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Asandeutertinib

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Asandeutertinib

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Medicine Name: Asandeutertinib
Generic Name (API): Asandeutertinib mesylate
Dosage Form & Strength: 40 mg
Route: Oral
Drug Class: Deuterated irreversible EGFR tyrosine kinase inhibitor

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
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What Is Asandeutertinib Used For?

Asandeutertinib is a new targeted tablet for EGFR-mutated lung cancer that has spread to the brain. It was developed in China by TYK Medicines, where it is called 甲磺酸氘申艾替尼片 (asandeutertinib mesylate tablets) and carries the brand name Kadasa®. During development it was known as TY-9591.

China's National Medical Products Administration (NMPA) granted it conditional approval in August 2026 as a first-line treatment for adults with:

  • Locally advanced or metastatic non-small cell lung cancer (NSCLC)
  • With an EGFR exon 19 deletion or exon 21 L858R mutation
  • That has spread to the central nervous system (CNS), such as brain metastases

Conditional approval means the NMPA accepted early results from the pivotal study, and the company must complete confirmatory studies to turn it into a full approval. It is a prescription cancer medicine and should only be used under a medical oncologist.

How It Works

Asandeutertinib is an irreversible EGFR inhibitor: it binds permanently to the faulty EGFR protein that drives these cancers and switches off its growth signal. Some of its hydrogen atoms are replaced with deuterium, a heavier form of hydrogen. This slows the way the body breaks it down, so it makes less of a metabolite linked to side effects, which lets it be given at a higher dose with the aim of reaching tumours in the brain more effectively.

What the Trial Showed

The approval is based on the first interim analysis of ESAONA, a pivotal phase 2 study presented as a late-breaking abstract at ASCO 2026. 224 patients with untreated EGFR-mutated lung cancer and brain metastases were randomly given asandeutertinib or a standard EGFR tablet used as a comparison medicine.

  • 95.5% of patients saw their brain tumours respond, compared with 79.6%, as judged by independent reviewers
  • The median time before brain tumours grew had not yet been reached, against 17.5 months on the comparison medicine (a 54% lower risk)
  • 75.2% were free of brain progression at 18 months and 61.6% at 24 months
  • 89.2% responded overall, compared with 77.9%; overall survival data are not yet mature

Recommended Dosage

  • In the ESAONA study, the dose was 160 mg once a day by mouth
  • It was taken every day until the disease progressed or side effects became unmanageable

The marketing application accepted by the NMPA in February 2026 was for a 40 mg tablet. Full dosing instructions are in the Chinese prescribing information supplied with the pack, and your oncologist sets the dose for you.

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

Warnings and Precautions

Blood counts: drops in blood counts were the most common side effects in ESAONA. White cells fell in 64% of patients, neutrophils in 52.3%, platelets in 46.8%, and anaemia was seen in 61.3%. Most were mild or moderate, but regular blood tests are needed throughout treatment.

  • Lung inflammation (ILD): interstitial lung disease occurred in 6.3% of patients. Report any new cough, breathlessness or fever straight away.
  • Heart rhythm: QT prolongation on the ECG was reported in 17.1% (severe in 4.5%). ECGs and blood salts such as potassium are usually checked.
  • Muscle enzyme (CPK): a rise in creatine phosphokinase was seen in 54.1%. Tell your doctor about unexplained muscle pain or weakness.
  • Other common effects: weight loss (47.7%), diarrhoea (42.3%), rash (40.5%), poor appetite (36.9%) and mouth sores (23.4%).
  • Pregnancy and breastfeeding: safety has not been established in the published data. Discuss contraception, pregnancy and breastfeeding with your oncologist before starting.

Overall: severe (grade 3 or higher) side effects were more frequent than with the comparison medicine. The company reports grade 3 treatment-related side effects in 43.2% against 15.9%, though most settled with treatment pauses or dose reductions, and only 4 patients in each group stopped treatment because of side effects.

How to Access Asandeutertinib 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 Asandeutertinib 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
  • Diagnostic reports, including the biopsy report, the EGFR mutation test (exon 19 deletion or L858R) and brain MRI or CT showing the metastases
  • 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 Asandeutertinib available in India?

No. It is approved only in China, where it received conditional approval in August 2026. 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 the medicine is newly launched in China, we confirm supply availability before quoting. For other EGFR lung cancer situations, see our pages on Zegfrovy and Lazcluze.

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. In mainland China, TYK Medicines has licensed Qilu Pharmaceutical to make the active ingredient and to market and sell the tablets, so we work through that authorised chain. As it has only just been approved, we check stock with the authorised channel first and plan supply month by month once the prescription is confirmed. The tablets travel in their sealed original packs under temperature-controlled shipping and should 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.

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

Neuro-oncology and lung cancer teams in Delhi treat many patients with brain metastases, and our New Delhi dispatch point keeps delivery quick.

Mumbai

Oncologists in Mumbai can request the medicine for a named patient once the EGFR report and brain scans are shared.

Bangalore

Patients in Bangalore can have monthly supplies sent to their home or hospital pharmacy.

Chennai

Cancer centres in Chennai see patients from across South India who need treatment that reaches the brain.

Hyderabad

We confirm availability with the authorised channel before sharing a quote and delivery date.

Kolkata

Patients in Kolkata and the eastern states can use the same documented import route, with updates at every stage.

Pune

The treating oncologist can send the prescription and reports to begin the import.

Ahmedabad

Oncologists in Ahmedabad can coordinate access for newly diagnosed patients with brain metastases.

Jaipur

Patients across Rajasthan can receive the tablets at home, as long as the import is in their name.

Chandigarh

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

Lucknow

We arrange delivery for patients treated at cancer hospitals across Uttar Pradesh.

Kochi

Patients across Kerala can have their supply delivered to 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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