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Sourced directly from the authorized manufacturer network to ensure authenticity and quality.
Ready to proceed? Start a request for Culmerciclib 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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Culmerciclib is a once-daily capsule for advanced breast cancer that is hormone receptor-positive and HER2-negative (HR+/HER2−). It was developed in China by Chia Tai Tianqing Pharmaceutical Group (CTTQ), part of Sino Biopharmaceutical, and is sold there as 赛坦欣®. Its Chinese generic name is 库莫西利胶囊. It is always taken together with fulvestrant, a monthly hormone injection.
China's National Medical Products Administration (NMPA) approved it in December 2025 and widened the approval in April 2026. It is now approved for adults with HR+/HER2− locally advanced or metastatic breast cancer, in combination with fulvestrant:
It is a prescription cancer medicine and should only be used under a medical oncologist.
Breast cancer cells use enzymes called cyclin-dependent kinases (CDKs) to keep dividing. Culmerciclib blocks three of them at once, CDK2, CDK4 and CDK6, with a particularly strong hold on CDK4 and a weaker effect on CDK6. The company describes it as the world's first approved CDK2/4/6 inhibitor. Blocking CDK2 as well is meant to delay the resistance that often develops to this type of treatment, while the lighter touch on CDK6 is meant to spare the bone marrow.
According to the Chinese prescribing information:
Capsules come in 50 mg and 60 mg strengths, which lets the doctor lower the dose if side effects appear. Treatment continues until the cancer grows or side effects become too hard to manage. 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: the most common side effect, seen in 87.1% of patients in the phase 3 trial, though it was severe in only 7.2%. It was managed with anti-diarrhoea medicine or a dose change, and no one stopped treatment because of it. Have anti-diarrhoea medicine at home and tell your doctor at the first loose stool.
Overall: in the phase 3 trial, severe (grade 3 or higher) side effects occurred in 61.3% on culmerciclib and 20.2% on placebo. 34.0% needed a dose reduction, but only one patient (0.5%) stopped treatment because of side effects. Safety in pregnancy, breastfeeding and children under 18 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 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. Because it is used with fulvestrant, your oncologist will plan both together. For other targeted options in HR-positive advanced breast cancer, see our pages on Itovebi and Orserdu.
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. Because it is a daily capsule taken for months, we plan supplies with the oncologist and match the capsule strength to the current dose. The capsules 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.
Breast oncology teams here can start a request quickly, and orders leave from our New Delhi dispatch point.
We work with the treating oncologist so the capsules arrive before the next fulvestrant injection is due.
A written quote for each month's supply is shared before anything is ordered.
Patients in Chennai can have repeat supplies scheduled so treatment is never interrupted.
If the dose is lowered, we reorder the right capsule strength in line with the new prescription.
Shipments to Kolkata and the north-east are tracked from dispatch to delivery.
Patients in Pune can follow the same documented import route, with updates at each stage.
The oncologist can begin the process by sharing the prescription and HR/HER2 report.
Patients treated in Vellore can choose delivery to the hospital or to their home address.
Supports patients from Punjab, Haryana, Himachal Pradesh and Jammu on long-term oral therapy.
We arrange regular deliveries for patients across Uttar Pradesh.
Patients across Kerala can receive their capsules in Kochi and surrounding 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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