July 14, 2025
Source: drugdu
87
According to industrial and commercial information, in May 2025, Roche Biopharmaceuticals (Suzhou/Shanghai) Co., Ltd. (Roche Accelerator Member) has completed a new round of market-oriented financing . The new financing came from Jianfa Emerging Investment, Suzhou Angel Fund, Xinxi Capital, and Qisheng Capital.
Just a few months ago, in October 2024, Shize Bio officially announced the completion of more than 100 million yuan in B1 round of market-oriented financing : the B1 round of financing was led by Tailong/Taikun Capital, co-invested by Qisheng Capital and Tianhui Capital, and additional investments from old shareholders such as Frees Capital, Qiming Venture Partners, Lilly Asia Fund, and Sequoia China. The B1 round of financing will be used to improve Shize Bio's clinical-grade iPS-derived cell drug pipeline for the treatment of neurological diseases, further conduct clinical research, and promote multiple registered clinical trials.
During the overall downturn of the pharmaceutical industry from 2022 to 2025, Shize Biopharma achieved high-quality and rapid development against the trend, and completed a total of 300-400 million yuan in pure market-oriented financing . All the financing was used for the development of multiple new drugs and domestic and foreign clinical business. It is reported that the company's previous financing has not involved any additional investment conditions for relocation or pipeline transfer, which reflects the core value and development strategy of Shize Biopharma's new drugs.
Shize Bio is a leading pharmaceutical company in China for cell therapy of Parkinson's disease. It was founded by Dr. Li Xiang, the founder of Shize Bio, who returned to China full-time in 2021. Corresponding to the continued support from well-known market-oriented investment institutions is Shize Bio's continued high growth and outstanding progress in its new drug clinical business. According to public information, Shize Bio focuses on developing clinical-grade, allogeneic, "off-the-shelf" iPSC-derived cell drugs for the treatment of neurological diseases (CNS Diseases), and has achieved significant leading advantages:
Shize Bio has obtained seven clinical trial registration approvals from the China National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (USFDA) for China. Several universal iPSC-derived neural cell new drugs are in the clinical trial registration stage in China and the U.S., including for the treatment of:
The world's second largest neurodegenerative disease, primary Parkinson's disease (Phase I clinical trial registered in China and the United States); early-onset Parkinson's disease (Phase I/II clinical trial registered in China); spinal cord injury, a major neurological disease (Phase I clinical trial registered in China and the United States); amyotrophic lateral sclerosis/ALS (Phase I/II clinical trial registered in China and Phase I clinical trial registered in the United States). It is China's first independently developed iPSC-derived cell drug to be certified by the U.S. FDA and granted global orphan drug status.
In the field of universal iPSC cell therapy for Parkinson's disease, Shize Bio has taken the lead in achieving breakthroughs in multiple fields and has become a leading benchmark in China. Not only has long-term follow-up of multiple patients with Parkinson's disease proved that cell therapy is safe and effective, but it has also completed dual filing and approval of universal cell therapy in China and the United States, and has jointly carried out registration clinical trials with Parkinson's disease experts from the top hospitals in China:
In 2024, the "first in China" iPSC-derived cell therapy for the treatment of neurological diseases was approved for national clinical registration. In collaboration with the team of Dr. Liu Zhongmin, President of Shanghai Oriental Hospital, we completed GCP/GMP-level cell therapy for multiple Parkinson's disease patients, including the "first in China". The follow-up was more than 12 months, with good safety. The patients' "on-off time", MDS-UPDRS scores and multiple non-motor indicators were significantly improved, and passed the GCP/GMP standard double inspection of the National Health Commission;
In 2025, the U.S. Food and Drug Administration (FDA) has fully and without supplementation approved the Investigational New Drug (IND) application of Shize Bio for universal iPSC-derived dopaminergic neural precursor cell injection for the registration clinical phase I trial for the treatment of Parkinson's disease in the United States. In the same month, the U.S. FDA approved the direct exemption of the registration clinical phase II and the confirmation clinical phase III trial of the universal cell therapy for Parkinson's disease of BlueRock Therapeutics (wholly acquired by the German Bayer Group in 2019).
In 2025, the first phase I registration clinical trial of allogeneic generic “off-the-shelf” iPSC-derived dopaminergic neural precursor cells (XS411 injection) will be conducted in China, led by Director Feng Tao of Beijing Tiantan Hospital, a national neurological disease medical center, and jointly with Directors Bao Xinjie, Wang Renzhi and Wang Han of Peking Union Medical College Hospital, for the treatment of idiopathic Parkinson's disease, the second largest neurodegenerative disease in the world .
In 2025, China's first registered clinical Phase I/II trial using the highest level of evidence, "randomized double-blind controlled" design, will be led by Director Wang Jian/Director Chen Liang/Director Zhang Jing of Huashan Hospital Affiliated to Fudan University (also a national-level neurological disease medical center), and conducted in collaboration with Director Liu Chunfeng of the Second Affiliated Hospital of Soochow University , for the treatment of early-onset Parkinson's disease (EOPD).
Shize Bio's clinical-grade iPSC-derived dopaminergic neural precursor cells were transplanted into the striatum putamen of Parkinson's patients to treat patients with moderate to severe Parkinson's disease with a maximum follow-up period of >12 months. Long-term clinical follow-up results showed that no cell therapy-related adverse events occurred, and key efficacy indicators such as the on-off time and MDS-UPDRS score scale and multiple non-motor indicators of many patients were significantly improved. In addition to the clinical follow-up results showing that long-term cell therapy is safe and effective, many patients reported a significant improvement in their quality of life:
In addition to the leading breakthrough in allogeneic universal cell therapy for Parkinson's disease, other allogeneic universal iPSC cell therapy new drugs for nervous system diseases developed by Shize Bio have also achieved breakthrough milestones, and are in the position of "world's first" and "world's first", demonstrating Shize Bio's technological innovation capabilities, platform system advantages and efficient clinical transformation capabilities in the field of universal cell therapy for CNS diseases:
In 2023, "China's first" iPSC-derived cell medicine (XS228 injection) was certified by the U.S. FDA and granted global orphan drug status;
In 2024, the national clinical study of the "world's first" iPSC-derived cells (XS228 injection) for the treatment of amyotrophic lateral sclerosis (ALS) was approved. In cooperation with the Oriental Hospital, multiple patient treatments, including the "world's first", were completed, with good safety and preliminary results showing that it can effectively delay the progression of the disease.
In 2025, the "world's first (FIC) " allogeneic universal "off-the-shelf" iPSC-derived subtype neural progenitor cell new drug registration clinical Phase I trial will be led by Rong Limin, President of the Third Affiliated Hospital of Sun Yat-sen University, and jointly conducted by Liu Jing, President of the First Affiliated Hospital of Dalian Medical University, for the treatment of spinal cord injury (SCI), a major neurological disease .
In 2025, the registration clinical Phase I/II trial of the " world's first (FIC)" allogeneic universal "off-the-shelf" iPSC-derived subtype neural precursor cell new drug (XS228 injection) will be led by Director Fan Dongsheng of Peking University Third Hospital for the treatment of amyotrophic lateral sclerosis (ALS), "one of the world's four incurable diseases . "
Shize Bio is a leading innovative pharmaceutical company in the field of cell therapy for Parkinson's disease in China. It has achieved a clear leading edge in the development of multiple "China's first" or "world's first" iPSC-derived neural cell drugs. With the long-term support of well-known market-oriented investment institutions, Shize Bio is conducting a number of registration clinical trials with breakthrough value with top hospitals and clinical expert teams across the country. In the future, we expect Shize Bio to make more innovations and contributions in the development of clinical-grade iPSC-derived neural cell new drugs to treat neurological diseases (CNS Diseases) represented by Parkinson's disease, spinal cord injury and ALS, and to benefit the vast number of suffering neurological disease patients in China and around the world with its unparalleled innovative stem cell regenerative therapy drugs!
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