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Ongericimab

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Ongericimab

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: Ongericimab
Generic Name (API): Ongericimab
Dosage Form & Strength: 150 mg/1 mL
Route: Subcutaneous (SC) injection
Drug Class: Anti-PCSK9 monoclonal antibody (humanised IgG1)

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
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What Is Ongericimab Used For?

Ongericimab is a cholesterol-lowering antibody injection for adults with high LDL ("bad") cholesterol. It was developed in China by Shanghai Junshi Biosciences and is sold there as JUNSHIDA® (君适达®). Junshi says it was the first Chinese-developed PCSK9 medicine approved for people who cannot take statins.

China's National Medical Products Administration (NMPA) first approved it in October 2024 and added two more uses in May 2025. Alongside a healthy diet, it is approved for adults with:

  • Primary (non-familial) hypercholesterolaemia or mixed dyslipidaemia whose LDL is still above target on a moderate or higher dose of a statin, used together with the statin (with or without one more cholesterol-lowering tablet)
  • Heterozygous familial hypercholesterolaemia, the inherited form of high cholesterol
  • Non-familial hypercholesterolaemia or mixed dyslipidaemia in people who cannot tolerate statins, or should not take them, used on its own or with one non-statin cholesterol tablet

It is a prescription heart and cholesterol medicine and should be started and followed up by a cardiologist or lipid specialist.

How It Works

The liver pulls LDL cholesterol out of the blood using LDL receptors. A protein called PCSK9 latches on to these receptors and has them destroyed. Ongericimab is a lab-made humanised antibody (IgG1 type) that binds PCSK9 and keeps it away from the receptors. More receptors stay on the liver cells to clear LDL, so blood levels drop.

What the Trials Showed

All the main trials were randomised, double-blind and compared with placebo:

  • JS002-003 (806 patients with primary high cholesterol or mixed dyslipidaemia, published in the Journal of the American Heart Association, 2024): LDL cholesterol fell by more than 60% compared with placebo, and the effect held over 52 weeks.
  • JS002-006 (255 patients, 12 weeks): LDL fell by 72.7% more than placebo with the pre-filled syringe and 71.1% with the autoinjector pen.
  • JS002-005 (135 adults with inherited high cholesterol, 24 weeks, published in Atherosclerosis): LDL fell by 69.4% more than placebo with 150 mg every 2 weeks and 80.6% with 450 mg every 4 weeks, and lipoprotein(a) fell by 50% from baseline.

Non-HDL cholesterol, apolipoprotein B and total cholesterol also came down. These trials measured cholesterol levels rather than heart attacks or strokes.

Recommended Dosage

Ongericimab is injected under the skin. Each pre-filled syringe or autoinjector pen holds 150 mg in 1 mL. The schedules used in the trials were:

  • 150 mg once every 2 weeks (one injection)
  • 300 mg once every 4 weeks in the main JS002-003 trial
  • 450 mg once every 4 weeks in the inherited-cholesterol trial

The exact approved schedule for each use is in the Chinese prescribing information, and your cardiologist decides which one is right for you.

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

Warnings and Precautions

Side effects: Junshi reports no new safety signals in the main JS002-003 trial, and in the inherited-cholesterol trial side effects were about as common as with placebo. Detailed side-effect percentages had not been published in the sources we reviewed, so your doctor will go through the full list in the Chinese prescribing information.

  • Injection site: as with any injection under the skin, check the area afterwards and tell your doctor about redness, pain or swelling that does not settle.
  • Allergy: seek medical help straight away if you notice a rash, swelling of the face or lips, or trouble breathing after a dose.
  • Other treatment: if your doctor has prescribed it together with a statin, keep taking the statin. Stopping it on your own can let cholesterol rise again.
  • Follow-up: regular lipid tests show how well the treatment 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.

How to Access Ongericimab 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 Ongericimab 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 cardiologist or physician
  • Recent lipid profile reports and a note of current cholesterol treatment, or of statin intolerance where that applies
  • 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 Ongericimab available in India?

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.

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.

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 pre-filled syringes or pens are stored and shipped exactly as directed on the Chinese pack, using temperature-controlled shipping to the patient or hospital. Each device holds one 150 mg dose, so we work out the number needed from the schedule your doctor prescribes. 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 patient or treating hospital on a valid doctor's prescription.

Delhi

Delhi's cardiology centres treat many people with inherited or hard-to-control cholesterol, and our New Delhi base keeps delivery quick.

Mumbai

Doctors in Mumbai can request the pens or syringes for a named patient, with the full cost shared in writing first.

Bangalore

Patients in Bangalore can receive each supply at home or at the clinic managing their cholesterol.

Chennai

Lipid and heart clinics in Chennai can arrange access for patients who cannot take statins or whose LDL stays high.

Hyderabad

We match the number of devices in each shipment to the dosing schedule the doctor has set.

Kolkata

Shipments to Kolkata and eastern India are packed to keep within the conditions printed on the pack.

Pune

Patients in Pune use the same documented import route, with updates shared at each step.

Ahmedabad

A cardiologist in Ahmedabad can send us the prescription and lipid reports to start the process.

Jaipur

Patients across Rajasthan can be supplied without travelling, once the import is cleared in their name.

Chandigarh

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

Lucknow

We coordinate delivery for patients seen by cardiologists in public and private hospitals across Uttar Pradesh.

Kochi

Patients in Kerala can have their supply delivered 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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