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For the treatment of rare genetic diseases, the new drug authorized by Suoyuan Biotechnology was approved for clinical use in the United States and obtained the qualification of orphan drug

 Last Update: 2022-01-02
 Source: Internet
 Author: User

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On December 14, Suoyuan Biopharmaceuticals announced that its license-out partner Aytu Biopharma has received from the US FDA the critical clinical application of Suoyuan Bio's research product DB102 for the treatment of Vascular Ehlers- Danglow Syndrome (VEDS) The trial was approved by the IND, and the FDA granted DB102 the orphan drug designation for the treatment of VEDS
.

A pivotal clinical trial for the treatment of vascular Ehlers-Danlos syndrome (VEDS)

DB102 is a potential "first-in-class" small-molecule serine/threonine kinase inhibitor .
It acts on key tumor targets in the tumor field such as PKCβ, PI3K and AKT.
It can induce tumor cell death and hinder tumor cells.
The direct effect of hyperplasia and the indirect effect of inhibiting tumor-induced angiogenesis
.

DB102 is DB102 serine / threonine kinase inhibitors a potential "first-in-class" small molecule acts on a key target in the field of cancer tumor PKCβ, PI3K and AKT etc.

Public information shows that DB102 was originally developed by Eli Lilly and Company, and Suoyuan Bio will have global rights to the drug
.

In April of this year, Suoyuan Biotech signed a global license-out agreement to authorize Aytu BioPharma to develop DB102 for the treatment of VEDS.

Aytu BioPharma will be responsible for the clinical development and commercialization of VEDS.

The FDA has not yet approved any VEDS therapy

Dr.
Michael F.
Haller, Chief Commercial Officer of Suoyuan Biotech, said: “Since obtaining the authorization of Suoyuan Biopharmaceuticals, Aytu BioPharma has made significant progress in the treatment of VEDS patients with DB102
.

This cooperation not only extends Suoyuan Biotech’s existing product pipeline to The new indication field also enables Suoyuan Biology to have the ability to generate revenue before the release of the DB102 clinical first indication ENGINE research data, highlighting the multiple advantages of Suoyuan Biology’s business model

The press release also stated that the DB102 obtained the FDA orphan drug qualification this time, and it will enjoy policy support in terms of follow-up research and development, registration and commercialization, including a 7-year exclusivity period after the FDA approves the listing
.

It is worth mentioning that DB102 has previously been used for the treatment of diffuse large B-cell lymphoma (DLBCL) and glioma (GBM) and has obtained orphan drug designation in the United States and Europe

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