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Sourced directly from the authorized manufacturer network to ensure authenticity and quality.
Ready to proceed? Start a request for Ebronucimab 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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Ebronucimab is a cholesterol-lowering antibody injection for adults whose LDL ("bad") cholesterol stays above target even on a statin. It was developed in China by AD Pharmaceuticals, a joint venture of Akeso and Dawnrays, and is sold there as 伊喜宁®. It is Akeso's first medicine outside cancer.
China's National Medical Products Administration (NMPA) approved it in September 2024 for adults with:
It is a prescription heart and cholesterol medicine and should be started and monitored by a cardiologist or lipid specialist.
LDL cholesterol is removed from the blood by LDL receptors on liver cells. A protein called PCSK9 makes the liver break these receptors down. Ebronucimab is a fully human antibody (IgG1 type) that binds PCSK9 and stops it attaching to the receptors. More receptors stay on the liver cells, so more LDL is cleared and blood levels fall.
The approval was based on four pivotal trials: three in primary high cholesterol and mixed dyslipidaemia, and one in the inherited form. The main phase 3 trial, published in Pharmacological Research in 2024, included 461 Chinese adults with primary hypercholesterolaemia (including the inherited form) or mixed dyslipidaemia, compared with placebo:
Akeso reports that the effect seen at 12 weeks was kept up over 52 weeks of treatment, and that total cholesterol, non-HDL cholesterol and apolipoprotein B fell while HDL ("good") cholesterol rose. These trials measured cholesterol levels rather than heart attacks or strokes.
The Chinese prescribing information gives two schedules. The doctor and patient choose between them based on how often the patient prefers to inject:
Each pen or syringe holds 150 mg in 1.5 mL. If a dose is missed, the label allows it to be given up to 7 days late and the usual schedule then continues. If it is more than 7 days late, the dose is given as soon as possible and a new schedule starts from that date. The medicine is used on top of the statin, with a healthy diet.
This information is not a treatment plan. For personalized medical advice, consult your doctor and refer to the full prescribing information.
Common side effects: in the phase 3 trial, the side effects reported most often during the placebo-controlled period were:
From the Chinese label: the most common side effects (in 2% or more of patients) were injection site reactions, upper respiratory tract infections and raised uric acid. Allergic reactions, such as rash, eczema, itching and, rarely, hives, have been reported. If a serious allergic reaction occurs, the medicine must be stopped and treated. People allergic to ebronucimab or any ingredient in the injection must not use it.
Overall safety: the trial authors describe a favourable safety profile, including immunogenicity (the body making antibodies against the medicine). Akeso reports no safety signals in older patients.
Keep up your other treatment: ebronucimab is added to a statin, not used in place of it. Do not stop your statin or change your diet without asking your doctor. Regular lipid tests show how well it is working.
Before you start: tell your cardiologist about every medicine you take, any allergy to antibody medicines, and whether you are pregnant, planning a pregnancy or breastfeeding. The sources we reviewed did not include safety data for pregnancy, breastfeeding or children, so your doctor will go through the Chinese prescribing information with you.
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 and is not sold in Indian pharmacies, and we found no US FDA or European approval.
In China it is approved under drug approval numbers 国药准字S20240041 and S20240042.
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 see how we handle other imported heart medicines, such as Camzyos.
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. As an antibody medicine, it is stored and shipped exactly as directed on the Chinese pack, using temperature-controlled shipping through to the patient or hospital. Since treatment is long term, supply can be planned in blocks that match the dosing 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.
Patients across India can access this medicine through regulated import pathways, with delivery arranged to the patient or treating hospital on a valid doctor's prescription.
Many patients with hard-to-control cholesterol are treated at Delhi's heart centres, and dispatch from New Delhi keeps the journey short.
A cardiologist in Mumbai can send the prescription and lipid reports, and we share a written quote before ordering.
Supplies can be delivered to the patient's home or straight to the treating clinic in Bangalore.
Lipid clinics in Chennai that follow families with inherited high cholesterol can request the medicine for a named patient.
We plan each shipment around the dose interval the doctor has chosen, so there is no gap between injections.
Deliveries to Kolkata and the eastern states are packed to keep the medicine within the conditions on the pack.
Patients in Pune follow the same documented import route, with updates at every stage.
Doctors in Ahmedabad can start the import by sharing the prescription and recent test results.
Patients across Rajasthan can receive the medicine without travelling, once the import is approved in their name.
Covers patients from Punjab, Haryana and Himachal Pradesh, with delivery to the patient or treating hospital.
We arrange delivery for patients under the care of cardiologists in public and private hospitals across Uttar Pradesh.
Patients in Kerala can receive their supply in Kochi or nearby cities, at home or at their clinic.
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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