Binhui Bio, a leading biotechnology company specializing in the research, development, and pilot production of innovative drugs, places patient wellbeing at the forefront of our priorities. Among our breakthroughs, the OH2 injection, a unique product derived from oncolytic viruses, has garnered attention by securing five INDs and one orphan drug approval from China NMPA and US FDA since 2018. The OH2 injection, designed for monotherapy and combination therapy for advanced melanoma cancer.
Recognizing that there may be scenarios where patients require access to our yet-to-be-approved medicines beyond the scope of clinical trials, we have established guidelines to address these unique situations. Such exceptions might arise when patients battling serious or life-threatening diseases have no other means to join a clinical trial, and lack satisfactory alternative treatment options. Under these circumstances, a healthcare professional (HCP) may be granted the use of an unlicensed medicine for patient treatment. This kind of utilization of unapproved medicines outside the framework of clinical trials is commonly referred to as "compassionate use" or "expanded access".
This policy delineates Binhui's approach to the treatment use of our unlicensed pharmaceutical products and the criteria we employ to assess requests from HCPs.
• The patient's condition being addressed is either life-threatening or causes significant impairment to daily life.
• There are no other satisfactory treatment options available, as confirmed by the treating HCP.
• Sufficient evidence is available that indicates the potential benefits of the unlicensed medicine for the patient outweigh the potential risks involved.
Moreover, we consider several additional factors when making decisions about supplying unlicensed medicines:
• There should be enough detailed information available to guide the correct application of the investigational medicine, particularly concerning the appropriate dosage and duration of treatment for the patient.
• We assess the potential impact of the treatment use of the investigational medicine on any concurrent clinical trials or its regulatory pathway.
• We only allow the use of our medicines in countries with an adequate medical infrastructure to safely administer the treatment.
• We only extend use in broad access programs to countries where Binhui Bio intends to pursue regulatory approval and subsequently make the medicine available. This condition may not necessarily apply to individual-named patients.
• We consider the ethical implications of our decisions, with particular attention to the principle of fair treatment for all patients.
• We ensure that the proposed use of our treatment is in accordance with local legal and regulatory frameworks.
Our senior medical staff, strictly following medical and ethical criteria, makes decisions to supply unlicensed medicines for treatment use.
We at Binhui Bio strongly believe that participation in one of our clinical trials is the most effective way to access our OH2.
HCPs seeking to request unlicensed medicines for treatment use should file the treatment IND to FDA and submit relevant information to IRB.
For further information on submitting a request for treatment use of our investigational medicines, HCPs are directed to follow this link. https://www.binhui-bio.com/
Binhui Bio currently has only one clinical drug product that can be used for EA, which is OH2 for the treatment of patients with unresectable stage III or IV melanoma that are resistant to anti-PD1 therapy.