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Recaticimab

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Recaticimab

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: Recaticimab
Generic Name (API): Recaticimab
Dosage Form & Strength: 150 mg
Route: Subcutaneous (SC) injection
Drug Class: PCSK9 inhibitor, humanised IgG1 monoclonal antibody (long-acting)

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
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What Is Recaticimab Used For?

Recaticimab is a long-acting cholesterol-lowering injection for adults whose "bad" LDL cholesterol stays too high. It was developed in China by Jiangsu Hengrui Pharmaceuticals and is licensed through its subsidiary, Guangdong Hengrui Pharmaceutical Co., Ltd., under the brand name 艾心安®. Its main selling point is how rarely it is needed: one injection under the skin every four or every eight weeks.

China's National Medical Products Administration (NMPA) approved it in January 2025, alongside a cholesterol-lowering diet, for adults with:

  • Primary hypercholesterolaemia (including heterozygous familial and non-familial forms) or mixed dyslipidaemia whose LDL cholesterol is still above target despite a moderate or higher dose of a statin. Here it is used together with the statin, with or without other lipid-lowering treatment.
  • Non-familial hypercholesterolaemia or mixed dyslipidaemia, used on its own, to lower LDL cholesterol, total cholesterol and apolipoprotein B (ApoB)

It is a prescription heart and cholesterol medicine and should be used under a cardiologist, endocrinologist or lipid specialist.

How It Works

The liver clears LDL cholesterol from the blood using LDL receptors. A protein called PCSK9 tags these receptors for destruction, so fewer are left to do the job. Recaticimab is a humanised monoclonal antibody that grabs PCSK9 and stops it binding to the receptors. More receptors survive, and more LDL cholesterol is pulled out of the blood. Its antibody tail has been engineered so the body recycles it for longer, which is why the doses can be spaced weeks apart.

What the Trials Showed

Three phase 3 trials in China, run by Hengrui with Chinese heart hospitals, support the approval:

  • REMAIN-2 (JACC, 2024): 689 people still above target on a statin. At 24 weeks, LDL cholesterol fell by 62.2%, 59.7% and 53.4% more than placebo with the every-4, every-8 and every-12-week schedules, and the effect held to week 48.
  • REMAIN-1 (JACC, 2024): 703 people at low-to-moderate heart risk, on diet alone. Used on its own, it lowered LDL cholesterol by 45.0% to 52.8% more than placebo.
  • REMAIN-3 (Cardiovascular Research, 2025): 143 people with heterozygous familial hypercholesterolaemia. LDL cholesterol fell by 54.4% at 12 weeks against 4.5% on placebo.

Non-HDL cholesterol, ApoB and lipoprotein(a) also improved. These trials measured changes in cholesterol levels, not heart attacks or strokes.

Recommended Dosage

The approved schedules in China are:

  • 150 mg as an injection under the skin every 4 weeks, or
  • 300 mg (two vials) under the skin every 8 weeks
  • Taken alongside a cholesterol-lowering diet, and with the statin where the doctor prescribes it

Each vial contains 150 mg of recaticimab. Your doctor will choose the schedule and check your lipid levels after a few weeks to see how well it is working.

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

Warnings and Precautions

Overall safety: in the trials, side effects were broadly similar to placebo. In REMAIN-2, treatment-related side effects were reported in 28.5% of people on recaticimab and 26.6% on placebo, and serious treatment-related events in 0.4% of each group.

  • Injection-site reactions: the most common side effect linked to the medicine, such as redness, pain or swelling where it was injected. They affected 4.9% over 24 weeks in REMAIN-1 and 8.4% (against 0% on placebo) in REMAIN-3.
  • Muscle enzyme (CK) rise: a raised creatine phosphokinase blood test was seen in 5.3% against 2.1% on placebo in REMAIN-3. Tell your doctor about unexplained muscle pain or weakness, especially if you also take a statin.
  • Antibodies to the medicine: some people form antibodies against it (18.6% in one analysis), but this did not reduce its cholesterol-lowering effect or change side-effect rates.
  • Allergy: as with any antibody medicine, seek urgent help for rash, swelling of the face or lips, or breathing difficulty after an injection.

Statin rules still apply: when used with a statin, the statin's own precautions continue, including liver and muscle checks. Information on use in pregnancy, breastfeeding and children was not available in the sources we reviewed, so discuss this with your doctor before starting.

How to Access Recaticimab 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 Recaticimab 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, endocrinologist or physician
  • A recent lipid profile and notes on current cholesterol treatment (for example, the statin and dose)
  • 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 Recaticimab 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. Because it is a long-term treatment, we can plan supply several doses at a time so there is no gap between injections.

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 vials are kept in their sealed original packs, stored as directed on the Chinese pack, and travel under temperature-controlled shipping. Each vial holds 150 mg, so one vial covers a 4-weekly dose and two vials cover an 8-weekly 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.

Availability Across Major Cities in India

Patients across India can access this medicine through regulated import pathways, with delivery arranged to the patient or the treating clinic on a valid specialist's prescription.

Delhi

Lipid and heart clinics in Delhi see patients from across North India, and our New Delhi dispatch point means short delivery times.

Mumbai

Cardiologists in Mumbai can request the medicine for a named patient, with supply planned around the 4- or 8-week schedule.

Bangalore

Patients in Bangalore can have the vials delivered to their clinic once the prescription and lipid report are checked.

Chennai

A long-standing centre for preventive cardiology in South India, used to managing imported medicines for individual patients.

Hyderabad

Doctors in Hyderabad can share the prescription and latest lipid profile with us to start the import.

Kolkata

For Kolkata and the eastern states, we time deliveries so the next dose arrives before it is due.

Pune

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

Ahmedabad

Specialists in Ahmedabad treating familial or hard-to-control high cholesterol can arrange access for a named patient.

Jaipur

Patients in Rajasthan can receive the medicine without travelling, as long as the import is in their name.

Chandigarh

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

Lucknow

We coordinate delivery for patients treated at public and private heart hospitals across Uttar Pradesh.

Kochi

Patients across Kerala can have their doses delivered to their 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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