2019年4月12日， 威尚生物控股获FDA批准其创新药物WSD0922在美国开展临床试验。WSD0922是世界首创能穿透血脑屏障的EGFR/EGFRvIII 靶向抑制剂，适应症为脑胶质母细胞瘤（GBM），间变型胶质瘤（AA）以及其他肿瘤的神经中枢转移。
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.
WSD0922由威尚生物医药有限公司自主研发，其临床试验“A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of WSD0922-FU”在梅奥诊所（Mayo Clinic）的明尼苏达州、亚利桑那州和佛罗里达州三个临床中心开展。
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.
GBM是恶性脑胶质瘤，也是原发脑部肿瘤中最常见的脑瘤，多发于成人，患者生存期极短。GBM治疗手段稀缺，复发率几乎100%。复发后，至今无标准治疗方案。WSD0922有可能会成为治疗GBM和其他脑部肿瘤的突破性治疗手段。
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.
“我们很荣幸FDA接受了WSD0922在美国的临床试验申请，这是具有里程碑意义的一步，”CEO兼创始人钟卫博士说， “WSD0922是世界上首个且目前唯一一个可以穿透血脑屏障（BBB）的在研EGFR/EGFRvIII靶向抑制剂。WSD0922的发明设计体现了我们的创新能力和公司的承诺，其临床潜力得到FDA的认可，靶向未满足临床需求的肿瘤。”
"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. “
“脑瘤的治疗靶点如果只能选择一种，那就是EGFR/EGFRvIII。”中枢神经肿瘤领域的专家KOLs如是评价。
“If only one target can be picked for brain cancer, it’s EGFR/EGFRvIII." Comments from KOLs in Neuro-Oncology field.
“我们致力于改变！WSD0922是由中国科学家发明设计，FDA接受我们的临床试验申请是WSD0922整个研发之路的重要一步。通过FDA及Mayo的帮助，我们会迅速推进这个项目，让患者早日获益。相信临床数据会对脑部肿瘤的治疗和理解做出举足轻重的贡献。”VP及共同创始人张金强说。
"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."
Commented by Jinqiang Zhang, Ph.D., VP and co-founder at Wayshine.
关于威尚生物医药有限公司
威尚生物医药有限公司是一家跨国药物研发公司，遵循科学，致力创新，主要专注于未满足临床需求的脑部肿瘤靶向药物研发。运作模式以基因学为基础，寻找生物靶点，验证靶点，设计化合物，与国内外CRO进行实验合作。WSD0922是世界首创能穿透血脑屏障的EGFR/EGFRvIII 靶向抑制剂，适应症为脑部肿瘤，目前已经得到FDA临床批件在美国开展I期临床试验，合作方为梅奥诊所。公司的策略性研发管线，以WSD1227为例，可以单药或联合用药治疗脑部肿瘤，目前在临床前IND准备阶段。了解更多信息，请访问：
http://www.wayshinebiopharm.com
