In the new year, Dizal Pharmaceutical has achieved breakthrough progress in both commercialization and innovative R&D. In the first quarter of this year, its products Sunvozertinib (brand name: Sunvozertinib®) and Golidocitinib (brand name: Golidocitinib®) continued to ramp up, with market penetration and sales revenue maintaining rapid growth, propelling the company into a phase of explosive performance.
In the R&D field, the company has multiple innovative achievements set to debut at the American Society of Clinical Oncology (ASCO) Annual Meeting. Among them, the international multi-center Phase III clinical study “WU-KONG28” for Sunvozertinib has been selected for a Late-Breaking Abstract (LBA) oral presentation, making it the first and only drug globally to receive the highest honor of LBA at the ASCO conference in the treatment of non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins).
Dr. Zhang Xiaolin, founder, chairman, and CEO of Dizal Pharmaceutical, stated: “In the first quarter of 2026, Dizal achieved multiple breakthrough milestones. The company’s revenue continues to grow, operational efficiency steadily improves, and global influence strengthens. Sunvozertinib® met its primary endpoint in the ‘WU-KONG28’ study. As the first oral targeted drug globally to succeed in an international multi-center Phase III clinical trial for first-line treatment of EGFR exon20ins NSCLC, it was selected for the LBA session at the ASCO conference, garnering widespread attention from the international academic community. Additionally, DZD6008 was selected for its first ASCO oral presentation, reflecting the company’s continuous breakthroughs and iterative capabilities in the NSCLC treatment field. Looking ahead, we will adhere to our core strategy of original innovation, accelerate the clinical development and commercialization of core pipelines, while continuously optimizing R&D resource allocation and operational efficiency, rewarding shareholders with high-quality business results.”
Strong Start to the First Quarter
Sunvozertinib and Golidocitinib have entered their second year under medical insurance coverage. With the expansion of insurance coverage, both products have successfully achieved a “strong start,” with significantly accelerated year-over-year growth and sequentially increasing revenue increments.
In 2026, the company will steadily enhance the market coverage and penetration of both products, further closing the market penetration loop, driving a leap in commercialization conversion efficiency, and achieving sustained revenue growth.
As commercial revenue scales up, Dizal Pharmaceutical continues to optimize commercialization efficiency, consolidating the results of commercial profitability and accelerating the path toward full profitability.
In the first quarter, the sales expense ratio was 49%, a year-over-year decrease of 28%. For the first quarter of 2026, the net loss attributable to shareholders of the parent company narrowed by 50% year-over-year. The company’s sales expense ratio has achieved a stepwise decline for multiple consecutive quarters. In the first year of product inclusion in medical insurance, commercialization efficiency saw a significant leap. In 2025, the company achieved its first full year of commercial profitability. In the industry, newly launched products typically require several years of commercial cultivation before reaching an inflection point in expense ratios.
Wu Qingyi, Chief Commercial Officer of Dizal Pharmaceutical, stated: “The continuous improvement in commercialization operational efficiency is becoming a solid pillar of the company’s core competitiveness. In the first quarter of this year, the company once again achieved a ‘strong start’ with growth exceeding expectations, laying a good foundation for achieving annual targets.”
Expanding Indications Across Multiple Fronts
During the reporting period, Dizal Pharmaceutical has established seven globally competitive original innovation pipelines, forming a relay-chain expansion ecosystem in the fields of lung cancer and hematologic malignancies, characterized by “deepening indication coverage + focusing on the development of high clinical value innovative drugs.”
In 2026, the company will accelerate the expansion of indications for Sunvozertinib and Golidocitinib. These two innovative products have built differentiated indication moats along the treatment pathway of “breakthrough in later lines, competition in first-line, and combination for enhanced efficacy.”
In the first quarter of this year, Sunvozertinib became the first and only oral targeted drug globally to achieve positive results in an international multi-center randomized controlled Phase III clinical study for first-line treatment of EGFR exon20ins NSCLC, and was successfully selected for an LBA oral presentation at the highest honor session of ASCO.
LBA slots are typically reserved only for groundbreaking studies that may immediately change global clinical practice. This selection for the LBA session at the most authoritative international oncology conference, ASCO, not only highlights the high recognition of its significant clinical value by the global academic community but also establishes a voice for Chinese original drugs on the world’s top oncology academic stage.
Previously, Sunvozertinib as a monotherapy for first-line treatment of EGFR exon20ins NSCLC had received “Breakthrough Therapy Designation” (BTD) from both China and the United States. Based on data from the “WU-KONG28” study, the company will submit new indication applications to drug regulatory authorities in China, the U.S., and Europe, striving for systematic transformation from clinical results to global commercial value, achieving commercial implementation of innovative achievements in multiple markets. Based on the EGFR exon20ins indication, AVIC Securities predicts that its peak sales in the Chinese market could reach 3.076 billion yuan, with global peak sales potentially exceeding 12.9 billion yuan.
Meanwhile, the company has initiated a Phase III clinical study of Sunvozertinib as adjuvant therapy for EGFR exon20ins/PACC NSCLC. If this indication is successfully expanded, it could further broaden the market space.
At this year’s ASCO conference, the company will also present the latest research progress on a combination of Golidocitinib and an anti-PD-1 antibody for first-line treatment of NSCLC without driver gene mutations.
Preclinical studies have shown that JAK inhibitors reverse T-cell exhaustion and improve the tumor immune microenvironment. Combined with immunotherapy, they can potentially reverse resistance to PD-1 inhibitors, providing a mechanistic basis for the combination of Golidocitinib with anti-PD-1/PD-L1 therapy. Expanding from precise targeted therapy to the large population market of immune combination therapy will greatly broaden the commercial potential of this drug.
“First-in-Class” Pipelines Competing in the International Market
During the reporting period, key clinical trials were efficiently advanced, achieving a series of milestones in pipeline development. The company has accumulated seven important designations from the U.S. Food and Drug Administration (FDA), including a “Breakthrough Therapy Designation” for its core product Sunvozertinib, which was also granted accelerated approval by the FDA through priority review.
From the FDA approval of Sunvozertinib to the successful completion of an international multi-center Phase III clinical study, the company has established a replicable, full-chain paradigm for independent R&D and regulatory submission, validated by the global market. This provides a high level of credibility and a pathway reference for subsequent pipelines in clinical advancement and global registration, significantly increasing the certainty of R&D and approval.
In the NSCLC field, where Dizal Pharmaceutical has deep expertise, the latest clinical study of DZD6008 in patients with previously treated EGFR C797X mutant NSCLC will be presented as an oral presentation at the ASCO conference. As a novel, highly selective, fourth-generation EGFR TKI capable of fully penetrating the blood-brain barrier, DZD6008 has the potential to address the unmet clinical need after resistance to third-generation EGFR TKIs.
In the hematologic malignancy field, Dizal Pharmaceutical continues to innovate. Birelentinib, a first-in-class LYN/BTK dual-target inhibitor, has received FDA “Fast Track Designation.”
Currently, birelentinib is undergoing an international multi-center Phase III clinical study for relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (r/r CLL/SLL). Additionally, birelentinib has shown favorable anti-tumor efficacy and safety in patients with relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL).
The company is actively advancing clinical studies of this product as monotherapy and in combination across the full treatment spectrum of CLL/SLL and DLBCL. In the future, Birelentinib is expected to become another core engine driving the company’s sustained rapid growth.
GW5282 is a next-generation EZH1/2 dual inhibitor. By simultaneously and equivalently inhibiting EZH1 and EZH2, it effectively blocks common compensatory pathway activation in tumors, overcoming treatment escape that may arise from single-target inhibition. Preliminary clinical data have demonstrated its longer half-life, better oral bioavailability, and significantly reduced risk of bone marrow toxicity.
The company is accelerating the Phase I/II clinical trials of this product, aiming to complete proof-of-concept as early as possible in both hematologic malignancies and solid tumors.
During the reporting period, the company will accelerate the expansion of indications for marketed products and the clinical development of subsequent pipelines, with multiple clinical studies being conducted simultaneously in China, the U.S., Europe, and other regions. This ensures that study data can gain recognition from major global regulatory authorities, laying a solid foundation for maximizing the global commercial value of the products.
The above-mentioned efficiently advancing multi-tiered R&D plan forms a positive cycle with the company’s continuously strengthening commercial profitability. Benefiting from efficient commercial ramp-up and stable cash flow support, the company can continue to invest in original innovation. With marketed products steadily realizing global value and subsequent pipelines taking over in a timely and orderly manner, Dizal will accelerate its transition to a stage of sustainable profitability, achieving a leap in corporate value.
About Dizal Pharmaceutical
Dizal Pharmaceutical (Stock Code: 688192.SH) is a global innovative biopharmaceutical company focused on the research, development, and commercialization of innovative therapies in the fields of oncology and hematologic diseases. The company adheres to the R&D philosophy of original innovation, aiming to introduce first-in-class drugs and breakthrough potential treatments to fill unmet global clinical needs. Based on its industry-leading translational science and drug molecule design and screening technology platforms, the company has established a pipeline of seven globally competitive products. Among them, two leading products that have met primary endpoints in global pivotal clinical trials—Sunvozertinib®, approved for marketing in both China and the U.S., and Golidocitinib®, approved for marketing in China. For more information, please follow the WeChat public account: Dizal Dizal, or visit www.dizalpharma.com.