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Velaglucerase Beta

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Velaglucerase Beta

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: Velaglucerase Beta
Generic Name (API): Velaglucerase beta
Dosage Form & Strength: 400 U
Route: Intravenous (IV) infusion
Drug Class: Enzyme replacement therapy (recombinant human glucocerebrosidase)

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
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What Is Velaglucerase Beta Used For?

Velaglucerase beta is an enzyme replacement therapy (ERT) for Gaucher disease, a rare inherited condition. It was developed in China by CANbridge Pharmaceuticals, in partnership with WuXi Biologics, and is sold there as 戈芮宁® (Gaurunning). In research it was called CAN103.

China's National Medical Products Administration (NMPA) approved it on 15 May 2025, through priority review, for:

  • Long-term enzyme replacement therapy in adolescents aged 12 and over and adults with type I or type III Gaucher disease

It is the first enzyme replacement therapy for Gaucher disease developed within China. It is a prescription rare disease medicine and should be managed by a specialist experienced in Gaucher disease.

How It Works

People with Gaucher disease lack enough of an enzyme called glucocerebrosidase. Without it, a fatty substance builds up inside cells of the spleen, liver and bone marrow. This causes a swollen spleen and liver, anaemia, low platelets and bone problems, and in type III the brain is also affected. Velaglucerase beta is a lab-made version of the human enzyme. Given as a drip, it tops up the missing enzyme so the cells can clear the build-up.

What the Trial Showed

The approval is based on a phase 1/2 programme in China that included a randomised, double-blind comparison of two doses in people not treated before, followed by an extension. Peking Union Medical College Hospital led the study, which enrolled 35 patients.

  • Spleen size: the main goal, the average shrinking of the spleen after nine months, was met at both doses tested (60 U/kg and 30 U/kg), with clear statistical significance.
  • Dose effect: the benefit was larger with the higher dose. Patients on 60 U/kg, both children and adults, showed clear improvement in their symptoms, and the benefit lasted with ongoing treatment.

Recommended Dosage

Each vial contains 400 units of freeze-dried powder, which is made up and given as a drip into a vein. In the pivotal trial, patients received 60 U/kg or 30 U/kg every other week. As an example, at 60 U/kg a 50 kg patient would need 3,000 units, or 7.5 vials, per infusion. Treatment is long term. Your specialist sets the dose according to the Chinese prescribing information and your response.

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

Warnings and Precautions

Published safety data are limited. The full list of side effects, contraindications and precautions is in the Chinese package leaflet, and your doctor will go through it with you before treatment starts.

  • Tolerability in the trial: the study team reported good safety and tolerability across all doses, with up to two years of data, and side effects did not become more frequent at higher doses.
  • Infusion setting: because it is a protein given into a vein, it should be given in a hospital or day-care unit where staff can watch for and manage any infusion or allergic reaction.
  • Age: it is approved from the age of 12. A separate trial in younger children is still under way.
  • Monitoring: spleen and liver size, blood counts and bone health are usually followed over time to check that treatment is working.

Overall: report any new or unusual symptom to your treating team. Safety in pregnancy and breastfeeding should be discussed with your specialist.

How to Access Velaglucerase Beta 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 Velaglucerase Beta to India?

The vials 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 specialist (haematologist, paediatrician or metabolic specialist)
  • Diagnostic reports confirming Gaucher disease (enzyme or genetic test), with the type and body weight
  • 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 Velaglucerase Beta 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. For other lysosomal storage disorder medicines we can import, see our pages on Zavesca and Vimizim.

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 stored as directed on the pack and travel under temperature-controlled shipping to the hospital giving the infusion. Because treatment is every other week, we plan supplies a few infusions ahead so there are no missed doses. 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 hospital on a valid specialist's prescription.

Delhi

Specialist centres here look after rare metabolic disorders, and our New Delhi dispatch point keeps transit short.

Mumbai

Vials are delivered to the hospital or day-care unit in time for each fortnightly infusion.

Bangalore

Doctors treating Gaucher disease in Bangalore can send a named-patient request, with the quote shared before ordering.

Chennai

Hospitals with experience in long-term enzyme infusions can receive regular supplies directly.

Hyderabad

We schedule deliveries around the every-other-week infusion calendar.

Kolkata

Shipments to Kolkata and the eastern states follow the storage conditions on the pack throughout.

Pune

The treating specialist can share the diagnosis and weight with us so the right number of vials is ordered.

Ahmedabad

Families in Ahmedabad receive updates at each step of the import.

Vellore

Patients treated at hospitals in Vellore can have each supply delivered to the hospital pharmacy.

Chandigarh

Serves patients from Punjab, Haryana and Himachal Pradesh under specialist care.

Lucknow

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

Kochi

Patients across Kerala can receive their infusions with supplies delivered to hospitals 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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