Parkinson's stem cell therapy officially launches Phase II clinical trials, and "RegeiBio" secures over 200 million yuan in financing | Exclusive from 36Kr
Text | Hu Xiangyun
Editor | Hai Ruojing
36Kr learned that "Rejoin Therapeutics", a company engaged in the development of cell therapy drugs, recently completed a Series B+ financing round exceeding 100 million yuan. This round of financing was led by Fengchuan Capital, followed by Hetang Venture Capital. ECapital served as the exclusive financial advisor. The raised funds will be used to accelerate the China-US clinical trials of the company's core product pipeline, the R & D of multiple innovative pipelines, and the construction of clinical capabilities.
It is also understood that not long ago, Rejoin Therapeutics just obtained Series B financing. The cumulative funds raised in the two Series B financings exceeded 200 million yuan.
Rejoin Therapeutics was founded in 2017, focusing on the development of small molecule chemical transcription regulation-induced pluripotent stem cell (iPSC) products. It is also a company that 36Kr has been tracking for a long time. Recently, in addition to completing large-scale fundraising in succession, the core product pipeline NouvNeu001 (a chemically induced functional human dopaminergic neuron precursor cell) independently developed by Rejoin Therapeutics for the treatment of Parkinson's disease has recently launched Phase II clinical trials. Taking this opportunity, we revisited Wei Jun, the founder and CEO of Rejoin Therapeutics, to talk about the company's business progress and expectations for the development of the stem cell track.
Parkinson's disease is a common degenerative disease of the central nervous system in the middle - aged and elderly. The root cause of its onset lies in the large - scale apoptosis of dopaminergic neurons in the patient's brain. However, the existing clinical treatment methods for Parkinson's disease are mainly drugs and surgery, which can only "alleviate symptoms" and cannot prevent the continuous neurodegeneration in the patient's lesion area. Moreover, the efficacy of drug treatment will decline or adverse reactions will occur as the medication time increases, while surgical treatment faces the risks of high cost, limited scope of use, and large trauma, and also cannot prevent the progression of the disease.
Scientists therefore believe that if the disappeared cells can be "transplanted" back, it may reverse the condition of Parkinson's patients, and iPSC technology is the basic platform to realize this idea. Wei Jun introduced that the ideal therapeutic effect comes from the ability of transplanted cells to efficiently perform their comprehensive functions. The cells transplanted into the brain need to "re - connect the upstream and downstream neural circuits missing due to Parkinson's disease within an efficient time window and at the same time have the function of secreting dopamine".
Under this idea, in the previous Phase I clinical study, Rejoin Therapeutics focused on analyzing the following two issues: First, whether the lesions in the patient's brain caused by the degenerative death of nerve cells can be repaired due to the transplantation of new functional nerve cells; Second, whether the repair of such lesions will further lead to improvements in the patient's behavior and other symptoms.
From the results of 10 enrolled cases accumulated by NouvNeu001, six months after transplantation, when using the MDS Unified - Parkinson Disease Rating Scale (MDS - UPDRS) to detect various indicators of patients after transplantation, the patients' motor functions "showed a significant clinical improvement trend"; non - motor symptoms, including anxiety and "on - time" indicators, also reached the clinically significant improvement standard.
At the same time, PET imaging analysis also confirmed the colonization and function of cells in the brain after transplantation. The results showed that as the transplantation time increased, the activity of dopamine transporter enzymes in the transplantation area significantly increased.
Especially in the low - dose group, the longest follow - up time of the subjects has exceeded 60 weeks, and the improvement effect on the patients' behavior is still stably continuing. This may indicate that "universal cell transplantation for the treatment of Parkinson's disease is highly feasible, and the transplanted cells can play a long - term role in the patient's body".
"Different from the clinical trials of similar overseas products, we included a wider range of Parkinson's disease subjects in this clinical trial, covering moderate to extremely severe cases. The purpose is to understand in which patients NouvNeu001 responds better and guide the better clinical application of the product. Among them, there was a subject who was in an extremely severe state at the time of enrollment and needed family care for daily activities. After taking the drug, the subject could stand up independently soon, and six months after taking the drug, the walking ability was very stable, greatly improving the quality of life." Wei Jun said.
It is also understood that to achieve full - course coverage of Parkinson's treatment, Rejoin Therapeutics has also developed a cell therapy product NouvNeu003 mainly targeting early - onset Parkinson's patients under 50 years old. This product was approved by the National Medical Products Administration to enter Phase I clinical trials at the end of 2023, and all patients have been enrolled.
Since 2024, Rejoin Therapeutics has also made certain progress in promoting overseas clinical research. In that year, the IND application of NouvNeu001 in the United States was approved, and it obtained a special exemption granted by the FDA. It is expected to officially start enrolling patients in Phase I clinical trials in the first half of this year; another product NouvSight001 targeting the ophthalmic disease field also received the orphan drug designation from the FDA in March last year for the treatment of a series of indications of retinitis pigmentosa.
In addition, when talking about the pricing of the company's stem cell therapy products, Wei Jun mentioned that the future pricing of the products will comprehensively consider factors such as the national medical insurance affordability, patients' payment ability, and corporate costs to achieve a win - win situation for all parties and a price that patients can afford. At present, the company's cost advantage in the production process lays the foundation for achieving this goal.
Views of the founder and investors:
Dr. Wei Jun, the founder and CEO of Rejoin Therapeutics, said: "I am very honored to receive strong support from new shareholders continuously during the development of Rejoin Therapeutics. I also very much appreciate the contributions made by all old shareholders to the development of Rejoin Therapeutics. I would also like to especially thank the close cooperation between ECapital and the Rejoin Therapeutics team. Rejoin Therapeutics has always adhered to the tenet of 'starting from the needs of patients and solving real clinical needs' and uses 'original innovation' to create new therapies that can truly reverse the course of the disease for patients. This round of financing will further consolidate the foundation for Rejoin Therapeutics to accelerate clinical progress. The team will surely make persistent efforts to bring a new treatment experience to a large number of patients. In addition, the completion of this financing not only lays the foundation for NouvNeu001 to enter the confirmatory clinical stage but also provides impetus for Rejoin to further explore the international market."
Xiang Duan, the founder of Fengchuan Capital, said: "Fengchuan Capital is very honored to participate in this round of investment in Rejoin Therapeutics. The company develops a new generation of chemically induced universal cell therapies with its globally leading small molecule chemical transcription regulation iPSC technology platform. The company's pipeline focuses on unmet clinical needs, showing impressive safety and efficacy potential and broad commercial prospects. Through solid technological R & D and clinical advancement, Rejoin Therapeutics has gradually grown into a global leading enterprise in the iPSC field. We look forward to Rejoin Therapeutics further accelerating the industrialization and commercialization of each pipeline through this round of financing and bringing revolutionary changes to the global medical and health field. Fengchuan Capital will also continue to cooperate with Chinese biotech companies to promote the rapid development of original new drugs in China."
Guo Kai, the managing director of Hetang Venture Capital, said: "The drug - making strategy of dopaminergic precursor cell transplantation for the treatment of Parkinson's disease has a clear biological mechanism and has recently received preliminary clinical efficacy data support. It is expected to become the first therapy that can significantly delay the progression of the disease, with great social and commercial value. Rejoin Therapeutics' core product NouvNeu001 is the world's first iPSC - derived dopaminergic precursor cell therapy product to enter the clinical stage, with significant advantages in clinical progress, clinical efficacy, and production cost. We have high hopes for the company's products and will help the company actively promote the ongoing China - US clinical trials to benefit a large number of Parkinson's disease patients as soon as possible."