Zelun BioPharma Secures Nearly RMB 400 Million in Series B+ Financing to Advance Innovative Drug Pipeline with Differentiated Molecular Scaffolds and Novel Targets

Recently, Zenitar announced the completion of nearly 400 million RMB in financing. The funds from this round will be mainly used to advance several innovative drugs with global competitiveness into pivotal Phase III clinical trials, and to support the continuous expansion of new R&D pipelines.

Zenitar, founded in 2019, is an innovative drug research and development company driven by structural biology and artificial intelligence. Zenitar focuses on significant unmet medical needs in clinical settings, specializing in key therapeutic areas such as oncology, autoimmune diseases, inflammation, and neurological disorders. It is committed to discovering, developing, and commercializing First-in-Class (FIC) and Best-in-Class (BIC) innovative drugs. The company has established a comprehensive innovation platform covering the entire lifecycle of new drug development, with full-process collaborative capabilities including AI molecular design, structural biology, organoid-based high-throughput screening, PDX model construction, CMC research, clinical strategy formulation and execution, and new drug registration applications. This continuously empowers the efficient transformation of original innovations into clinical value.

Currently, Zenitar has independently developed seven globally-licensed products with differentiation and international competitiveness, establishing a pipeline covering multiple major disease areas. Among these, one indication has entered pivotal Phase III clinical trials, while five indications have progressed to Phase II clinical trials. The company's core product, Purinostat Mesylate (PM), is the world’s first highly selective HDAC inhibitor used as a monotherapy in clinical trials for relapsed/refractory lymphoma. To date, Purinostat Mesylate monotherapy has completed Phase I clinical trials for hematological tumors and Phase IIa/IIb multicenter clinical trials across China for relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL). Simultaneously, Phase I/II clinical trials are ongoing for T-cell lymphoma, solid tumors, and breast cancer. In the Phase IIa study for r/r DLBCL, the objective response rate (ORR) reached 69.0%, showing non-inferiority or even superiority compared to bispecific antibodies and ADC combination therapies (ORR approximately 50%-65%). Currently, this product has successfully advanced into pivotal Phase III clinical research.

Another heavy-hitting product, Flonoltinib Maleate (FM), is a highly selective JAK2/FLT3/CDK6 triple-target inhibitor with First-in-Class (FIC) potential. It has demonstrated significant and breakthrough efficacy in the clinical development for Myelofibrosis (MF). In the primary endpoint (the 24-week spleen volume response rate assessed by IRC), the proportion of patients in the FM treatment group achieving a ≥35% reduction in spleen volume (SVR35) exceeded 80%. Additionally, significant reductions in the degree of bone marrow fibrosis (assessed through serial bone marrow biopsy pathology) were observed in some patients treated with FM, with some cases showing signs of histological reversal. Flonoltinib Maleate is expected to become an important treatment option for patients with myeloproliferative neoplasms, driving the evolution of the treatment landscape in this disease area. Its unique, globally first-in-class mechanism of action and the currently observed clinical benefits position it as a potentially advantageous therapy for the significantly unmet medical needs in Myelofibrosis, and it is about to enter pivotal Phase III clinical trials.

Professor Chen Lijuan, founder of Zenitar, stated: "As the company's two core products enter pivotal Phase III clinical trials, Zenitar is firmly advancing on its path to international development. 2025 will mark the beginning of Zenitar’s globalization, as we accelerate our expansion into overseas markets and move toward the central stage of global innovative drug development. At the same time, Zenitar will strengthen its three core technology platforms — 'Structural Biology Platform,' 'AI-Driven Drug Design Platform,' and 'Organoid-PDX Dual-Track Validation Platform.' Leveraging these technological platforms, Zenitar is rapidly advancing a pipeline of innovative drugs with differentiated molecular scaffolds and novel targets, aiming to address unmet clinical needs."