Wayshine Biopharm holding limited Announces ORPHAN DRUG DESIGNATION GRANTED By The FDA For WSD0922 IN GLIOMA (including GLIOBLASTOMA AND ANAPLASTIC ASTROCYTOMA)

JULY 25, 2019

Wayshine Biopharm, a clinical-stage pharmaceutical company, today announced that its First-in-Class CNS penetrable EGFR/EGFRvIII inhibitor, namely WSD0922, has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of glioma (including Glioblastoma and Anaplastic Astrocytoma). Orphan drug designation was created to encourage the development of drugs which may provide significant benefit to patients suffering from rare diseases.

WSD0922 has previously received IND approval from FDA for the treatment of Glioblastoma, Anaplastic Astrocytoma and cancers with CNS metastasis patients. Phase I/IIA to evaluate safety, tolerability, pharmacokinetics and anti-tumor activity of WSD0922 is ongoing at Minnesota, Arizona and Florida, the three campuses of Mayo Clinic.

"Orphan Drug Designation by the FDA for glioma is another significant milestone in the WSD0922 development program," commented Dr. Wei Zhong, Ph.D., CEO and Founder of Wayshine Biopharm. " We are very pleased that the FDA has granted broader indication than the indication proposed (GBM and AA). Fast grant for orphan drug designation by the FDA based on encouraging preclinical data truly reflects our innovation and commitments and the clinical potential of WSD0922 has been recognized and endorsed by the FDA, for this substantial unmet medical need and expansion to lower grade brain cancer.”

Orphan drug designation by the FDA is granted to promote the development of drugs that target diseases affecting 200,000 or fewer U.S. patients annually and that are expected to provide significant therapeutic advantage over existing treatments. Orphan drug designation qualifies a company for benefits that apply across all stages of drug development, including an accelerated approval process, eligibility for orphan drug grants, seven years of market exclusivity following marketing approval, tax credits on U.S. clinical trials, and a waiver of certain administrative fees.