On August 22 evening, Dizal (Jiangsu) Pharmaceutical Co., Ltd. (688192.SH, stock price 83.3 yuan, market cap 38.269 billion yuan) released its 2025 interim results. During the reporting period, the company achieved operating revenue of 355 million yuan, representing a 74.40% year-over-year increase. Driven by medical insurance coverage, sales of its flagship products Suvoritinib tablets and Golicitinib capsules continued to expand significantly. Net loss attributable to shareholders was 377 million yuan compared to 345 million yuan in the same period last year.
Regarding overseas expansion, in July this year, Suvoritinib received FDA approval in the United States through priority review, becoming the world's first and only domestically developed innovative drug approved by the FDA for EGFR exon 20 insertion mutation non-small cell lung cancer (NSCLC). It is also China's first independently developed first-in-class new drug approved in the US.
On August 23, Dizal Pharmaceutical responded that for overseas market expansion, the company is actively evaluating diversified cooperation approaches, assessing options based on pipeline synergy, global commercialization capabilities, and development potential to seek optimal solutions.
**Peak Sales Potential for Two Innovative Drugs Expected to Exceed 4 Billion Yuan**
The core driver of Dizal Pharmaceutical's revenue growth comes from two innovative drugs - Suvoritinib and Golicitinib, both targeting previously underserved niche indications with unmet clinical needs.
Suvoritinib primarily targets NSCLC patients with EGFR exon 20 insertion mutations. According to Frost & Sullivan estimates, global newly diagnosed EGFR Exon20 ins NSCLC patients are expected to reach 74,000 and 86,000 by 2024 and 2030 respectively, with China accounting for 35,000 and 42,000 new cases.
Golicitinib is the world's first and only highly selective oral JAK1 inhibitor specifically for peripheral T-cell lymphoma (PTCL). According to Frost & Sullivan, PTCL patient numbers are projected to grow at a 2.2% CAGR from 2024 to 2030, with China and global new cases expected to reach 29,000 and 47,000 respectively by 2030.
Despite the relatively small market size of these "niche indications," the significant treatment gaps often enable rapid uptake within shorter timeframes. Suvoritinib was first approved in August 2023, while both Suvoritinib and Golicitinib were included in medical insurance coverage through price negotiations in 2024, with formal implementation beginning in 2025.
Dizal Pharmaceutical stated in written responses that with medical insurance expansion support, both Suvoritinib and Golicitinib will continue scaling up sales. According to third-party research institutions, following medical insurance inclusion, the combined domestic peak sales of both products could exceed 4 billion yuan. The commercialization of Suvoritinib and Golicitinib has significantly improved the company's revenue-generating capability, potentially helping achieve break-even targets sooner.
**Actively Evaluating Diversified Overseas Market Cooperation Approaches**
The interim report shows Dizal Pharmaceutical's R&D investment reached 408 million yuan in H1, up 6.66% year-over-year. As the first unprofitable company to complete refinancing under the "Science and Technology Innovation Board Eight Measures" framework, Dizal Pharmaceutical successfully raised 1.796 billion yuan, planning to allocate approximately 1 billion yuan toward new drug development projects.
Regarding Suvoritinib and Golicitinib, Dizal Pharmaceutical indicated the company is actively exploring expansion into broader therapeutic areas to continuously break through commercialization growth ceilings. The global Phase III registration study for Suvoritinib as first-line treatment for EGFR exon20ins NSCLC completed patient enrollment in H1. Historical research data suggests Suvoritinib has potential to reshape first-line treatment paradigms.
Long-term follow-up data for Golicitinib maintenance therapy in PTCL patients who achieved remission after first-line systemic treatment was selected for oral presentation at the 2025 International Conference on Malignant Lymphoma (ICML). The 2-year disease-free survival (DFS) rate remained at 74.2%, with 50% of partial response (PR) patients achieving complete response (CR).
For Dizal Pharmaceutical, innovative drug overseas expansion represents a more strategically significant inflection point. Particularly in the US market with stronger payment capabilities, Suvoritinib's peak sales potential in the US market is estimated at $500 million. However, internationalization presents challenges, as the competitive landscape for Exon20 ins NSCLC indications globally remains favorable, with Suvoritinib's primary competitor being Johnson & Johnson's Rybrevant.
According to research reports, clinical data shows Suvoritinib's efficacy approaches that of Rybrevant, but from a safety perspective, Suvoritinib demonstrates significantly better safety profiles than Rybrevant. Going forward, commercialization capabilities will be key to competing in US and other overseas markets.
Regarding overseas market expansion, Dizal Pharmaceutical responded that many domestic innovative pharmaceutical companies have attempted various approaches, with market performance showing successful cases for both self-built overseas commercialization teams and partnerships with multinational pharmaceutical companies. Therefore, the company is actively evaluating diversified cooperation approaches, assessing options based on pipeline synergy, global commercialization capabilities, and development potential to seek optimal solutions.
"The company's primary objective is project value maximization, with R&D potential fostering commercial value, maintaining focus on industrial independence while preserving exploration space for specific overseas strategy implementation," Dizal Pharmaceutical emphasized.
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