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Ready to proceed? Start a request for Envonalkib on our secure patient portal to submit your prescription, upload documents and track your approval status.
Supplied with complete CDSCO-approved import and customs documentation, including Form 12A & 12B, CDEC, GST Bill of Entry, Commercial Invoice, and Packing List.
Manufacturer / Innovator:
China
Regulatory Approval:
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Envonalkib is a targeted capsule for a specific type of lung cancer: non-small cell lung cancer (NSCLC) that carries an ALK gene change. It was developed in China by Chia Tai Tianqing Pharmaceutical Group, part of Sino Biopharmaceutical, and is sold there as 安洛晴® (Anluoqing). It is taken by mouth twice a day, on its own, for as long as it keeps the cancer under control.
China's National Medical Products Administration (NMPA) approved it in June 2024 for patients with:
It is a prescription lung cancer medicine and should only be used under a medical oncologist, after a validated test has confirmed that the tumour is ALK-positive.
In ALK-positive lung cancer, a faulty ALK protein keeps sending "grow" signals to the cancer cells. Envonalkib is a tyrosine kinase inhibitor that blocks this protein and switches off the signal. Lab studies show it also acts on two related targets, ROS1 and c-Met. In the main trial it was also active against cancer that had spread to the brain.
The phase 3 trial, published in Signal Transduction and Targeted Therapy in 2023, included 264 people in China with untreated ALK-positive advanced NSCLC. Half took envonalkib and half took an older, first-generation ALK medicine. With envonalkib, the cancer was kept in check for a median of 24.87 months, compared with 11.60 months on the comparison medicine, which is a 53% lower risk of the disease getting worse. Responses also lasted longer (median 25.79 vs 11.14 months).
In people whose brain lesions could be measured at the start, 78.95% saw those lesions shrink, against 23.81% on the comparison medicine. Among those without brain spread at the start, new brain metastases appeared in 2.15% compared with 11.70%. Survival data were still too early to compare when the results were published.
If a dose is missed, take it unless the next dose is due in less than 6 hours. If you vomit after a dose, do not take another one; just take the next dose at the usual time.
This information is not a treatment plan. For personalized medical advice, consult your doctor and refer to the full prescribing information.
Stomach and bowel: these are the most common side effects. In the safety data on the Chinese label (293 patients at the full dose), diarrhoea affected 90.4%, vomiting 81.2%, nausea 64.2% and loss of appetite 50.9%. They are usually managed with anti-diarrhoea and anti-sickness medicines, fluids, and a pause or dose reduction if needed. Severe or ongoing diarrhoea needs a blood test for salts such as potassium.
Overall: in the phase 3 trial, severe treatment-related side effects occurred in 55.73% of patients on envonalkib against 42.86% on the comparison medicine. 33.59% needed a lower dose, 6.11% stopped because of side effects, and there were no treatment-related deaths in the envonalkib group. Women who could become pregnant, and the partners of men taking it, must use effective contraception during treatment and for at least 3 months after the last dose; hormonal contraceptives may work less well. It has not been studied in children under 18, or in people with moderate to severe liver or kidney impairment.
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.
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:
Once we have received and checked a valid prescription and, where needed, an import permit.
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. If the tumour test shows a ROS1 fusion rather than ALK, see our pages on Ibtrozi and Augtyro.
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.
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 28 capsules (four blister strips of seven). The label says to keep them sealed, protected from light and at no more than 30°C, so they travel in their original packs under temperature-controlled shipping. Because treatment is daily and ongoing, we plan supply month by month so there is no gap between packs. 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.
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.
Thoracic oncology teams in Delhi treat lung cancer patients from across North India, and our New Delhi dispatch point means capsules can reach them quickly.
Oncologists in Mumbai can request the medicine for a named patient once the ALK report is in hand, with monthly supply planned ahead.
Patients in Bangalore can have the capsules delivered home or to their cancer centre after the documents are checked.
A major centre for lung cancer care in South India, where molecular testing for ALK is routinely available.
Medical oncologists in Hyderabad can share the prescription and biomarker report with us to start the import.
For Kolkata and the eastern states, we time each delivery so the next box arrives before the current one runs out.
Patients in Pune can use the same documented import route, with updates shared at every step.
Oncologists in Ahmedabad can coordinate access for patients newly diagnosed with ALK-positive lung cancer.
Serves patients from Punjab, Haryana and Himachal Pradesh, with delivery to the patient or the treating hospital.
Patients in Rajasthan can receive the capsules without travelling, as long as the import is in their name.
We coordinate delivery for patients treated at public and private cancer hospitals across Uttar Pradesh.
Patients across Kerala can have their monthly supply delivered to their home or hospital in Kochi and nearby cities.
Access can also be coordinated for patients in other Indian cities, subject to a valid prescription and regulatory requirements.
Written By
Nitin GoswamiDeputy Manager – Content & Social Media, Ikris Pharma Network
Sources: NMPA • CDSCO
Last Updated: 19 October 2026
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