HeD Bio's hNPC01: The World’s First iPSC-Derived Forebrain Neural Progenitor Cell Therapy for Ischemic Stroke-Induced Hemiplegia

Forebrain Neural Progenitor CellsThese are stem cells responsible for developing into human brain tissue during neurodevelopment. The brain, which accounts for approximately 90% of the central nervous system’s volume (with the cerebellum, brainstem, spinal cord, and midbrain making up the remainder), governs all critical sensory, motor, and cognitive functions. Hundreds of neurological disorders are associated with the brain, including major conditions with no effective treatments such as stroke (commonly known as apoplexy), traumatic brain injury, cerebral palsy, epilepsy, Alzheimer’s disease, and autism.

CurrentlyTraditional drugs or medical devices struggle to provide targeted treatment for functional symptoms caused by acute injury, degenerative death, or dysplasia of a large number of nerve cells., imposing a heavy burden on families and society. Currently, there are approximately 100 million stroke survivors with hemiplegia worldwide, with about 12 million new cases each year. One in four people will experience a stroke, of whom approximately 22% are aged 15–49 years and 67% are under 70 years (WSO Global Stroke Fact Sheet 2022). Moreover, six months post-stroke, neither rehabilitation nor any other treatment is likely to yield significant improvement, highlighting an urgent and substantial unmet clinical need.

March 29, 2024,Hopstem Biotechnology’s globally innovative Class 1.1 iPSC-derived allogeneic off-the-shelf forebrain neural progenitor cell injection, hNPC01, has received prior notification from the FDA within the 30-day tacit approval period, granting permission to conduct a Phase 1/2a registrational clinical trial for post-stroke hemiplegia sequelae of ischemic stroke, without any additional conditions.。

Preliminary results from the ongoing Phase I registrational clinical trial of hNPC01 for the same indication at Xiangya Hospital in China support itsIschemic Stroke in Cranial TransplantationIn patients more than 12 months post-stroke, it demonstrated a favorable safety profile and sustained improvement in motor and language impairments. Meanwhile, Dr. Fan Jing emphasizedhNPC01 has also demonstrated significant potential in animal studies for expanding into multiple indications, including cerebral palsy and epilepsy.。

On Monday, April 29, at 19:30, the 58th session of VCBeat Select New Product Review will featureDr. Fan Jing, Founder & CEO of Hopstem Biotechnology、Dr. Zhang Shuning, Vice President of Hopstem Biotechnology, bringingSelf-developed iPSC-derived Cell Therapy Product for Post-stroke Hemiplegia Sequelae of Ischemic Stroke"hNPC01 Injection"product sharing.

hNPC01 human forebrain neural progenitor cells are the first off-the-shelf allogeneic universal cell therapy product (development code: hNPC01) under development by Hopstem Biotechnology. It is a cell replacement therapy administered via intracranial transplantation for conditions such as stroke and traumatic brain injury. Currently, it has the fastest registration progress among similar products worldwide. Its potential indications can be expanded to include cerebral palsy, traumatic brain injury, epilepsy, and other disorders.

Enhanced Therapeutic Mechanisms of Cell Replacement and Neural Circuit Remodeling

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Dr. Jing Fan

Founder & CEO of Hopstem Biotechnology

Founder & CEO of Hopstem Biotechnology. Recognized as one of the 30 Global Innovative Elites on the 2018 Huachuang Elite List; named to Forbes’ 2022 “Top 50 Women in Tech in China”; Member of the Special Committee on Regulatory Research for Cell and Gene Therapy Products under the Chinese Society for Drug Regulation; Zhejiang Provincial Leading Entrepreneurial Talent and 115 Intelligence Introduction Expert.

12–20 years of experience in the induced differentiation of pluripotent stem cells and research on neurological diseases, leading teams to rapidly advance the development and regulatory filing of multiple products.

Dr. Shuning Zhang

Vice President, Hopstem Biotechnology

Master of Medicine from Peking University Health Science Center, Ph.D. from Rensselaer Polytechnic Institute in the United States, and postdoctoral fellow at Albany Medical Center in New York. Recipient of the 2018 Overseas High-Level Talent Award in Hangzhou Future Sci-Tech City, Zhejiang Province; honored as a Young Scientific and Technological Talent at the Hangzhou Academician and Expert Workstation in 2019; and core member of the Zhejiang Provincial Leading Innovation Team Award in 2020. Responsible for the company’s clinical development and clinical medical affairs.

Hopstem Biotechnology Inc., established in January 2017, is a globally innovative biotechnology company dedicated to the development of iPSC-derived universal cell therapy products. It operates a total of 10,000 square meters of facilities in Qiantang District, Hangzhou, including an R&D center for cell-based drugs, GMP-compliant cell production workshops, a quality control center, and office spaces.

Hopstem Biotechnology holds leading global patents and innovative technological advantages in iPSC reprogramming, pluripotent stem cell neural differentiation, and various cell engineering disciplines. The company has established a CMC platform for iPSC cell products, featuring fully suspended automated production processes and multiple innovative analytical methods. Hopstem Biotechnology has developed GMP-compliant iPSC cell lines suitable for commercial licensing both domestically and internationally, and maintains a pipeline of multiple investigational products (including various neural cells, ophthalmic cells, etc.). Among these, its first-in-class human forebrain neural progenitor cell injection, hNPC01, is currently undergoing Phase I registrational clinical trials in China and has received FDA clearance for investigational new drug application. It is the fastest-developing iPSC cell product of its kind globally, addressing significant unmet clinical needs such as stroke, sequelae of traumatic brain injury, cerebral palsy, and epilepsy.

Since its establishment, Hopstem Biotechnology has completed multiple rounds of financing totaling hundreds of millions of yuan, led and continuously supported by renowned investment institutions including Qiantang Venture Capital, Datai Investment, Zhuhai Longmen, Yuansheng Venture Capital, Hillhouse Investment, and Lilly Asia Ventures. In late 2022, Qiantang Venture Capital further injected nearly RMB 100 million in a Series B+ round.

“Artery Select New Product Launch” is a live-streaming series under “Artery Select” designed to support medical enterprises in launching innovative products. The program’s mission is to facilitate the milestone launch of every medical innovation product.

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