Wayshine (Hangzhou) Biopharm Co., Ltd. (hereinafter “Wayshine Biopharm”) was established in 2016 as a multinational Biopharm enterprise that proactively and strategically advances the R&D of innovative oncology drugs with a global vision. The group’s parent company is registered in Delaware, USA, with overseas entities in California, USA, and Hong Kong. As the group’s core entity in China, Wayshine Biopharm is headquartered in Xujiahui, Shanghai, and operates subsidiaries including Shanghai Weidao and Hangzhou Weiruibo, thereby forming a global R&D and operational footprint spanning China and the United States.
R&D strength is the core competitiveness of Wayshine Biopharm. Guided by the R&D philosophy of “Follow Science, Dedicate to Innovation,” the company focuses on small-molecule targeted drugs for brain tumors with a forward-looking strategic vision. It has established a core technology platform for efficient blood-brain barrier (BBB) penetration, along with a comprehensive R&D system spanning “target discovery — target validation — compound design — preclinical development.” The company collaborates extensively with renowned CRO organizations both domestically and internationally to efficiently advance the drug development process, and is committed to translating cutting-edge scientific achievements into clinical treatments that benefit patients.
The company’s core product, WSD0922, is an EGFR/EGFRvIII targeted inhibitor with blood-brain barrier (BBB)-penetrating capability for indications including non-small cell lung cancer (NSCLC) and glioma. In 2019, the product obtained clinical trial clearance from the U.S. Food and Drug Administration (FDA) and is conducting Phase I/II clinical trials in the United States in collaboration with the internationally renowned Mayo Clinic. In 2024, the product initiated domestic clinical research for first-line treatment of NSCLC patients who developed resistance to third-generation EGFR inhibitor therapy (C797S mutation), and has now advanced to Phase III clinical stage, having been granted NMPA Breakthrough Therapy Designation (BTD).
Additionally, the company has strategically laid out a forward-looking R&D pipeline: WSD0628 (an ATM targeted inhibitor) has successively received FDA Orphan Drug Designation and U.S. clinical trial clearance, and is currently conducting Phase I clinical trials in the United States; WSD1227 (an anti-angiogenic agent) with brain-penetrating capability is currently in the preclinical IND preparation stage.
"Wayshine" was founded by Dr. Zhong Wei, a returning overseas Chinese scientist. Dr. Zhong has over twenty years of experience in novel drug molecule R&D and has worked extensively in the field of brain-penetrating drug development, with profound academic and industrial expertise. He previously worked at AstraZeneca’s Global New Drug R&D Center, where he led a breast cancer Her2 brain metastasis project that was awarded AstraZeneca’s “Science Star” honor. Among the molecules he personally developed, one has entered Phase III clinical trials, three have entered Phase II, and one has entered Phase I, all demonstrating favorable safety and efficacy profiles. During his postdoctoral tenure, he participated in the R&D of enzalutamide, which was licensed to Medivation for USD 100 million at the preclinical stage, and apalutamide, which was licensed to Johnson & Johnson for USD 1 billion at the Phase I stage.
