New Stock News | Dizhe Pharmaceutical (688192.SH) has submitted another application to the Hong Kong Stock Exchange. Shuwozhe has already been listed in mainland China and approved in the United States.

According to the announcement released by the Hong Kong Stock Exchange on August 27, Dijie (Jiangsu) Pharmaceutical Co., Ltd. (abbreviated as Dijie Pharmaceutical (688192.SH)) has submitted its listing application to the main board of the Hong Kong Stock Exchange, with Goldman Sachs and Huatai International serving as co-sponsors. The company previously submitted a listing application to the Hong Kong Stock Exchange on January 23. Company Overview The prospectus shows that Dijie Pharmaceutical is a biopharmaceutical company at the commercialization stage, with a core focus on the treatment of oncology and hematologic diseases. During the track record period, the company developed and commercialized Golitinib (Goryeche), a new generation highly selective Janus kinase 1 (JAK1) inhibitor, in mainland China. Additionally, the company developed, commercialized, and licensed Shuwozhe, the worlds first approved small molecule epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) for treating EGFR exon 20 insertion (exon20ins) mutation lung cancer. Before its establishment in 2017, Dijie was part of AstraZeneca's Global Oncology Translational Science Center - Asia Innovative Medicine and Early Development Center (iMED Asia). Leveraging the companys experience in disease research as well as capabilities in translational science and drug design, it has built a product pipeline that includes Shuwozhe and Goryeche, a candidate drug, Biritinib (DZD8586), in the registration clinical stage; three assets in the post-proof of concept stage; and one asset in the early clinical stage. Shuwozhe has been launched in mainland China and approved in the United States, being the first lung cancer drug developed in China to receive breakthrough therapy designation from both the U.S. FDA and Chinas National Medical Products Administration. The total revenue breakdown by product is as follows: As of the last practical date, Shuwozhe is currently the only small molecule drug recommended by the internationally recognized NCCN guidelines for non-small cell lung cancer (NSCLC) treatment for EGFR exon 20 insertion mutation, and is also the only targeted drug included in the National Reimbursement Drug List (NRDL) in China for treating EGFR exon 20 insertion recurrent or refractory (r/r) indications. As of the same date, Goryeche is the worlds first and only JAK1 inhibitor approved for the treatment of recurrent or refractory peripheral T-cell lymphoma (r/r PTCL). Based on its clinical value, the U.S. FDA has granted Goryeche fast track and orphan drug designation. Goryeche has also been included in Chinas National Reimbursement Drug List. During the track record period, both Shuwozhe and Goryeche were commercialized and generated revenue in mainland China. On July 14, 2026, the company signed a licensing agreement (AstraZeneca Agreement) with AstraZeneca UK Limited (AstraZeneca), under which the company granted AstraZeneca exclusive rights to develop and commercialize Shuwozhe globally. AstraZeneca is expected to pay the company an upfront, non-refundable, and non-offsettable payment of $600 million as part of the consideration for these rights, according to Zhenzhong Consulting, this is the largest upfront payment to date in a single-asset licensing transaction for small molecule drugs in China. In addition, the company is entitled to receive up to $400 million in development milestone payments and up to $500 million in sales milestone payments, contingent on specific development, regulatory, and sales milestone events being achieved. The company is also entitled to receive a tiered royalty of low double-digit percentages on Shuwozhes global sales. Financial Information Revenue: For the years 2023, 2024, 2025, and the six months ending June 30 of 2025 and 2026, the company generated revenues of approximately 91.29 million, about 360 million, about 801 million, about 355 million, and about 523 million RMB, respectively. Losses: For the years 2023, 2024, 2025, and the six months ending June 30 of 2025 and 2026, losses amounted to approximately 1.108 billion, 940 million, 769 million, 379 million, and 213 million RMB, respectively. Gross Margin: For the years 2023, 2024, 2025, and the six months ending June 30 of 2026, the gross margins were 96.5%, 97.4%, 95.7%, and 96.0%, respectively. Industry Overview According to Zhenzhong Consulting, the global oncology drug market is expected to grow from $167 billion in 2020 to $304.1 billion in 2025, with a compound annual growth rate (CAGR) of 12.7%, and projected to reach $729.2 billion by 2035, with a CAGR of 9.1% from 2025 to 2035. In China, the market size is expected to grow from $25.8 billion in 2020 to $39.1 billion in 2025, reaching $131.2 billion by 2035, with a CAGR of 12.9% from 2025 to 2035. The growth of the global oncology treatment market is driven by the rising incidence of cancer, expanded access to diagnosis and treatment, increased adoption of innovative therapies, ongoing R&D investments, and favorable reimbursement and policy support, particularly in high-growth markets like China, further accelerating this growth trend. In the global oncology treatment sector, lung cancer and hematological malignancies (HM) are expected to account for approximately 40% of the total oncology treatment market by 2025. Among solid tumors, lung cancer is consistently the most frequently diagnosed type, with over 2.5 million new cases globally in 2025, approximately 40% of which will occur in Chinawhere the incidence of lung cancer is about twice that of the next most common cancer. The five-year survival rate remains low, at 28.1% in the U.S. and 28.7% in China. In 2025, the number of new cases of HM caused by hematopoietic stem cell abnormal differentiation is expected to exceed 5.7 million globally, with more than 1 million cases occurring in China, accounting for about 20% of the global total. Lung cancer remains one of the most burdensome cancers worldwide, with non-small cell lung cancer (NSCLC) accounting for about 85% of all cases, and incidence rates continuing to climb in major regions. According to data from Zhenzhong Consulting, the global incidence of NSCLC is expected to rise from approximately 1.9 million cases in 2020 to 2.9 million cases by 2035. China has significantly contributed to this growth, with expected new cases rising from about 800,000 in 2020 to 1.3 million by 2035. Furthermore, 55% of NSCLC patients are diagnosed at an advanced stage. Therefore, NSCLC remains a leading cause of cancer mortality, with significant and persistent unmet medical needs both globally and in China. According to data from Zhenzhong Consulting, the global NSCLC drug market is expected to grow from $22.5 billion in 2020 to $54.3 billion in 2025, with a CAGR of 19.2%, and is projected to reach $115.8 billion by 2035, with a CAGR of 7.9% from 2025 to 2035. China remains a key growth engine, with the market size expected to increase from $5.3 billion in 2020 to $7.7 billion in 2025, at a CAGR of 7.5%, and projected to reach $23 billion by 2035, with a CAGR of 11.6% from 2025 to 2035. EGFR exon20ins mutations account for approximately 12% to 15% of all EGFR mutation patients. The global incidence of EGFR exon20ins NSCLC is expected to rise from 63,700 cases in 2020 to 76,700 by 2025, and is projected to reach 99,600 cases by 2035. In China, the incidence is expected to grow from 41,200 cases in 2020 to 50,100 by 2025, rising to 65,700 by 2035. The incidence of second-line/second-line plus EGFR exon20ins NSCLC is expected to increase from 41,300 cases in 2020 to 49,700 cases by 2025, and is projected to reach 64,500 cases by 2035. In China, the incidence is projected to rise from 27,100 cases in 2020 to 32,900 cases by 2025, reaching 43,200 by 2035. Approximately 75% of EGFR exon20ins NSCLC cases are diagnosed at an advanced stage globally. By 2025, among these patients, approximately 90% are expected to receive first-line treatment, with global projections estimating 69,000 cases and Chinese projections estimating 45,100 cases. Subsequently, by 2025, about 70% of patients receiving first-line treatment will require second-line and subsequent therapies, with 49,700 cases globally and 32,900 cases in China. According to the NCCN guidelines, first-line treatment for advanced non-squamous NSCLC patients with EGFR exon20ins mutations consists of carboplatin/pemetrexed combined with Evarizumab. Subsequent treatment regimens include Shuwotai, Evarizumab, or other systemic therapies. According to the CSCO guidelines, first-line treatment for advanced NSCLC with EGFR exon20ins mutations is preferentially recommended as Evarizumab combined with chemotherapy (Class I). In subsequent treatments, Shuwotai is recommended as a Class I option, while chemotherapy regimens for patients with negative driver genes are classified as Class II, and the Evarizumab regimen is classified as Class III. For second-line advanced EGFR exon20ins NSCLC, prior to the advent of targeted therapies such as Shuwozhe and Ruike, chemotherapy provided only limited response rates and disease control, underscoring the significant gap compared with classic EGFR mutations. Currently, there are no oral drugs approved for first-line therapy. For resectable tumors, no targeted treatment recommendations for mutations exist, and platinum-based chemotherapy remains the standard treatment option in the perioperative setting. The global market for EGFR exon20ins NSCLC is projected to grow from $700 million in 2020 to $1.6 billion by 2025, with a CAGR of 16.7%, and is expected to reach $8 billion by 2035, with a CAGR of 17.7% from 2025 to 2035. The global second-line/second-line plus EGFR exon20ins NSCLC market size is expected to grow from $200 million in 2020 to $400 million by 2025, projected to reach $2.4 billion by 2035, with a CAGR of 19.5% from 2025 to 2035. The second-line/second-line plus EGFR exon20ins NSCLC market in China is projected to grow from $40 million in 2020 to $100 million by 2025, expected to reach $600 million by 2035, with a CAGR of 20.7% from 2025 to 2035. Board Information The board of directors will comprise seven members, including two executive directors, two non-executive directors, and three independent non-executive directors. Shareholding Structure As of the last practical date, the company is owned (i) 1.94% by Dr. Zhang Xiaolin; (ii) 12.35% by Wuxi Dijie, which is a limited partnership, owned by the following individuals: (a) Wuxi Dunhe, as its general partner, owns 0.000065%, of which Dr. Zhang, who is the chairman and CEO, and Dr. Yang Zhenfan, the vice president and chief medical officer, own 90% and 10%, respectively; (b) Dr. Zhang Xiaolin, as a limited partner, owns 61.11%; (c) Dr. Yang Zhenfan, as a limited partner, owns 14.65%; (d) the companys chief financial officer, Mr. Lv Hongbin, as a limited partner, owns 5.91%; (e) the companys vice president, Ms. Chen Suqin, as a limited partner, owns 4.35%; (f) 32 other limited partners, each with holdings of less than 2%; and (iii) ZYTZ owns 1.11%, which is a limited liability company registered in Hong Kong, wholly owned by Dezent Partners Limited, a limited liability company registered in the British Virgin Islands, with Dr. Zhang, Dr. Yang Zhenfan, Dr. Xu Hanzhong, and Dr. Zeng Qingbei holding 75%, 10%, 7%, and 8% of the equity, respectively. Both Wuxi Dijie and ZYTZ serve as employee stock ownership platforms of the company. Advisory Team Co-sponsors: Goldman Sachs (Asia) LLC and Huatai Financial Holdings (Hong Kong) Limited Company Legal Advisors: For Hong Kong and U.S. law: Cadwalader, Wickersham & Taft LLP; for Chinese law: Zhonglun Law Firm Legal Advisors to the Co-sponsors: For Hong Kong and U.S. law: Freshfields Bruckhaus Deringer; for Chinese law: Fangda Partners Reporting Accountant and Independent Auditor: Hong Kong Lixin DHH CPA Limited Industry Consultant: Zhenzhong Industry Consulting Compliance Advisor: FIRST SHANGHAI Securities Limited