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Sourced directly from the authorized manufacturer network to ensure authenticity and quality.
Ready to proceed? Start a request for Retlirafusp Alfa 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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Retlirafusp alfa is an immunotherapy medicine for advanced stomach cancer, developed in China by Jiangsu Hengrui Pharmaceuticals and sold there as 艾泽利® (瑞拉芙普α注射液). Hengrui describes it as the first approved medicine in the world that blocks PD-L1 and traps TGF-β in a single molecule. It is used together with chemotherapy.
China's National Medical Products Administration (NMPA) approved it in January 2026. Its approved use is:
It is a prescription cancer medicine and should only be used under a medical oncologist.
Stomach cancers protect themselves in two ways. They show PD-L1, which switches off the T cells that should attack them, and they surround themselves with TGF-β, a signal that weakens the immune response around the tumour. Retlirafusp alfa is a fusion protein: an anti-PD-L1 antibody joined to the outer part of the TGF-β receptor II. One end releases the PD-L1 brake, while the other soaks up TGF-β, so the immune system can work more effectively inside the tumour.
The approval is based on the randomised, double-blind phase 3 RELIGHT trial (SHR-1701-III-307), published in the Journal of Clinical Oncology in 2026. It included 731 people in China with previously untreated, HER2-negative advanced stomach or GEJ cancer. Everyone had capecitabine and oxaliplatin (CAPOX) chemotherapy, plus either retlirafusp alfa or a placebo by drip every 3 weeks:
The PD-L1 positive and liver figures come from the maker's 2026 China national insurance submission; the all-patient figures are from the journal paper.
The Chinese prescribing information gives:
It comes as a 300 mg in 6 mL vial of solution, so a 1,800 mg dose uses six vials. Your oncologist sets the exact plan along with the chemotherapy.
This information is not a treatment plan. For personalized medical advice, consult your doctor and refer to the full prescribing information.
Overall: in RELIGHT, severe (grade 3 or higher) treatment-related side effects occurred in 62.6% of patients on retlirafusp alfa plus chemotherapy and 59.0% on placebo plus chemotherapy, so the rates were broadly similar. The safety summary in the Chinese label adds that low white cells, low neutrophils and low platelets were less common with retlirafusp alfa (by 11.2, 10.1 and 8.7 percentage points), which suggests it may lessen the blood-count drop caused by chemotherapy.
Older patients: 42% of trial patients were 65 or older, and no difference in safety or benefit was seen, so no dose change is needed for age.
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S20260002, January 2026), which was its first approval anywhere. It has no CDSCO approval and is not sold in Indian pharmacies, and we found no US FDA or European 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. For another stomach and GEJ cancer medicine we can help import, see our page on Vyloy.
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, with temperature-controlled shipping to the treating hospital, timed to the chemotherapy cycles. 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.
Gastrointestinal oncology teams here treat stomach cancer patients from across North India, and our New Delhi dispatch point keeps delivery quick.
Supply can be delivered to the hospital day-care unit ahead of each chemotherapy cycle.
Oncologists in Bangalore can request it for a named patient once the PD-L1 result is available, with a written quote first.
A major centre for GI cancer care in South India, familiar with imported infusion medicines.
We line up each delivery with the chemotherapy calendar so treatment is not held up.
Patients from Kolkata and the north-eastern states can receive supply at their treating hospital through the same route.
Families in Pune get updates at each step, from prescription check to hospital delivery.
The treating oncologist can send the prescription, biopsy and PD-L1 reports to start the import.
Patients treated at hospitals in Vellore can have supply sent directly to the hospital pharmacy.
Serves patients from Punjab, Haryana and Himachal Pradesh, with delivery to the treating cancer centre.
We coordinate delivery to public and private cancer hospitals across Uttar Pradesh.
Patients across Kerala can receive the medicine at hospitals 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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