Pipeline

Our pipelines focus on central nervous system (CNS), cardiovascular and cerebrovascular, and autoimmune diseases

Target

Compound

Indications

pre-clinical Phase 1 Phase 2 Phase 3 NDA

CNS

HIF-1a

GD-11

Stroke

GD BioPharma is eligible for 13% share of profits

GD-11 is a blood-brain barrier (BBB)-targeting HIF-1α inhibitor, and capable of exerting potent neuroprotective effects in stroke lesions. Stroke is the leading cause of death and disability among adults in China. GD-11's dual-targeting properties endow it with brain-targeted delivery and neuroprotective functions, demonstrating good therapeutic effects in acute stroke patients across all clinical stages.


COX-2

GD-19

Pain

A novel nonsteroidal anti-inflammatory drug (NSAID) for perioperative pain management and cancer pain

GD-19 is the optically active isomer of an arylpropionic acid-based anti-inflammatory and analgesic agent. It is designed to selectively accumulate at sites of inflammation, tissue injury (including post-surgical, chemotherapy-induced, or radiotherapy-related damage), infection, and nerve infiltration, thereby maximizing its therapeutic efficacy while minimizing systemic exposure and adverse effects.

Multiple Targets

GD-20

Multiple Sclerosis

Oral immunomodulator for autoimmune diseases

GD-20 demonstrates broad immunomodulatory, neuroprotective, and analgesic efficacy across multiple preclinical models, including inhibition of T and B cell proliferation, downregulation of T cell-mediated responses, reduction of pro-inflammatory cytokines production, protection against oxidative stress-induced neuronal damage, and amelioration of disease severity in experimental autoimmune encephalomyelitis (EAE).

GD-20 has successfully completed Phase I clinical trials, demonstrating favorable safety, tolerability, and pharmacokinetic profiles that support progression to Phase II development in Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorders.

Nav 1.8

GD-25

Acute pain

A novel non-opioid Nav1.8 inhibitor for moderate-to-severe acute pain

GD-25 is a selective NaV1.8 inhibitor for acute and chronic pain by AI-Driven Design, and currently advancing toward IND-enabling studies. GD-25 possess stronger efficacy than FDA approved drug Suzetrigine while holding a simple but unique molecular structure. All in vitro and in vivo results from preclinical studies of GD-25 demonstrate superior efficacy, pharmacokinetic, and safety profiles compared to VX-548.




Multiple Targets

GD-26

Insomnia

Oral agent for the treatment of insomnia and major depressive disorder
Oncology

CRBN / IKZF1 / IKZF3

GD-07

Multiple myeloma

CRBN / IKZF1 / IKZF3

GD-09

Multiple myeloma

Immunology&Inflammation

PDE4

GD-17

Inflammatory Diseases

S1P

GD-21

Inflammatory Bowel Disease/ Multiple Sclerosis

*Expanded Access Policy

Expanded Access involves the use of an investigational new drug for patient treatment outside the context of a clinical trial. At GD BioPharma, Inc., we are dedicated to advancing therapies developed through our proprietary AI-Powered Drug Discovery Platform, prioritizing the clinical trials necessary to secure regulatory approvals. We believe that enrollment in one of our clinical trials represents the optimal pathway for patients to access our investigational product candidates, whenever feasible. At this time, GD BioPharma, Inc. does not provide expanded access to investigational drugs outside of clinical trials. If and when we commence offering expanded access for any investigational drug, this website and policy will be revised to notify the public of the applicable request procedures and evaluation criteria.

Applicability

 This Expanded Access Policy applies generally to all investigational drugs manufactured or distributed by GD BioPharma, Inc. intended for use in serious diseases or conditions.

Questions

For additional inquiries, please contact guduibio@126.com. Further information on our ongoing clinical trials is available at Chinadrugtrials.org.cn. GD BioPharma, Inc. endeavors to respond to all Expanded Access Policy inquiries within 7 business days.