Dizhe Pharma Surpasses 500 Million Yuan in First-Half Revenue, Seals Global Exclusive Licensing Pact with AstraZeneca for Sunvozertinib

Deep News
Aug 20

On August 20, Dizhe Pharma unveiled its 2026 interim financial report, disclosing total operating revenue of 523 million yuan for the reporting period, a 47% surge compared to the same period last year. The company's net losses narrowed substantially, contracting by 44% year-on-year, signaling continued progress toward financial stability.

The phase III clinical study "WU-KONG28," evaluating sunvozertinib as a first-line monotherapy for EGFR exon20ins non-small cell lung cancer (NSCLC), was presented as a late-breaking abstract in an oral session. This therapy stands as the first and only oral targeted monotherapy worldwide validated by an international, multicenter, randomized, controlled phase III trial in this indication. Building on these results, the company has submitted new drug applications for sunvozertinib as a first-line treatment to both China's National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA). Notably, the NMPA has accepted the application and granted it priority review status. To date, sunvozertinib is the only innovative drug globally to have earned dual "Breakthrough Therapy Designations" (BTD) from both China and the U.S. for first-line and later-line treatment of EGFR exon20ins NSCLC.

Preliminary findings for DZD6008, targeting patients resistant to third-generation EGFR TKIs, were selected for an oral presentation at ASCO for the first time. As a novel, fourth-generation EGFR TKI with full blood-brain barrier penetration, DZD6008 has the potential to address a significant unmet medical need. The company is actively exploring its use as a monotherapy or in combination regimens for both first-line and later-line treatment of EGFR-sensitive mutation NSCLC.

Golidocitinib, when combined with an anti-PD-1 antibody, has demonstrated durable antitumor efficacy in NSCLC patients without driver gene mutations. Across various treatment stages and subtypes of peripheral T-cell lymphoma (PTCL), golidocitinib continues to show robust antitumor activity and a manageable safety profile. Meanwhile, biretitnib as a monotherapy has exhibited broad and sustained antitumor effects in relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL). As the next growth driver in the hematologic oncology pipeline, biretitnib is also being evaluated in an international, multicenter phase III study for relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), for which it received FDA "Fast Track designation" in August 2025. Concurrently, a phase II/III study combining biretitnib with R-CHOP as a first-line therapy for DLBCL is being expedited. The company is likewise assessing biretitnib's potential in first-line CLL/SLL treatment.

In July, Dizhe Pharma signed a global exclusive licensing agreement with AstraZeneca PLC, granting the latter exclusive rights to develop and commercialize sunvozertinib worldwide. Under the terms of the agreement, Dizhe Pharma will receive a one-time, non-refundable upfront payment of $600 million, along with milestone payments of up to $400 million for clinical development and up to $500 million for sales achievements. Additionally, the company is entitled to tiered royalties based on a percentage of global net sales of sunvozertinib.

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