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Sourced directly from the authorized manufacturer network to ensure authenticity and quality.
Ready to proceed? Start a request for Lerociclib 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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Lerociclib is a targeted tablet for advanced breast cancer that is fuelled by hormones. It was developed by Genor Biopharma (now part of Edding Genor Group) together with G1 Therapeutics, and is sold in China as 汝佳宁® (Rujianing). It is never taken on its own: it is always paired with hormone (endocrine) therapy, which it helps to work for longer.
China's National Medical Products Administration (NMPA) approved it on 27 May 2025 for adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer, used:
It is a prescription cancer medicine and should only be used under a medical oncologist.
Cancer cells need two enzymes, CDK4 and CDK6, to move from the resting stage of the cell cycle into the stage where they copy their DNA and divide. Lerociclib is a selective CDK4/6 inhibitor: it blocks these enzymes and holds the cancer cells in the resting stage, so the tumour grows more slowly. Hormone therapy cuts off the oestrogen signal at the same time, and the two together work better than hormone therapy alone. It is designed to be taken every day without a break week.
After earlier hormone therapy (LEONARDA-1): this phase 3 trial, published in Nature Communications in 2025, enrolled 275 people in China whose cancer had grown on hormone therapy. Adding lerociclib to fulvestrant doubled the time before the disease got worse, a median of 11.07 months against 5.49 months with placebo plus fulvestrant (a 55% lower risk of progression). Tumours shrank in 23.4% of patients, compared with 8.7%.
As first treatment for advanced disease (LEONARDA-2): in 279 patients given lerociclib or placebo together with an aromatase inhibitor, the risk of progression fell by about 54% (hazard ratio 0.464). At a median follow-up of 12.9 months, the median time to progression had not yet been reached with lerociclib, against 16.56 months without it, and 59.1% of patients responded.
If a dose is missed, skip it and take the next one at the usual time. The oncologist may lower the dose if blood counts drop.
This information is not a treatment plan. For personalized medical advice, consult your doctor and refer to the full prescribing information.
Low white blood cells: this is the main side effect. In the pooled data on the Chinese label (307 patients), neutropenia occurred in 91.5% and was severe (grade 3 or higher) in 48.9%. In LEONARDA-1, severe neutropenia was seen in about 47% of patients, but none developed fever with neutropenia. Blood counts are checked regularly, and the dose can be paused or reduced. Tell your doctor straight away about fever, chills or signs of infection.
Overall in LEONARDA-1: serious side effects were reported in 5.8% of patients on lerociclib and 8.0% on placebo. 38.0% needed a dose reduction, but only 0.7% stopped treatment because of side effects. Safety in pregnancy and breastfeeding has not been established in the published data, so discuss this with your oncologist before starting.
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 import options in hormone-receptor-positive breast cancer, see our pages on Orserdu and Inluriyo.
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 usual dose of six 50 mg tablets a day, one 28-day cycle needs 168 tablets, so we plan quantities cycle by cycle. The tablets 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.
Breast cancer clinics in Delhi see patients from across North India, and our New Delhi dispatch point keeps transit time short.
Tablets can be delivered to the patient or the hospital pharmacy before the next 28-day cycle begins.
Oncologists in Bangalore can request the medicine for a named patient, with a written quote shared before ordering.
A major referral centre for breast cancer in South India, with delivery arranged to the treating hospital.
We time each shipment so the daily tablets never run out between cycles.
Patients in Kolkata and the eastern states can use the same documented import route.
Families in Pune receive updates at every stage, from prescription check to delivery.
The treating oncologist can send the prescription and receptor-status reports to start the import.
Patients treated in Vellore can have supply sent directly to their hospital.
Serves patients from Punjab, Haryana and Himachal Pradesh, with delivery to the treating centre.
We coordinate delivery to cancer hospitals across Uttar Pradesh.
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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