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Zeprumetostat

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Zeprumetostat

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: Zeprumetostat
Generic Name (API): Zeprumetostat
Dosage Form & Strength: 50 mg
Route: Oral
Drug Class: EZH2 inhibitor

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
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What Is Zeprumetostat Used For?

Zeprumetostat is a targeted tablet for peripheral T-cell lymphoma (PTCL) that has come back or stopped responding after earlier treatment. PTCL is a rare, aggressive group of lymphomas, and options after first treatment are limited. The medicine was developed in China by Jiangsu Hengrui Pharmaceuticals, where it was known in research as SHR2554.

China's National Medical Products Administration (NMPA) gave it conditional approval in August 2025 (announced by Hengrui on 1 September 2025) for adults with:

  • Relapsed or refractory peripheral T-cell lymphoma (R/R PTCL)
  • Who have already had at least one earlier line of systemic treatment

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

How It Works

Inside every cell, an enzyme called EZH2 helps decide which genes stay switched off. In many lymphomas this enzyme is overactive, keeping the cancer cells growing. Zeprumetostat is an oral, selective EZH2 inhibitor. By blocking the enzyme, it helps reset the abnormal gene "switches", which slows the cancer cells and pushes them towards dying. Hengrui reports it is the first EZH2 inhibitor developed in China.

What the Trial Showed

Approval was based on the PTCL expansion part of Hengrui's phase 1 study (NCT03603951), presented at the European Hematology Association congress in 2025. It included 67 adults whose PTCL had come back after chemotherapy and at least one newer medicine.

  • Response rate: 64.2% of patients responded, and 32.8% had a complete response (no sign of lymphoma on scans)
  • How long it lasted: responses lasted a median of 18.7 months, and the median time before the disease got worse was 10.0 months
  • Subtypes: responses were seen across PTCL subtypes, including 70.3% in angioimmunoblastic T-cell lymphoma and 57.1% in PTCL not otherwise specified

An earlier analysis of 28 patients, published in Clinical Cancer Research in 2024, showed a similar 61% response rate and a 12-month survival rate of 92%. A larger phase 3 trial against a comparison medicine is now under way.

Recommended Dosage

  • Tablet strength: 50 mg
  • Dose used in the trials: 350 mg twice a day by mouth (seven 50 mg tablets per dose)

The approved Chinese label dose was not available to us, so your haematologist will confirm the exact dose and any changes.

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

Warnings and Precautions

Blood counts: the main side effect is a fall in blood counts. In the 67-patient study, side effects of any kind occurred in 92.5% and severe (grade 3 or more) side effects in 61.2%. The most common severe ones were low platelets (28.4%), low neutrophils (26.9%), low white cells (25.4%) and anaemia (23.9%). Regular blood tests are needed, and the dose can be paused or reduced.

  • Bleeding: because platelets can fall, report unusual bruising, nosebleeds or bleeding gums.
  • Infection: low white cells raise the risk of infection. Report fever, chills or cough straight away.
  • Tiredness and breathlessness: may be signs of anaemia and should be checked.
  • Other medicines: Hengrui has studied how strong enzyme-blocking medicines change its levels in the body, so tell your doctor about every medicine and supplement you take.

Overall: in the earlier 28-patient analysis, no deaths were linked to treatment. Full Chinese prescribing information was not available to us, so ask your specialist about pregnancy, breastfeeding and other individual risks.

How to Access Zeprumetostat 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 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 Zeprumetostat to India?

The tablets 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
  • Pathology reports confirming peripheral T-cell lymphoma, with details of previous 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 Zeprumetostat 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 PTCL, see our pages on Beleodaq and Folotyn.

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 tablets are stored and shipped as directed on the pack, under controlled shipping conditions. Because the dose is several tablets twice a day, we plan supply month by month so there is no gap in treatment. 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 lymphoma clinics here see T-cell lymphoma patients from across North India, and supply leaves from our New Delhi base.

Mumbai

Tablets can be delivered to the hospital or, where allowed, to the patient against the prescription.

Bangalore

Haematologists in Bangalore can request the medicine for a named patient and receive the quote before ordering.

Chennai

A long-standing referral centre for rare lymphomas in South India.

Hyderabad

We plan monthly refills so that a twice-daily tablet course is not interrupted.

Kolkata

Patients in Kolkata and the eastern states can use the same documented import route.

Pune

The treating doctor can share the pathology report and prescription with us to begin the import.

Ahmedabad

We keep families updated at each step, from document check to delivery.

Vellore

Patients treated at hospitals in Vellore can have supplies delivered directly to the hospital.

Chandigarh

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

Lucknow

We coordinate supply for patients treated at cancer hospitals across Uttar Pradesh.

Kochi

Patients across Kerala can receive the medicine through 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: 19 October 2026

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