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Vorolanib

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Vorolanib

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: Vorolanib
Generic Name (API): Vorolanib
Dosage Form & Strength: 100 mg
Route: Oral
Drug Class: Multi-target tyrosine kinase inhibitor (VEGFR2, PDGFR, KIT, FLT3, RET)

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
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What Is Vorolanib Used For?

Vorolanib is a once-daily tablet for advanced kidney cancer that has grown despite earlier targeted treatment. It is made by Betta Pharmaceuticals in Hangzhou, China, and sold there as 伏美纳® (Fumeina). Its Chinese name is 伏罗尼布片, and in research it was called CM082. It is always taken together with another tablet, everolimus.

China's National Medical Products Administration (NMPA) approved it in June 2023 as a Category 1 innovative drug, for:

  • Advanced renal cell carcinoma (RCC) in patients whose earlier treatment with a tyrosine kinase inhibitor has failed
  • Used in combination with everolimus

It is a prescription cancer medicine and should only be used under a medical oncologist or uro-oncologist. Betta reports that it was added to China's national reimbursement drug list in December 2023.

How It Works

Kidney cancers depend heavily on new blood vessels to feed their growth. Vorolanib is a multi-target kinase inhibitor that blocks VEGFR2, PDGFR, KIT, FLT3 and RET, switches that drive blood-vessel growth and tumour growth. Everolimus blocks a different pathway, called mTOR, inside the cancer cell. Using the two together attacks the tumour from two sides.

What the Trial Showed

The phase 3 CONCEPT trial, published in the European Journal of Cancer in 2023, enrolled 399 people in China whose kidney cancer had grown after one earlier VEGFR-targeted tablet. They were split into three equal groups: vorolanib plus everolimus, vorolanib alone, or everolimus alone.

  • Time before the cancer grew: a median of 10.0 months with the combination, against 6.4 months with everolimus alone (a 30% lower risk of progression)
  • Response: the tumour shrank in 24.8% with the combination, against 8.3% with everolimus alone
  • Vorolanib on its own did no better than everolimus alone, which is why it is approved only as a combination

Survival data were not mature at the time of publication.

Recommended Dosage

In the CONCEPT trial registration, vorolanib was taken as:

  • Vorolanib: 200 mg (two 100 mg tablets) by mouth once a day
  • Everolimus: taken by mouth once a day alongside it, at the dose your oncologist prescribes
  • In 28-day cycles, continued while it keeps working and side effects are manageable

Each box holds 20 tablets of 100 mg, which is 10 days of treatment at 200 mg a day, so about three boxes cover one 28-day cycle. Your oncologist sets the exact plan and may lower the dose if side effects occur.

This information is not a treatment plan. For personalized medical advice, consult your doctor and refer to the full prescribing information.

Warnings and Precautions

Overall safety: almost everyone in the CONCEPT trial had some side effect. Severe (grade 3 or higher) treatment-related side effects occurred in 72.2% of patients on the combination, compared with 53.4% on everolimus alone and 39.1% on vorolanib alone. This means the combination needs regular check-ups and blood and urine tests.

The detailed side-effect list comes from the earlier phase 1 study of vorolanib plus everolimus in 22 patients (EBioMedicine, 2020). Most effects were mild to moderate:

  • Protein in the urine: seen in all patients. Urine tests are checked regularly, as this can signal strain on the kidneys.
  • Low white blood cells: 77%, which can raise the risk of infection. Report fever promptly.
  • Raised blood fats: high cholesterol (77%), raised LDL (68%) and high triglycerides (64%). Lipid levels are checked during treatment.
  • High blood sugar: 59%. People with diabetes need closer monitoring.
  • Tiredness: 55%.
  • Low platelets: one patient on the highest dose had a severe drop in platelets.

Everolimus has its own warnings and side effects, which your oncologist will explain before you start. Safety in pregnancy, breastfeeding and children has not been established.

How to Access Vorolanib 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 Vorolanib to India?

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:

  • A valid prescription from a qualified medical oncologist or uro-oncologist
  • Diagnostic reports confirming advanced renal cell carcinoma, with details of earlier targeted treatment
  • 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 Vorolanib 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 another kidney cancer medicine we help patients import, see our page on Welireg.

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 box holds 20 tablets of 100 mg, so about three boxes cover a 28-day cycle at the trial dose. The tablets travel in their sealed original packs under temperature-controlled shipping, 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.

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 specialist's prescription.

Delhi

Uro-oncology departments in Delhi treat kidney cancer patients from across North India, and our New Delhi dispatch point means short delivery times.

Mumbai

Tablets can be delivered to the patient's home or the treating hospital, cycle by cycle.

Bangalore

Oncologists in Bangalore can request the medicine for a named patient and receive a written quote first.

Chennai

A long-standing referral hub for kidney cancer surgery and treatment in South India.

Hyderabad

We plan supply a cycle ahead so the daily tablets never run out.

Kolkata

Patients in Kolkata and the eastern states can use the same documented import route.

Pune

Families in Pune receive updates from prescription check to delivery.

Ahmedabad

The treating oncologist can send us the prescription and treatment history to begin.

Vellore

Patients treated at hospitals in Vellore can have tablets sent directly to them or the hospital.

Chandigarh

Serves patients from Punjab, Haryana and Himachal Pradesh, with delivery to the patient or the treating hospital.

Lucknow

We arrange delivery across Uttar Pradesh for patients on long-term oral treatment.

Kochi

Patients across Kerala can receive their supply 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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