Dizal (Jiangsu) Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company") has officially received approval from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) of its independently developed Sulvoteran® (English trade name: ZEGFROVY®, generic name: Sulvotinib Tablets). It is indicated for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations (Exon20ins) as detected by an FDA-approved testing kit, whose disease has progressed during or after platinum-containing chemotherapy.

Sulvoteran® was approved for marketing through the Priority Review process, becoming the world's first and currently the only domestically innovative drug approved in the U.S. for EGFR Exon20ins NSCLC. It has achieved significant innovations in molecular design at the source, breaking through intractable targets, and is China's first globally first-in-class innovative drug independently developed and approved in the U.S.

I. Information Related to the Drug
Sulvoteran® is an oral, irreversible, and highly selective EGFR tyrosine kinase inhibitor (TKI) targeting multiple EGFR mutation subtypes. It was approved for marketing in China in August 2023 and is currently the only standard treatment option for second-line/later-line EGFR Exon20ins NSCLC, filling a nearly 20-year clinical gap in this field. Based on its excellent efficacy and safety, Sulvoteran® is the only drug in the global EGFR Exon20ins NSCLC treatment field with "Breakthrough Therapy Designation (BTD)" in both China and the U.S. across all lines of therapy. After submitting the NDA in the U.S., it was granted Priority Review status by the FDA.

The approval by the FDA through Priority Review is based on the efficacy and safety data of Sulvoteran® in previously treated EGFR Exon20ins NSCLC patients from the international multi-center registration clinical trial "WU-KONG1B". The results of this study were presented as an oral report at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and recently published in full in the top international journal Journal of Clinical Oncology (impact factor: 42.1). The findings further demonstrated globally that Sulvoteran® has "potent tumor shrinkage, safe and controllable profile, and potential to be the best-in-class".

The FDA also approved Thermo Fisher Scientific's Oncomine™ Dx Express Test as the next-generation sequencing (NGS)-based companion diagnostic (CDx) for Sulvoteran® in the U.S., for detecting EGFR Exon20ins in NSCLC patients. For EGFR Exon20ins NSCLC patients, NGS testing is efficient and accurate. When used in combination with the Ion Torrent™ Genexus™ Dx system, it can provide test results in as fast as 24 hours, offering critical basis for timely clinical medication decisions. Currently, NGS testing technology has become one of the key technologies in the field of tumor genetic testing.

In addition, the global Phase III confirmatory clinical trial "WU-KONG28" evaluating Sulvoteran® as first-line therapy for EGFR Exon20ins NSCLC has recently completed full patient enrollment and is actively ongoing in 16 countries and regions worldwide. A pooled analysis presented at the 2023 European Society for Medical Oncology (ESMO) Annual Meeting showed that the confirmed objective response rate (ORR) of Sulvoteran® monotherapy as first-line treatment for EGFR Exon20ins NSCLC reached 78.6%, with a median progression-free survival (mPFS) of 12.4 months in the 300mg group. Its potent tumor shrinkage effect and safe, controllable profile are expected to further reshape the first-line treatment landscape in this field.

II. Risk Disclosure
The approval and marketing of Sulvoteran® in the U.S. are of great significance to the Company's business development. The Company attaches great importance to drug research and development and strictly controls the quality and safety in the links of drug research and development, manufacturing, and sales. The production and sales of Sulvoteran® after approval may be affected by various factors such as policy environment, market competition, and sales model, with uncertainties. Investors are kindly advised to make prudent decisions and pay attention to preventing investment risks.

The Company will perform its information disclosure obligations in a timely manner regarding subsequent developments in accordance with relevant regulations. For information about the Company, please refer to the announcements published on the website of the Shanghai Stock Exchange and the Company's designated disclosure media: Shanghai Securities News, Securities Times, and Securities Daily.