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Zuberitamab

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Zuberitamab

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: Zuberitamab
Generic Name (API): Zuberitamab
Dosage Form & Strength: 100 mg/10 mL
Route: Intravenous (IV) infusion
Drug Class: Anti-CD20 chimeric monoclonal antibody

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
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What Is Zuberitamab Used For?

Zuberitamab is an antibody medicine for diffuse large B-cell lymphoma (DLBCL), the most common fast-growing type of non-Hodgkin lymphoma. It was developed in China by Zhejiang BioRay Biopharmaceutical and is sold there as 安瑞昔® (Anruixi®). It is given as a drip together with CHOP chemotherapy.

China's National Medical Products Administration (NMPA) approved it in May 2023 for adults with:

  • CD20-positive diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS)
  • Used in combination with standard CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine and prednisone)

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

How It Works

Most B-cell lymphoma cells carry a marker on their surface called CD20. Zuberitamab is a chimeric (part human, part mouse) monoclonal antibody that sticks to CD20. Once attached, it flags the cancer cell so the immune system can destroy it. BioRay describes it as China's first home-grown innovative anti-CD20 antibody, rather than a copy of an existing one.

What the Trial Showed

The phase 3 trial, published in the Journal for ImmunoTherapy of Cancer in 2024, included 487 adults with newly diagnosed CD20-positive DLBCL. Two out of three received zuberitamab plus CHOP and the rest received a standard comparison antibody plus CHOP, for six cycles.

  • Response rate: 83.5% with zuberitamab against 81.4% with the comparison treatment, which met the goal of being at least as good (non-inferior)
  • Complete response: 75.2% against 67.9% in all treated patients; among patients who followed the protocol fully, 85.7% against 77.3%, a statistically significant difference
  • Longer term: after a median of 29.6 months, there was a trend towards longer progression-free survival and overall survival, but these differences did not reach statistical significance

Recommended Dosage

The Chinese prescribing information says zuberitamab must not be used on its own; it is always combined with standard CHOP chemotherapy:

  • Zuberitamab: 375 mg per square metre of body surface area, as a drip on the first day of each chemotherapy cycle, given before the CHOP medicines (in the phase 3 trial it was given on day 0, the day before CHOP)
  • Infusion speed: the first infusion starts slowly at 50 mg per hour and is increased step by step, up to 400 mg per hour, if there is no reaction; later infusions can start at 100 mg per hour. The label does not recommend lowering the zuberitamab dose.
  • CHOP on day 1: cyclophosphamide 750 mg/m², doxorubicin 50 mg/m² and vincristine 1.4 mg/m² (no more than 2 mg), with prednisone by mouth
  • Repeated every 21 days; safety and benefit data cover up to six cycles

It comes as a 100 mg in 10 mL vial of solution. The dose depends on height and weight, so the number of vials differs from person to person; for example, a body surface area of 1.6 m² needs 600 mg, or six vials. Your haematologist 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.

Warnings and Precautions

Infusion reactions: reactions during or soon after the drip were the main difference from the comparison treatment (32.1% vs 19.9%). They were mostly chills (20.8%), fever (16.5%) and a rise in blood pressure (5.2%), usually within 1 to 2 hours of the first infusion. Almost all were mild or moderate; 1.5% of patients had a grade 3 reaction. The drip is given in hospital so the team can slow or pause it if needed.

  • Low blood counts: with CHOP, low white cells (89.6%) and low neutrophils (89.3%) were very common, and were severe in 67.9% and 75.5% of patients. The rates were similar in the comparison group. Report fever or signs of infection straight away.
  • Anaemia: occurred in 56.6% of patients, severe in 12.8%.
  • Hepatitis B: hepatitis B came back (reactivated) in 2.1% of patients on zuberitamab and 1.3% on the comparison treatment. Tell your doctor about any past hepatitis B infection.
  • Chemotherapy partners: the CHOP medicines carry their own warnings, which your oncologist will explain.

Overall: side effect rates were similar between the two groups. 13.5% of patients on zuberitamab stopped the trial because of side effects, compared with 17.9% in the comparison group. Full Chinese prescribing information was not available to us, so ask your specialist about pregnancy, breastfeeding and other individual risks.

How to Access Zuberitamab 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 Zuberitamab 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 haematologist or medical oncologist
  • Biopsy and pathology reports confirming CD20-positive diffuse large B-cell lymphoma
  • 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 Zuberitamab available in India?

No. It is approved only in China (approval number 国药准字S20230028, May 2023). 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 lymphoma that comes back after first treatment, see our pages on Monjuvi and Zynlonta.

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. It is stored and shipped exactly as directed on the pack, using temperature-controlled shipping where the pack requires it. Because the dose is worked out from body surface area, we confirm the number of vials for each cycle before ordering. 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

Large cancer hospitals here treat lymphoma patients from across North India, and dispatch from New Delhi keeps delivery times short.

Mumbai

Vials can be delivered to the hospital pharmacy ahead of each three-weekly CHOP cycle.

Bangalore

Oncologists in Bangalore can request the medicine for a named patient and receive a written quote before any order is placed.

Chennai

A major referral centre for lymphoma care in South India, with hospitals used to handling imported cancer medicines.

Hyderabad

We time each shipment around the patient's planned cycle date so treatment is not held up.

Kolkata

Patients in Kolkata and the eastern states can use the same documented import route.

Pune

The treating oncologist can share the pathology report and prescription with us to start the process.

Ahmedabad

We coordinate delivery to the treating hospital and keep the family updated at each step.

Vellore

Patients treated at hospitals in Vellore can have each cycle's vials delivered directly to the hospital.

Chandigarh

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

Lucknow

We arrange supply to public and private cancer hospitals across Uttar Pradesh.

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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