About us

Founded in 2016, Darwincell Biotech is a national “High and New Technology Enterprise” and a recognized "specialized, refined, distinctive, and innovative small and medium-sized enterprise" in China. Our core expertise lies in our revolutionary platform technology (ECIWEP) in developing therapeutic protein complexes from stimulated stem cells. We are committed to tackling the most pressing medical challenges of our time—namely, CNS disease and neurorepair, articular cartilage regeneration, and organ restoration. We operate three GMP-standard laboratories: a central R&D lab, a clinical lab, and a pilot-scale process development lab. Among our three wholly owned subsidiaries, two specialize in biopharmaceuticals and biomedical consumables, while the third is a manufacturing entity equipped with a fully integrated GMP-compliant freeze-drying production line, handling consumables manufacturing.

Our first innovative biologic drug, ALT001, exhibits multiple biological activities, including restoring mitochondrial and lysosomal damages, promoting axonal growth in neurons, reducing cellular stress responses, and modulating neuroinflammatory reactions. It employs a multi-pathway, multi-target therapeutic strategy, demonstrating unparalleled advantages over conventional drugs in treating CNS diseases.

In 2024, a double-blind IIT clinical study led by the National Center for Neurological Disorders (Beijing Tiantan Hospital) showed that ALT001 significantly slowed motor function decline in amyotrophic lateral sclerosis (ALS) patients—even experiencing restoration of neurological functions—and demonstrated an excellent safety profile.

In preclinical studies for stroke, ALT001 was shown to effectively reduce brain infarction and edema, and promote neurological function recovery. Tiantan Hospital is currently conducting an IIT clinical trial for ischemic stroke (both acute stage and convalescent stage) to further validate these results. Additional IIT studies in Alzheimer’s disease (AD), multiple system atrophy (MSA), and cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL) have also been initiated.

As the world’s first innovative therapeutic protein complex derived from stimulated stem cells, ALT001 has successfully completed industrial-scale transformation. Our foundational and clinical research confirms that ALT001 breaks through the boundaries of conventional drug development and pioneers an entirely new therapeutic direction. With the potential accelerated approval from orphan drug designation and breakthrough therapy designation in ALS, and extended clinical development plans for common CNS indications, ALT001 will fulfill the unmet clinical needs in major CNS diseases and realize its unexceptionable global impact as the first drug capable of restoring neurological function, as well as remarkable commercial value. Derived from cells, we aim to make non-cell, no exosome, potent but safe therapeutics with industrialized manufacturing scale for patients in need all over the world.

Based on the potency and safety of ALT001, we are also developing non-invasive formulations including nasal spray (ALT002), microneedle (ALT003) and oral formulations for additional CNS indications and out-of-hospital use.

In addition, we are very proud to be the first biopharmaceutical company to lead the Sci-Tech Innovation Consortium organized by the Beijing Association for Science and Technology, and also one of the founding entities of the Beijing Neurorepair Industry Innovation Center. Together with Beijing Tiantan Hospital and Capital Medical University (the National Center for Neurological Disorders), we have co-established a joint translational laboratory focused on ALS and neurorepair technologies.