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Lisaftoclax

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Lisaftoclax

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: Lisaftoclax
Generic Name (API): Lisaftoclax
Dosage Form & Strength: Target dose 600 mg once daily after ramp-up
Route: Oral
Drug Class: Selective BCL-2 inhibitor

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
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What Is Lisaftoclax Used For?

Lisaftoclax is a targeted tablet for chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL), two forms of the same slow-growing blood cancer. It was discovered and developed in China by Ascentage Pharma, where it is sold under the brand name 利生妥® (Chinese generic name 利沙托克拉, research code APG-2575).

China's National Medical Products Administration (NMPA) granted it conditional approval in July 2025 for adults with:

  • CLL or SLL who have already had at least one systemic treatment
  • That earlier treatment must have included a BTK inhibitor

It is a prescription blood cancer medicine and should only be started and monitored by a haematologist.

How It Works

CLL cells survive far longer than they should because they make too much of a protein called BCL-2, which blocks the cell's built-in self-destruct programme (apoptosis). Lisaftoclax is a small molecule that selectively blocks BCL-2, so the cancer cells lose that protection and die off. It is the first BCL-2 inhibitor developed in China to reach the market, and the company describes it as the second BCL-2 inhibitor approved anywhere in the world.

What the Trial Showed

The approval rests on a registrational phase 2 study (APG2575CC201, NCT05147467) of lisaftoclax on its own in people whose CLL/SLL had come back or stopped responding. Most were hard to treat: 87% no longer responded to a BTK inhibitor and 39% had high-risk del(17p) or TP53 changes. Results presented at the 2025 ASH meeting (77 enrolled, 72 evaluable) showed:

  • Overall response rate: 62.5%
  • Median progression-free survival: 23.9 months, with 66.4% free of progression at 12 months
  • Median duration of response: 18.5 months
  • Overall survival: median not reached; 78% were alive at 30 months

Recommended Dosage

It is taken by mouth once a day. In the pivotal study, patients started on a short daily ramp-up and then took a target dose of 600 mg once daily, in 28-day cycles. The Chinese prescribing information sets out the exact ramp-up steps and tablet strengths, and your haematologist will plan the doses and blood tests for the first weeks.

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

Warnings and Precautions

Blood counts: the main serious side effects in the pivotal study were low blood counts. Severe (grade 3 or higher) neutropenia occurred in 27.3% of patients, low platelets in 16.9% and anaemia in 9.1%. Blood counts are checked regularly, especially early on, and the dose can be paused or adjusted.

  • Infections: severe pneumonia was reported in 3.9%. Report fever, cough, chills or breathlessness straight away.
  • Tumour lysis syndrome (TLS): medicines that block BCL-2 can kill cancer cells quickly, and the contents released can upset blood salts and strain the kidneys. No TLS was seen in the pivotal study, which used a daily ramp-up, but your doctor will still check blood chemistry and advise you to drink enough fluids at the start.
  • Other side effects: most treatment-related side effects were mild to moderate (grade 1 or 2), and no treatment-related deaths were reported.
  • Other medicines: tell your haematologist about every medicine, herbal product or supplement you take before starting.

Overall: lisaftoclax has conditional approval, which means the company must confirm its benefit in further studies; phase 3 trials are under way. Safety in pregnancy, breastfeeding and children has not been established in the published data.

How to Access Lisaftoclax 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 Lisaftoclax 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 or SLL, with details of earlier treatment, 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 Lisaftoclax available in India?

No. It is approved only in China. It has no CDSCO approval, it is not sold in Indian pharmacies, and it has not been approved by the US FDA or the European Medicines Agency.

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 previously treated CLL, 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 treatment starts with a ramp-up, the first order covers the starting doses and later orders the daily target dose, so we plan quantities with the haematologist. The tablets travel in their sealed original 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

Large haematology departments here see many CLL patients from North India, and our New Delhi dispatch point keeps transit times short.

Mumbai

Tablets can be delivered to the patient or to the hospital pharmacy before the ramp-up begins.

Bangalore

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

Chennai

A major referral centre for blood cancers in South India, with experience in import paperwork for unapproved medicines.

Hyderabad

We time the first delivery so the patient can start the ramp-up on the day the doctor plans.

Kolkata

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

Pune

Families in Pune receive regular updates from prescription check to delivery.

Ahmedabad

The treating haematologist 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 there is no gap in daily dosing.

Chandigarh

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

Lucknow

We coordinate supply for patients treated at public and private 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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