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Ready to proceed? Start a request for Izalontamab Brengitecan 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
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Izalontamab brengitecan, often shortened to iza-bren, is a targeted cancer medicine developed in China by Sichuan Biokin Pharmaceutical (Baili-Tianheng) and its US arm, SystImmune. In China it is sold as 宜泽康, its Chinese generic name is 伦康依隆妥单抗, and during research it was known as BL-B01D1. It is the first bispecific antibody-drug conjugate approved anywhere in the world, according to the company.
China's National Medical Products Administration (NMPA) approved it on 22 June 2026, and added a second use in July 2026. It is approved for adults with:
The Chinese label states that the nasopharyngeal cancer approval is a conditional approval, based on an interim analysis of a phase 3 trial in China; full approval depends on the final results.
It is a prescription cancer medicine and should only be used under a medical oncologist experienced with antibody-drug conjugates.
Most targeted antibodies lock on to one protein. This one has two arms: one grabs EGFR and the other grabs HER3, two growth signals found in large amounts on many cancers of the head, neck and gut. Blocking both cuts off signals the cancer uses to grow. The antibody also carries a chemotherapy payload, a topoisomerase I inhibitor, which is released once the cancer cell pulls the antibody inside, killing the cell from within.
Nasopharyngeal cancer: the phase 3 PANKU-NPC01 trial, published in The Lancet in 2025, included 386 people at 55 hospitals in China whose cancer had grown after chemotherapy and immunotherapy. The tumour shrank in 54.6% of patients on iza-bren against 27.0% on standard chemotherapy. The cancer was held back for a median of 8.38 months versus 4.34 months, and responses lasted longer (8.5 vs 4.8 months). Survival data were not yet mature.
Oesophageal cancer: in the phase 3 PANKU-Esophagus01 trial of 497 patients, people lived longer with iza-bren (median 9.8 vs 7.2 months), and the cancer was held back for 4.2 months against 2.0 months with chemotherapy.
For nasopharyngeal cancer, the Chinese prescribing information gives:
It comes as a 120 mg vial of powder, which the hospital pharmacy dissolves in 10 mL of sterile water and then dilutes. As an example, a 60 kg patient would need 165 mg on each dosing day, so two vials. In the oesophageal cancer trial the dose was 2.5 mg/kg on days 1 and 8 of each 3-week cycle. Your oncologist sets the exact plan.
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 problem is a drop in blood counts. In the nasopharyngeal cancer trial, severe (grade 3 or higher) side effects linked to treatment included:
Blood tests are checked before each dose, and the dose may be lowered or delayed. In the trial, 41.8% of patients needed a dose reduction and 61.4% a pause, but only 2.6% stopped treatment because of side effects.
Overall: severe treatment-related side effects occurred in 80% of patients on iza-bren and 62% on chemotherapy, so close monitoring at an experienced cancer centre is essential. Safety in pregnancy, breastfeeding and children has not been established, and the Chinese approvals are for adults only.
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. It has no CDSCO approval, it is not sold in Indian pharmacies, and the US FDA and European Medicines Agency have not approved it. The US FDA has given it Breakthrough Therapy designation for one use, which speeds up review but is not an approval.
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. To read about other antibody-drug conjugates we help patients import, see our pages on Datroway and Trodelvy.
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 must be kept in a refrigerator at 2 to 8°C, protected from light, so they are shipped using cold-chain, temperature-controlled shipping all the way to the hospital. Because each cycle has two doses a week apart, we plan quantities cycle by cycle so both days are covered. 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 oncologist's prescription.
Large cancer centres in Delhi treat head, neck and oesophageal cancers from across North India, and our New Delhi dispatch point keeps transit short.
Vials can reach the hospital pharmacy ahead of both the day 1 and day 8 infusions.
Oncologists in Bangalore can request the medicine for a named patient and get a written quote before anything is ordered.
A key referral centre in South India with experience handling imported injectable cancer medicines.
We schedule each delivery around the two-doses-per-cycle plan so treatment is not delayed.
Shipments to Kolkata and the eastern states are routed to follow the pack's storage directions throughout.
Patients in Assam and the North-East can have each cycle delivered to their treating cancer hospital.
Families in Pune receive updates at every stage of the import.
The treating oncologist can send us the prescription and treatment history to start the process.
Patients treated in Vellore can have supply sent straight to the hospital.
We coordinate delivery to government and private cancer hospitals across Uttar Pradesh.
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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