"Gemcell Regenerative Medicine" Secures Tens of Millions of Yuan in Series B+ Financing, and Its Pulmonary Stem Cell Product is About to Initiate Phase III Clinical Trials | Exclusive from 36Kr

Text｜Hu Xiangyun

Editor｜Hai Ruojing

36Kr has learned that "Gemcell Regenerative Medicine Group" has recently completed a tens of millions of yuan Series B+ financing round. The investor in this round is FirStream Capital, and the raised funds will be mainly used for the clinical research and development and filing of the company's related stem cell products.

Established in 2015, Gemcell Regenerative Medicine Group focuses on the field of human organ regenerative medicine using stem cells. By developing innovative cell and gene therapy products, it aims to achieve the repair, regeneration, and enhancement of human tissues and organs. When conducting the Series B financing in 2022, 36Kr reported on Gemcell Regenerative Medicine Group's technology platform and product layout.

This time, coinciding with the completion of the Series B+ financing round, we conducted an interview with Dr. Zhang Ting, the founder and CEO of Gemcell Regenerative Medicine Group, to discuss the company's business progress in the past two years and its thoughts on the future development of the stem cell industry.

Zhang Ting mentioned that in the past two years, the company's business progress has mainly focused on the clinical aspect. Firstly, the company's independently developed innovative lung regenerative medicine product REGEND001 has successively completed two Phase II clinical studies, targeting chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF) respectively.

Among them, "The COPD is currently undergoing a mid-term analysis, and it is expected that the communication and exchange for the Phase III clinical trial with the regulatory authorities will be initiated in the first half of this year."

In addition, the company has recently received tens of millions of yuan in support from the National Key Research and Development Program "Stem Cell Research and Organ Repair" special project. Led by Dr. Zhang Ting, in conjunction with more than ten domestic medical institutions and scientific research units, a Phase III confirmatory clinical study for COPD and IPF is being carried out. The kick-off meeting of this national major project was officially held at Shanghai Ruijin Hospital on February 9, 2025. Academician Pei Gang from the Chinese Academy of Sciences, Professor Qu Jieming, the chairman of the Respiratory Disease Branch of the Chinese Medical Association, and Professor Li Shiyue, the vice chairman, and other industry experts are all deeply involved in the initiation of this important project.

Source: Gemcell Regenerative Medicine Group

According to Zhang Ting's observation, in recent years, there have been many changes in the industry's attention to the field of cell therapy. On the one hand, with the continuous deepening of research and the improvement of the regulatory level, "Everyone has recognized that stem cells can be registered and listed as drugs." Recently, after the National Medical Products Administration conditionally approved the listing of the first stem cell therapy product, the industry's confidence has been further strengthened;

On the other hand, although the capital market performance is relatively sluggish and the risk-averse mentality still exists, there is still interest in technology enterprises that are engaged in a leading innovative direction, with products close to listing and a good cash flow reserve. "In the case of Gemcell Regenerative Medicine Group, we are in a relatively leading position in the field of lung stem cell products, and for institutions, the overall investment risk is relatively small."

Take the COPD indication that REGEND001 is developing as an example: This is a serious respiratory disease caused by irreversible damage to lung tissue, and patients mainly face two major problems: airway ventilation and gas exchange. Currently, although there are many mature products on the market, however, "Traditional antibody products mainly exert their effects by inhibiting fibrosis and inflammation", which can solve the ventilation problem, but it is difficult to have an effect on the decline in the gas exchange capacity of the lungs caused by irreversible structural damage. In contrast, the new drug REGEND001 based on airway basal stem cells can effectively re-epithelialize the damaged alveolar area functionally, thereby achieving the regeneration and repair of lung fibrosis damage, and is expected to fundamentally solve this problem.

In 2024, the research published in Science Translational Medicine by the team of Professor Zuo Wei from Tongji University in collaboration with Academician Zhong Nanshan stated that after treatment with REGEND001, the lung gas exchange function of more than 70% of COPD patients improved significantly, and their exercise capacity increased. In addition, long-term follow-up suggests that the survival period of COPD patients has been significantly prolonged. The team's research on the relevant cellular mechanism of action has also been recently published in the Nature sub-journal "Nature Communications".

Zhang Ting introduced: "After COPD progresses to a certain extent, the gas exchange capacity of patients will actually have problems. We believe that this product may become a necessary demand for all moderate to severe COPD patients in the future. Regarding the research and development progress, it is expected that REGEND001 is expected to be approved within the next three years, and it may become the world's first listed lung regenerative medicine product, complementing the existing respiratory system drugs and gradually replacing organ transplantation."

It is worth mentioning that the company's new generation of lung stem cell product Pulmovinci has recently received the Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for the treatment of idiopathic pulmonary fibrosis (IPF). Pulmovinci is an optimized version of REGEND001 with process changes, using advanced reprogramming technology to rejuvenate the cells and improve the efficiency of product transportation. The company plans to initiate a clinical trial for Pulmovinci in the United States within the next one to two years to kick off the company's internationalization strategy.

In addition, the company has made considerable progress in the research and development of products for major kidney system diseases. The new drug REGEND003 developed based on autologous kidney progenitor cells has completed the Pre-IND submission. This product is benchmarked against the kidney repair product of the US-based ProKidney Company, and it is expected to initiate a clinical trial for type II diabetic kidney disease this year. Another universal cell pipeline REGEND008 for kidney regeneration and repair has also completed the IIT study, and the data shows a significant effect of this product in the repair of kidney function in patients.

Although in the traditional perception of the public, cell therapies represented by CAR-T often appear with an image of "sky-high prices". However, due to the different manufacturing processes, stem cell products have an advantage in price, "which can be within the acceptable range of the national medical insurance."

On the other hand, another advantage of stem cell products is that "they can be used for a very wide range of indications". From metabolic diseases such as diabetes that were more involved in the early stage to neurodegenerative diseases, autoimmune diseases, and refractory diseases such as COPD and IPF nowadays, the boundary of indications covered by stem cell therapy is continuously expanding.

"In the field of cell therapy, although the development of stem cells lags behind CAR-T by a few years as a whole, with the support of these two advantages, I believe that more stem cell products will be approved one after another in the coming years." Zhang Ting said.

Introduction to the Investment Institution:

FirStream Capital was founded in 2021 and is an emerging investment fund in the field of biomedicine and health. The company specializes in innovative investment and value discovery in the global biomedical industry. The team brings together high-level talents from the industry, scientific research, and venture capital fields, with rich experience in the pharmaceutical industry and investment. FirStream Capital adheres to the core concept of "seeking truth from facts, conducting in-depth research and wisdom", maintains the investment principle of "forward-looking and independence", and is committed to creating sustainable value for investors, shareholders, and the whole society through rigorous project evaluation and scientific investment decisions. As a meticulous cultivator in the field of healthcare, FirStream Capital not only pursues the success and return of investment projects, but also is committed to promoting the progress of medical technology and benefiting human health. It works hand in hand with outstanding scientists and entrepreneurs, remains true to its original aspiration, and jointly writes a new chapter in life science.