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Sourced directly from the authorized manufacturer network to ensure authenticity and quality.
Ready to proceed? Start a request for Tagitanlimab 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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Tagitanlimab is an immunotherapy medicine for nasopharyngeal carcinoma (NPC), a cancer of the upper part of the throat behind the nose, when it has come back or spread. It was developed and is made in China by Sichuan Kelun-Biotech Biopharmaceutical, where it is sold as 科泰莱® (Ketailai). During development it was called KL-A167.
China's National Medical Products Administration (NMPA) has approved it for two uses in recurrent or metastatic nasopharyngeal carcinoma:
Kelun-Biotech reports that both uses were added to China's national reimbursement drug list in 2025. It is a prescription cancer medicine and should only be used under a medical oncologist.
Tumours often carry a protein called PD-L1, which switches off the T cells that would otherwise attack them. Tagitanlimab is a humanised monoclonal antibody that binds to PD-L1 and blocks it from reaching PD-1 on T cells, so the immune system can go after the cancer again. According to its label, it does not kill cells directly through antibody-dependent pathways (ADCC or CDC); it works by lifting the brake on immunity.
First-line (KL167-III-08): in this phase 3 trial, 295 people with recurrent or metastatic NPC were randomly given tagitanlimab or a placebo, both with cisplatin and gemcitabine. Adding tagitanlimab cut the risk of the cancer growing or death by 53% (hazard ratio 0.47). Median time before the cancer grew was not yet reached, against 7.9 months with chemotherapy alone. The response rate was 81.7% vs 74.5%, and responses lasted a median of 11.7 vs 5.8 months.
After chemotherapy (KL167-2-05-CTP): in a phase 2 study of 132 patients who had already had at least two lines of chemotherapy, published in The Lancet Regional Health – Western Pacific, the tumour shrank in 26.5%. Median overall survival was 16.2 months and responses lasted a median of 12.4 months.
Each vial holds 200 mg in 10 mL. A 900 mg dose uses 45 mL (four and a half vials' worth) and a 1,200 mg dose uses six vials, diluted in about 200 mL of saline and infused over roughly 2 hours. In the trial, chemotherapy was given for up to six cycles, then tagitanlimab continued alone. 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.
Immune-related side effects: the label warns that the immune system may attack healthy tissue during or after treatment, sometimes severely. In the phase 2 NPC study, immune-related side effects occurred in 20.3% of patients, and 3.9% were severe. An underactive thyroid was the most common (13.1%).
Overall: with tagitanlimab alone, side effects of any grade occurred in 76.0% of 434 patients and severe ones in 15.4%. With cisplatin and gemcitabine, the figures were 92.9% and 60.9%, mostly low blood counts linked to the chemotherapy. Safety in children under 18 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. It does not appear in CDSCO's lists of approved biological (rDNA) medicines, 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. We also import another China-approved PD-L1 antibody, Adebrelimab, which is used for a different cancer (small-cell lung 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.
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 at 2°C to 8°C and away from light, so they travel under temperature-controlled shipping all the way to the hospital. Because a dose needs several vials, we plan quantities to match the 2-weekly or 3-weekly schedule. 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.
Head and neck cancer units in Delhi treat patients from across North India, and our New Delhi dispatch point keeps the cold chain short.
Refrigerated vials are delivered to the hospital pharmacy before each infusion day.
Oncologists in Bangalore can request the medicine for a named patient and receive a written quote first.
A long-established centre for head and neck oncology, with hospitals experienced in storing refrigerated imported biologics.
We schedule deliveries around the 2-weekly or 3-weekly treatment cycle so doses stay on time.
Shipments to Kolkata and the eastern and north-eastern states are kept within 2°C to 8°C throughout.
Serves patients from Punjab, Haryana and Himachal Pradesh, with refrigerated delivery to the treating hospital.
Patients in Pune can use the same documented import route, with updates at each stage.
The treating oncologist can send the prescription, biopsy report and treatment history to begin the import.
Patients treated at hospitals in Vellore can have each cycle's vials delivered directly to the hospital.
We coordinate cold-chain delivery to public 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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