New stock news | Di Zhe Pharmaceutical (688192.SH) submits documents to the Hong Kong Stock Exchange. The two approved drugs are Shuwozhe and Gaoruizhe.

According to the disclosure from the Hong Kong Stock Exchange on January 23, DiZhe (Jiangsu) Pharmaceutical Co., Ltd. (referred to as DiZhe Pharmaceutical (688192.SH)) has submitted its listing application to the Main Board of the Hong Kong Stock Exchange, with Goldman Sachs and Huatai International as its joint sponsors. Company Overview According to the prospectus, DiZhe Pharmaceutical is a commercial-stage biopharmaceutical company, with its core therapeutic areas being oncology and hematologic diseases. The company's listed product ShuvoZhe is the only small molecule epidermal growth factor receptor tyrosine kinase inhibitor approved globally for the treatment of EGFR exon 20 insertion mutant lung cancer. Established in 2017, DiZhe Pharmaceutical originated from AstraZeneca and was formerly AstraZeneca's Global Oncology Translation Science Center - Asia Innovative Drug and Early Development Center. The company has significant competitive advantages, including a strong research heritage, a scientific team with extensive experience and a track record in drug discovery and development, and insights into the commercialization of innovative targeted therapies. Relying on the company's specialized expertise in disease mechanism research and advanced translational science and drug design platforms, DiZhe Pharmaceutical has built a rich and competitive product pipeline. This includes two approved drugs ("ShuvoZhe and GaoRuiZhe"), a candidate drug in the registrational clinical stage, three assets in the post-POC stage, and one asset in the early clinical stage. ShuvoZhe has been launched in China and approved in the United States, making it the first lung cancer drug developed in China to receive breakthrough therapy designation from both the FDA and China's NMPA. As of January 18, 2026, ShuvoZhe is the only small molecule drug recommended for the treatment of EGFR exon 20 insertion mutant NSCLC in the international authoritative NCCN guidelines, and it is the only targeted therapy included in China's national medical insurance catalog for the treatment of this refractory or difficult-to-treat indication. GaoRuiZhe is a new generation highly selective Janus kinase 1 inhibitor, and as of the same date, is the first and only globally approved JAK1 inhibitor for the treatment of relapsed or refractory peripheral T-cell lymphoma. Due to its significant clinical value, GaoRuiZhe has been granted fast track and orphan drug designation by the FDA. GaoRuiZhe has also been included in China's national medical insurance catalog. Financial Data Revenue For the fiscal years 2023, 2024, and the nine months ended September 30, 2025, the company achieved revenues of RMB 91.289 million, RMB 360 million, and RMB 5.86 billion respectively. R&D Expenses For the fiscal years 2023, 2024, and the nine months ended September 30, 2025, the company's R&D expenses were approximately RMB 806 million, RMB 724 million, and RMB 644 million respectively. Gross Profit Margin For the fiscal years 2023, 2024, and the nine months ended September 30, 2025, the company's gross profit margin was approximately 96.5%, 97.4%, and 95.7% respectively. Industry Overview According to data from Zebra Insight, the global market for cancer therapeutics drugs increased from USD 167 billion in 2020 to USD 262.1 billion in 2024, with a compound annual growth rate of 11.9%, and is expected to reach USD 724.9 billion by 2035, with a compound annual growth rate of 9.7%. In China, the market size increased from USD 25.8 billion in 2020 to USD 37.2 billion in 2024, and is expected to reach USD 143.7 billion by 2035, with a compound annual growth rate of 13.1% from 2024 to 2035. Lung cancer remains one of the most burdensome cancers globally, with non-small cell lung cancer (NSCLC) accounting for approximately 85% of cases, and incidence rates continuing to rise in major regions. According to Zebra Insight data, global NSCLC cases are projected to increase from approximately 1.9 million in 2020 to 2.9 million by 2035. China is driving much of this growth, with cases expected to increase from approximately 800,000 in 2020 to 1.3 million by 2035. Additionally, 55% of NSCLC patients are diagnosed at an advanced stage. Therefore, NSCLC remains a major cause of cancer-related mortality, with significant and unmet medical needs globally and in China. According to Zebra Insight data, the global NSCLC drug market increased from USD 22.5 billion in 2020 to USD 49.2 billion in 2024, with a compound annual growth rate of 21.6%, and is expected to reach USD 97.5 billion by 2035, with a compound annual growth rate of 6.4% from 2024 to 2035. China remains a key growth engine, with the market size increasing from USD 5.3 billion in 2020 to USD 7.1 billion in 2024, and expected to reach USD 23 billion by 2035, with a compound annual growth rate of 11.3% from 2024 to 2035. The global market size for EGFR exon 20 insertion mutant NSCLC increased from USD 700 million in 2020 to USD 1 billion in 2024, with a compound annual growth rate of 9.0%, and is expected to reach USD 8 billion by 2035, with a compound annual growth rate of 20.5% from 2024 to 2035. Board of Directors Data The Board of Directors will consist of eight members, including two executive directors, two non-executive directors, and four independent non-executive directors. According to the Articles of Association, directors are elected and appointed by shareholders for a term of three years, with the possibility of reelection upon term expiration. Ownership Structure As of January 18, 2026, the company has (i) Dr. Zhang Xiaolin owning 1.83%; (ii) Jiangsu Wuxi Dizhe Enterprise Management Partnership Enterprise (Limited Partnership) owning 12.38%. Wuxi Dizhe is a limited partnership owned by: (a) Wuxi Dunhe Business Consulting Co., Ltd., as its general partner owning 0.000065%, with Dr. Zhang Xiaolin, Chairman and CEO, and Dr. Yang Zhenfan, Deputy General Manager and Chief Medical Officer, owning 90% and 10% respectively; (b) Dr. Zhang Xiaolin as a limited partner owning 61.11%; (c) Dr. Yang Zhenfan as a limited partner owning 14.65%; (d) Mr. Lv Hongbin, Secretary to the Board, as a limited partner owning 5.91%; (e) Ms. Chen Suqin, Deputy General Manager, as a limited partner owning 4.35%; (f) 32 other limited partners, each holding less than 2% of the partnership interests; and (iii) ZYTZ Partners Limited owning 1.11%. ZYTZ is a limited partnership controlled by Dr. Zhang Xiaolin through Dezent Partners Limited, a limited liability company registered in the British Virgin Islands, with Dr. Zhang Xiaolin, Dr. Yang Zhenfan, Dr. Xu Hanzhong, and Dr. Zeng Qingbei holding 75%, 10%, 7%, and 8% respectively. Wuxi Dizhe and ZYTZ are both employee shareholding platforms of the company. Intermediary Team Joint Sponsors: Goldman Sachs (Asia) LLC, Huatai Financial Holdings (Hong Kong) Limited Company Legal Advisors: For Hong Kong and U.S. law: Kirkland & Ellis LLP; for Chinese law: Zhong Lun Law Firm Legal Advisors to Joint Sponsors: For Hong Kong and U.S. law: Freshfields Bruckhaus Deringer LLP; for Chinese law: Fangda Partners Reporting Accountants and Independent Auditors: Deloitte Touche Tohmatsu Limited Industry Consultant: Zebra Insight Industry Consulting Limited Compliance Advisor: FIRST SHANGHAI Securities Co., Ltd.