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Sourced directly from the authorized manufacturer network to ensure authenticity and quality.
Ready to proceed? Start a request for Bireociclib 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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Bireociclib is an oral tablet, taken twice a day, for advanced breast cancer that is hormone receptor-positive and HER2-negative (HR+/HER2−). It was discovered and developed in China by Xuanzhu Biopharmaceutical, part of the Sihuan Pharmaceutical group, and is sold there as 轩悦宁® (Xuanyuening®). Its Chinese generic name is 吡洛西利片.
China's National Medical Products Administration (NMPA) first approved it in May 2025 and added a first-line use in February 2026. It is now approved for adults with HR+/HER2− locally advanced or metastatic breast cancer:
That last use is unusual: in China it is the only medicine of its class approved to be taken alone for advanced breast cancer. It is a prescription cancer medicine and should only be used under a medical oncologist.
Breast cancer cells rely on proteins called cyclin-dependent kinases (CDKs) to move through the cell cycle and divide. Bireociclib blocks CDK4 and CDK6, and also has some effect on CDK2 and CDK9. The company designed it to hit CDK4 much harder than CDK6 (about 18 times more selective), because strong CDK6 blockade is linked to low white blood cell counts. Paired with hormone therapy, it helps hold back tumour growth for longer.
According to the Chinese prescribing information:
Because there is only one tablet strength, the dose is lowered simply by taking fewer tablets. Your oncologist 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.
Diarrhoea: this is the most common side effect. In BRIGHT-2 it affected 92.6% of patients on bireociclib with fulvestrant, usually in the first cycle and mostly mild. The company reports severe (grade 3–4) diarrhoea in 6.4%, with no grade 4 cases. Keep anti-diarrhoea medicine at home, drink plenty of fluids and tell your doctor early.
Overall: in BRIGHT-2, severe (grade 3 or higher) side effects occurred in 74.5% of patients on bireociclib and 19.8% on placebo, mainly blood count and gut effects. 42.2% needed a dose reduction, but only 4.4% stopped bireociclib because of side effects. There is no boxed warning on the Chinese label. Safety in pregnancy, breastfeeding and children has not been established.
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 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:
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 targeted options in HR-positive advanced breast cancer, see our pages on Orserdu and Truqap.
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. Each box holds 56 tablets of 120 mg. At the combination dose of six tablets a day, one box lasts about nine days, so we plan quantities with your oncologist month by month. The tablets travel in their sealed original packs and are stored as directed on the pack, with temperature-controlled shipping to protect them in transit. 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 breast cancer units here see patients from across North India, and supplies leave from our New Delhi dispatch point.
Oncologists in Mumbai can send the prescription and reports, and the tablets are delivered to the patient or the hospital pharmacy.
We share a written quote for a month's supply before anything is ordered, so families can plan ahead.
Patients treated in Chennai's cancer hospitals can have refills timed so there is no gap between boxes.
We coordinate with the treating oncologist whenever the dose changes, so the right number of tablets is ordered.
Deliveries to Kolkata and the eastern states are tracked from dispatch to doorstep.
Patients in Pune can use the same documented import route, with an update at every stage.
The treating oncologist can start the request by sharing the prescription and pathology report.
Patients under care in Vellore can have supplies sent to the hospital or to their home address.
Serves patients from Punjab, Haryana and Himachal Pradesh who are on long-term oral treatment.
We arrange regular deliveries for patients across Uttar Pradesh on continuing therapy.
Patients across Kerala can receive their tablets in Kochi and nearby cities.
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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