Recently, the US FDA officially granted NouvNeu004 Injection, a subsidiary of Ruijian Yilian Pharmaceutical Technology Co., Ltd., special exemption status and further approved the international phase I clinical trial of NouvNeu004 Injection for multiple system atrophy. It is reported that this is a further significant international progress made by NouvNeu004 injection after the National Medical Products Administration (NMPA) of China officially approved the Phase I-III full cycle clinical trial application of NouvNeu004 injection on October 23, 2025.
It is worth mentioning that currently, NouvNeu004, which is used by Ruijian Pharmaceutical to treat multiple system atrophy, and NouvNeu001, which is used for Parkinson's disease, have become the first international generic cell drugs derived from iPSCs. Both have been granted "Special Exemption" by the FDA and have achieved dual reporting and approval in China and the United States.
Special Exemption is a temporary policy exemption granted by the US DA for specific drugs or therapies, allowing them to conduct clinical trials or market applications without fully complying with routine regulatory requirements. Since the beginning of this year, multiple innovative drugs under development in China have received this special approval.
On November 24th, LY03017, independently developed by Green Leaf Pharmaceutical Group, obtained the "Special Exemption" special exemption qualification granted by the US FDA. After FDA review, it is believed that based on the chemical structure characteristics, existing safety data, and preclinical research results of LY03017, the first step of traditional Phase I clinical trials (SAD) can be skipped and directly entered into the phase of multiple dose escalation.
It is understood that LY03017 is intended for the treatment of Alzheimer's disease psychiatric disorders (ADP), Parkinson's disease psychiatric disorders (PDP), and negative symptoms of schizophrenia (NSS). Preclinical studies have shown that LY03017 has significantly better in vitro and in vivo pharmacological activity, tissue distribution, and cardiac safety than marketed and investigational drugs with the same target indication.
On February 1st, the US FDA officially approved the investigational new drug application (IND) for the generic iPS derived dopaminergic precursor cell injection of Szeze Biopharmaceutical (Suzhou) Co., Ltd. for the registration of clinical trials for the treatment of Parkinson's disease. In addition, the US FDA also officially approved the special exemption for Szeze Biopharmaceutical's new drug for Parkinson's disease, to support Szeze Biopharmaceutical's registration of clinical trials for generic cell therapy of Parkinson's disease.
In China, the drug has also been officially approved by the National Medical Products Administration (NMPA) for the treatment of Parkinson's disease, a neurodegenerative disease, without a single dose supplement.
In 2025, multiple Chinese innovative drugs will receive special exemptions from the FDA, which not only proves the research and development capabilities of enterprises, but also demonstrates that the current Chinese pharmaceutical industry is accelerating its transition from a generic drug country to an innovative drug country. In the next 3-5 years, the Chinese pharmaceutical industry is expected to occupy an increasingly important position in the global innovation landscape, becoming a crucial source for patients worldwide to obtain high-quality innovative drugs.