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Socazolimab is an immunotherapy medicine for cervical cancer that has come back or spread. It was developed by Lee's Pharmaceutical and is made in China by its company Zhaoke (Guangzhou) Oncology Pharmaceutical, where it is sold as 善克钰® (Shan Ke Yu). It is given as a drip every two weeks and, for cervical cancer, it is used on its own.
China's National Medical Products Administration (NMPA) approved it in December 2023 for:
In July 2025 the NMPA added a second use: extensive-stage small-cell lung cancer, as a first treatment given together with carboplatin and etoposide chemotherapy.
It is a prescription cancer medicine and should only be used under a medical oncologist or gynaecological oncologist.
Many tumours protect themselves by showing a protein called PD-L1, which acts like a brake on the immune system's T cells. Socazolimab is a monoclonal antibody that sticks to PD-L1 and takes that brake off, so the body's own immune cells can recognise and attack the cancer again. The company also reports that it can recruit immune cells through a second route, called ADCC.
The cervical cancer approval rests on a phase 1 study (NCT03676959) published in Clinical Cancer Research in 2022. In the main expansion part, 92 women with recurrent or metastatic cervical cancer received 5 mg/kg every two weeks. The tumour shrank in 15.4% of them, as judged by an independent review committee. Median survival was 14.7 months, and median time before the cancer grew again was 4.4 months.
Responses were seen whether or not the tumour tested positive for PD-L1 (16.7% in PD-L1-positive and 17.9% in PD-L1-negative patients), and no treatment-related deaths were reported.
For small-cell lung cancer, a phase 3 trial of 498 patients, published in Signal Transduction and Targeted Therapy in 2025, found that adding socazolimab to chemotherapy extended median survival from 11.58 to 13.90 months.
As an example, a 60 kg patient needs 300 mg, or three vials, per dose. In small-cell lung cancer the trial gave 5 mg/kg on day 1 of each 3-week chemotherapy cycle for four cycles, followed by socazolimab alone as maintenance. The label says treatment must be led by a doctor experienced in cancer care, and your oncologist sets the exact plan.
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: because this medicine releases a brake on the immune system, the immune system can sometimes turn on healthy organs. In the phase 3 lung cancer trial, immune-related side effects were seen in 19.3% of patients on socazolimab plus chemotherapy, compared with 9.7% on chemotherapy alone. The most common were an underactive thyroid (3.6%), an overactive thyroid (2.8%) and raised liver enzymes (2.8%). Severe (grade 3 or higher) immune-related effects occurred in 6.0%.
Overall: in the cervical cancer study, the authors reported no treatment-related deaths and a safety profile similar to other medicines that block the PD-1/PD-L1 pathway. The published English summary of the label does not cover pregnancy or breastfeeding, so talk to your oncologist about contraception and feeding before treatment begins.
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, 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 kept and transported exactly as directed on the pack, using temperature-controlled shipping to the treating hospital. Because the dose depends on body weight and is repeated every two weeks, we plan the number of vials dose by dose. 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.
Large cancer centres in Delhi see women with advanced cervical cancer from across North India, and our New Delhi dispatch point keeps transit times short.
Vials can be delivered to the hospital pharmacy ahead of each two-weekly infusion day.
Oncologists in Bangalore can request the medicine for a named patient and receive a written quote before anything is ordered.
A major referral centre for gynaecological cancers in South India, with hospitals used to handling imported biologic medicines.
We line up each delivery with the patient's infusion schedule so no dose is missed.
Shipments to Kolkata and the eastern states travel under temperature-controlled conditions to the treating hospital.
Patients in Pune can use the same documented import route, with updates at every step.
The treating oncologist can send us the prescription, biopsy report and treatment history to begin the import.
Patients treated at hospitals in Vellore can have each supply delivered directly to the hospital pharmacy.
Serves patients from Punjab, Haryana and Himachal Pradesh, with delivery to the treating cancer hospital.
We coordinate delivery to public and private cancer hospitals across Uttar Pradesh.
Patients across Kerala can receive the medicine at their 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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