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Pimicotinib

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Pimicotinib

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: Pimicotinib
Generic Name (API): Pimicotinib (as hydrochloride)
Dosage Form & Strength: 50 mg once daily (dose used in MANEUVER)
Route: Oral
Drug Class: CSF-1R inhibitor (targeted therapy)

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
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What Is Pimicotinib Used For?

Pimicotinib is a once-a-day capsule for tenosynovial giant cell tumour (TGCT), a rare, locally aggressive tumour that grows in or around a joint and causes swelling, stiffness and pain. It was discovered and developed by Abbisko Therapeutics in Shanghai and is commercialised worldwide by Merck KGaA, Darmstadt, Germany. In China it is sold as 贝捷迈® (pimicotinib hydrochloride capsules).

China's National Medical Products Administration (NMPA) approved it in December 2025, the first approval anywhere in the world, for:

  • Adults with symptomatic TGCT
  • Where surgery to remove the tumour could cause loss of function or relatively severe complications

It is a prescription tumour medicine and should only be used under an orthopaedic oncologist, sarcoma specialist or medical oncologist.

How It Works

In TGCT, a small number of tumour cells make too much of a signalling protein called CSF-1. It acts like a magnet, drawing in large numbers of inflammatory cells that carry the CSF-1 receptor (CSF-1R), and these make up most of the swelling. Pimicotinib is a highly selective CSF-1R blocker. By cutting that signal, it starves the tumour of the cells that build it up, so the mass shrinks and the joint can move more freely.

What the Trial Showed

The global phase 3 MANEUVER trial, published in The Lancet in 2026, enrolled 94 adults with TGCT from China, Europe, the US and Canada whose tumours could not be removed safely by surgery. They were randomly given pimicotinib or a dummy capsule (placebo) for 24 weeks.

  • Tumour shrinkage at week 25: 54% with pimicotinib against 3.2% with placebo (independent review)
  • Daily life: range of movement, physical function, stiffness and pain all improved significantly compared with placebo
  • Longer term: after a median of 14.3 months, the response rate in patients treated from the start rose to 76.2%

Recommended Dosage

  • Dose studied: 50 mg by mouth once a day
  • Taken every day for as long as it helps and side effects are manageable
  • If side effects build up, the doctor may pause treatment or lower the dose; in the trial, 8% of patients needed a lower dose

The specialist confirms the exact dose and how to take it using the Chinese prescribing information.

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

Warnings and Precautions

In the 24-week placebo-controlled part of MANEUVER, side effects were mainly mild, and only 1 of 63 patients (2%) stopped treatment because of them.

  • Blood test changes: the most common findings were raised muscle enzyme CPK (71%), LDH (57%) and the liver enzyme AST (54%), as well as amylase (35%). These usually caused no symptoms. CPK was the only severe (grade 3–4) side effect seen in more than 1 in 10 patients (13%). Regular blood tests are part of treatment.
  • Skin: itching (52%) and rash (35%) were common.
  • Swelling: facial swelling affected 48% and swelling around the eyes 32%.
  • General: tiredness (29%), nausea (27%) and headache (21%) were also reported.
  • Liver: no cholestatic liver damage or drug-induced liver injury was seen, and there was no lightening of the skin or hair.

Serious side effects occurred in 3 of 63 patients (4.8%) on pimicotinib and 1 of 31 (3.2%) on placebo. It is approved for adults only. Tell your doctor about all other medicines you take, and if you are pregnant, planning a pregnancy or breastfeeding, so they can check the full Chinese prescribing information.

How to Access Pimicotinib 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 Pimicotinib to India?

The capsules 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 orthopaedic oncologist, sarcoma specialist or medical oncologist
  • Diagnostic reports confirming TGCT (MRI and biopsy reports), with the surgeon's or specialist's note on why surgery is not suitable
  • 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 Pimicotinib available in India?

No. It is approved only in China. It has no CDSCO approval and is not sold in Indian pharmacies. In the US, the FDA has accepted the application for review (January 2026), but it has not been approved there yet, and we found no European Medicines Agency approval.

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. We also help import Romvimza, another CSF-1R medicine used for TGCT.

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 capsules travel in their sealed original packs under temperature-controlled shipping and should be stored as directed on the pack. As this is a daily, long-term treatment, we plan repeat orders in advance so there is no gap in supply. 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 patient or treating hospital on a valid specialist's prescription.

Delhi

Orthopaedic oncology and sarcoma teams in Delhi see TGCT patients from across North India, close to our New Delhi dispatch point.

Mumbai

Patients in Mumbai can send the specialist's prescription with MRI and biopsy reports, and the capsules are delivered as advised.

Bangalore

A written quote is shared first, so patients can plan for months of daily treatment.

Chennai

Chennai's bone and soft-tissue tumour units can request the medicine for a named patient.

Hyderabad

We schedule repeat orders ahead of time so daily dosing is never interrupted.

Kolkata

Supplies to Kolkata and the eastern states are tracked from dispatch to delivery.

Pune

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

Ahmedabad

The treating specialist can share the prescription and the reason surgery is not advised to start the request.

Vellore

Patients treated at hospitals in Vellore can have their supply sent to the hospital pharmacy or home.

Chandigarh

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

Lucknow

We coordinate delivery to orthopaedic and cancer hospitals across Uttar Pradesh.

Kochi

Patients across Kerala can receive the capsules in Kochi and nearby cities, with the import papers handled for them.

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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