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Sourced directly from the authorized manufacturer network to ensure authenticity and quality.
Ready to proceed? Start a request for Tafolecimab 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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Tafolecimab is a cholesterol-lowering injection for adults whose "bad" LDL cholesterol stays too high even though they already take a statin. It was developed in China by Innovent Biologics and is sold there as SINTBILO® (信必乐®). It was the first PCSK9 antibody developed in China to be approved there.
China's National Medical Products Administration (NMPA) approved it in August 2023, alongside a healthy diet, for adults with:
It is a prescription heart and cholesterol medicine and should be started and followed up by a cardiologist or lipid specialist.
The liver clears LDL cholesterol from the blood using LDL receptors on its cells. A protein called PCSK9 tags these receptors for destruction, so fewer are left to do the job. Tafolecimab is a fully human antibody (IgG2 type) that grabs PCSK9 and stops it working. More receptors survive, and more LDL cholesterol is pulled out of the blood.
Approval rested on three phase 3 trials in Chinese patients, CREDIT-1, CREDIT-2 and CREDIT-4, each compared with placebo:
Total cholesterol, non-HDL cholesterol, apolipoprotein B and lipoprotein(a) also came down. These trials measured cholesterol levels; they were not designed to show fewer heart attacks or strokes.
Three dosing schedules are approved in China, all given as an injection under the skin:
The marketed product is 150 mg in 1 mL, so the longer schedules use several 150 mg doses on the same day. The statin and diet carry on as before. Your cardiologist chooses the schedule that suits you.
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 a pooled safety analysis of 1,091 patients treated with tafolecimab, the side effects reported during the placebo-controlled phase were:
Uric acid: in the 48-week CREDIT-1 trial, raised uric acid (hyperuricaemia) was also one of the more common findings, so your doctor may check it, especially if you have had gout.
Keep up your other treatment: tafolecimab is an add-on. Stopping your statin or diet changes without your doctor's advice can let cholesterol rise again. 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, it is not sold in Indian pharmacies, and Innovent states it is not approved in the United States.
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. It is a protein medicine, so it is kept and shipped exactly as directed on the Chinese pack, using temperature-controlled shipping all the way to the patient or hospital. Because it is a long-term treatment, we can plan supply a few months at a time to 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.
Large cardiology centres here see patients with stubborn high cholesterol from across North India, and our New Delhi dispatch point keeps transit time short.
Cardiologists in Mumbai can request the injection for a named patient, with a written quote shared before anything is ordered.
Patients in Bangalore can have each supply delivered to their home or to the clinic that manages their lipids.
A major centre for heart care in South India, where families with inherited high cholesterol are often looked after.
We time deliveries to the dosing schedule, whether the doctor has chosen every 2, 4 or 6 weeks.
Shipments to Kolkata and the eastern states are packed to stay within the conditions printed on the pack.
Patients in Pune can use the same documented import route, with updates shared at each step.
The treating cardiologist can send us the prescription and lipid reports to begin the import.
Patients in Rajasthan can receive the medicine without travelling, as long as the import is in their name.
Serves patients from Punjab, Haryana and Himachal Pradesh, with delivery to the patient or treating hospital.
We coordinate delivery for patients followed at public and private heart hospitals across Uttar Pradesh.
Patients across Kerala can receive their supply at home or at their cardiology 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.
Written By
Nitin GoswamiDeputy Manager – Content & Social Media, Ikris Pharma Network
Sources: NMPA • CDSCO
Last Updated: 19 October 2026
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