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Garsorasib

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Garsorasib

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: Garsorasib
Generic Name (API): Garsorasib
Dosage Form & Strength: 200 mg
Route: Oral
Drug Class: KRAS G12C inhibitor (covalent)

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
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What Is Garsorasib Used For?

Garsorasib is a targeted tablet for advanced non-small cell lung cancer (NSCLC) driven by a gene change called KRAS G12C. It was discovered by InventisBio in Shanghai, where it was known as D-1553, and is sold in China by the Chia Tai Tianqing group as 安方宁® (Anfangning®).

China's National Medical Products Administration (NMPA) granted it conditional approval in November 2024, through priority review, for adults with:

  • Advanced non-small cell lung cancer with a KRAS G12C mutation
  • Who have already received at least one systemic treatment

The mutation must be confirmed by a validated test before it is prescribed. It is a prescription lung cancer medicine and should only be used under an oncologist.

How It Works

KRAS works like a switch that turns cell growth on and off. The G12C mutation jams that switch in the "on" position, so the cancer cells keep getting the message to grow. Garsorasib attaches to the faulty KRAS G12C protein and holds it in its inactive form, which cuts off the growth signal inside the tumour cell.

It is designed only for tumours with this exact mutation, so it is not used for lung cancers driven by other gene changes.

What the Trial Showed

The approval rests on the D1553-102 phase 2 study, run at 43 hospitals in China and published in The Lancet Respiratory Medicine in 2024. It enrolled 123 adults whose KRAS G12C lung cancer had grown after platinum chemotherapy and immunotherapy. In the updated analysis used in the Chinese label:

  • 52.0% saw their tumours shrink, as judged by an independent review panel
  • The disease was brought under control in 88.6%
  • Responses lasted a median of 12.45 months
  • Median time before the cancer grew again was 9.07 months, and median overall survival was 14.09 months (57.2% alive at one year)

This is a conditional approval based on a single-arm study. Full approval depends on the results of a confirmatory trial.

Recommended Dosage

  • 600 mg twice a day (three 200 mg tablets per dose)
  • Taken at the same times each day, on an empty stomach or after food
  • Swallow the tablets whole; do not chew, crush or split them
  • Continued until the disease progresses or side effects become unacceptable

If a dose is more than 4 hours late, skip it and carry on with the next planned dose. If you vomit after taking it, do not take another dose. For side effects, the oncologist may pause treatment or step the dose down to 600 mg once a day, and then to 400 mg once a day.

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

Warnings and Precautions

Liver effects: this is the main safety concern. In 306 patients on the recommended dose, liver-related side effects occurred in 62.7%, and were severe (grade 3 or 4) in 28.1%, mostly as raised liver enzymes. Liver tests are done before starting, every 3 weeks for the first 3 months, and then monthly. In the trials, severe liver changes settled after the dose was paused or lowered, and no liver-related deaths were reported. People with existing liver disease need careful assessment first.

  • Common side effects: raised AST (42.5%), ALT (36.9%) and GGT (31.7%), raised bilirubin (24.8%), anaemia (24.8%), diarrhoea (21.2%), nausea (19.6%) and vomiting (18.6%).
  • Lung inflammation: non-infectious pneumonitis was reported in 1.3% of patients, all mild to moderate. Report new or worsening breathlessness, cough or fever straight away; treatment is stopped for good if interstitial lung disease is confirmed.
  • Other effects to know about: acute pancreatitis (1.3%) and a longer QT interval on the ECG (4.6%) were seen in the safety data, so your doctor may check these.
  • Other medicines: strong CYP3A inhibitors and inducers should be avoided, because they change the level of garsorasib in the blood. Garsorasib itself raises the levels of some other medicines, so share a full list of what you take.
  • Pregnancy: it may harm an unborn baby and is not recommended in pregnancy. Women who could become pregnant need a pregnancy test first, and both women and men should use effective contraception during treatment and for 120 days after.

Overall: 35.0% of patients needed a pause or a lower dose because of side effects, but only 1.6% had to stop treatment for good. Safety in children and during breastfeeding has not been established, so discuss this with your doctor.

How to Access Garsorasib 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 Garsorasib 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 confirming non-small cell lung cancer, a molecular test report showing the KRAS G12C mutation, and a summary of previous 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 Garsorasib 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 lung cancers with other driver mutations, see our pages on Hernexeos (HER2) and Ibtrozi (ROS1).

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 bottle holds 42 tablets of 200 mg, which is one week of treatment at six tablets a day, so four bottles cover about a month. The label says to keep the bottle sealed below 30°C, and it travels that way under temperature-controlled shipping. 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

Lung cancer specialists in Delhi see patients from all over North India, and being close to our New Delhi dispatch point keeps weekly refills simple.

Mumbai

Oncologists in Mumbai can request the tablets for a named patient once the KRAS G12C test report is ready.

Bangalore

Patients in Bangalore can receive a month's supply at a time, delivered to home or to the treating hospital.

Chennai

A leading centre for thoracic oncology in South India, with experience in imported targeted therapies.

Hyderabad

We time deliveries around the regular liver test visits so patients in Hyderabad stay on schedule.

Kolkata

For Kolkata and the eastern states, we share the quote and timeline before anything is ordered.

Pune

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

Ahmedabad

Oncologists in Ahmedabad can send us the prescription and molecular report to begin the import.

Chandigarh

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

Jaipur

Patients in Rajasthan can continue oral treatment at home without travelling for each refill.

Lucknow

We coordinate delivery to public and private cancer hospitals across Uttar Pradesh.

Kochi

Patients across Kerala can have the tablets delivered 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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