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Fovinaciclib

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Fovinaciclib

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: Fovinaciclib
Generic Name (API): Fovinaciclib citrate
Dosage Form & Strength: 100 mg, 25 mg
Route: Oral
Drug Class: CDK4/6 inhibitor

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
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What Is Fovinaciclib Used For?

Fovinaciclib is an oral capsule for advanced breast cancer that is hormone receptor-positive and HER2-negative (HR+/HER2−). It is made in China by Jinzhou Avanc Pharmaceutical, a subsidiary of Fosun Pharma, and is sold there as 复妥宁®. Its Chinese name is 枸橼酸伏维西利胶囊 (fovinaciclib citrate capsules). It is always combined with a hormone (endocrine) medicine.

China's National Medical Products Administration (NMPA) approved it in May 2025 and added a first-line use in September 2025. It is approved for adults with HR+/HER2− locally advanced or metastatic breast cancer:

  • First treatment: together with an aromatase inhibitor, as the initial endocrine therapy
  • After hormone therapy has stopped working: together with fulvestrant

It can be used whether a woman is before, around or after menopause. It is a prescription cancer medicine and should only be used under a medical oncologist.

How It Works

Hormone-sensitive breast cancer cells depend on two enzymes, CDK4 and CDK6, to move from resting to dividing. Fovinaciclib blocks both. Combined with hormone therapy, which cuts off the oestrogen signal that feeds the tumour, it holds back cancer growth for longer than hormone therapy alone. The company says its molecule was designed to reduce gut side effects and liver enzyme problems.

What the Trials Showed

  • First-line (FCN-437c-III201, phase 3, 417 women): published in JAMA Oncology in June 2026. Adding fovinaciclib to an aromatase inhibitor lowered the risk of the cancer growing or death by 45% on independent review (HR 0.55). Median progression-free time had not been reached, against 20.2 months with placebo. 66.3% responded, compared with 39.2%.
  • After hormone therapy (FCN-437c-III202, phase 3): with fulvestrant, the median time before the cancer grew was 14.0 months against 5.6 months with placebo (HR 0.484). 27.5% responded compared with 14.5%, and 60.0% had lasting clinical benefit compared with 40.9%.

Recommended Dosage

According to the Chinese prescribing information:

  • Fovinaciclib: 200 mg by mouth once a day, with or without food, at about the same time each day
  • Taken for 21 days, then a 7-day break, making a 28-day cycle
  • Fulvestrant, when used: 500 mg on days 1, 15 and 29, then once a month
  • Aromatase inhibitor, when used: at the dose in its own prescribing information
  • Women who are pre- or perimenopausal also receive a GnRH agonist
  • If a dose is missed, take it the same day as soon as you remember; if the next dose is 8 hours away or less, skip it

Capsules come in 100 mg and 25 mg strengths; the usual 200 mg dose is two 100 mg capsules. Treatment continues while it is helping and side effects are acceptable. 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.

Warnings and Precautions

Low blood counts: the label's pooled safety data from 464 patients show that drops in white cells, neutrophils and platelets, and anaemia, are the most common side effects (each in 20% or more). These are also the most common severe effects. Blood counts are checked regularly, and your doctor can pause or adjust treatment. Report fever, bruising or unusual tiredness straight away.

  • Liver tests and blood fats: raised AST and ALT and high triglycerides were each reported in 20% or more of patients, so these are monitored with routine blood tests.
  • Heart rhythm: QT prolongation on the ECG was among the severe side effects seen in at least 2% of patients. Your doctor may check an ECG, especially if you take other medicines that affect heart rhythm.
  • Gut side effects: the company's summary reports no severe (grade 3 or higher) diarrhoea with fovinaciclib, and that only 1.4% stopped treatment because of side effects.
  • Other medicines: CYP3A4 inhibitors and inducers can change blood levels, so give your doctor a full list of what you take.
  • Allergy: do not take it if you are allergic to fovinaciclib or any ingredient.

Overall: in the first-line trial, severe treatment-related side effects occurred in 85.1% on fovinaciclib and 14.4% on placebo, mostly low blood counts found on tests. Serious side effects were 14.4% vs 11.5%, and only 2 patients in each group stopped because of treatment-related side effects. Safety in pregnancy, breastfeeding and children has not been established.

How to Access Fovinaciclib 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 Fovinaciclib 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 medical oncologist
  • Pathology reports confirming HR-positive, HER2-negative breast cancer, recent scans, and details of any earlier hormone therapy
  • 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 Fovinaciclib available in India?

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 Truqap 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.

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. Each 28-day cycle uses 21 days of capsules, and we plan quantities cycle by cycle so the next supply arrives before the break ends. 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.

Availability Across Major Cities in India

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.

Delhi

Oncology centres here treat breast cancer patients from across North India, and orders are dispatched from New Delhi.

Mumbai

We time each delivery to the 7-day break, so the next cycle can start on schedule.

Bangalore

Oncologists can request supply for a named patient and receive a written quote before ordering.

Chennai

Patients in Chennai can have cycle-by-cycle supplies sent to the hospital or to home.

Hyderabad

If the dose is reduced, we adjust the mix of 100 mg and 25 mg capsules to match the new prescription.

Kolkata

Deliveries to Kolkata and eastern India are tracked from dispatch to arrival.

Pune

Patients in Pune can use the same documented import route, with updates at each step.

Ahmedabad

The treating oncologist can begin the process by sending the prescription and receptor report.

Vellore

Patients under treatment in Vellore can receive supplies directly at the hospital.

Chandigarh

Serves patients from Punjab, Haryana and Himachal Pradesh on continuing oral therapy.

Lucknow

We arrange repeat deliveries for patients across Uttar Pradesh.

Kochi

Patients across Kerala can receive their capsules in Kochi and nearby cities.

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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