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Sourced directly from the authorized manufacturer network to ensure authenticity and quality.
Ready to proceed? Start a request for Enlonstobart 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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Enlonstobart is an immunotherapy medicine for cervical cancer that has come back or spread after chemotherapy. It is made in China by CSPC Megalith Biopharmaceutical, part of CSPC Pharmaceutical Group, and is sold there as 恩舒幸® (Enshuxing). It was first discovered by Hangzhou Sumgen Biotech under the code SG001, and is given on its own as a drip.
China's National Medical Products Administration (NMPA) granted it conditional approval in June 2024 for:
"Conditional" means it was approved early on the strength of a phase 2 study, while a larger phase 3 trial continues. It is a prescription cancer medicine and should only be used under a medical oncologist or gynaecological oncologist.
Immune cells called T cells carry a switch named PD-1. Cancer cells can flip that switch off, which stops T cells from attacking them. Enlonstobart is a fully human antibody that covers PD-1 and blocks this signal, so the immune system can recognise and fight the tumour again.
The approval is based on a single-arm phase 2 study (NCT04886700), published in Gynecologic Oncology in 2024. It enrolled 107 women with PD-L1-positive cervical cancer that had progressed on, or could not tolerate, first-line platinum chemotherapy. The tumour shrank in 29.0% of patients, including two complete responses, and the disease was brought under control in 54.2%.
When it worked, it tended to last: the median duration of response was 16.6 months. Median time before the cancer grew again was 3.1 months, and median overall survival had not yet been reached at about 14 months of follow-up.
The dose is a fixed amount rather than one based on body weight. It comes as a 100 mg in 10 mL vial of solution, so each 240 mg dose (24 mL) is drawn from three vials. Your oncologist sets the exact plan from the full Chinese prescribing information.
This information is not a treatment plan. For personalized medical advice, consult your doctor and refer to the full prescribing information.
Immune-related side effects: by switching the immune system back on, this medicine can sometimes cause inflammation in healthy organs. In the phase 2 study, an underactive thyroid occurred in 15.0% of patients and an overactive thyroid in 11.2%. Thyroid tests are usually checked before and during treatment.
Overall: 97.2% of patients had at least one side effect of any cause during the study, and 35.5% had a severe (grade 3 or higher) one. The Chinese label reports side effects linked to the medicine in 85.0% of the 107 patients, and severe ones in 28.0%. The study authors described the safety as acceptable. Safety in pregnancy and breastfeeding has not been established in the published data, so discuss contraception with your oncologist.
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, cold-chain 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 injection 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 does not appear in CDSCO's lists of approved biological (rDNA) medicines, 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 import option in advanced cervical cancer after chemotherapy, see our page on Tivdak.
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. The vials are stored and transported exactly as directed on the pack, using temperature-controlled shipping to the treating hospital. As doses are given every two weeks, we can plan supply a few doses at a time. 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 treating hospital on a valid specialist's prescription.
Delhi's cancer hospitals treat many women with advanced cervical cancer, and supply leaves from our New Delhi dispatch point.
We deliver to the hospital pharmacy so each two-weekly infusion can go ahead on schedule.
Gynaecological oncologists in Bangalore can send the PD-L1 report and prescription to start the request.
Hospitals here regularly manage imported immunotherapy, and supply is arranged directly to the treating centre.
Deliveries are timed around the infusion calendar the oncologist sets.
We arrange temperature-controlled delivery to cancer hospitals in Kolkata and eastern India.
Patients in Pune follow the same documented import process, with a written quote first.
Treating doctors in Ahmedabad can share the biopsy, PD-L1 and treatment history with us to begin the import.
Supply can be sent straight to the hospital pharmacy in Vellore for each treatment block.
Covers patients from Punjab, Haryana, Himachal Pradesh and Jammu, with delivery to the treating hospital.
We coordinate supply to government and private oncology centres across Uttar Pradesh.
Patients in Kerala can receive the medicine at their treating hospital in Kochi or nearby.
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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