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Tinengotinib

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Tinengotinib

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: Tinengotinib
Generic Name (API): Tinengotinib
Dosage Form & Strength: As per Chinese pack (trial dose 10 mg once daily)
Route: Oral
Drug Class: Multi-kinase inhibitor (FGFR, JAK, VEGFR, Aurora)

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
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    Temperature-controlled logistics ensuring safe, reliable, and timely medicine delivery.

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What Is Tinengotinib Used For?

Tinengotinib is a targeted tablet for bile duct cancer (cholangiocarcinoma) driven by an FGFR2 gene change, in people whose cancer has kept growing after an earlier FGFR-targeted tablet. It was discovered and developed by TransThera Sciences (Nanjing) in China, where it is sold as Yochanra® (Chinese brand name 捷恩泰®).

China's National Medical Products Administration (NMPA) granted it conditional marketing approval in August 2026 for adults with:

  • Unresectable advanced or metastatic cholangiocarcinoma
  • An FGFR2 fusion or rearrangement in the tumour
  • Who have already had systemic therapy and an FGFR inhibitor

It is a prescription cancer medicine and should only be used under a medical oncologist. The approval is conditional, which means a randomised phase III study against chemotherapy is running in China to confirm the benefit.

How It Works

Tumours driven by FGFR2 often respond well to a first FGFR-blocking tablet, but many later pick up new mutations that let the cancer escape. Tinengotinib is a multi-kinase inhibitor: it blocks FGFR together with JAK, VEGFR and Aurora kinases. The company describes it as working through precise targeting, lineage reprogramming and immune activation, which is why it is being studied after resistance has set in.

What the Trial Showed

The approval is based on a pivotal single-arm phase II trial in China (FIRST-08) of 50 people with advanced cholangiocarcinoma. All had already had chemotherapy and one FGFR inhibitor. After a median follow-up of 12 months, an independent central review found:

  • 28.0% had their tumours shrink (14 confirmed partial responses), and 82.0% had their disease brought under control
  • Responses lasted a median of 8.5 months
  • Median progression-free survival was 6.0 months, and median overall survival was 20.7 months

A separate phase 2 trial at 32 US centres, published in The Lancet Gastroenterology & Hepatology (2026), found a 30.0% response rate in people whose FGFR2-fusion tumours had become resistant to an earlier FGFR inhibitor.

Recommended Dosage

In the published US phase 2 trial and in China's confirmatory phase III study, the starting dose is:

  • 10 mg by mouth once a day, every day
  • In 28-day cycles, for as long as it is working and side effects are manageable

The tablet strength and exact label instructions are those printed on the Chinese pack and leaflet. Your oncologist sets the dose and may lower or pause it 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

The figures below come from the 55-patient US phase 2 trial in cholangiocarcinoma, the most complete safety data published so far.

  • High blood pressure: the most important side effect. Severe (grade 3) hypertension linked to treatment occurred in 31% of patients, and in the first-in-human study it was the most common side effect overall (50.0%). Ask your oncologist how often your blood pressure should be checked while you take it.
  • Hand-foot syndrome: severe redness, soreness or peeling of the palms and soles in 13%.
  • Mouth sores: severe stomatitis in 11%. Tell your team early if eating becomes painful.
  • Rare serious events: grade 4 side effects occurred in 4% (one raised lipase and one case of posterior reversible encephalopathy syndrome, a rare brain swelling condition). Seek urgent help for a severe headache, confusion, fits or sudden changes in vision.

Overall: no treatment-related deaths were reported. Discuss pregnancy, breastfeeding and contraception with your oncologist before starting, and tell your doctor about every other medicine you take. Always read the leaflet supplied with the pack.

How to Access Tinengotinib 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 Tinengotinib 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
  • Reports confirming cholangiocarcinoma with an FGFR2 fusion or rearrangement, and a treatment history showing earlier chemotherapy and an FGFR inhibitor
  • 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 Tinengotinib available in India?

No. It is approved only in China. It has no CDSCO approval and is not sold in Indian pharmacies. The US FDA and European Medicines Agency have not approved it; it holds orphan drug and fast-track designations in the US and an orphan designation in the EU, which support development but are not approvals.

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 people whose biliary tract cancer is HER2-positive, see our page on Ziihera.

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. The tablets travel in their sealed original packs under temperature-controlled shipping and are stored as directed on the pack. Since it is taken every day in 28-day cycles, we plan each order so the next supply arrives before the current one runs out. 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

GI and liver cancer specialists here treat bile duct cancer patients from across North India, close to our New Delhi dispatch point.

Mumbai

Oncologists can send the prescription and FGFR2 report, and the tablets are delivered to the patient or hospital.

Bangalore

A written quote per 28-day supply is shared before anything is ordered.

Chennai

A long-standing referral centre for hepatobiliary cancers in South India.

Hyderabad

We time repeat orders so daily treatment is not interrupted.

Kolkata

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

Pune

Patients and their oncologist get updates at each stage, from permit to delivery.

Ahmedabad

The treating oncologist can share the treatment history, including the earlier FGFR inhibitor, to begin the import.

Vellore

Supplies can be delivered directly to hospitals in Vellore for patients treated there.

Chandigarh

Serves patients from Punjab, Haryana and Himachal Pradesh, with home or hospital delivery.

Lucknow

We coordinate deliveries to cancer hospitals across Uttar Pradesh.

Kochi

Patients across Kerala can receive the tablets at home or at their hospital in Kochi.

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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