Group 1 - The core focus events for Dize Pharmaceutical in 2026 and beyond include the progress of H-share listing, key milestones in the R&D pipeline, annual business plan review, and commercialization and market expansion [1] - Dize Pharmaceutical submitted its H-share listing application to the Hong Kong Stock Exchange on January 23, 2026, aiming for a dual listing in Hong Kong to enhance its global strategy and attract international investors [2] - The company plans to advance multiple core products into clinical data update stages in 2026, including the global multi-center Phase III study of Shuwotai (Shuwotai) for EGFR Exon20ins non-small cell lung cancer, which has completed patient enrollment [3] Group 2 - Dize Pharmaceutical plans to hold a board meeting in 2026 to review the annual sales plan, which is yet to be finalized and will be disclosed after board approval [4] - The company aims to leverage the inclusion of core products Shuwotai and Guaizhe in the national medical insurance catalog to deepen domestic market coverage and promote overseas commercialization in 2026 [5] - The sales expense ratio decreased to 72% in the first three quarters of 2025, and the company plans to further enhance operational efficiency in 2026 [5]

Core Viewpoint - DIZHE Pharmaceutical (688192.SH) is pursuing an "A+H" listing by submitting an application to the Hong Kong Stock Exchange, aiming to raise funds for clinical development, sales, and operational expenses, while currently being in the commercialization phase with two approved products [2][3]. Financial Performance - The company raised approximately 2.1 billion yuan in its 2021 IPO and 1.8 billion yuan through a private placement in April 2025 [2]. - DIZHE expects to achieve revenue of around 800 million yuan in 2025, representing a year-on-year growth of approximately 122.28%, with a projected net loss of about 770 million yuan [2][5]. - The company reported a net profit of approximately -1.1 billion yuan in 2023 and -846 million yuan in 2024, with an expected reduction in net loss by about 75.96 million yuan in 2025 [7]. Product Pipeline and Market Strategy - DIZHE has two approved products, Shuwotini (舒沃哲) and Gelixitini (高瑞哲), which are expected to significantly enhance patient accessibility after being included in the national medical insurance catalog [4][5]. - The company is focusing on expanding the indications for its existing products and advancing its pipeline, which includes seven products currently in clinical stages [8]. R&D Investment and Challenges - DIZHE is in the early stages of commercialization and continues to incur significant R&D expenses, with an expected R&D expenditure of around 860 million yuan in 2025, reflecting a year-on-year increase of approximately 18.84% [7]. - The company is facing challenges in achieving positive operating cash flow, as it continues to invest heavily in R&D while striving for commercial profitability [6][8]. Market Position and Future Outlook - DIZHE aims to leverage its products' inclusion in the medical insurance directory to enhance market penetration and drive revenue growth, with a sales expense ratio significantly reduced to 72% in the first three quarters of 2025 [6]. - The company is committed to ensuring the advancement of its core global pipeline and key market development while maintaining a focus on sustainable high-quality profitability [8][9].

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 Viewpoint - DIZHE Pharmaceuticals, established in 2017 and listed in 2021, focuses on innovative therapies for malignant tumors and has a competitive product pipeline with two products already on the market [1] Business Performance - For Q3 2025, DIZHE Pharmaceuticals reported revenue of 586 million yuan, ranking 73rd in the industry, while the industry leader, Huadong Medicine, reported revenue of 32.664 billion yuan [2] - The net profit for the same period was -583 million yuan, placing the company 109th in the industry, with the top performer, Heng Rui Medicine, achieving a net profit of 5.76 billion yuan [2] Financial Ratios - As of Q3 2025, the company's debt-to-asset ratio was 51.15%, higher than the industry average of 35.26%, but down from 73.38% year-on-year, indicating reduced debt pressure [3] - The gross profit margin stood at 95.68%, significantly above the industry average of 57.17%, despite a slight decrease from 97.73% in the previous year, reflecting strong profitability [3] Executive Compensation - Chairman and CEO Xiaolin Zhang's compensation for 2024 was 6.0572 million yuan, a decrease of 3.4776 million yuan from 2023 [4] Shareholder Information - As of September 30, 2025, the number of A-share shareholders increased by 5.01% to 8,806, with an average holding of 46,500 shares, up 108.97% from the previous period [5] Revenue and Profit Forecast - According to Huatai Securities, DIZHE Pharmaceuticals is expected to achieve nearly 800 million yuan in revenue from its product Shuwotini in 2025, with a domestic peak potential of over 2 billion yuan [6] - Donghai Securities highlighted the company's strong R&D and commercialization capabilities, predicting revenues of 700 million, 1.225 billion, and 2.314 billion yuan for 2025 to 2027 [7]

Core Insights - Dize Pharmaceutical (Jiangsu) Co., Ltd. reported a revenue of 586 million yuan for the first three quarters of 2025, marking a 73% year-on-year increase [2] - The company achieved quarterly revenues of 160 million yuan, 195 million yuan, and 231 million yuan in Q1, Q2, and Q3 respectively, with a compound growth rate of 20% [2] Commercialization and Operational Efficiency - The core products, Shuwozhe® (Shuwotini tablets) and Gao Ruizhe® (Golisitinib capsules), have shown significant growth in market penetration and sales revenue, driving robust revenue growth [3] - Dize Pharmaceutical achieved commercial profitability for the first time in H1 2025, with revenues covering costs beyond R&D expenses, indicating a developing financial sustainability model [3] R&D and Product Pipeline - The company is actively expanding clinical research for its two marketed products and has entered Phase III clinical trials for its globally innovative LYN/BTK dual-target inhibitor, birelentinib, which has received Fast Track designation from the FDA [3] - Dize Pharmaceutical is focusing on non-small cell lung cancer (NSCLC), covering approximately 70% of NSCLC patients, and has made significant progress in 11 recent studies presented at the 2025 World Lung Cancer Conference [4][5] Market Potential and Future Plans - The company is targeting a potential market worth billions in the hematological malignancies sector with its core pipelines, Gao Ruizhe® and birelentinib, aimed at T-cell and B-cell lymphomas [5] - Dize Pharmaceutical's CEO highlighted the historical revenue peak driven by the commercialization of core products and emphasized the commitment to addressing unmet clinical needs while enhancing value creation capabilities [6]

Core Insights - The company reported a significant revenue increase of 73.23% year-on-year, reaching 586 million yuan in the first three quarters of 2025, driven by the commercialization of its core products, Shuwozhe® and Gaoruizhe® [1][2] - The company achieved commercial profitability for the first time in the first half of 2025, marking a milestone in its financial sustainability [2][3] - The company is advancing its innovative pipeline, with the dual-target inhibitor Birelentinib entering Phase III clinical trials and receiving Fast Track designation from the FDA [1][6] Commercialization and Financial Performance - Revenue growth showed a quarterly upward trend, with Q1, Q2, and Q3 sales of 160 million yuan, 195 million yuan, and 231 million yuan respectively, indicating a compound growth rate of 20% [2][3] - The sales expense ratio decreased to 72% in the first three quarters, down from 124% in the previous year, reflecting improved cost control and operational efficiency [3] Research and Development Progress - The company is actively expanding the indications for its two marketed products and has a robust pipeline with seven globally competitive products, each with first-in-class or best-in-class potential [5][6] - Recent research presented at the World Lung Cancer Conference highlighted positive results for Shuwozhe® in treating various NSCLC mutations, showcasing its efficacy and safety [4][5] Strategic Focus and Market Position - The company is committed to addressing unmet clinical needs globally, enhancing its core competitiveness, and creating value for shareholders [2] - The strategic focus on source innovation and global development has led to significant milestones, including the FDA's accelerated approval of Shuwozhe® [6]

Core Insights - The company reported a significant revenue increase of 73% year-on-year, reaching 586 million yuan in the first three quarters of 2025 [1] - The core products have shown substantial market penetration and sales growth, with ongoing clinical research for two already launched products [1] - The company’s innovative drug birelentinib has entered Phase III clinical trials and received Fast Track designation from the FDA [1] - Another key product, DZD6008, is advancing in dosage expansion studies targeting EGFR mutation non-small cell lung cancer [1] - The CEO highlighted that the revenue growth is attributed to the commercialization of core products and the establishment of a global innovation strategy [1] Financial Performance - Revenue for the first three quarters reached 586 million yuan, marking a 73% increase compared to the previous year [1] - The company achieved a historical high in revenue during this period [1] Product Development - Birelentinib, a dual-target inhibitor, is in Phase III clinical trials [1] - DZD6008, an EGFR TKI, is progressing in clinical studies for EGFR mutation non-small cell lung cancer [1] Strategic Vision - The company is focusing on unmet clinical needs globally and aims to expand treatment boundaries [1] - Milestones in the company’s global innovation blueprint have been reached [1]

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 Insights - Dize Pharmaceutical achieved a revenue of 355 million yuan in the first half of 2025, representing a year-on-year growth of 74.4% [1] - The company reported a net profit attributable to shareholders of -378 million yuan, marking a 12% reduction in losses compared to the previous year [1] - Dize Pharmaceutical has reached commercial profitability, indicating that its drug sales now cover production and promotion costs, excluding R&D expenses [1] Commercialization and Product Development - The company’s core products, Shuwozhe® and Gaoruizhe®, have seen significant sales growth, driven by support from medical insurance [1] - Shuwozhe® received FDA approval in July, becoming the first and only domestically developed innovative drug for EGFR exon 20 insertion mutation non-small cell lung cancer (NSCLC) approved in the U.S. [1] - Dize Pharmaceutical is accelerating its R&D efforts, with a global Phase III clinical trial for Shuwozhe® in first-line treatment of EGFR exon 20 insertion NSCLC completed patient enrollment in the first half of this year [2] Clinical Research and Future Prospects - At the ASCO conference, Dize Pharmaceutical presented clinical results for DZD6008, showing an 83.3% tumor reduction rate in patients previously treated with third-generation EGFR TKIs [2] - The company’s product Birelentinib received FDA "Fast Track" designation in August, which may expedite its Phase III clinical progress for relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) [2] - The founder and CEO emphasized the recognition of the company’s innovative achievements in the global market and the importance of steady revenue growth and cash flow for efficient R&D [3]