can send us the prescription, HER2 test report and treatment history to begin the import.

Vellore

Hospitals in Vellore can receive supplies for patients who travel there for cancer care.

Chandigarh

Serves patients from Punjab, Haryana and Himachal Pradesh, with delivery to the treating hospital.

Lucknow

We coordinate delivery to cancer hospitals across Uttar Pradesh, planned around each patient's treatment dates.

Kochi

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.

Author Details

Nitin Goswami

Written By

Nitin Goswami

Deputy Manager – Content & Social Media, Ikris Pharma Network

Sources: NMPA • CDSCO

Dr. Chirag C Shah

Medically Reviewed By

Dr. Chirag C Shah

MBBS

Last Updated: 19 October 2026

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