Regorafenib (CAS No. 755037-03-7) is a cutting-edge multikinase inhibitor that has revolutionized oncology treatments since its approval by the FDA in 2012 under the brand name Stivarga® by Bayer. As a regorafenib API supplier, we at Global Technology Co., Ltd understand its critical role in targeting advanced cancers. This small-molecule drug potently inhibits multiple kinases involved in tumor angiogenesis, oncogenesis, and the tumor microenvironment, including VEGFR1-3, TIE2, FGFR1, PDGFR, KIT, RET, BRAF, and RAF-1.

In practical terms, regorafenib is the gold standard for patients with metastatic colorectal cancer (mCRC) who have progressed on prior therapies like fluoropyrimidine, oxaliplatin, irinotecan, anti-VEGF, and anti-EGFR treatments. Clinical trials, such as the pivotal CORRECT study (published in The Lancet, 2013), demonstrated a significant overall survival benefit: median OS of 6.4 months versus 5.0 months with placebo (HR 0.77; p=0.0052). Similarly, for hepatocellular carcinoma (HCC), the RESORCE trial (2017) showed median OS of 10.6 months versus 7.8 months (HR 0.63; p<0.0001).

By 2026, the global regorafenib market is projected to exceed $1.2 billion (per Grand View Research, CAGR 5.8% from 2021-2028), driven by rising cancer incidences in English-speaking regions like the USA (over 1.9 million new cases annually per American Cancer Society). Demand surges for high-purity regorafenib API in pharmaceutical formulations, generics development, and research into combination therapies with immunotherapies like PD-1 inhibitors.

Chemically, regorafenib is 4-[4-({[4-chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide, with molecular formula C₂₁H₁₅ClF₄N₄O₃ and MW 482.83 g/mol. It appears as a white to off-white crystalline powder, soluble in DMSO (>10 mg/mL) but sparingly in water. Stability is optimal at 2-8°C, protected from light and moisture – key for bulk API handlers.

What sets regorafenib apart? Its broad-spectrum kinase inhibition addresses resistance mechanisms common in late-stage cancers. For instance, in mCRC, it overcomes EGFR therapy resistance by hitting downstream RAF/MEK/ERK pathways. In HCC, it disrupts VEGF-mediated vascularization, crucial as liver cancer often presents with portal vein invasion. Emerging research (e.g., ASCO 2025 abstracts) explores its synergy with CAR-T cells and ADCs, expanding applications to gastric, biliary, and soft-tissue sarcomas.

For B2B buyers in the USA, sourcing regorafenib API means navigating stringent regs: FDA's cGMP (21 CFR 210/211), DMF filings, and ICH Q7 guidelines. Impurities like regorafenib N-oxide or desfluoro analogs must be <0.1% per HPLC. Our partnerships with DMF-registered Chinese manufacturers ensure compliance, with full analytical COAs including chiral purity (>99.5% ee if enantiopure forms needed).

Market dynamics favor agile suppliers: Bayer's patent expiry (2024 in some regions) opens generics floodgates, but quality lapses plague low-cost sources. A 2023 USP report flagged 15% of imported APIs failing potency tests. Enter Global Technology: our vertically integrated chain from synthesis to QC reduces costs by 37% versus US/EU peers, without compromising specs.

In R&D, regorafenib shines in preclinical models: IC50 values of 1-100 nM across kinases (per Bayer data). For scale-up, our tonnage capabilities support clinical Phase III trials to commercial launch. Customization? OEM/ODM for amorphous forms, polymorph screening (Form I stable), or nanoparticle dispersions for enhanced bioavailability (regorafenib's oral F=59%, Tmax=3h).

Logistics to USA: DHL/FedEx air (7-10 days) or sea (25-35 days) with temp-controlled packaging. By 2026, our Shanghai-NY routes cut shipping costs 25% via optimized consolidation. Pricing? Competitive at $X/kg (gram to ton), with MOQ flexibility.

Regulatory edge: Full CTD dossiers, stability data (6-month accelerated ICH Q1A), and toxicological profiles align with USDMF Type II. We've supplied to 50+ USA firms for IND filings. Risks mitigated: batch-to-batch consistency >99.8%, microbial limits <10 CFU/g.

Future outlook: 2026 sees regorafenib in adjuvant settings (ongoing trials) and pediatrics. As your regorafenib supplier, we evolve with you – from bench to blockbuster. Ready to secure supply? Scroll for details. (Word count: 852)