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Vunakizumab

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Vunakizumab

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: Vunakizumab
Generic Name (API): Vunakizumab
Dosage Form & Strength: 120 mg/1 mL
Route: Subcutaneous (SC) injection
Drug Class: Anti-IL-17A humanised monoclonal antibody

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
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What Is Vunakizumab Used For?

Vunakizumab is an injectable antibody for psoriasis and ankylosing spondylitis. It was developed in China by Jiangsu Hengrui Pharmaceuticals and is made by its subsidiary Suzhou Suncadia Biopharmaceuticals. In China it is sold as 安达静® and is injected under the skin.

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

  • Moderate-to-severe plaque psoriasis who are suitable for systemic treatment or phototherapy (approved August 2024)
  • Active ankylosing spondylitis that has not responded well enough to conventional treatment (approved April 2025)

It is a prescription immunology medicine and should be used only under a dermatologist or rheumatologist.

How It Works

IL-17A is an immune messenger that drives the fast skin-cell growth and redness of psoriasis, and the inflammation in the spine and tendons in ankylosing spondylitis. Vunakizumab is a humanised monoclonal antibody that binds IL-17A and stops it from reaching its receptor, which calms the inflammation at its source. It stays in the body for a long time (a half-life of about 24 days), and after the starting doses it is given once every four weeks.

What the Trials Showed

Psoriasis: the phase 3 trial, published in the Journal of the American Academy of Dermatology in 2025, included 690 adults with moderate-to-severe plaque psoriasis. After 12 weeks, 76.8% of people on vunakizumab had at least 90% clearer skin (PASI 90), against 0.9% on placebo. 93.6% reached PASI 75 and 36.6% had completely clear skin (PASI 100). The benefit held through week 52.

Ankylosing spondylitis: in a phase 2/3 trial of 548 adults (JAMA Network Open, 2026), 65.6% of people on vunakizumab 120 mg reached the ASAS20 response at week 16, compared with 42.5% on placebo, and 46.3% versus 24.0% reached the stricter ASAS40. Responses lasted to week 32.

Recommended Dosage

Each pre-filled pen or syringe holds 120 mg in 1 mL. The regimens used in the trials and described in the published literature are:

  • Plaque psoriasis: 240 mg (two 120 mg injections) at weeks 0, 2, 4 and 8, then 240 mg every 4 weeks
  • Ankylosing spondylitis: 120 mg at weeks 0, 2 and 4, then 120 mg every 4 weeks

Your specialist will confirm the exact schedule from the current Chinese prescribing information and decide how long to continue.

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

Warnings and Precautions

Blood tests: in the psoriasis trial, the most common changes were in blood chemistry. Over 52 weeks, raised uric acid (hyperuricaemia) was seen in 18.9% of patients, high blood fats in 13.3%, high triglycerides in 9.8% and a rise in the liver enzyme ALT in 11.1%. Your doctor may check uric acid, lipids and liver tests from time to time, especially if you have gout, diabetes or a fatty liver.

  • Infections: upper respiratory infections (colds, sore throat) were common, affecting 22.0% of patients over 52 weeks. Because this medicine works on the immune system, tell your doctor about any current infection or past tuberculosis before you start, and report fever or a persistent cough.
  • Injection-site reactions: redness or soreness where the injection was given affected 10.9% over 52 weeks and was usually mild.
  • Bowel symptoms: a published case report described severe ulcerative colitis during treatment. Report ongoing diarrhoea, blood in the stool or tummy pain promptly, and tell your doctor if you have inflammatory bowel disease.
  • Pregnancy and breastfeeding: there is no published safety information in pregnancy or breastfeeding, so discuss this with your doctor before starting.

Overall: during the first 12 weeks of the psoriasis trial, side effects were about as frequent as with placebo (69.1% vs 71.6%). Severe side effects occurred in 1.5% and only 0.7% stopped treatment because of them. Over 52 weeks, 2.2% stopped because of side effects.

How to Access Vunakizumab 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 Vunakizumab 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 dermatologist or rheumatologist
  • Medical records confirming the diagnosis (plaque psoriasis or ankylosing spondylitis) and the treatments already tried
  • 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 Vunakizumab available in India?

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 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 another psoriasis medicine we can import, see our page on Bimzelx.

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 as directed on the pack, using temperature-controlled shipping all the way to the hospital or patient. Because the starting doses come close together, we plan the first order to cover the loading phase. 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 or clinic on a valid specialist's prescription.

Delhi

Dermatologists and rheumatologists in Delhi can request the injection for a named patient, with dispatch from our New Delhi base.

Mumbai

The first order is timed so the closely spaced starting doses arrive together.

Bangalore

Specialists in Bangalore can send the prescription and treatment history to begin the import.

Chennai

Patients with long-standing psoriasis can have supplies delivered to their treating hospital.

Hyderabad

We share a written quote and delivery timeline before anything is ordered.

Kolkata

Shipments to Kolkata and the eastern states are handled under controlled conditions throughout.

Pune

Patients with ankylosing spondylitis in Pune can use the same documented import route.

Ahmedabad

The treating doctor can share earlier treatment details so the import file is complete from the start.

Vellore

Patients treated at hospitals in Vellore can have monthly supplies sent directly to the hospital.

Chandigarh

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

Lucknow

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

Kochi

Patients across Kerala can receive the injection 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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