Zelgen Biopharma Files for Hong Kong IPO with Two Drug Candidates in Phase 3 Registration Trials

According to the Zhongtong Finance APP, on January 13, Zenitar (Chengdu Zenitar Biopharmaceutical Technology Co., Ltd.) submitted an application for listing on the Main Board of the Hong Kong Stock Exchange, with Jefferies and CICC acting as its joint sponsors.

Company Profile

According to the prospectus, Zenitar is a clinical-stage biotechnology company dedicated to integrating structural biology, artificial intelligence, and clinically relevant disease models to develop highly differentiated small-molecule therapies with first-in-class or best-in-class potential.

Zenitar is dedicated to addressing significant unmet medical needs in the fields of hematological disorders, oncology, central nervous system, and immune/inflammatory diseases. The company has established a robust and diversified pipeline consisting of eight proprietary assets, covering both clinical and preclinical stages.

As of January 5, 2026, Zenitar's pipeline includes two core products (namely, Flunotinib Maleate and Puvirostib Mesylate for Injection), two additional clinical-stage drug candidates (namely, ZL-82 and ZL-85), and four preclinical-stage drug candidates (namely, ZL-65, ZL-69, ZL-59, and ZL-89). Two drug candidates have entered Phase 3 registrational clinical trials, including Flunotinib Maleate ("FM") for the treatment of myelofibrosis and Puvirostib Mesylate ("PM") for the treatment of relapsed/refractory diffuse large B-cell lymphoma.

Among them, FM is a novel triple-target inhibitor of Janus kinase 2, FMS-like tyrosine kinase 3, and cyclin-dependent kinase 6, mainly used for the treatment of myeloproliferative neoplasms, including myelofibrosis and polycythemia vera. Myelofibrosis is a hematological malignancy caused by mutations in JAK2V617F (65%), CALR (20-35%), or MPL (5-8%), characterized by splenomegaly and symptoms affecting quality of life.

PM is a next-generation selective HDAC I/IIb class inhibitor designed to address unmet medical needs and possesses broad therapeutic potential. PM features an innovative nonlinear large triangular cap structure that significantly enhances its binding affinity with HDAC I/IIb classes, demonstrating superior inhibitory activity and selectivity compared to approved HDAC inhibitors. Its molecular design emphasizes selectivity and safety. The roles of Class IIa and IV HDACs in tumorigenesis remain controversial, with increasing evidence suggesting that inhibition of Class IIa and IV HDACs may lead to more cardiovascular toxicity and immunosuppression-related adverse effects. By suppressing key genes and signaling pathways associated with tumor cell survival while promoting anti-tumor immune responses, PM achieves more precise and effective cancer treatment.

Financial Information

Income

Zenitar currently has no products approved for commercial sale and has not generated any revenue from product sales. For the year ended December 31, 2024, and the nine months ended September 30, 2025, the company's other income and gains were RMB 19.661 million and RMB 7.126 million, respectively.

Profit

During the track record period, the company incurred operating losses. For the year ended December 31, 2024, and the nine months ended September 30, 2025, the company's losses for the respective periods were RMB 91.656 million and RMB 119 million, primarily due to research and development expenses and changes in the carrying amount of redemption liabilities.

Industry Overview

Globally, cancer remains one of the leading causes of high incidence and mortality rates. According to the CIC Report, the global market size for cancer treatment drugs grew from $1,670 billion in 2020 to $2,621 billion in 2024, with a compound annual growth rate (CAGR) of 11.9%. It is projected to increase to $7,249 billion by 2035, reflecting a CAGR of 9.7% from 2024 to 2035. In China, the market size expanded from $258 billion in 2020 to $372 billion in 2024 and is expected to reach $1,437 billion by 2035, with a CAGR of 13.1% from 2024 to 2035.

Myeloproliferative Neoplasms ("MPN") are a group of clonal hematopoietic stem cell disorders characterized by the overproduction of one or more blood cell lines, including Philadelphia chromosome-positive (Ph-positive) MPN (chronic myeloid leukemia) and Philadelphia chromosome-negative MPN.

According to the CIC Report, the global Philadelphia chromosome-negative drug market grew from US$4.5 billion in 2020 to US$6.8 billion in 2024, with a compound annual growth rate (CAGR) of 10.9%. It is expected to reach US$18.7 billion by 2035, with a CAGR of 9.6% from 2024 to 2035. In China, the market size increased from US$300 million in 2020 to US$400 million in 2024, reflecting a CAGR of 13.3%. It is projected to rise to US$1.6 billion by 2035, with a CAGR of 12.0% from 2024 to 2035.

Myelofibrosis is a rare and aggressive hematologic malignancy characterized by progressive bone marrow fibrosis, which impairs normal hematopoiesis, leading to cytopenia, extramedullary hematopoiesis (mainly in the spleen), and chronic systemic symptoms that are incurable. According to the CIC Report, the global myelofibrosis drug market size grew from US$1.6 billion in 2020 to US$3.0 billion in 2024, with a compound annual growth rate (CAGR) of 15.9%. The market size is expected to reach US$6.4 billion by 2030 and US$11.1 billion by 2035, with a CAGR of 12.7% from 2024 to 2035.

In the United States, the market size for myelofibrosis drugs grew from US$900 million in 2020 to US$1.5 billion in 2024, with a compound annual growth rate (CAGR) of 15.9%. It is projected to reach US$3.4 billion by 2030 and US$5.9 billion by 2035, reflecting a CAGR of 13.0% from 2024 to 2035. In China, the market size expanded from US$100 million in 2020 to US$200 million in 2024, with a remarkable CAGR of 29.4%. It is expected to reach US$600 million by 2030 and US$1 billion by 2035, showing a CAGR of 14.6% from 2024 to 2035.

Meanwhile, the market size of myelofibrosis drugs in other regions of the world grew from US$700 million in 2020 to US$1.2 billion in 2024, with a compound annual growth rate (CAGR) of 14.0%. It is expected to reach US$2.4 billion by 2030 and US$4.2 billion by 2035, with a CAGR of 11.9% from 2024 to 2035.

PV is a chronic MPN characterized by clonal proliferation of hematopoietic stem cells and persistent overproduction of red blood cells, leading to polycythemia and increased blood viscosity. According to the CIC Report, the global prevalence of PV increased from 1.7258 million in 2020 to 1.9332 million in 2024, and is expected to reach approximately 2.6166 million by 2035. In China, the prevalence increased from 312,100 in 2020 to 336,200 in 2024, and is projected to reach 425,500 by 2035.

Board Materials

The company's board of directors consists of eleven members, including four executive directors, three non-executive directors, and four independent non-executive directors.

Equity Structure

As of January 5, 2026, Dr. Chen has the right to exercise approximately 25.6% of the voting rights attached to the Company's total issued share capital, including: (i) approximately 19.8% of the total issued share capital directly held by Dr. Chen; and (ii) approximately 3.2%, 2.4%, and 0.3% of the total issued share capital of the Company controlled by Dr. Chen in his capacity as the general partner of Zhongxin Huizhi, Zhongxin Hengsheng, and Zhongxin Ruichuang, respectively.

Intermediary Team

Joint Sponsors: Jefferies Hong Kong Limited, China International Capital Corporation Hong Kong Securities Limited

Company Legal Advisors: Regarding Hong Kong and U.S. laws: Kirkland & Ellis; regarding Chinese laws: King & Wood Mallesons

Joint Sponsors' Legal Counsel: Regarding Hong Kong and U.S. Laws: Ashurst LLP; Regarding Chinese Laws: Commerce & Finance Law Offices

Reporting Accountant and Independent Auditor: Ernst & Young LLP

Industry Consultant: CIC Industry Consulting Co., Ltd.

Compliance Advisor: Guoyuan Financing (Hong Kong) Co., Ltd.