Humanwell 
Pharmaceutical US

02/25/2025 

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Humanwell Pharmaceutical US, Inc., a biotechnology company dedicated to innovative drug development to treat pain, CNS disease, autoimmune disease and cancer, has received an official letter from the U.S. Food and Drug Administration (FDA), confirming the completion of the agency’s safety review for the clinical protocol submitted under the Investigational New Drug (IND) application for RFUS-250. The FDA’s clearance allows Humanwell US to proceed with clinical investigation of the novel therapeutic candidate.

 

The successful completion of the safety review marks a crucial milestone in the development of RFUS-250, which is being explored for its potential in the treatment of acute pain, chronic pain, neuropathic and pruritus. With the FDA’s green light, Humanwell US is now preparing to initiate the phase 1 clinical trial to evaluate the safety, tolerability, and efficacy of RFUS-250 with FDA reviewed clinical protocols.

 

“This FDA clearance is a significant step forward for Humanwell US and our mission to bring innovative treatments to patients in need,” said Dr. Jun Yang, president at Humanwell Pharmaceutical US. “We are eager to advance RFUS-250 into clinical development and look forward to generating critical data that will guide its further progression.”

 

The company plans to initiate the clinical study in the second half of 2025, contingent on everything proceeding as planned, and will provide updates as the trial progresses.

 

About RFUS-250

RFUS-250 is a novel small molecule with unique pharmacodynamic (PD) and safety profiles; it binds to all three opioid receptors at sub or nanomolar binding affinities but with distinct receptor-specific features; it acts as agonists for both opioid receptor subtypes KOR (EC50= 0.054 nM) and DOR (EC50 = 0.62 nM) but partial agonist for MOR receptor (EC50=0.68 nM); these unique in vitro PD profile translates it into a very potent analgesics in many in vivo animal models including rat formalin model, rat incision model, and SNL neuropathic pain model with minimized side effects; it showed about 100 times more potent efficacy than morphine in both rat formalin and incision models.  RFUS-250 showed no respiratory depression, minimal constipation and addiction in safety evaluation. As a KOR agonist, it did not show sedation at effective therapeutic dose (3-10 ug/kg) in vivo animal studies which distinguished it from other traditional KOR agonists.

 

About Humanwell Pharmaceutical US

Humanwell Pharmaceutical US, Inc. is a Ballwin, MO-based pharmaceutical company focused on discovery and development of novel therapeutics in pain, CNS, autoimmune and oncology to address unmet medical needs. At Humanwell, we work towards improving patients' quality of life and are committed to creating a healthier world of tomorrow.

 

Safe Harbor Statement

This press release contains forward-looking statements that are subject to risks and uncertainties, including but not limited to statements regarding the development, regulatory approval, and potential benefits of RFUS-250. Actual results may differ materially from those indicated by such statements due to various factors, including changes in regulatory requirements, clinical trial results, and the company’s ability to successfully commercialize its products. Humanwell US undertakes no obligation to update any forward-looking statements, except as required by law.

 

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