February 2026 — Regend Therapeutics Limited (“Regend Therapeutics” or the “Company”), a leading innovator in organ regenerative medicine, today announced the successful completion of its Series C financing, raising approximately RMB 350 million.

The round introduced seven new investors, including Yuze Capital, Hefei High-Tech Investment, Hongtai Fund, Hefei Industry Investment, and Gongqingcheng Fuhui, among other prominent institutions. Existing shareholders such as Lengshanxi Capital and Tasly Capital also increased their stakes, demonstrating continued confidence in the Company's long-term growth.

As a globally advanced, fully integrated developer of organ function regenerative therapies, Regend Therapeutics will leverage this financing to accelerate the clinical translation of its core stem/progenitor cell products and lay a strong foundation for large-scale commercialization.

Regenerative Medicine Enters an Inflection Point as Regend Therapeutics Seizes Early-Mover Advantage

Regenerative therapies are rapidly emerging as a primary growth engine within the biopharmaceutical industry. Traditional chronic disease treatments often manage symptoms rather than address underlying pathology, whereas progenitor cell therapies offer distinct advantages in organ repair and functional regeneration, positioning them as a transformative solution.

Progenitor cells comprise regenerative cell populations residing within adult organs. While sharing the self-renewal and differentiation capabilities of stem cells, progenitor cells demonstrate more directed tissue regeneration potential and favorable drug development characteristics.

According to Frost & Sullivan, the global progenitor cell therapy market is projected to expand from USD 100 million in 2024 to USD 11 billion by 2030, representing a remarkable 111.4% compound annual growth rate (CAGR). Favorable regulatory developments—including the classification of progenitor-cell regenerative therapies as Advanced Therapy Medicinal Products (ATMPs) and policy support enabling clinical translation—combined with China’s large patient population, are expected to drive China’s market to RMB 14.1 billion by 2030.

Since its founding in 2015, Regend Therapeutics has established a strategic leadership position in regenerative medicine. The Company is currently focused on three major disease areas—chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF), and chronic kidney disease (CKD)—each characterized by large patient populations, significant unmet clinical needs, and strong market potential.

COPD

As the third leading cause of death globally, COPD presents an especially heavy disease burden in China. Frost & Sullivan forecasts that global prevalence will reach 301 million by 2030, with China accounting for 36.88% of cases. Existing therapies alleviate airway obstruction and inflammation but cannot reverse alveolar damage or restore gas exchange capacity, highlighting the urgent clinical need and substantial market opportunity for regenerative therapies such as REGEND001, designed to enable alveolar regeneration.

IPF

Although less prevalent than COPD, idiopathic pulmonary fibrosis carries mortality rates comparable to many cancers. Global incidence is projected to reach 932,100 cases by 2030, while China’s incidence is expected to grow at a 10.7% CAGR, significantly outpacing the global average.

Only three drugs-pirfenidone, nintedanib, and nerandomilast- have been approved worldwide for IPF treatment. These therapies slow the decline in forced vital capacity (FVC) but neither prevent alveolar damage nor repair injured tissue. REGEND001’s regenerative capability therefore positions it with strong competitive potential.

CKD

Chronic kidney disease has become a major global health challenge, with prevalence expected to reach 1.022 billion worldwide and 171.6 million in China by 2030. Diabetic kidney disease (DKD), the primary subtype, accounts for over 30% of cases.

Current treatment options—including pharmacotherapy, dialysis, and transplantation—primarily delay disease progression or replace lost kidney function without reversing underlying pathology.

Regend Therapeutics's REGEND003, the first kidney progenitor cell therapy in China to receive IND approval from the National Medical Products Administration (NMPA), has initiated Phase I clinical trials. Utilizing a proprietary non-invasive method to isolate progenitor cells from urine, the therapy directly regenerates nephrons and has received support from China’s National Key R&D Program, positioning it to unlock a new regenerative treatment pathway in the DKD market.

Core Pipeline Advances Through Critical Clinical Milestones, Building a Multi-Organ Technology Barrier

Guided by its mission to develop innovative cell and gene therapies that repair, regenerate, and enhance human tissues and organs, Regend Therapeutics has built a differentiated pipeline supported by proprietary platforms.

Lung Regeneration Pipeline: REGEND001 Leads Global Clinical Progress

REGEND001 is the world’s first autologous lung regenerative therapy and is being evaluated across multiple severe pulmonary diseases, including COPD, interstitial lung disease (ILD), IPF, bronchiectasis, and pediatric bronchiolitis obliterans.

Phase II trials in COPD and IPF have been completed, with clinical data demonstrating statistically significant improvements in key efficacy endpoints compared with control groups. Beyond enhanced pulmonary function and quality of life, REGEND001 has shown unprecedented advantages in repairing structural lung damage, delivering increases of several hundred milliliters in lung volume.

An optimized-process product, REGEND001, has received U.S. FDA Orphan Drug Designation for IPF and has launched three clinical translation programs in the Boao Lecheng International Medical Tourism Pilot Zone, where the therapy has been approved at a treatment price of RMB 150,000 per administration. To date, more than 140 patients have received the therapy, providing early validation of its commercial potential.

Kidney Regeneration Pipeline: REGEND003 Opens a Non-Invasive Therapeutic Pathway

Approved by the NMPA in May 2025 for Phase I trials in DKD and CKD, REGEND003 employs a first-in-class, non-invasive urine-derived cell acquisition approach. Progenitor cells are expanded using the proprietary R-Clone platform before reinfusion to regenerate renal tubular and glomerular cells.

Preclinical data demonstrate robust regenerative activity, with significant improvements observed in renal histopathology, serum creatinine, and blood urea nitrogen levels.

Technology Platform: R-Clone Breaks Industry Bottlenecks

At the core of Regend’s rapid multi-organ pipeline expansion is the proprietary R-Clone progenitor cell expansion platform. Using specialized systems and media formulations, the platform expands only a handful of progenitor cells obtained from minimally invasive samples into tens to hundreds of millions of functional cells per treatment—while preserving stemness and organ-specific differentiation capacity.

This innovation overcomes longstanding industry challenges associated with low expansion efficiency and functional loss in primary cell culture. The platform has already been applied across multiple organs, including lung, kidney, liver, uterus, testes, and the nervous system, establishing a foundation for future multi-organ regenerative therapies.

Complementary platforms—including the IntelCell gene engineering system, MIX0109 cellular rejuvenation technology, and the REGEN-WK AI-powered medical decision platform—collectively form a comprehensive regenerative medicine ecosystem. Through a standardized and modular architecture, Regend has transformed regenerative R&D into a scalable and reproducible industrial process, enabling rapid therapy development across disease areas while strengthening its technological moat.

Regend Therapeutics Product Pipeline Overview

World-Class R&D Capabilities Establish a Global Innovation Hub

Regend Therapeutics has built a highly defensible R&D foundation anchored by academic leadership, proprietary technologies, and integrated infrastructure.

Professor Wei Zuo, Founder, is a tenured professor at Tongji University School of Medicine and Principal Investigator of China’s National Key Stem Cell Translational Research Program. He has published more than 30 papers as first or corresponding author in top-tier journals including Nature, Science Translational Medicine, Nature Communications, and Science Advances, with individual publications cited over 2,000 times.

Co-founder and General Manager Dr. Ting Zhang, who holds a PhD in Biology from Tsinghua University and conducted research in the United States and Singapore, also serves as a principal investigator under the National Key R&D Program and has been recognized in Shanghai’s leading talent initiatives.

Regend has established an end-to-end innovation system spanning basic research through industrialization. Proprietary platforms—including the MiniOrgan organoid system and Chimera chimeric animal validation platform—enable cross-species functional testing and significantly shorten in vivo validation timelines.

The Company maintains clinical operations teams across China and the United States capable of executing international multi-center trials. In manufacturing, construction began in late 2025 on a Shanghai-based facility designed to meet China GMP, U.S. FDA, and EMA standards, complementing the existing Zhangjiang “Super Organ R&D Center” and Suzhou Industrial Park site, with a combined footprint of approximately 5,000 square meters.

In partnership with Haier Biomedical, Regend has also launched China’s first intelligent automated cell manufacturing platform, Xianhe No. 1, integrating automation, AI, and advanced imaging to enable fully traceable, end-to-end cell production while minimizing manual error. The platform received the First Prize of the Shandong Provincial Science and Technology Progress Award in 2025.

Xianhe No. 1 — China’s First Intelligent Automated Cell Manufacturing Platform

Positioning for Accelerated Global Expansion

Dr. Ting Zhang, General Manager of Regend Therapeutics, commented:

“The successful completion of our Series C financing provides substantial capital to advance our core clinical programs, expand our global strategy, build commercial infrastructure, and attract top-tier talent. To support accelerating clinical progress, we will continue scaling manufacturing capacity and plan to establish at least two additional regional production centers nationwide to ensure a seamless transition from late-stage clinical products to commercial launches.”

Yuze Capital, the lead investor, stated:

“Regend Therapeutics is an innovation-driven company with leading clinical progress and systematic competitive advantages in regenerative medicine. With three indications already achieving clinical translation and commercial charging in the Boao Lecheng Pilot Zone, the Company has entered an early commercialization phase. We believe Regend is well positioned to continue leading organ regenerative therapy development and grow into a globally competitive enterprise.”

Co-lead investor Lengshanxi Capital added:

“Irreversible degenerative diseases pose a severe threat to human health, and existing therapies rarely deliver fundamental reversal. Regend has achieved breakthroughs in progenitor cell technology, successfully completing Phase II trials in major indications such as COPD and IPF, demonstrating lung tissue regeneration and improved pulmonary function with compelling efficacy. Meanwhile, its kidney regeneration pipeline has entered Phase I trials, confirming that the first-in-class R-Clone platform can expand into multiple therapeutic fields. Having led consecutive financing rounds, we remain firmly committed to supporting Regend in advancing the future of regenerative medicine.”

Looking Ahead

Regend Therapeutics remains committed to its vision of “leveraging the power of scientific discovery to extend human lifespan and improve quality of life.” The Company will continue to deepen its expertise in progenitor cells and regenerative medicine, accelerate the development, clinical advancement, and commercialization of innovative therapies, and further strengthen its core competitive advantages.

With a clear strategic trajectory, Regend is dedicated to becoming a global leader in regenerative medicine by delivering internationally competitive, breakthrough therapies that bring new hope to patients worldwide.