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Aponermin

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Aponermin

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: Aponermin
Generic Name (API): Aponermin
Dosage Form & Strength: 100 mg
Route: Intravenous (IV) infusion
Drug Class: Recombinant circularly permuted TRAIL, DR4/DR5 agonist

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
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    Temperature-controlled logistics ensuring safe, reliable, and timely medicine delivery.

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What Is Aponermin Used For?

Aponermin is a first-of-its-kind cancer medicine for multiple myeloma that keeps coming back. It was developed in China by Wuhan Hiteck Biological Pharma, together with Beijing Sunbio Biotech, and is sold there as 沙艾特®. It is given as a drip alongside two familiar tablets, thalidomide and dexamethasone.

China's National Medical Products Administration (NMPA) approved it in November 2023 for adults with:

  • Relapsed or refractory multiple myeloma who have already had at least two earlier systemic treatments
  • Used in combination with thalidomide and dexamethasone

It is a prescription blood cancer medicine and should only be used under a haematologist or oncologist.

How It Works

Our bodies have a natural signal, called TRAIL, that tells damaged cells to self-destruct. Aponermin is a re-engineered, more stable version of that signal, made by bacteria in the lab. It locks on to two "death receptors" on myeloma cells, DR4 and DR5, and switches on the cell's own shutdown process. It is the first approved medicine anywhere that works through these receptors, so it attacks the cancer in a different way from proteasome inhibitors, IMiDs or antibodies.

What the Trial Showed

The phase 3 CPT-MM301 trial, published in BMC Cancer in 2023, included 417 people whose myeloma had come back after at least two treatments. Adding aponermin to thalidomide and dexamethasone nearly doubled the time before the disease got worse (median 5.5 vs 3.1 months). People also lived longer, a median of 22.4 months against 16.4 months in the updated analysis, and more than twice as many responded to treatment (30.4% vs 13.7%).

Recommended Dosage

In the trial, each 28-day cycle looked like this:

  • Aponermin: 10 mg per kg of body weight, as a drip on days 1 to 5
  • Thalidomide: 150 mg by mouth every day
  • Dexamethasone: 40 mg by mouth on days 1 to 4
  • Repeated for up to 18 cycles, as long as it was working and side effects were manageable

Each vial holds 100 mg of powder, which is dissolved and added to a 250 mL drip that runs for about 90 minutes. As an example, a 60 kg patient needs 600 mg a day, or six vials, on each of the five dosing days. Your haematologist 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

Liver enzymes: the main side effect is a rise in liver enzymes. ALT went up in about half of patients (52.5%) and AST in 51.1%, though most rises were mild and short-lived. Severe (grade 3–4) rises happened in 9.4% (ALT) and 12.0% (AST). Liver tests are checked during each cycle, and the dose can be lowered or paused. In the trial, fewer than 3% had to change or stop treatment because of the liver, and no liver failure was reported.

  • Infections: severe pneumonia affected about a quarter of patients in both groups (25.0% vs 23.7%), which reflects how fragile the immune system is in advanced myeloma. Report fever, cough or breathlessness straight away.
  • Blood counts: severe drops in neutrophils occurred at the same rate with or without aponermin (about 27%). The company reports no clear evidence that the drug itself harms blood counts, kidneys or the heart.
  • Blood sugar: severe high blood sugar was more common with aponermin (21.0% vs 12.2%), partly because of the dexamethasone. People with diabetes need closer checks.
  • Thalidomide rules: thalidomide causes severe birth defects and raises the risk of blood clots, so its own strict pregnancy-prevention and clot-prevention rules apply throughout treatment.

Overall: serious side effects occurred in 40.6% of patients on aponermin and 37.4% on placebo. 8.7% stopped because of side effects, compared with 7.2%. Safety in pregnancy, breastfeeding and children has not been established.

How to Access Aponermin 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 Aponermin 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 haematologist or medical oncologist
  • Diagnostic reports confirming multiple myeloma, with details of the previous lines of treatment
  • 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 Aponermin 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 options in relapsed myeloma, see our pages on Talvey and Xpovio.

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 freeze-dried vials must be kept at 2°C to 8°C and away from light, so they travel under temperature-controlled shipping all the way to the hospital. Because each cycle needs five days of doses, we plan quantities cycle by cycle. 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

Major haematology centres here treat myeloma patients from across North India, and our New Delhi dispatch point keeps the cold-chain journey short.

Mumbai

Vials are delivered straight to the hospital pharmacy in time for day 1 of each cycle.

Bangalore

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

Chennai

A long-standing referral hub for blood cancers in South India, with experience handling refrigerated imported biologics.

Hyderabad

We plan deliveries around the five-day dosing window so each cycle starts on time.

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 haematologist can send us the prescription and treatment history to begin the import.

Vellore

Patients treated at hospitals in Vellore can have each cycle's supply delivered directly to the hospital.

Chandigarh

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

Lucknow

We coordinate cold-chain delivery to public and private cancer hospitals across Uttar Pradesh.

Kochi

Patients across Kerala can receive the medicine at their hospital 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: 16 October 2026

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