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Firsekibart

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Firsekibart

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Medicine Name: Firsekibart
Generic Name (API): Firsekibart
Dosage Form & Strength: 200 mg
Route: Subcutaneous (SC) injection
Drug Class: Fully human anti-IL-1β monoclonal antibody

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
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What Is Firsekibart Used For?

Firsekibart is an injection for painful gout flares in people who cannot use the usual flare treatments. It was developed in China by Changchun GeneScience Pharmaceutical (GenSci), is sold there as 金蓓欣® (Jinbeixin), and was earlier known as genakumab. A single injection under the skin both eases the flare and lowers the chance of the next one.

China's National Medical Products Administration (NMPA) first approved it in July 2025 as a powder for injection, and approved a ready-made 200 mg solution in April 2026. It is approved for adults with:

  • Acute gout flares (gouty arthritis) in whom NSAID painkillers and/or colchicine are not allowed, not tolerated or not effective
  • And for whom repeated courses of steroids are not suitable

It is a prescription immunology medicine and should be given under the care of a rheumatologist or a doctor experienced in treating gout.

How It Works

When urate crystals build up in a joint, the immune system releases a signal called interleukin-1β (IL-1β). It is the main driver of the sudden heat, swelling and severe pain of a gout attack. Firsekibart is a fully human monoclonal antibody that binds IL-1β and stops it from reaching its receptor, which switches off this inflammatory chain reaction. In the trials, its effect lasted well beyond the attack itself, which is why one injection also lowered the chance of new flares in the following weeks.

What the Trial Showed

The phase 3 trial, published in The Innovation in 2025, included 311 people with frequent gout flares who could not take standard flare treatments. They received either one 200 mg firsekibart injection or a steroid injection.

  • Pain relief: at 72 hours, pain in the affected joint fell by 57.1 mm on a 100 mm scale with firsekibart and by 53.8 mm with the steroid, so it worked at least as well.
  • Fewer new flares: over 12 weeks, the risk of a new flare was 90% lower with firsekibart (hazard ratio 0.10). Half of the steroid group had a new flare by day 45, while in the firsekibart group that point was never reached.
  • Longer follow-up: by week 48, 44.9% of the firsekibart group had another flare, compared with 74.8% of the steroid group.

Recommended Dosage

According to the Chinese prescribing information:

  • Dose: 200 mg (one vial of 1.33 mL) as a single injection under the skin
  • Where: upper thigh, abdomen, upper arm or buttock, choosing a different site each time and avoiding broken, bruised or scarred skin
  • Repeat doses: safety data cover 24 weeks, and the current data support a single dose only

Your doctor will decide whether and when it 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

Infections: blocking IL-1β can raise the risk of infections, including serious ones. People with an active infection, repeated infections or a high infection risk should only use it with care. It is not recommended together with TNF-blocking medicines, because that may increase the risk of serious infection.

  • Tuberculosis: there are no safety data in people with TB. The label advises checking for active and latent TB before treatment (for example a skin test, T-SPOT or chest imaging) and watching for persistent cough, weight loss or low fever afterwards.
  • Vaccines: avoid live or live-attenuated vaccines while on treatment, and vaccines may work less well.
  • Blood fats: the most common side effect was raised triglycerides, seen in 24.0% of patients against 17.2% with the steroid, followed by raised cholesterol (8.6% against 7.5%). Triglycerides rose above five times the upper normal limit in 7.4% of patients.
  • Liver tests: ALT rose in 6.3% and AST in 5.7%. Rises above three times the normal limit were uncommon (1.9% and 0.6%), and none above five times were seen.
  • Other: upper respiratory infection (2.0%), raised bilirubin (2.6%) and raised creatinine (2.3%) were also reported.

Who should not use it: anyone allergic to firsekibart or any ingredient. There are no data in pregnancy or breastfeeding, and animal studies show it crosses the placenta, so it should be used with caution or avoided. It is not established for under-18s. In mild liver problems and mild to moderate kidney problems no dose change is needed, though experience is limited.

How to Access Firsekibart 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 Firsekibart 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 rheumatologist or treating physician
  • Medical notes confirming gout (for example serum uric acid and joint findings), the flare history and why NSAIDs, colchicine or repeated steroids cannot be used
  • 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 Firsekibart 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. Our pages on Ilaris and Kineret cover other IL-1 blocking medicines we can help import.

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 must be kept at 2°C to 8°C and protected from light, so they travel under temperature-controlled shipping all the way to the clinic or hospital. Because a gout flare needs treatment quickly, we share realistic delivery times with the quote so your doctor can plan. 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 treating clinic or hospital on a valid doctor's prescription.

Delhi

Rheumatology clinics here see many people with hard-to-treat gout, and our New Delhi dispatch point keeps the cold-chain journey short.

Mumbai

The refrigerated vial is delivered straight to the treating clinic or hospital pharmacy.

Bangalore

Rheumatologists in Bangalore can request the injection for a named patient, with the quote shared before anything is ordered.

Chennai

A key referral centre in South India for complex arthritis, used to handling refrigerated imported biologics.

Hyderabad

We confirm the delivery date with the treating doctor so the injection can be given without delay.

Kolkata

Shipments to Kolkata and the eastern states are routed to stay within 2°C to 8°C throughout.

Pune

Patients in Pune can use the same documented import route, with updates at each stage.

Ahmedabad

The treating doctor can send us the prescription and notes on past flare treatments to begin the import.

Jaipur

Patients in Rajasthan can have the vial delivered to their doctor's clinic under cold-chain conditions.

Chandigarh

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

Lucknow

We coordinate refrigerated delivery to public and private hospitals across Uttar Pradesh.

Kochi

Patients across Kerala can receive the injection at 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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