Zanubrutinib

Zanubrutinib (CAS 1691249-45-2), originally codenamed BGB-3111, is a potent, highly selective second-generation Bruton‘s tyrosine kinase (BTK) inhibitor developed by BeiGene. It forms a covalent bond with the BTK active site, irreversibly blocking B-cell receptor (BCR) signaling and inhibiting the proliferation of malignant B-cells.

A key milestone for Zanubrutinib is its status as the first FDA-approved China-originated novel drug. On November 14, 2019, the FDA approved Zanubrutinib for mantle cell lymphoma, marking the first anti-cancer drug entirely developed by a Chinese company to receive FDA approval — a historic achievement in China’s pharmaceutical innovation.

Compared with first-generation BTK inhibitors such as ibrutinib, Zanubrutinib was designed with optimized pharmacokinetics, achieving higher BTK occupancy with fewer off-target effects. This results in improved efficacy and a lower incidence of atrial fibrillation, bleeding events, and other adverse reactions.

At Cosperpharm, we produce Zanubrutinib API under strict GMP conditions, achieving ≥99.5% purity by HPLC. We hold a valid pharmaceutical export license, ensuring smooth customs clearance and providing full documentation support for your regulatory filings.

Product Parameters

The above specifications are a comprehensive reference version based on general standards of EMA (Europe) and FDA (USA).

Why Cosperpharm? – Our Competitive Advantages

Product Applications

Therapeutic Indications - Zanubrutinib is a BTK inhibitor indicated for the treatment of adult patients with:

Zanubrutinib has also been designated as an orphan drug by the FDA for multiple B-cell malignancies, reflecting its significant therapeutic value in rare cancer populations.

Clinical Achievements

Global Milestones:

`2019 (Nov): First FDA-approved China-originated novel drug — a historic breakthrough in China‘s pharmaceutical innovation.

`2020 (Jun): NMPA approval in China, providing a new treatment option for MCL and CLL/SLL patients.

`2025 Tablet Formulation: FDA approved a new tablet formulation for all five indications, reducing the required pill count from 4 capsules to 2 tablets daily, significantly improving patient convenience and compliance.

`Orphan Drug Designations: Granted by FDA for MCL, WM, CLL, and MZL, underscoring its clinical significance in treating rare cancers.

Head-to-Head Clinical Data:

`ASPEN Trial (Phase 3): In Waldenström‘s macroglobulinemia, the zanubrutinib arm achieved a response rate of 77.5%, with an event-free duration of response at 12 months of 94.4%.

`ALPINE Trial (Phase 3): In relapsed/refractory CLL/SLL, zanubrutinib demonstrated superior progression-free survival (PFS) compared to ibrutinib, with lower rates of atrial fibrillation and cardiac events — establishing zanubrutinib as a best-in-class BTK inhibitor.

Market Leadership:

`Following the FDA approval of its tablet formulation in 2025, zanubrutinib became the overall market share leader for BTK inhibitors, surpassing ibrutinib in the U.S. market.

`Zanubrutinib has been included in China’s National Reimbursement Drug List (NRDL), enhancing patient affordability and accessibility.

`Approved in over 60 countries worldwide, including the US, EU, China, Canada, Australia, Brazil, South Korea, Japan, and the UK.

Product Features & Differentiation

Why Zanubrutinib Stands Out Among BTK Inhibitors:

Key Selling Points for Zanubrutinib API:

`High purity & low impurities — suitable for oral solid dosage formulations

`Customizable particle size — optimize your tablet dissolution profile

`Valid export license — Cosperpharm is an authorized Zanubrutinib exporter

Production Details & Quality Assurance

Cosperpharm specializes in the production of Zanubrutinib API within state-of-the-art GMP-compliant multi-purpose workshops, which are equipped with six Class D clean zone production lines. Our facility boasts over 150 reactors, ranging from 20L to 5000L, capable of supporting high/low-temperature reactions, anaerobic processes, and hydrogenation conditions—enabling flexible production scalability from kilogram to metric ton scale.

Every batch of Zanubrutinib API undergoes stringent quality control (QC) testing, including HPLC, GC, LC-MS analysis, residual solvent testing in line with ICH Q3C standards, heavy metal detection, and genotoxic impurity analysis. We ensure full traceability throughout the entire production process, from raw material procurement to the final finished API.

FAQ

Q1: What is your MOQ for Zanubrutinib API?

A: 10g for R&D samples. For commercial orders, the MOQ ranges from 100g to 1kg. Larger quantities are available upon request.

Q2: What is your typical lead time?

A: In-stock R&D samples can be delivered within one week. Bulk orders will be ready in 1–2 months after payment confirmation.

Q3: Which countries have you exported to?

A: We have exported to the USA, Canada, Germany, UK, Spain, India, Brazil, South Korea, Japan, and many other countries. We are well experienced with local customs procedures and regulatory requirements.

Q4: Can you provide third-party testing or customer audits?

A: Yes. We welcome customer on-site audits as well as inspections by SGS, BV or other authorized agencies. Third-party testing can be arranged at the buyer’s expense.

Q5: What certificates do you hold?

A: We hold GMP certification, ISO 9001:2015, pharmaceutical import and export license, and COA is provided for each batch.

Q6: Do you offer customized packaging?

A: Yes. We can provide customized packaging including size, labeling, and inner lining materials according to your specific requirements.

Q7: Is Zanubrutinib API stable for long-term storage?

A: Yes. Zanubrutinib API remains stable for 24 months when stored at 2–8°C in an airtight, light-protected container. Accelerated and long-term stability data are available upon request.

Q8: What makes Zanubrutinib clinically different from ibrutinib?

A: As a second-generation BTK inhibitor, zanubrutinib features optimized selectivity and improved bioavailability. Clinical studies including ALPINE and ASPEN have shown better progression-free survival, as well as lower incidences of atrial fibrillation and bleeding events compared with ibrutinib, making it a best-in-class BTK inhibitor.

Contact Us

Looking to source high-quality Zanubrutinib API? Reach out to Cosperpharm today to request samples or receive a competitive quotation. We are ready to be your trusted long-term China supplier for Zanubrutinib API.