Core Viewpoint - Dize Pharmaceutical is seeking to list on the Hong Kong Stock Exchange to alleviate its ongoing financial pressures despite recent revenue growth and reduced losses from its core products [1][4]. Financial Performance - In 2024, Dize Pharmaceutical's revenue is projected to be 360 million RMB, with losses narrowing to 940 million RMB; in the first three quarters of 2025, revenue is expected to rise to 586 million RMB, a year-on-year increase of over 73%, while losses are expected to decrease to 583 million RMB [1][4]. - The company has accumulated losses exceeding 4.567 billion RMB since its establishment in 2017, with R&D expenses totaling 3.853 billion RMB from 2018 to 2024 [6]. Product Development - Revenue growth is primarily driven by two core products: Shuwozhe® (Shuwotini tablets) and Gaoruizhe® (Golisitin capsules), which were launched in August 2023 and June 2024, respectively, and are expected to be included in the national medical insurance directory by the end of 2024 [4][6]. - The flagship product, Shuwozhe®, is projected to contribute revenues of 311 million RMB in 2024 and 422 million RMB in the first three quarters of 2025 [4]. Funding and Capital Strategy - Dize Pharmaceutical has relied heavily on capital markets for funding, raising approximately 2.103 billion RMB through its IPO on the STAR Market in 2021 and planning to raise about 1.796 billion RMB through a private placement in 2025 [6]. - The company aims to use the proceeds from its Hong Kong listing to enhance its R&D efforts and support the clinical development of its products [7]. Market Positioning - The decision to list in Hong Kong is part of Dize Pharmaceutical's strategy to deepen its global presence and enhance its international brand image, while also addressing the structural challenges of "increasing revenue without increasing cash" [4][7].

Core Viewpoint - Dize Pharmaceutical Co., Ltd. has submitted its listing application to the Hong Kong Stock Exchange, focusing on its innovative cancer treatment products, particularly Shuwozhe and GaoRuizhe, which are pivotal for the company's revenue generation [1][2]. Group 1: Company Overview - Dize Pharmaceutical is a commercial-stage biopharmaceutical company specializing in oncology and hematological diseases [1]. - The company’s main product, Shuwozhe, is the only approved small molecule EGFR tyrosine kinase inhibitor for treating EGFR 20 insertion mutation lung cancer globally [1]. - GaoRuizhe is the first and only JAK1 inhibitor approved for treating relapsed or refractory peripheral T-cell lymphoma [2]. Group 2: Financial Performance - Revenue for Dize Pharmaceutical during the reporting period (2023, 2024, and the first three quarters of 2025) was RMB 91.29 million, RMB 360 million, and RMB 586 million respectively [2][3]. - Shuwozhe's revenue contribution was 100%, 86.4%, and 72% over the same periods, indicating a decline in its revenue share but still being the primary income source [2]. - The company reported net losses of RMB 1.11 billion, RMB 940 million, and RMB 649 million for the respective years [2][3]. Group 3: Cost Structure and Profitability - The company has incurred significant R&D expenses, amounting to RMB 806 million, RMB 724 million, and RMB 644 million, which are substantially higher than its revenue [4]. - Gross profit margins were relatively high at 96.5%, 97.4%, and 95.7%, attributed to strong R&D capabilities and pricing power from innovative products [4]. - The company has faced continuous net losses since its establishment, accumulating over RMB 4 billion in losses from 2018 to 2024 [3][4]. Group 4: Market Position and Client Concentration - Dize Pharmaceutical's revenue is highly concentrated, with the top five customers accounting for 90.8%, 89.6%, and 81.7% of total revenue during the reporting periods, and the largest customer contributing around 40% [5]. - The company also relies on a limited number of suppliers, with the top five suppliers representing 60.6%, 57.0%, and 57.8% of total procurement [5]. - Dize Pharmaceutical was founded in October 2017 and was listed on the Shanghai Stock Exchange in December 2021, with a current market capitalization of RMB 27.84 billion [5].

Company Overview - Dize Pharmaceutical Co., Ltd. is a commercial-stage biopharmaceutical company focused on oncology and hematology diseases, with its core product, Shuwozhe®, being the only approved small molecule EGFR tyrosine kinase inhibitor for treating EGFR 20 insertion mutation lung cancer globally [3] - The company was established in 2017, originating from AstraZeneca's global oncology translational science center, and possesses significant competitive advantages, including a strong research heritage and a mature scientific team with experience in drug discovery and development [3] - Dize has a robust product pipeline, including two approved drugs (Shuwozhe® and Gaoruizhe®), one candidate drug in the registration clinical stage, three assets in the concept validation stage, and one asset in the early clinical stage [3] Product Details - Shuwozhe® has been approved in China and the U.S., recognized as the first lung cancer drug developed in China to receive breakthrough therapy designation from both the FDA and the National Medical Products Administration of China [4] - Gaoruizhe® is the first and only approved JAK1 inhibitor for treating relapsed or refractory peripheral T-cell lymphoma, having received fast track and orphan drug designations from the FDA [4] Financial Performance - The company reported revenues of approximately 91.29 million RMB for the fiscal year 2023, projected to increase to 360 million RMB in 2024 and 586 million RMB in 2025 [5][7] - Research and development expenses were approximately 806 million RMB in 2023, decreasing to 724 million RMB in 2024 and 644 million RMB in 2025 [6][7] - The gross profit margin for the company was approximately 96.5% in 2023, 97.4% in 2024, and 95.7% in 2025 [8] Industry Overview - The global oncology drug market is expected to grow from $167 billion in 2020 to $262 billion by 2024, with a compound annual growth rate (CAGR) of 11.9%, and projected to reach $724.9 billion by 2035 [9] - In China, the oncology drug market is anticipated to expand from $25.8 billion in 2020 to $37.2 billion by 2024, with a CAGR of 13.1%, reaching $143.7 billion by 2035 [9] - Non-small cell lung cancer (NSCLC) accounts for approximately 85% of lung cancer cases, with the global incidence expected to rise from about 1.9 million cases in 2020 to 2.9 million by 2035 [12] - The global NSCLC drug market is projected to grow from $22.5 billion in 2020 to $49.2 billion by 2024, with a CAGR of 21.6%, and expected to reach $97.5 billion by 2035 [12]

Company Overview - DIZHE Pharmaceutical is a commercial-stage biopharmaceutical company focused on oncology and hematology diseases, with its core product, Shuwozhe®, being the only approved small molecule EGFR TKI for treating EGFR 20 insertion mutation lung cancer globally [2] - Founded in 2017, DIZHE originated from AstraZeneca's Global Oncology Translational Science Center, possessing significant competitive advantages in drug discovery and development [2] - The company has a robust product pipeline, including two approved drugs (Shuwozhe® and Gaoruizhe®), one candidate in the registration clinical stage, three assets in the concept validation stage, and one in early clinical stage [2] Product Information - Shuwozhe® is the first lung cancer drug developed in China to receive both FDA and NMPA breakthrough therapy designations, and it is the only drug recommended by the NCCN guidelines for treating EGFR 20 insertion mutation NSCLC [3] - Gaoruizhe® is the first and only approved JAK1 inhibitor for treating relapsed or refractory peripheral T-cell lymphoma, having received fast track and orphan drug designations from the FDA [3] Financial Performance - Revenue for the fiscal years 2023, 2024, and the nine months ending September 30, 2025, were approximately RMB 91.29 million, RMB 359.90 million, and RMB 586.30 million respectively [4] - Research and development expenses for the same periods were approximately RMB 806 million, RMB 724 million, and RMB 644 million respectively [5] - Gross profit margins for 2023, 2024, and the nine months ending September 30, 2025, were approximately 96.5%, 97.4%, and 95.7% respectively [8] Industry Overview - The global oncology drug market is projected to grow from USD 167 billion in 2020 to USD 262 billion by 2024, with a CAGR of 11.9%, and is expected to reach USD 724.9 billion by 2035 [9] - In China, the oncology drug market is expected to grow from USD 25.8 billion in 2020 to USD 37.2 billion by 2024, with a CAGR of 13.1%, reaching USD 143.7 billion by 2035 [9] - Non-small cell lung cancer (NSCLC) accounts for approximately 85% of lung cancer cases, with the global incidence expected to rise from about 1.9 million cases in 2020 to 2.9 million by 2035 [11] - The global NSCLC drug market is anticipated to grow from USD 22.5 billion in 2020 to USD 49.2 billion by 2024, with a CAGR of 21.6%, and is projected to reach USD 97.5 billion by 2035 [11] - The market for EGFR 20 insertion mutation NSCLC is expected to grow from USD 700 million in 2020 to USD 1 billion by 2024, with a CAGR of 9.0%, and is projected to reach USD 8 billion by 2035 [13]

Company Overview - Dize Pharmaceutical Co., Ltd. is a commercial-stage biopharmaceutical company focused on oncology and hematological diseases, with its core product, Shuwozhe®, being the only approved small molecule EGFR tyrosine kinase inhibitor for treating EGFR 20 insertion mutation lung cancer globally [3][4] - Founded in 2017, Dize originated from AstraZeneca's global oncology translational science center, possessing significant competitive advantages in drug discovery and development [3] - The company has a robust product pipeline, including two approved drugs (Shuwozhe® and Gaoruozhe®), one candidate in the registration clinical stage, three assets in the concept validation stage, and one in early clinical stage [3] Financial Performance - Revenue for the fiscal years 2023, 2024, and the nine months ending September 30, 2025, were approximately RMB 91.29 million, RMB 360 million, and RMB 586 million respectively [5][7] - Research and development expenses for the same periods were approximately RMB 806 million, RMB 724 million, and RMB 644 million respectively [6][8] - Gross profit margins for 2023, 2024, and the nine months ending September 30, 2025, were approximately 96.5%, 97.4%, and 95.7% respectively [9][10] Industry Overview - The global oncology drug market is projected to grow from USD 167 billion in 2020 to USD 262 billion by 2024, with a compound annual growth rate (CAGR) of 11.9%, and expected to reach USD 724.9 billion by 2035 [11] - In China, the oncology drug market is expected to grow from USD 25.8 billion in 2020 to USD 37.2 billion by 2024, with a CAGR of 13.1%, reaching USD 143.7 billion by 2035 [11] - Non-small cell lung cancer (NSCLC) accounts for approximately 85% of lung cancer cases, with the global incidence expected to rise from about 1.9 million cases in 2020 to 2.9 million by 2035 [14] - The global NSCLC drug market is projected to grow from USD 22.5 billion in 2020 to USD 49.2 billion by 2024, with a CAGR of 21.6%, and expected to reach USD 97.5 billion by 2035 [14]

Group 1 - The core viewpoint of the article is that Dize Pharmaceutical (Jiangsu) Co., Ltd. has submitted its listing application to the Hong Kong Stock Exchange, with Goldman Sachs and Huatai International as joint sponsors [1] - Dize Pharmaceutical is a commercial-stage biopharmaceutical company focusing on the treatment of oncology and hematological diseases [1] - The company's flagship product, Shuwozhe®, is the only approved small molecule epidermal growth factor receptor tyrosine kinase inhibitor globally for treating EGFR exon 20 insertion mutation lung cancer [1]

Group 1 - The core viewpoint of the article is that Dize Pharmaceutical (688192.SH) has submitted its listing application to the Hong Kong Stock Exchange, with Goldman Sachs and Huatai International as joint sponsors [1] - Dize Pharmaceutical is a commercial-stage biopharmaceutical company focusing on the treatment of oncology and hematological diseases [1] - The company's flagship product, Shuwozhe®, is the only approved small molecule epidermal growth factor receptor tyrosine kinase inhibitor globally for treating EGFR exon 20 insertion mutation lung cancer [1]

Group 1 - The core viewpoint of the article is that Dize Pharmaceutical (Jiangsu) Co., Ltd. has submitted its listing application to the Hong Kong Stock Exchange, with Goldman Sachs and Huatai International as joint sponsors [1] - Dize Pharmaceutical is a commercial-stage biopharmaceutical company focusing on the treatment of oncology and hematological diseases [1] - The company's listed product, Shuwozhe, is the only approved small molecule epidermal growth factor receptor tyrosine kinase inhibitor globally for treating EGFR exon 20 insertion mutation lung cancer [1]

证券代码：688192 证券简称：迪哲医药 公告编号：2026-006 迪哲（江苏）医药股份有限公司 关于向香港联交所递交境外上市外资股（H 股）发行 并上市的申请并刊发申请资料的公告 本公司董事会及全体董事保证公告内容不存在任何虚假记载、误导性陈述或 者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 迪哲（江苏）医药股份有限公司（以下简称"公司"）已于 2026 年 1 月 23 日向香港联合交易所有限公司（以下简称"香港联交所"）递交了发行境外 上市外资股（H 股）并在香港联交所主板挂牌上市（以下简称"本次发行并上 市"）的申请，并于同日在香港联交所网站刊登了本次发行并上市的申请资料。 该申请资料为公司按照香港证券及期货事务监察委员会（以下简称"香港证监 会"）及香港联交所的要求编制和刊发，为草拟版本，其所载资料可能会适时 作出更新和修订。 鉴于本次发行并上市的认购对象仅限于符合相关条件的境外投资者及依据 中国相关法律法规有权进行境外证券投资的境内合格投资者，公司将不会在境 内证券交易所的网站和符合境内监管机构规定条件的媒体上刊登该申请资料， 但为使境内投资者及时了解该等申请资料披露的本次 ...

每经AI快讯，1月23日，港交所文件显示，迪哲(江苏)医药股份有限公司向港交所提交上市申请书。 ...