香港聯合交易所有限公司與證券及期貨事務監察委員會對本申請版本的內容概不負責，對其準確性或完整 性亦不發表任何意見，並明確表示概不就因本申請版本全部或任何部分內容而產生或因倚賴該等內容而引 致的任何損失承擔任何責任。 DIZAL PHARMACEUTICAL CO., LTD. 迪哲（江蘇）醫藥股份有限公司 （「本公司」） （於中華人民共和國註冊成立的股份有限公司） 的申請版本 警告 本申請版本乃根據香港聯合交易所有限公司（「聯交所」）及證券及期貨事務監察委員會（「證監 會」）的要求而刊發，僅用作提供資訊予香港公眾人士。 本申請版本為草擬本，其內所載資訊並不完整，亦可能會作出重大變動。閣下閱覽本文件，即 代表閣下知悉、接納並向本公司、聯席保薦人、整體協調人、聯席全球協調人、顧問或承銷團 成員表示同意： 倘於適當時候向香港公眾人士提出要約或邀請，有意投資者務請僅依據與香港公司註冊處處長 註冊的本公司招股章程作出投資決定；招股章程的文本將於發售期內供公眾查閱。 (a) 本文件僅為向香港公眾人士提供有關本公司的資料，概無任何其他目的；投資者不應根 據本文件中的資料作出任何投資決定； (b) 在聯交所網站登載本文件或其 ...

The Stock Exchange of Hong Kong Limited and the Securities and Futures Commission take no responsibility for the contents of this Application Proof, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this Application Proof. Application Proof of DIZAL PHARMACEUTICAL CO., LTD. 迪哲(江蘇)醫藥股份有限公司 (the "Company") (A joint stock company incorporated in the People's R ...

Core Viewpoints - The company reported a significant increase in revenue and a reduction in net loss, indicating strong commercial growth driven by its dual product strategy in the healthcare sector [1] - The global Phase III trial for Shuwotini has completed enrollment, with ongoing expansion into resistant NSCLC and other indications, showcasing its clinical value [2] - The efficacy of Gaurizhe has been recognized with top-level recommendations, and the company is exploring its combination with PD-1 for resistant NSCLC, indicating potential in solid tumor applications [3] Financial Performance - In the first half of the year, the company achieved a revenue of 355 million yuan, representing a 74% increase, while net loss narrowed to 379 million yuan [1] - The sales expense ratio decreased by 24 percentage points to 76%, and cash and cash equivalents increased by 172% to 2.251 billion yuan [1] Pipeline Development - The company has a diverse pipeline with multiple innovative products, including Birelentinib, which has shown significant anti-tumor activity and received FDA fast track designation [4] - DZD6008 is positioned as a fourth-generation EGFR TKI targeting resistant mutations, with registration clinical trials expected to start in 2026 [4] - GW5282 demonstrates potential in both hematological and solid tumors, validating the company's diversified innovation strategy [4] Revenue Forecast and Investment Recommendations - The company is projected to achieve revenues of 860 million, 1.47 billion, and 2.2 billion yuan in 2025, 2026, and 2027, respectively, with year-on-year growth rates of 138.6%, 71.0%, and 49.9% [5] - The company is expected to remain in a loss position in 2025 and 2026, with net profits projected to turn positive in 2027 [5] - The dual product strategy and ongoing clinical developments support a "buy" rating based on the FCFF valuation method [5]

Core Viewpoint - The report highlights the significant progress and achievements of Dize (Jiangsu) Pharmaceutical Co., Ltd. in the first half of 2025, focusing on innovative drug development, sales growth, and corporate governance improvements [1][2][7]. Group 1: Product Development and Clinical Trials - The company received FDA accelerated approval for its core product, ZEGFROVY, making it the first domestically developed drug approved in the U.S. for EGFR Exon20ins NSCLC [1]. - DZD8586, a new dual-target inhibitor for B-cell non-Hodgkin lymphoma, showed an objective response rate (ORR) of 84.2% in heavily pre-treated patients [3][4]. - DZD6008, a selective EGFR TKI, demonstrated promising early clinical data in patients with EGFR-mutant NSCLC, with 83.3% of patients showing tumor shrinkage [6]. Group 2: Financial Performance - The company achieved sales revenue of 355 million yuan in the first half of 2025, representing a year-on-year growth of 74.4% [7]. Group 3: Fundraising and Investment - The company successfully completed a fundraising round, raising 1.796 billion yuan to accelerate core product development and establish a self-research production base [7]. Group 4: Corporate Governance - The company has enhanced its governance structure by implementing a new market value management system and revising internal management regulations to ensure compliance and operational efficiency [8][9]. Group 5: Investor Relations - The company emphasizes investor relations by actively communicating through various channels, including announcements and direct interactions, to enhance transparency and investor understanding of its operations [9][10].

Group 1 - The core viewpoint of the articles highlights the significant revenue growth and commercialization progress of DiZhe Pharmaceutical, with a reported revenue of 360 million yuan in 2024, marking a year-on-year increase of 294.24% [1] - The company has successfully launched two commercialized products, which have seen nearly doubled sales revenue, achieving a year-on-year growth of 96% in the first quarter of this year [1] - DiZhe Pharmaceutical has established a competitive product pipeline with seven products, including two that are in global clinical trials and have been approved for marketing in China [1][2] Group 2 - In 2024, the company invested 724 million yuan in R&D, accounting for 201.08% of its revenue, with an additional 210 million yuan spent in the first quarter [2] - The company plans to allocate nearly 1 billion yuan from its recent fundraising to the development of core pipeline drugs, including Shuwotini and DZD8586 [2] - DiZhe Pharmaceutical's innovative drug development is characterized by long cycles and high costs, with potential uncertainties in future sales revenue due to various market factors [3] Group 3 - The company is expected to remain unprofitable in the short term, with cumulative losses likely to increase due to ongoing investments in drug registration and market promotion [3] - Analysts believe that DiZhe Pharmaceutical's focus on oncology and innovative products will drive rapid growth in performance as commercialized products gain market traction [3]