Venetoclax (Venclexta) 10/50/100mg Tablets | China NMPA-Approved BCL-2 Inhibitor for CLL/SLL & AML | GLT

Generic Information: Venclexta (Venetoclax)

Venclexta (venetoclax) is the world's first-in-class, orally bioavailable, selective inhibitor of the B-cell lymphoma-2 (BCL-2) protein, developed by AbbVie. By restoring the natural process of programmed cell death (apoptosis) in cancer cells, venetoclax has transformed the treatment landscape of chronic lymphocytic leukemia (CLL) and acute myeloid leukemia (AML). The China version of Venclexta (Chinese trade name 唯可来) is approved by China's National Medical Products Administration (NMPA) — in March 2022 the NMPA approved venetoclax in combination with azacitidine for newly diagnosed AML in adults who are ineligible for intensive induction chemotherapy — and it is manufactured under strict GMP conditions.

What Is Venclexta (Venetoclax) Used For?

Venclexta (venetoclax) is indicated for the treatment of adult patients with:

• Chronic lymphocytic leukemia (CLL) — both previously untreated and relapsed/refractory disease, including patients with 17p deletion or TP53 mutation, where it delivers deep, durable remissions as fixed-duration oral therapy.
• Small lymphocytic lymphoma (SLL) — the tissue-based counterpart of CLL.
• Acute myeloid leukemia (AML) — in combination with azacitidine (or low-dose cytarabine) for newly diagnosed AML in adults who are 75 years or older, or who have comorbidities that preclude intensive induction chemotherapy.

In the pivotal CLL14 trial, first-line venetoclax plus obinutuzumab achieved superior progression-free survival with high rates of undetectable minimal residual disease (MRD), allowing fixed-duration treatment instead of indefinite therapy. In the VIALE-A trial, venetoclax plus azacitidine achieved a complete response rate of 66.4% and median overall survival of 14.7 months in newly diagnosed AML patients unfit for intensive chemotherapy — roughly double the response rate of azacitidine alone.

How Does Venclexta (Venetoclax) Work?

Venetoclax is a selective, orally bioavailable small-molecule inhibitor of the anti-apoptotic BCL-2 protein. CLL cells and AML blasts depend on BCL-2 for survival: the protein is over-expressed and shields malignant cells from apoptosis while also mediating resistance to chemotherapy. Venetoclax binds directly to BCL-2, displacing pro-apoptotic proteins such as BIM and BH3 domain proteins. Freed from BCL-2's grip, these proteins re-activate the apoptotic machinery, and the cancer cell self-destructs. Because healthy cells rely far less on BCL-2 alone, venetoclax achieves targeted cytotoxicity with a manageable safety profile.

Indications

• Chronic lymphocytic leukemia (CLL) — previously untreated and relapsed/refractory
• Small lymphocytic lymphoma (SLL)
• Acute myeloid leukemia (AML) — combination with azacitidine or low-dose cytarabine in unfit patients
• Effective in high-risk cytogenetics including 17p deletion / TP53 mutation

Dosage & Administration

Available strengths: 10mg × 14's; 50mg × 7's; 100mg × 14's; 100mg × 28's.

For CLL, venetoclax is given as a 5-week once-daily ramp-up (20 mg → 50 mg → 100 mg → 200 mg → 400 mg) to gradually reduce tumour burden and minimize the risk of tumor lysis syndrome (TLS), followed by a 400 mg once-daily maintenance dose, typically in fixed-duration combinations. For AML in combination with azacitidine, the ramp-up is 100 mg → 200 mg → 400 mg once daily on days 1–3 of cycle 1, then 400 mg daily. Tablets are taken orally with food and water at the same time each day, swallowed whole. TLS risk assessment (tumour burden, renal function), prophylactic hydration and laboratory monitoring are mandatory during initiation; hospitalized monitoring is required for high-risk patients during the early ramp-up. Dose modifications apply with strong CYP3A4 inhibitors. Treatment must be initiated and supervised by an experienced hematologist/oncologist.

Side Effects

The most clinically important risk is tumor lysis syndrome (TLS), particularly during initiation in patients with high tumour burden — strict ramp-up, hydration and monitoring protocols are mandatory. Common adverse reactions include neutropenia (with risk of febrile neutropenia and infection), diarrhoea, nausea, anaemia, thrombocytopenia, fatigue and cough. Concomitant use of strong CYP3A4 inhibitors or inducers requires dose adjustment or avoidance. Venetoclax can cause fetal harm; effective contraception is required during treatment and for at least 30 days after the last dose.

Storage

Store Venclexta tablets at controlled room temperature (20–25 °C) in the original packaging, protected from moisture. Keep out of reach of children. Ambient (non-cold-chain) shipping is suitable for oral tablets.

Why Choose the China Version of Venclexta (Venetoclax)?

• Globally synchronized originator quality, made accessible — the China version of Venclexta is produced under the same AbbVie GMP standards and NMPA-approved, at a fraction of the price of US/EU market versions.
• NMPA-approved indication — venetoclax plus azacitidine is approved in China for newly diagnosed unfit AML, aligned with global label.
• First-in-class BCL-2 inhibition — restores apoptosis in CLL/SLL and AML, delivering deep remissions and MRD-negative outcomes as fixed-duration oral therapy.
• Oral home-based treatment — no infusion required; treatment is administered by tablet under physician supervision.
• Reliable supply by GLT — GIVE LIFE TIME LIMITED ships authentic, batch-traceable Venclexta with full documentation (CoA and batch records) worldwide.

How to Order Venclexta (Venetoclax) from GLT?

1. Contact us via WhatsApp +86 15234153837 or email [email protected] with the product name, specification and quantity.
2. Receive a formal quotation, payment instructions and estimated delivery time.
3. Complete payment via our secure payment channel (Hao Yi Lian / 好易联).
4. Goods are dispatched with batch documentation; tracking provided until delivery.

We serve both licensed institutions (hospital procurement, pharmacies, importers) and individual patients. A valid prescription may be requested before dispatch.

FAQ

1. What strengths of Venclexta (venetoclax) are available?

Venclexta is available as 10mg × 14's; 50mg × 7's; 100mg × 14's; 100mg × 28's film-coated tablets. CLL therapy uses a 5-week ramp-up to the 400 mg daily target dose; AML combination therapy ramps to 400 mg daily.

2. Is the China version of Venclexta the same as the US/EU version?

Yes. The China version is the AbbVie originator venetoclax approved by the NMPA, manufactured under the same global GMP quality standards, offered by GLT at a substantially lower cost.

3. Why is the ramp-up schedule so important?

Venetoclax rapidly destroys CLL cells, which can flood the blood with metabolic by-products and cause tumor lysis syndrome (TLS). The gradual 5-week ramp-up, hydration and lab monitoring are designed to keep TLS risk manageable and are mandatory safety measures.

4. How is Venclexta shipped internationally?

As an oral tablet, Venclexta ships via ambient temperature-controlled courier with full batch documentation (CoA, batch traceability). Typical delivery is 7–14 days depending on destination.

5. Can I order Venclexta for personal use?

GLT serves both institutions and individual patients. Individual buyers should hold a valid prescription from a licensed physician and use this medicine under hematologist/oncologist supervision.