Rejoin Therapeutics Raises Over 300 Million Yuan in Series B Financing, Parkinson's Stem Cell Therapy Gets FDA Fast Track Designation | Exclusive from 36Kr

36Kr has learned that recently, Rejoin Therapeutics (Chengdu) Co., Ltd. (hereinafter referred to as "Rejoin Therapeutics") has completed a new round of Series B+ financing. This round of financing was jointly invested by institutions such as Northern Light Venture Capital, Vision Capital, and Yuanxi Haihe, with China eCapital serving as the exclusive financial advisor.

The funds raised in this round will be used to accelerate the clinical R & D of the company's Parkinson's disease treatment products NouvNeu001/NouvNeu003 and ophthalmic treatment product NouvSight001, as well as team building and industrialization capabilities.

Rejoin Therapeutics was founded in 2017 and focuses on the development of small - molecule chemical transcription - regulated induced pluripotent stem cell (iPSC) products. In April this year, Rejoin Therapeutics officially announced a Series B+ financing of over 100 million yuan. The cumulative amount of the company's Series B financing has exceeded 300 million yuan.

The core product of Rejoin Therapeutics, NouvNeu001, is a chemically induced functional human dopaminergic neuron precursor cell. When Rejoin Therapeutics completed its previous Series B+ financing, Wei Jun, the founder and CEO of Rejoin Therapeutics, told 36Kr that the product had launched a multi - center Phase II clinical trial. In the previous Phase I clinical trial, NouvNeu001 "showed good safety and tolerance" in patients 15 months after transplantation; at the same time, PET imaging analysis also showed that as the transplantation time increased, the cells achieved long - term survival in patients without immunosuppressants.

Recently, the internationalization progress of NouvNeu001 has accelerated again. In mid - August, the product was granted the Fast Track Designation (FTD) by the US FDA and was approved to expand its scope of application. This also means that the clinical application scope and commercial scenarios of NouvNeu001 may be further expanded.

According to the company, after obtaining the FTD qualification, the FDA will provide "targeted one - on - one guidance to the company in aspects including clinical trial design and data requirements". In addition, this qualification can be parallel to the FDA's Breakthrough Therapy Designation (BTD), Priority Review, and Accelerated Approval, which may accelerate the listing process of NouvNeu001.

In addition, Rejoin Therapeutics' self - developed product for early - onset Parkinson's disease, NouvNeu003, is also under simultaneous R & D. This is a cell therapy product for early - onset Parkinson's patients under 50 years old, and it has completed the Phase I clinical trial. The company said that the trial has successfully reached the research endpoint, and the safety and effectiveness of the product have been initially verified.

In the field of ophthalmic diseases, Rejoin Therapeutics' NouvSight001 obtained the Orphan Drug Designation (ODD) from the US FDA in March 2024. This product is mainly used to treat a series of indications of retinitis pigmentosa.

Views of the founder and investors:

Wei Jun, the founder and CEO of Rejoin Therapeutics, said that he is grateful for the trust and continuous support of new and old investors in Rejoin, and also thanks China eCapital for its close cooperation with the Rejoin team. Rejoin has always adhered to the attitude of a pioneer and hopes to achieve a breakthrough from 0 to 1 in the international major disease field. This round of financing will greatly accelerate Rejoin's international development and industrialization construction, help it get through the cycle, and promote the product listing as soon as possible.

Song Gaoguang, a partner of Northern Light Venture Capital, said that Rejoin Therapeutics focuses on iPSC drug development. With its leading chemical induction technology platform and professional execution team, it has made remarkable progress in the field of regenerative medicine. In particular, its first - in - class pipeline for treating Parkinson's disease has smoothly advanced to Phase II clinical trials, showing excellent safety and effectiveness in previous clinical trials. This also marks that China already has the strength to compete with the United States and Japan in the iPSC field.

Song Longtao, the managing partner of Vision Capital, said that as the world's first iPSC - derived universal Parkinson's cell therapy product to enter Phase II clinical trials, the Phase I clinical data of NouvNeu001 has shown the potential to be the best - in - class product globally and is expected to become the world's first approved iPSC - derived cell therapy. We are optimistic about the long - term accumulation and in - depth exploration of the founding team in the development of chemically induced cell drugs. Through the method of chemical small - molecule induction, the company can truly achieve the goal of low - cost and high - quality industrialization in the future.

The person in charge of Yuanxi Haihe Investment said that the Rejoin team has deep accumulation in the field of iPSC drugs. Through differentiated technology layout and efficient clinical development strategies, its first pipeline, NouvNeu001, has entered Phase II clinical trials and has currently shown superior efficacy and safety. At the same time, through the universal drug design, Rejoin can achieve low - cost and efficient production, making the drugs more accessible to a large number of Parkinson's patients.

Fang Yang, an executive director of China eCapital, said that China eCapital is honored to assist Rejoin Therapeutics in successfully completing this round of financing. The company has completed multiple rounds of financing of over 100 million yuan in a short period, which not only shows that the iPSC track continues to receive high attention from the capital market but also further confirms Rejoin Therapeutics' leading position in the technology platform and product R & D. We look forward to Rejoin Therapeutics bringing more disruptive innovations and breakthroughs to the global medical and health field in the future.