Darwin Cell Biotech: A Pioneer in Protein Polymer Technology and a Rising Contender in Neural Repair

"Nerve repair is globally recognized as an insurmountable technological peak."

There are over a thousand indications associated with neurological disorders, including central nervous system lesions, peripheral nervous system lesions, autonomic nervous system lesions, and neurodegenerative diseases. These conditions present with clinical symptoms such as sensory impairments, motor impairments, consciousness disturbances, and autonomic dysfunction. Characterized by low mortality, high disability rates, prolonged rehabilitation periods, and a lack of effective treatments, they impose a substantial economic burden on patients’ families and society.

The human brain’s structure is highly complex, and due to the influence of the blood-brain barrier, traditional therapeutic approaches such as craniotomy, intravenous injection, and intramuscular injection are unable to address technical challenges associated with brain injury, particularly neurological damage. To date,No therapeutic approach has yet been identified worldwide that can completely repair neurological damage.

Wang Yu, Founder and Chairman of Darwin Cell Biotechnology Co., Ltd., stated: “The field of neurological disorders is a key focus in the strategic layouts of multinational pharmaceutical companies, as well as a significant technical challenge. It is an indisputable fact that the number of approved drugs for treating neurological conditions is far less than 50% of those available in other therapeutic areas. The aforementioned data corroborates that neural repair, particularly cranial nerve repair, has become a critical technological hurdle that urgently needs to be overcome globally.”

Professor Chen Lin, CTO of REBIRTH BIOTECH, is the founding initiator of the discipline of “Neurorestoratology,” an internationally renowned clinical expert in neurorestoration, and currently serves as the Secretary-General of the International Association of Neurorestoratology. He has dedicated over two decades to the clinical translation of achievements in the field of neurorestoration. Leveraging more than twenty years of clinical accumulation by hundreds of expert members of the Chinese Committee of the International Association of Neurorestoratology,REBIRTH BIOTECH’s ECIWEP (protein polymer) has achieved breakthrough results in the field of nerve repair, poised to usher in a new chapter for neural restoration.

The company has taken the lead in advancing neurorestorative drugs for the treatment of stroke and its sequelae, and is preparing to submit an Investigational New Drug (IND) application based on completed preclinical research findings. In light of this progress, the company secured RMB 130 million in Series A+ financing in January 2022, led by a subsidiary fund of the National Small and Medium Enterprise Development Fund managed by Tsinghua Holdings Yinxing, with follow-on investment from Jinan Blue Sky Investment Co., Ltd.

After more than a decade of R&D accumulation, the research team at REBIRTH BIOTECH has successfully isolated and prepared ECIWEP, the world’s first protein polymer derived from human cells.“REBIRTH BIOTECH’s pioneering protein polymer technology is poised to open a new chapter in neural repair.”Wang Yu, Founder and Chairman of REBIRTH BIOTECH, Confidently States.

Preclinical research results, including in vitro cell assays, animal studies, and human trials conducted by the company, have demonstrated that protein polymers achieve ideal neurorestorative effects in the treatment of stroke and its sequelae. These findings suggest that protein polymers hold promise as a novel therapeutic approach, potentially replacing conventional treatments such as pharmacotherapy, gene therapy, stem cell therapy, and rehabilitation. Furthermore, preliminary evidence has confirmed that the protein polymerHigh safety, superior efficacy, good stability, high bioavailability, and convenient for storage and transportationand other advantages, it is poised to become a “Chinese (international) contender” in conquering the pinnacle of nerve repair technology.

Wang Yu stated, “We first isolated and prepared protein polymers from human-derived cells and confirmed their structure and composition. Meanwhile, the company has developed a new microbial synthesis technology for protein polymers, aiming to address the shortage of human cell resources and meet the demands of large-scale production.”

Currently,The company possesses advanced, mature technologies for the preparation of protein polymers and is capable of large-scale production., thereby establishing the technical foundation necessary for its clinical translation. Meanwhile, the company has assigned unique names to the newly engineered bacterial strains and completed their deposition in accordance with national regulations for microbial preservation. Furthermore, it has strategically deployed a high-value patent portfolio around these series of innovative achievements to fully leverage intellectual property protection for safeguarding its innovation rights and interests.

Stroke is among the top three causes of death in China. According to the Global Burden of Disease Study 2019 (GBD 2019), there were 3.94 million new stroke cases, a total prevalent population of 28.76 million stroke patients, and 2.19 million stroke-related deaths in China in 2019. The preferred clinical translation indication for the protein polymer (ECIWEP) is stroke and its sequelae, aiming to efficiently repair damaged nerves in patients, improve prognosis and self-care ability, effectively alleviate the heavy economic burden of disability on families and society, and open a window of hope for the global cure of stroke and its sequelae.

In addition to developing protein polymers (ECIWEP) for the clinical translation of nerve repair, the company leverages its proprietary core technologies to expand into diverse fields, including joint (cartilage) repair, tumor immunology, hair follicle regeneration, skin injury repair, medical aesthetics and anti-aging, and consumer beauty and personal care. Furthermore, it has incubated independent subsidiaries in these areas, each operated by dedicated teams.

The company initiated clinical translational trials of recombinant collagen scaffold materials for the treatment of osteoarthritis in 2022.Existing clinical trial results demonstrate that recombinant collagen scaffold materials can significantly reduce inflammatory responses by decreasing inflammatory cells and cytokines, reconstruct and repair the immune microenvironment at damaged sites, eliminate abnormal epiphyses hindering endogenous repair, and actively mobilize autologous cells and reparative materials for targeted, efficient restoration of injured tissues and regions. These findings suggest that such materials hold promise as a safer and more effective non-surgical therapeutic solution for osteoarthritis in clinical practice.

REBIRTH BIOTECH took the lead in filing an application in 2022, with its core technology centered on neurorestorative biotechnology products.Beijing Neural Repair Industry Innovation Center。

The Beijing Neural Repair Industry Innovation Center covers the entire industry chain, including innovation, R&D, achievement transformation, production, sales, and re-innovation. It aims to build an ecosystem for the neural repair industry and fully leverage the superior reparative properties of protein polymers (ECIWEP), as well as their synergistic effects with therapeutic drugs and innovative products for nervous system diseases. By partnering with more collaborators, the Center seeks to accelerate the clinical translation of innovative neural repair products and technologies.

Wang Yu, Founder and Chairman of REBIRTH BIOTECH, stated, “We are tackling technical challenges once deemed insurmountable and curing diseases previously considered incurable. Protein Polymer (ECIWEP) technology is an innovative, independently developed intellectual property pioneered in China. Leveraging the significant breakthroughs achieved by ECIWEP in the field of neural repair, we aim to overcome global therapeutic challenges. We firmly believe that Chinese teams can confidently engage with the market and lead the neural repair sector with distinction.”