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Sonrotoclax

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Sonrotoclax

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Medicine Name: Sonrotoclax
Generic Name (API): Sonrotoclax
Dosage Form & Strength: 320 mg once daily target dose (MCL), after ramp-up
Route: Oral
Drug Class: BCL2 inhibitor

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
  • US FDA
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What Is Sonrotoclax Used For?

Sonrotoclax is a next-generation targeted tablet for two B-cell blood cancers: chronic lymphocytic leukaemia / small lymphocytic lymphoma (CLL/SLL) and mantle cell lymphoma (MCL). It was discovered and developed by BeOne Medicines (formerly BeiGene). In China it is sold as 百悦达® (索托克拉片), and in the United States as BEQALZI™.

China's National Medical Products Administration (NMPA) gave it conditional approval on 30 December 2025, the first approval anywhere in the world, for adults with:

  • CLL or SLL who have had at least one earlier systemic treatment that included a BTK inhibitor
  • Relapsed or refractory MCL after at least two earlier systemic treatments, including a BTK inhibitor

The US FDA followed in May 2026 with an accelerated approval for the MCL use. It is a prescription blood cancer medicine and should only be used under a haematologist.

How It Works

Many B-cell cancers survive by making too much BCL2, a protein that stops damaged cells from switching on their own self-destruct programme. Sonrotoclax binds tightly to BCL2 and frees the signals that trigger that programme, so the cancer cells die. It has a short half-life and does not build up in the body.

What the Trials Showed

  • CLL/SLL (BGB-11417-202, phase 2, 100 patients in China): 80.5% responded on independent review, and 26.8% reached complete remission (CR/CRi). At 12 months, 84.7% of responses were still holding.
  • MCL (BGB-11417-201, phase 1/2, 103 patients): all had already had a BTK inhibitor. 52.4% responded and 15.5% had a complete response, with a median response length of 15.8 months. In the 34 Chinese patients the response rate was 61.8%.

Recommended Dosage

It is a tablet taken once a day with food and water, swallowed whole. Treatment always starts with a step-by-step ramp-up to lower the risk of tumour lysis syndrome. For MCL, the US label uses a 4-week ramp-up (1 mg, 2 mg, 5 mg, 10 mg, 20 mg, 40 mg, 80 mg and 160 mg, each for a few days) and then 320 mg once daily, which was also the dose in the MCL trial. The Chinese label sets out the dosing for each approved use, and your haematologist will plan the exact schedule.

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

Warnings and Precautions

Tumour lysis syndrome (TLS): as the cancer cells die quickly, they can release enough salts and uric acid into the blood to upset its chemistry and strain the kidneys. In the MCL study, laboratory or clinical TLS occurred in 7% of 115 patients who followed the ramp-up. It can happen within hours of the first dose or a dose increase, so patients get fluids and a uric acid-lowering medicine beforehand, and blood tests are checked closely.

  • Infections: serious infections occurred in 14% and severe (grade 3 or higher) infections in 17%. Pneumonia was the most common (10% severe), and 2.6% of patients died of infection. Report fever, cough or breathlessness straight away.
  • Neutropenia: severe drops in neutrophils occurred in 18%, so blood counts are checked throughout treatment.
  • Pregnancy: it can harm an unborn baby. Women who could become pregnant, and men with such partners, should use effective contraception during treatment and for 1 week after the last dose.
  • Medicine interactions: some antifungal, antibiotic and other medicines that strongly block the liver enzyme CYP3A must not be taken during the ramp-up. Tell your doctor about everything you take, including herbal products.

Overall: in the MCL study the most common side effects were pneumonia (16%), tiredness (16%), swelling (14%) and diarrhoea (14%). Serious side effects occurred in 37% of patients, and 8% stopped treatment because of them.

How to Access Sonrotoclax 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 Sonrotoclax 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 haematologist or medical oncologist
  • Diagnostic reports confirming CLL/SLL or mantle cell lymphoma, with details of the earlier treatments, including the BTK inhibitor
  • 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 Sonrotoclax available in India?

No. It has no CDSCO approval and is not sold in Indian pharmacies. It is approved in China (CLL/SLL and MCL) and in the United States (MCL only, accelerated approval); the European Medicines Agency has not approved it.

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 after earlier treatment of CLL or MCL, see our page on Jaypirca.

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. Because the first weeks use several low-dose steps, we plan the ramp-up supply and the later daily-dose supply separately with the treating haematologist. The tablets travel in their sealed original blister packs under temperature-controlled shipping and are 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 specialist's prescription.

Delhi

Leading haematology units here treat lymphoma and CLL patients from across North India, and our New Delhi dispatch point keeps delivery quick.

Mumbai

The ramp-up supply can reach the hospital before day 1, so TLS checks and the first dose can be planned together.

Bangalore

Haematologists in Bangalore can request the medicine for a named patient, with the quote shared before anything is ordered.

Chennai

A long-standing referral hub for lymphoma care in South India, familiar with named-patient import paperwork.

Hyderabad

We line up each delivery with the dose steps in the haematologist's plan.

Kolkata

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

Pune

Families in Pune get a clear timeline from prescription check to delivery.

Ahmedabad

The treating doctor can send us the prescription and treatment history to begin the import.

Vellore

Patients treated at hospitals in Vellore can have refills planned ahead so daily dosing is not interrupted.

Chandigarh

Serves patients from Punjab, Haryana and Himachal Pradesh, with delivery to home or hospital.

Lucknow

We coordinate supply for patients treated at cancer hospitals across Uttar Pradesh.

Kochi

Patients across Kerala can receive the tablets 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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