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Ivonescimab

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Ivonescimab

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: Ivonescimab
Generic Name (API): Ivonescimab
Dosage Form & Strength: 100 mg/10 mL
Route: Intravenous (IV) infusion
Drug Class: PD-1/VEGF bispecific antibody

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
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What Is Ivonescimab Used For?

Ivonescimab is a lung cancer medicine developed in China by Akeso, where it is sold as 依达方®. It is the first approved antibody that blocks two targets at once: PD-1, which helps the immune system attack the cancer, and VEGF, which tumours use to grow new blood vessels. It is given as a drip every three weeks, on its own or with chemotherapy, depending on the type of lung cancer.

China's National Medical Products Administration (NMPA) has approved it for three uses in non-small cell lung cancer (NSCLC):

  • May 2024: with chemotherapy, for EGFR-mutated, locally advanced or metastatic non-squamous NSCLC that has progressed after EGFR tyrosine kinase inhibitor (TKI) tablets
  • April 2025: on its own, as first treatment for advanced NSCLC that is PD-L1 positive (TPS ≥1%) and has no EGFR or ALK gene change
  • August 2026: with chemotherapy, as first treatment for advanced squamous NSCLC

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

How It Works

Cancer cells often hide from the immune system by switching off T cells through a "brake" called PD-1. At the same time, they release VEGF to build a blood supply. Ivonescimab is a single bispecific antibody that grips both. It releases the brake on the immune cells and starves the tumour of new blood vessels, so the two effects work together inside the tumour.

What the Trials Showed

After EGFR tablets stop working (HARMONi-A): this phase 3 trial, published in JAMA in 2024, included 322 people in China whose EGFR-mutated lung cancer had grown after TKI treatment. Adding ivonescimab to pemetrexed and carboplatin chemotherapy pushed back the time before the cancer grew again from a median of 4.8 to 7.1 months (hazard ratio 0.46). Half of patients responded to treatment (50.6%), against about a third (35.4%) on chemotherapy alone.

First treatment for PD-L1 positive lung cancer (HARMONi-2): in 398 patients, ivonescimab alone was compared with a widely used PD-1 immunotherapy. The median time before the disease got worse was 11.1 months against 5.8 months (hazard ratio 0.51). In September 2026 Akeso reported that an interim survival analysis also met its goal; full survival figures had not yet been published.

Squamous lung cancer (HARMONi-6): in 532 patients, ivonescimab plus chemotherapy was compared with a different PD-1 immunotherapy plus chemotherapy. Median survival was 27.9 months against 23.7 months (hazard ratio 0.66), and the time before the disease got worse was 11.1 against 6.9 months.

Recommended Dosage

In the HARMONi-A and HARMONi-2 trials the dose was:

  • Ivonescimab: 20 mg per kg of body weight, as an intravenous drip once every 3 weeks
  • In HARMONi-A: given with pemetrexed 500 mg/m² and carboplatin (AUC 5) for 4 cycles, then continued with pemetrexed as maintenance
  • Treatment continued as long as it was working and side effects were manageable

The vial on the official pack is marked 100 mg in 10 mL. As an example, at 20 mg per kg a 60 kg patient would need 1,200 mg, or 12 vials, per dose. Your oncologist sets the exact plan and decides whether chemotherapy is needed.

This information is not a treatment plan. For personalized medical advice, consult your doctor and refer to the full prescribing information.

Warnings and Precautions

Ivonescimab combines two kinds of side effects: immune-related ones, seen with PD-1 medicines, and blood-vessel related ones, seen with VEGF blockers. The figures below are from the HARMONi-A trial, where it was given with chemotherapy.

  • Immune-related side effects: 24.2% of patients had one (6.2% severe), against 6.2% on chemotherapy alone. The immune system can inflame the thyroid, lungs, liver, bowel, skin or other organs. Report a new cough, breathlessness, diarrhoea, rash, yellow skin or extreme tiredness quickly.
  • Protein in the urine: 17.4% against 8.1%. Urine is usually checked before each dose.
  • High blood pressure: 8.1% against 3.1%. Blood pressure is checked regularly.
  • Bleeding: 6.8% against 5.0%, mostly mild. Tell your doctor about any coughing up of blood, black stools or unusual bruising, and about any blood thinners you take.
  • Blood counts: severe drops in neutrophils (31.3%) were common, mainly because of the chemotherapy given alongside. Blood tests are done before each cycle.

Overall: severe treatment-related side effects occurred in 61.5% of patients on ivonescimab plus chemotherapy and 49.1% on chemotherapy alone, and 5.6% stopped ivonescimab because of side effects (2.5% in the comparison group). When used on its own in HARMONi-2, severe treatment-related side effects were reported in 29% of patients. Safety in pregnancy, breastfeeding and children has not been established.

How to Access Ivonescimab 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 Ivonescimab 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
  • Biopsy and imaging reports confirming non-small cell lung cancer, with EGFR/ALK and PD-L1 test results and details of earlier treatment
  • 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 Ivonescimab available in India?

No. It is approved only in China. It has no CDSCO approval and is not sold in Indian pharmacies. In the United States, the FDA is reviewing an application for its use after EGFR tablets, with a decision date of 14 November 2026, but it is not yet approved there or in Europe.

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 EGFR-mutated lung cancer medicines we can help import, see our pages on Rybrevant and Lazcluze.

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 vials are stored and shipped as directed on the pack, with temperature-controlled shipping to the treating hospital. Because the dose depends on body weight and is given every three weeks, we plan the number of vials cycle by cycle. 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 oncologist's prescription.

Delhi

Large thoracic oncology departments here see lung cancer patients from across North India, and our New Delhi dispatch point keeps transit time short.

Mumbai

Vials can be delivered to the hospital day-care unit ahead of each three-weekly infusion.

Bangalore

Oncologists in Bangalore can request it for a named patient after reviewing EGFR, ALK and PD-L1 results, with a written quote before ordering.

Chennai

A major referral centre for lung cancer in South India, used to handling imported biologic infusions.

Hyderabad

We match each shipment to the patient's weight-based dose so the right number of vials arrives for every cycle.

Kolkata

Patients from Kolkata and the eastern states can receive supply at their treating hospital through the same documented route.

Pune

Families in Pune get stage-by-stage updates from prescription check to hospital delivery.

Ahmedabad

The treating oncologist can send the prescription, biopsy and molecular test reports to start the import.

Vellore

Patients under care at hospitals in Vellore can have each cycle's vials sent directly to the hospital pharmacy.

Chandigarh

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

Lucknow

We coordinate delivery to public and private cancer hospitals across Uttar Pradesh.

Kochi

Patients across Kerala can receive their infusions 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.

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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