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Albipagrastim Alfa

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Albipagrastim Alfa

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: Albipagrastim Alfa
Generic Name (API): Albipagrastim alfa
Dosage Form & Strength: 20 mg
Route: Subcutaneous (SC) injection
Drug Class: Long-acting G-CSF, human serum albumin fusion protein

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
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What Is Albipagrastim Alfa Used For?

Albipagrastim alfa is a long-acting white blood cell booster for adults having chemotherapy. Strong chemotherapy often pushes neutrophils, the white cells that fight bacteria, down to very low levels, and a fever at that point can mean a serious infection. This medicine helps the bone marrow make neutrophils faster, with one injection under the skin in each chemotherapy cycle. It was developed by T-mab, a wholly owned subsidiary of Mabwell in Shanghai, and is sold in China as 迈粒生® (Mailisheng). Qilu Pharmaceutical holds the rights for Greater China and is named as the marketing authorisation holder on the current pack.

China's National Medical Products Administration (NMPA) approved it in May 2025 (approval number 国药准字 S20250021) for:

  • Adults with non-myeloid cancers (cancers that do not start in the bone marrow's myeloid cells)
  • Who are receiving myelosuppressive anti-cancer treatment that is likely to cause febrile neutropenia
  • To lower the rate of infection, seen as febrile neutropenia (fever with a low neutrophil count)

It is a prescription cancer supportive-care medicine and should be used only under an oncologist.

How It Works

G-CSF (granulocyte colony-stimulating factor) is the natural signal that tells the bone marrow to produce and release neutrophils. In this medicine, a highly active, modified G-CSF is fused to human serum albumin, the most common protein in our blood. The larger molecule is cleared from the body more slowly, so one dose lasts through a cycle; in breast cancer patients its half-life was about 34.8 hours. Because albumin is a natural body protein, no chemical PEG coating is needed, and it is made in yeast cells. Mabwell says it is the first albumin-fusion G-CSF to reach the market in China.

What the Trial Showed

The approval rests on a phase 3, double-blind trial in China, published in Breast Cancer Research in 2025. It included 496 women with breast cancer having TC or TAC chemotherapy, randomised 2:1 to this medicine or an established long-acting G-CSF.

  • Main goal met: in cycle 1, severe (grade 4) neutropenia lasted on average 0.24 days, against 0.25 days with the comparison medicine
  • Fewer severe drops later on: grade 4 neutropenia in cycle 2 affected 3.0% of patients, compared with 9.8%
  • Febrile neutropenia: low in both groups across all cycles (2.1% vs 3.7%, not a significant difference)

Recommended Dosage

According to the Chinese prescribing information:

  • Dose: 500 µg per kg of body weight, as a single injection under the skin
  • Timing: on day 3 after the chemotherapy drugs of that cycle have finished, once per chemotherapy cycle
  • Do not give it in the 14 days before cytotoxic chemotherapy or within 24 hours after it

Preparing the Injection

Each vial holds 20 mg of freeze-dried powder. The label says to add 1 mL of water for injection slowly down the side of the vial and swirl gently until it dissolves, without shaking hard. The solution should be clear and colourless to slightly yellow; do not use it if it has particles or has changed colour. If it is not used straight away, the made-up solution can be kept in a fridge at 2–8°C, away from sunlight, for up to 24 hours, and should be thrown away after that. Taking it out of the fridge 15–30 minutes before the injection makes it more comfortable.

Your oncologist works out the number of vials from your body weight and sets the exact plan.

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 in the trial: drug-related side effects were seen in 48.5% of patients, almost the same as with the comparison medicine (48.8%), and were mostly mild (grade 1–2). Only 2.7% had a severe (grade 3 or higher) drug-related side effect.

  • Most common: tiredness or weakness (18.0%) and bone pain (12.5%)
  • Also seen: raised liver enzymes ALT (9.5%) and AST (6.1%), general pain (8.2%) and nausea (7.6%)
  • Serious drug-related side effects: 1.1%, against 2.4% with the comparison medicine. The one death in the trial was caused by the cancer spreading to the brain and was not linked to the study drug.
  • Antibodies: the prescribing information reports that 61 of 320 people tested (19.1%) developed antibodies to the drug after treatment, with no neutralising antibodies, and no effect on how it works or on safety was found.

The prescribing information lists tiredness and bone pain as the side effects seen in 10% or more of people in clinical studies. In healthy volunteers, a rise in monocyte count, muscle tiredness and nosebleeds were also seen.

Rare risks of G-CSF medicines: the investigators specifically watched for spleen rupture, acute breathing problems and severe allergic reactions, which are known with this group of medicines. None were seen, but the trial was too small to rule them out. Report pain in the upper left belly or shoulder tip, breathlessness, or swelling and rash straight away.

The trial included only Chinese women with breast cancer. Safety in pregnancy, breastfeeding and children has not been established, and full contraindications should be checked in the pack leaflet.

How to Access Albipagrastim Alfa 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 Albipagrastim Alfa 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 medical oncologist
  • Diagnostic reports confirming the cancer, with the planned chemotherapy regimen, number of cycles and current 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 Albipagrastim Alfa 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 another long-acting option given once per chemotherapy cycle, see our page on Ryzneuta.

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. In Greater China, Mabwell has licensed Qilu Pharmaceutical to make and sell it, so we work through that authorised chain. The vials are stored and shipped exactly as directed on the pack, using temperature-controlled shipping to the hospital. Because the dose depends on body weight and one injection is needed per cycle, we confirm the number of vials before ordering. 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

Leading cancer hospitals here give chemotherapy to patients from all over North India, and our New Delhi dispatch point keeps transit short.

Mumbai

Vials can be delivered to the hospital pharmacy so the injection is ready for day 3 of the cycle.

Bangalore

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

Chennai

A busy centre for breast cancer care in South India, where hospital pharmacies are used to handling imported medicines.

Hyderabad

We line up each delivery with the chemotherapy calendar so the dose arrives on time.

Kolkata

Shipments to Kolkata and the north-east are planned to arrive before each new cycle begins.

Pune

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

Ahmedabad

The treating oncologist can share the prescription, chemotherapy plan and body weight to start the import.

Vellore

Patients treated at hospitals in Vellore can have each cycle's vials sent straight to the hospital.

Chandigarh

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

Lucknow

We arrange delivery to government and private oncology hospitals across Uttar Pradesh.

Kochi

Patients across Kerala can receive the medicine at their hospital in Kochi and nearby towns.

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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