FDA clears IND for SBC003 in RPFDA clears IND for SBC003 in Retinitis Pigmentosa·Read more
Building credibility through grants, awards, and strategic partnerships
SunRegen is actively building its Series A syndicate, targeting $35M+ from institutional life science investors and strategic partners, to fund IND-enabling activities and the Phase I/II clinical trial in Retinitis Pigmentosa. Inquiries welcome.
The U.S. Food and Drug Administration (FDA) has cleared SunRegen's Investigational New Drug (IND) application for SBC003 in Retinitis Pigmentosa, clearing the way for the planned Phase I/II clinical trial of our lead oral neuroprotective candidate.
SunRegen has been awarded an Innovation Project Grant from Innosuisse, the Swiss Innovation Agency, to support the development of SBC003 for the treatment of ischemic stroke. The two-year project, conducted in partnership with the University of Basel, will validate SBC003 as a novel oral neuroprotectant targeting mitochondrial quality control and bioenergetics. This collaboration strengthens SunRegen's commitment to rigorous translational research for one of medicine's most urgent unmet needs.
SunRegen has been admitted into the IGNITE@HSITP programme operated by the Hong Kong-Shenzhen Innovation and Technology Park Limited (HSITP). This four-year programme provides incubation support, laboratory and office facilities, and funding to accelerate SunRegen's research and development activities in the Greater China region. The award enables SunRegen to expand its presence in Asia while complementing its ongoing development programs in Switzerland and the United States.
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for SBC003 in the treatment of Retinitis Pigmentosa (RP). This regulatory milestone provides seven years of U.S. market exclusivity upon approval, a PDUFA fee waiver, and a 25% tax credit for qualified clinical trial expenditures. Retinitis Pigmentosa is a rare inherited retinal disease affecting approximately 1.5 million people worldwide, with limited treatment options currently available. This designation validates the significant unmet medical need and strengthens SunRegen's position in the orphan drug space.
This financing validates institutional confidence in SBC003's therapeutic potential and ensures the company remains well-capitalized to advance its Chemistry, Manufacturing, and Controls (CMC) studies and regulatory preparation.
SunRegen Healthcare AG was awarded a residency at JLABS@Shanghai, the third recognition by pharmaceutical industry leader Johnson & Johnson. JLABS employs the strictest global standards to select innovative biopharma projects. Enrollment provided access to J&J's global network, manufacturing expertise, and regulatory guidance in preparation for clinical development.
SunRegen presented pivotal preclinical data at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, demonstrating dose-dependent neuroprotective effects of SBC003 in NMU-induced photoreceptor degeneration murine models. OCT imaging confirmed statistically significant preservation of photoreceptor and neuroretinal layer thickness. The data was also published in the peer-reviewed journal Aging Cell.
Innosuisse approved a CHF 1 million grant for SunRegen Healthcare AG's innovation project, facilitating collaborative research with EPFL and the University of Zurich (UZH). The grant supported critical mechanistic studies of SBC003's neuroprotective pathways.
SunRegen Healthcare was announced as the winner of the BIO-Europe® 2018 Startup Slam competition, held in Copenhagen. Dr. Yuhong Dong presented SBC003 as a potentially transformative solution for neurodegenerative eye diseases, with the company recognized by international peers for scientific innovation and commercial strategy.
SunRegen received funding from the European Union's Horizon 2020 SME Instrument Phase 1 program under grant agreement No 827153. The prestigious EU Seal of Excellence validated SBC003's scientific credibility and commercial potential within the European innovation ecosystem.
SunRegen successfully closed its seed round financing, attracting strong support from industry scientists and academic investors. This capital enabled the company to advance SBC003 through critical preclinical milestones and initiate collaborative research with leading Swiss academic institutions.
SunRegen was selected as a Global Top 20 Finalist in the IMAGINE IF! global competition, recognizing the transformative potential of SBC003. SunRegen was awarded a special prize of 3 months' free membership to the incubator StartLab at the life science park Biopôle, Lausanne.
The SunRegen founder team presented their SBC003 project at the CTI coaching acceptance meeting. The jury acknowledged the high potential market value for treatments of neurodegenerative disorders. Swiss CTI decided to continue supporting SunRegen through professional coaching executed by Dr. Andreas J. Schulze.
In order to encourage research collaboration with Swiss research groups, CTI provided an innovation grant to SunRegen to collaborate with the Brain Mind Institute (BMI) in École polytechnique fédérale de Lausanne (EPFL). The collaboration with EPFL greatly expanded SunRegen's research capability and genomic screening capacity.
SunRegen SBC003 project was accepted as a phase I project by BaseLaunch, which is a healthcare accelerator backed by Novartis, Pfizer, Johnson & Johnson, and Roche. Selection by this elite cohort of global pharmaceutical leaders provided immediate validation of SBC003's therapeutic potential and commercial viability.
Formal establishment of SunRegen Healthcare AG in Basel, Switzerland (the epicenter of global pharmaceutical innovation) to advance the commercialization of SBC003. The company was founded with the singular mission of developing disease-modifying neuroprotective therapies beginning with severe retinal degenerative conditions.
Confirmed neuroprotective, neuro-rescuing, and axon-outgrowth-promoting effects of SBC003 in cellular models, including mouse primary neurons and human neurons derived from induced pluripotent stem cells (iPSCs). These results provided the foundational scientific rationale to advance toward formal drug development.
The identification of SBC003 as a potent neuroprotective agent, discovered through rigorous in vivo screening. The compound's ability to activate an endogenous neuroprotective pathway was characterized as the core mechanism, representing a novel pharmacological approach to halting neuronal apoptosis.
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