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Ready to proceed? Start a request for Tibremciclib on our secure patient portal to submit your prescription, upload documents and track your approval status.
Supplied with complete CDSCO-approved import and customs documentation, including Form 12A & 12B, CDEC, GST Bill of Entry, Commercial Invoice, and Packing List.
Manufacturer / Innovator:
China
Regulatory Approval:
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Tibremciclib is an oral targeted capsule for advanced breast cancer that is driven by hormones. It was discovered and developed in China by Betta Pharmaceuticals, and is sold there as 康美纳®. It is used together with fulvestrant, a hormone-blocking injection, once earlier hormone treatment has stopped working.
China's National Medical Products Administration (NMPA) approved it in mid-2025 (Betta announced the approval on 2 July 2025) for adults with:
It is a prescription cancer medicine and should only be used under a medical oncologist.
Before a cell can divide, it has to pass a checkpoint between its growth stage (G1) and the stage where it copies its DNA (S). Two enzymes, CDK4 and CDK6, act as the key to that checkpoint. Tibremciclib binds to CDK4 and CDK6 and blocks them, so cancer cells stay stuck in G1 and stop multiplying. Fulvestrant works on the hormone side at the same time, so the cancer is held back in two ways. Tibremciclib was designed by Betta and is a new molecule, not a copy of an older medicine.
The phase 3 TIFFANY trial, published in JAMA Oncology in 2025, enrolled 274 women at 69 hospitals in China whose cancer had grown on hormone therapy. Adding tibremciclib to fulvestrant almost tripled the time before the disease got worse: a median of 16.5 months against 5.6 months with placebo plus fulvestrant, a 63% lower risk of progression. Among patients with measurable tumours, 45.6% saw their tumours shrink, compared with 12.9%. Survival data were not yet mature at the time of analysis.
In the TIFFANY trial, treatment was given in 28-day cycles:
If side effects become troublesome, the dose can be lowered to 300 mg and then 200 mg a day. Your oncologist will set the exact plan from 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.
Diarrhoea: this was the most common side effect, affecting 79.3% of patients in the TIFFANY trial, though only 4.9% had severe diarrhoea. It usually started within the first month and then eased. Only 2.7% needed a lower dose because of it, and nobody stopped treatment for this reason. Keep anti-diarrhoea medicine at home as your doctor advises, drink plenty of fluids and report diarrhoea early.
Overall: serious side effects occurred in 13.0% on tibremciclib and 10.0% on placebo. 18.5% needed a dose reduction and only 2.2% stopped because of side effects. No treatment-related deaths occurred in the tibremciclib group. Safety in pregnancy and breastfeeding has not been established in the published data, so discuss this with your oncologist.
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.
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:
Once we have received and checked a valid prescription and, where needed, an import permit.
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 import options after hormone therapy in this type of breast cancer, see our pages on Veppanu and Itovebi.
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.
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. At the trial dose of four 100 mg capsules a day, a 28-day cycle needs 112 capsules, so we plan quantities cycle by cycle. The capsules travel in their sealed original packs under temperature-controlled shipping and should then be stored as directed on the pack. 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.
Patients across India can access this medicine through regulated import pathways, with delivery arranged to the patient or the treating hospital on a valid oncologist's prescription.
Large oncology centres in Delhi treat breast cancer patients from across the north, and dispatch from New Delhi keeps delivery quick.
Capsules can reach the patient or the hospital pharmacy in time for the fulvestrant injection day.
Oncologists in Bangalore can raise a named-patient request, and the quote is shared before anything is ordered.
Patients at Chennai's cancer hospitals can receive each cycle's supply at the hospital.
We plan deliveries so there is no gap in the daily capsules between cycles.
Patients in Kolkata and the north-east can use the same paperwork-based import route.
Families in Pune get clear updates from prescription check to doorstep delivery.
The oncologist can share the prescription and hormone-receptor reports to begin the import.
Supply for patients treated in Vellore can be sent straight to the hospital.
Serves patients from Punjab, Haryana and Himachal Pradesh, with delivery to the treating centre.
We arrange delivery to public and private cancer hospitals across Uttar Pradesh.
Patients across Kerala can collect their capsules at their hospital in Kochi or nearby.
Access can also be coordinated for patients in other Indian cities, subject to a valid prescription and regulatory requirements.
Written By
Nitin GoswamiDeputy Manager – Content & Social Media, Ikris Pharma Network
Sources: NMPA • CDSCO
Last Updated: 19 October 2026
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