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Amdokitug

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Ready to proceed? Start a request for Amdokitug on our secure patient portal to submit your prescription, upload documents and track your approval status.

Amdokitug

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: Amdokitug
Generic Name (API): Amdokitug
Dosage Form & Strength: As per Chinese pack (trial doses 80 mg / 160 mg)
Route: Subcutaneous (SC) injection
Drug Class: Humanised anti-IL-17A IgG1 monoclonal antibody

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
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    Temperature-controlled logistics ensuring safe, reliable, and timely medicine delivery.

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What Is Amdokitug Used For?

Amdokitug is a biologic injection for adults with moderate-to-severe plaque psoriasis. It was developed in China by Sunshine Guojian Pharmaceutical (Shanghai), where it was known as SSGJ-608. In China it is sold as 益赛拓® (安沐奇塔单抗注射液).

China's National Medical Products Administration (NMPA) approved it in February 2026 for:

  • Adults with moderate-to-severe plaque psoriasis
  • Who are suitable for systemic therapy or phototherapy

It is a prescription immunology medicine and should be used under the care of a dermatologist.

How It Works

Interleukin-17A (IL-17A) is one of the main chemical messengers behind psoriasis. It drives the inflammation that makes skin cells grow too fast and build up into red, scaly plaques. Amdokitug is a humanised IgG1 monoclonal antibody that binds IL-17A very specifically and stops it from attaching to its receptor, which calms the inflammation in the skin.

What the Trials Showed

The pivotal phase 3 trial, published in the American Journal of Clinical Dermatology in 2026, included 458 adults in China. At week 12, 95.1% of patients on the every-2-weeks schedule and 93.4% on the every-4-weeks schedule had at least a 75% improvement in their psoriasis score (PASI 75), compared with 8.8% on placebo. Skin rated clear or almost clear was seen in 76.1% and 67.2% respectively, against 1.1% on placebo. At week 52, PASI 75 was maintained in 93.7% and 93.6% of patients in the two groups.

A second, larger phase 3 study of 770 patients compared the two starting schedules and found them similar: at week 12, 92.7% and 95.1% reached PASI 75, and close to half (49.4% and 47.5%) had completely clear skin (PASI 100). Good responses were also seen in people who had used an IL-17 medicine before.

Recommended Dosage

In the pivotal trial, two schedules were tested:

  • Schedule A: 160 mg under the skin at week 0, then 80 mg every 2 weeks up to week 12, followed by 80 mg every 4 weeks
  • Schedule B: 160 mg every 4 weeks up to week 12, followed by 160 mg every 8 weeks

Sunshine Guojian says the approved product allows maintenance every 4 or every 8 weeks. The exact dose and pack strength your dermatologist prescribes should follow the Chinese prescribing information supplied with the medicine.

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

Warnings and Precautions

Amdokitug acts on part of the immune system. In the 770-patient phase 3 study, side effects were mostly mild, serious adverse events occurred in 1.8% of patients and only 0.4% stopped treatment because of a side effect.

  • Infections: drug-related infections occurred in 6.0% to 7.6% of patients, mostly upper respiratory tract infections such as colds (2.6% to 3.1%). Tell your doctor about fever, persistent cough or any infection that does not clear up. Doctors usually screen for tuberculosis (TB) before starting an IL-17A biologic.
  • Blood tests: the most common changes were raised triglycerides (5.2%), raised uric acid (4.4%), raised liver enzyme ALT (4.3%) and raised cholesterol (3.6%). Your doctor may check these from time to time.
  • Injection-site reactions: redness or discomfort where the injection is given affected 2.9% of patients.
  • Bowel and fungal infections: no cases of inflammatory bowel disease or Candida (thrush) infection were reported in that study. Even so, tell your doctor if you have Crohn's disease or ulcerative colitis, or if you develop persistent diarrhoea, tummy pain or white patches in the mouth.
  • Antibodies to the drug: the company reports that only 0.7% of 1,292 psoriasis patients developed anti-drug antibodies, and none were neutralising.

Other points: stop and seek urgent help if you notice swelling of the face, a widespread rash or difficulty breathing after an injection. Check with your doctor before any vaccine, as live vaccines are generally avoided with this type of medicine. Safety in pregnancy, breastfeeding and children has not been established.

How to Access Amdokitug 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 Amdokitug 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
  • Medical records confirming moderate-to-severe plaque psoriasis and the treatments tried so far
  • 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 Amdokitug 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. Our Bimzelx and Sotyktu pages cover other psoriasis medicines we help import.

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 injections are stored and shipped as directed on the pack, using temperature-controlled shipping, and kept in their original box until use. Because the starting weeks need more frequent doses than maintenance, we plan each order around the prescribed 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.

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 in Delhi care for psoriasis patients from across North India, and our New Delhi dispatch point keeps delivery times short.

Mumbai

Injections can be delivered to the clinic or hospital where the patient is being treated.

Bangalore

Skin specialists in Bangalore can request the medicine for a named patient, with a written quote shared first.

Chennai

We plan the first deliveries around the closely spaced starting doses so treatment is not interrupted.

Hyderabad

Patients in Hyderabad can use the same documented import route, with updates at every stage.

Kolkata

Orders for Kolkata and the eastern states travel in temperature-controlled packaging.

Pune

Once maintenance begins, we help patients in Pune order ahead of each 4- or 8-weekly dose.

Ahmedabad

The treating dermatologist can send us the prescription and treatment history to start the import.

Jaipur

Patients across Rajasthan can have the medicine delivered to their dermatologist in Jaipur.

Chandigarh

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

Lucknow

We coordinate delivery to hospitals and skin clinics across Uttar Pradesh.

Kochi

Patients in Kerala can receive the medicine at their hospital or clinic 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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