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Manufacturer / Innovator:
China
Regulatory Approval:
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Ebdarokimab is a biologic injection for adults with moderate-to-severe plaque psoriasis. It was developed in China by Akeso and is sold there under the brand name 爱达罗® (Aidaluo). After two starting doses, it is given just once every 12 weeks, which works out to four injections a year.
China's National Medical Products Administration (NMPA) approved it in April 2025 for adults with:
It is a prescription immunology medicine and should be started and supervised by a dermatologist experienced in treating psoriasis.
In psoriasis, the immune system sends out too many inflammatory signals that make skin cells grow far too fast, which builds up the thick, scaly plaques. Two of the key signals, interleukin-12 and interleukin-23, share a common piece called p40. Ebdarokimab is a fully human monoclonal antibody that latches on to this shared p40 piece, so both signals are blocked at once. This calms the overactive immune response that drives the plaques.
Approval was based on two pivotal phase 3 studies in Chinese adults. In AK101-302, 450 people were randomly given ebdarokimab or a placebo injection. By week 16, 79.4% of those on ebdarokimab had at least a 75% improvement in their psoriasis score (PASI 75), against 16.5% on placebo. About half (51.8%) reached PASI 90, meaning near-clear skin, compared with 7.7%, and 64% were rated clear or almost clear by their doctor, against 11.7%.
The follow-on AK101-303 study (950 people) looked at long-term use. Among those who carried on from the first study, 77.9% still had a PASI 75 response at week 52 on the every-12-weeks schedule. Quality of life improved too: the average skin-related quality-of-life score (DLQI) at week 16 was 5.6 with ebdarokimab against 12.5 with placebo, where lower is better.
According to the Chinese prescribing information:
Take the syringe out of the fridge at least 30 minutes before the injection so it reaches room temperature, and use it within 8 hours. Do not warm it any other way. Your dermatologist decides how long treatment should continue.
This information is not a treatment plan. For personalized medical advice, consult your doctor and refer to the full prescribing information.
Do not use if you are allergic to ebdarokimab or any of its ingredients, or if you have a clinically important active infection such as active tuberculosis (TB).
Side effects: in the 1,404 patients treated, each side effect occurred in fewer than 5%, and most were mild. The most frequent were raised bilirubin in blood tests (4.7%), hives (2.0%), eczema (1.2%) and dermatitis (0.9%). In the 12-week placebo-controlled phase, any adverse event happened in 53.2% on ebdarokimab against 61.2% on placebo.
Pregnancy and children: it is best avoided in pregnancy, and women who could become pregnant should use effective contraception during treatment and for at least 120 days after the last dose. Safety and effectiveness in people under 18 have 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 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. You can also read about other psoriasis medicines we help import, such as Bimzelx and Sotyktu.
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 pre-filled syringes must be kept at 2°C to 8°C, away from light and never frozen, so they travel under temperature-controlled shipping all the way to the patient or hospital. Since a year of maintenance needs only four syringes, orders are usually planned dose by dose. 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 or clinic on a valid specialist's prescription.
Dermatology departments in Delhi see psoriasis patients from across North India, and our New Delhi dispatch point keeps the cold-chain journey short.
Syringes can be delivered to the clinic or hospital where the dermatologist gives the injection.
Dermatologists in Bangalore can request the medicine for a named patient, with a written quote shared before anything is ordered.
We arrange refrigerated delivery so each dose arrives in time for the week 0, week 4 and 12-weekly schedule.
Patients in Hyderabad can use the same documented import route, with updates at every stage.
Shipments to Kolkata and the eastern states are packed to stay between 2°C and 8°C throughout transit.
Because doses are 12 weeks apart, we help patients in Pune plan each order well ahead of the due date.
The treating dermatologist can send us the prescription and treatment history to start the import process.
Patients in Rajasthan can have the syringe delivered to their dermatologist's clinic or hospital in Jaipur.
Serves patients from Punjab, Haryana and Himachal Pradesh, with cold-chain delivery to the treating centre.
We coordinate refrigerated delivery to hospitals and skin clinics 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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