At Senhwa Biosciences Inc., we are committed to identifying and developing innovative therapies that have the potential to fundamentally change the way patients are treated. Our central philosophy is to unearth validated targets or therapies that could significantly improve treatment but have not yet been properly exploited. Senhwa Biosciences aims to take innovative therapies that could impact the current standard of care and drive them through to clinical Proof-of-Concept. 

 

Our ultimate goal is to provide access to these therapies through marketing authorization. However, before our product candidates might be available through these means, Senhwa Biosciences is committed to carefully considering access to our investigational medicines through expanded access.

 

There is no guarantee that every request will be fulfilled; however, each request will be given careful consideration by Senhwa Biosciences whose decisions are final. 

 

Please see more about Senhwa Biosciences’ Expanded Access Policy.

 

Criteria for a Request for Expanded Access

• General Criteria:

o  Suffer from a serious or immediately life-threatening disease or condition.

o  Have undergone appropriate standard treatments without success, and no comparable or satisfactory alternative treatment is available or exists to treat the disease or condition.

o  Are ineligible for participation in any ongoing clinical study of an investigational medicine, which includes lack of access due to geographic limitations.

 

• For the Treating Physicians:

Please note that requests for expanded access must be made by a physician(s) who:

o      is (are) properly licensed and fully qualified to administer the product.

o      must agree in writing to comply with:

• Any applicable country-specific legal and regulatory requirements related to providing an investigational product under Expanded Access.
• Any Senhwa Biosciences requirements in terms of medical criteria, safety reporting, drug supply/use, collection of some relevant information on an ongoing basis while the patient receives the medicine, and protection of intellectual property.

 

• For the Patients

If you are a patient with questions concerning access to investigational medicine, please discuss with your treating physician. For more information on our clinical trials that may be recruiting, you can visit our website, or search “Senhwa Biosciences” at www.clinicaltrials.gov.

 

Requesting Expanded Access:

 

Physicians seeking expanded access for patients receiving an investigational product through compassionate use access should submit their requests to expandedaccess@senhwabio.com.  We will use our best efforts to acknowledge each submitted request within three (3) business days after receipt.

 

Any early access programs we provide will be in line with the laws and requirements of the country involved.

 

Senhwa may revise this expanded access policy at any time. This posting will be updated should there be any policy change.