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。 ...

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 ...

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 ...