Giemeri Announces Completion of Phase II Clinical Trial for REGEND001 in COPD, Paving the Way for Regenerative Medicine Breakthrough

Unlabored breathing is the most basic requirement for life. However, for patients with chronic obstructive pulmonary disease (COPD), it has become a luxury.

COPD (Chronic Obstructive Pulmonary Disease) is a respiratory disorder characterized by airflow obstruction. Patients typically experience chronic cough and sputum production in the early stages, which may progress to dyspnea and even respiratory failure in later stages. Although numerous risk factors for COPD have been identified, including age, genetic predisposition, air quality, and lifestyle habits, its precise pathogenesis remains unclear.Therefore, despite significant breakthroughs in the treatment of chronic obstructive pulmonary disease (COPD) in recent years, there is still no cure.

According to the China Adult Lung Health Study, chronic obstructive pulmonary disease (COPD) has become the third leading cause of death in China, with nearly 100 million patients. This vast patient population is eagerly awaiting a curative medication for COPD.Regend Therapeutics’ REGEND001 product, indicated for the treatment of chronic obstructive pulmonary disease (COPD), has completed Phase II clinical trials, thereby making this possibility a reality.

Zhang Ting, CEO of Regend Therapeutics, told Chengguo Bureau: “The breakthrough in the stem cell product REGEND001 may offer hope for a cure to patients with chronic obstructive pulmonary disease (COPD).”

In April 2024, Regend Therapeutics officially announced the completion of patient enrollment for all participants in the Phase II clinical trial of REGEND001 in China.The Phase III confirmatory clinical trial is expected to be initiated within the year.

It is worth mentioning that,Although this is not the only stem cell drug globally developed with chronic obstructive pulmonary disease (COPD) as its indication, it is the most advanced candidate in the field of lung regeneration worldwide.This may also be related to the type of epithelial cells selected by Regend Therapeutics.

Stem cell therapy refers to the use of stem cells' capacity to differentiate into various cell types, inducing them to become specific cell types needed to repair damaged tissues and organs. Stem cells are abundant, easy to isolate, and associated with fewer rejection reactions, offering higher safety compared to other regenerative therapies.

The stem cells selected by Regend Therapeutics are derived fromHuman Autologous Lung Progenitor Cells from the Basal Layer of Bronchial Epithelium, can directly participate in the repair and regeneration of alveolar structures, with convenient sourcing, no immune rejection, and no risk of tumorigenesis.

The team’s precise selection of this specific type of stem cell as the foundation was no accident. As early as 2015, Professor Zuo Wei, one of the founders of Regend Therapeutics, invented a method for tracheal transplantation of stem cells, creating the world’s first mouse model of “lung replacement.” The related research findings were published in the journal Nature. This extensive research experience has enabled the team to make rapid and accurate decisions when addressing pulmonary diseases.

The therapeutic efficacy of REGEND001 is now supported by extensive clinical data. In February 2024, the lead article in Science Translational Medicine featured the Phase I clinical trial results of REGEND001.

This study demonstrates that transplantation of lung progenitor cells can significantly enhance patients' pulmonary gas exchange function, achieving reversal of lung function and regenerative repair. Following cell therapy,Over 70%COPD patients demonstrated significant improvement in pulmonary gas exchange function accompanied by enhanced exercise capacity, exhibiting therapeutic efficacy far superior to that of conventional medications.Long-term follow-up indicates a significant extension of survival in patients with COPD.

More encouraging results have recently emerged from clinical trials of the second-generation product:“This product can restore lung function in patients with chronic obstructive pulmonary disease (COPD) to 97%.”

Since the establishment of Regend Therapeutics in 2015, chronic obstructive pulmonary disease (COPD) has been a critical challenge that the team has been striving to overcome. Over the past nine years, REGEND001 has not been the only achievement of Regend Therapeutics. While developing this product, the team has also summarized and adapted its underlying technology intoR-Clone Technology Platform，It can basically address injuries to all epithelial tissue organs.。

Theoretically, nearly all stem cell therapies repair damaged tissues through an “extraction–transplantation–differentiation” approach. However, Regend Therapeutics has carved out its own distinctive path. Zhang Ting told VCBeat, “We have established a unique technological moat.”

First, during the stem cell culture phase, Regend Therapeutics adopted a progenitor cell culture process.Obtaining lung tissue from the body in a nearly non-invasive manner, then extracting the extremely scarce progenitor cells from the tissue, and performing subculturing and large-scale expansion is a highly challenging technology. Currently, only a very few teams worldwide have mastered this technique.

Secondly, safety is of paramount importance in the transition from the laboratory to clinical practice.During the laboratory phase, some cell culture reagents exhibited slight toxicity. However, for stem cells to be approved as pharmaceutical products for clinical use, they must guarantee absolute safety and regulatory compliance. Consequently, the team had to continuously adjust the formulation to ensure stem cell expansion efficiency under conditions of absolute safety. Zhang Ting joked, “Just like Coca-Cola found its secret recipe after thousands of attempts, we did the same.”

Currently, Regend Therapeutics has established a strategic layout focusing on lung and kidney-related diseases.Top 10 Pipeline. According to Zhang Ting,The team is also exploring the application of stem cell therapy in the field of oncology.. By reconstructing healthy organ tissues, cancer is prevented, truly achieving both treatment and prevention of disease.

Over the past two decades, regenerative medicine has advanced rapidly, offering new therapeutic avenues for many diseases previously considered untreatable.

From 2022, when Professor Fei Jifeng’s team, in collaboration with BGI Research, Wuhan University, and other research groups, utilized spatial transcriptomics to identify key stem cell subtypes involved in salamander brain regeneration; to 2023, when Dai Jianwu’s team, in partnership with Nanjing Drum Tower Hospital, performed intracranial ovarian stem cell transplantation for patients with premature ovarian insufficiency using regenerative medicine techniques, resulting in live births—regenerative medicine has frequently appeared in top-tier international journals, repeatedly redefining the “impossible.”

In the industrial sector, this technology is also regarded as a future growth hotspot. In 2024, Novo Nordisk announced an $80 billion investment to strategically focus on the stem cell field. Many well-known pharmaceutical companies, including Johnson & Johnson, Bard, and Gilead, have entered the market early.

In China, this technology started relatively late; therefore, no products have been approved for marketing yet, with most remaining in the clinical stage. In 2023, the National Medical Products Administration (NMPA) issued a total of 35 Investigational New Drug (IND) approvals, while in the first half of 2024 alone, 11 IND approvals had already been issued.

From the perspectives of technological innovation, market potential, and regulatory approval, stem cell therapy holds significant promise.

Dr. Zhang Ting, who has been deeply engaged in the regenerative medicine sector for decades, has personally witnessed the advancements in this field. Both technical feasibility and the market environment have led her to believe that:“The era of regenerative medicine has arrived.”

Today, Regend Therapeutics has attracted numerous partners thanks to its outstanding clinical data, with multinational pharmaceutical companies already having reached preliminary cooperation agreements with the firm.Regend Therapeutics also hopes that more teams focused on regenerative medicine will join in collaboration to jointly advance the development of stem cell therapies.

During the interview, Zhang Ting had just returned to Suzhou from California, USA, bringing fresh insights after attending BIO US 2024. At the conference, the CEO of a dialysis product company approached her proactively for a discussion after hearing her presentation. This surprised Zhang Ting: “From a business logic perspective, dialysis products and regenerative medicine are competitive.”

The other party responded that, although the product types differ, our ultimate goal is to help patients regain their health—this is also the original intention behind the founding of Regend Therapeutics.

Medical innovation has no finish line. In the future, Regend Therapeutics will continue to deepen its expertise in the field of regenerative medicine, providing innovative treatment solutions for more patients and putting the brakes on disease progression.