The China Securities Regulatory Commission (CSRC) has issued a notice requesting supplementary materials for overseas listings. The CSRC's international department has asked eight companies to provide additional information, including Dizal (Jiangsu) Pharmaceutical Co., Ltd., which was requested to clarify the interrelationships among its directors and senior management.
According to a Hong Kong Stock Exchange filing on January 23, Dizal (Jiangsu) Pharmaceutical Co., Ltd. submitted a listing application for the main board. Goldman Sachs and Huatai International are serving as joint sponsors for the offering.
The CSRC has requested Dizal Pharmaceutical to provide clarification on the following matters, requiring legal verification and a clear legal opinion: First, the company must explain the establishment circumstances during its limited liability company period and changes in share capital and shareholders since establishment, in accordance with the applicable regulatory guidelines. Second, clarification is required regarding the interrelationships among directors and senior management, following the relevant overseas listing regulatory guidelines. Third, the company must confirm whether its business scope and actual operations involve human stem cells or genetic diagnosis and treatment technology development from the Foreign Investment Access Special Management Measures (Negative List) 2024 edition, providing clear supporting evidence.
According to its prospectus, Dizal Pharmaceutical is a biopharmaceutical company in the commercial stage, with core therapeutic focus areas in oncology and hematological diseases. The company's marketed product, Sunvozert®, is the only small-molecule EGFR tyrosine kinase inhibitor globally approved for treating EGFR exon 20 insertion mutation-positive non-small cell lung cancer.
Dizal Pharmaceutical was established in 2017, originating from AstraZeneca as the former AstraZeneca Global Oncology Translational Science Center - Asia Innovative Medicine and Early R&D Center. The company possesses significant competitive advantages including deep scientific heritage, a scientific team with comprehensive experience in drug discovery and development, and insights into commercializing innovative targeted therapies.
Leveraging its expertise in disease mechanism research and advanced translational science and drug design platforms, Dizal Pharmaceutical has built a rich and competitive product pipeline. This includes two approved drugs (Sunvozert® and Gorezert®), one candidate drug in registrational clinical stage, three assets in post-proof-of-concept stage, and one asset in early clinical stage.
Comments