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Ready to proceed? Start a request for Stapokibart on our secure patient portal to submit your prescription, upload documents and track your approval status.
Supplied with complete CDSCO-approved import and customs documentation, including Form 12A & 12B, CDEC, GST Bill of Entry, Commercial Invoice, and Packing List.
Manufacturer / Innovator:
China
Regulatory Approval:
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Stapokibart is an injectable antibody for allergic-type (type 2) inflammation of the skin and nose. It was developed in China by Keymed Biosciences and is sold there as 康悦达® (Kangyueda). It comes as a ready-to-use injection that is given under the skin once every two weeks.
China's National Medical Products Administration (NMPA) has approved it for:
It is a prescription immunology medicine and should be used only under a dermatologist, ENT specialist or allergist.
In eczema, nasal polyps and hay fever, two immune messengers called IL-4 and IL-13 keep the inflammation going. Both of them need the same "docking point" on cells, a receptor called IL-4Rα. Stapokibart is a humanised IgG4 antibody that sits on this receptor, so neither messenger can pass on its signal. Calming both signals at once reduces itch, skin inflammation, swelling of the nasal lining and allergy symptoms.
Eczema in adults: the phase 3 CM310AD005 trial enrolled 500 adults with moderate-to-severe atopic dermatitis. After 16 weeks, 66.9% of people on stapokibart had at least a 75% improvement in their eczema score (EASI-75), against 25.8% on placebo. Clear or almost clear skin (IGA 0/1) was reached by 44.2% versus 16.1%. With continued treatment to week 52, EASI-75 rose to 92.5%.
Eczema in teenagers: in a phase 3 study of 180 adolescents, 73.9% reached EASI-75 at week 18, compared with 43.3% on placebo.
Nasal polyps: in the CROWNS-2 trial (180 adults, published in JAMA in 2025), the nasal polyp score fell by 2.6 points with stapokibart against 0.3 points with placebo over 24 weeks, and nasal blockage also improved clearly.
Hay fever: in a phase 3 trial of 108 adults during pollen season (Nature Medicine, 2025), nasal symptoms improved significantly more than with placebo within two weeks, and eye symptoms and quality of life improved too.
According to the Chinese prescribing information:
It is injected under the skin of the tummy (avoiding 5 cm around the navel), thigh or upper arm, rotating the site each time. If eczema has not improved after 16 weeks, the doctor should consider stopping. A missed dose can be given within 7 days of the planned date; after that, give it as soon as possible and restart the two-weekly schedule. For adolescents, the dose is set by the treating specialist.
This information is not a treatment plan. For personalized medical advice, consult your doctor and refer to the full prescribing information.
Eye problems: conjunctivitis (red, sore or sticky eyes) is one of the most common side effects. In the 52-week eczema study it affected roughly 5% to 6% of people. Dry eye is also common, and inflammation of the eyelid or the clear front of the eye (blepharitis, keratitis) is uncommon. See an eye doctor if conjunctivitis does not settle with usual treatment, or if your vision is affected.
Overall: in the adult eczema trial, side effects during the first 16 weeks occurred at similar rates with stapokibart and placebo, and most were mild or moderate. It should not be used by anyone allergic to stapokibart or any ingredient in the injection.
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.
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. Each vial or pre-filled pen must be kept at 2°C to 8°C, protected from light and never frozen, so it travels under temperature-controlled shipping from the source to the hospital or patient. Because doses are given every two weeks, we plan supply a few doses at a time. 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.
Dermatologists and ENT surgeons in Delhi can request the injection for a named patient, and our New Delhi dispatch point keeps the cold-chain journey short.
Supplies are delivered in insulated packs so the two-weekly schedule is not interrupted.
Skin and allergy specialists in Bangalore can send the prescription and records to start the import.
Patients with long-standing eczema or nasal polyps can have doses delivered to their treating hospital.
We share a written quote and timeline before anything is ordered.
Shipments to Kolkata and the eastern states are routed to stay within 2°C to 8°C throughout.
Patients in Pune can use the same documented import route, with updates at each stage.
The treating specialist can share past treatment details so the import file is complete from day one.
Patients treated at hospitals in Vellore can have supplies sent directly to the hospital.
Serves patients from Punjab, Haryana and Himachal Pradesh, including those with seasonal pollen allergy.
We coordinate refrigerated delivery to public and private hospitals across Uttar Pradesh.
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.
Written By
Nitin GoswamiDeputy Manager – Content & Social Media, Ikris Pharma Network
Sources: NMPA • CDSCO
Last Updated: 19 October 2026
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