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Media release


April 12,2019 IND approval by FDA
Wayshine Biopharm has received IND approval from FDA about its innovative experimental medicine WSD0922, a First-in-Class CNS penetrable EGFR/EGFRvIII inhibitor for the treatment of Glioblastoma, Anaplastic Astrocytoma and cancers with CNS metastasis patients. The WSD0922 program is under the sponsorship of Wayshine and the clinical trial, entitled “A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of WSD0922-FU” will be performed at Minnesota, Arizona and Florida, the three campuses of Mayo Clinic. Glioblastoma is the most aggressive malignant primary brain tumor in adults and is nearly always fatal. Treatment options for GBM are scarce and recurrence is inevitable. After recurrence, no standard treatment has been established. WSD0922 could be a potential game-changing program in treating GBM and other brain cancers.


"We are very pleased that the FDA has approved the application of IND, which is a significant development milestone in advancing our Portfolio," said?Wei Zhong, Ph.D., CEO and Founder of Wayshine Biopharm. "WSD0922 is the first and only BBB penetrable EGFR/EGFRvIII inhibitor under development. The discovery of WSD0922 truly reflects our innovation and commitments and the clinical potential has been recognized and endorsed by the FDA, for this substantial unmet medical need. “


?“If only one target can be picked for brain cancer, it’s EGFR/EGFRvIII." Comments from KOLs in Neuro-Oncology field.


"We make difference! WSD0922 is discovered and developed by Chinese scientists and the IND approval in?US?is a very important progress in its development. With the help from FDA and Mayo Clinic, we can definitely move this program forward quickly to benefit patients who are suffering Glioblastoma and the data generated from the study in cancer patients will significantly contribute to the brain cancer field.

Copyright ? 2018 Wayshine Biopharm International Ltd. Cayman
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