Zion Pharma Announces Global Agreement with Roche to Develop and Commercialize a Blood Brain Barrier Penetrant Oral HER2 Tyrosine Kinase Inhibitor

HONG KONG & SUZHOU, China & SHANGHAI–(BUSINESS WIRE)–Zion Pharma Limited, a Chinese biotechnology company focused on the development of brain-penetrable compounds, today announced that Roche has acquired the global rights to Zion’s lead program, ZN-A-1041. ZN-A-1041 is an orally administered selective tyrosine kinase inhibitor targeting the Human Epidermal Growth Factor Receptor 2 (HER2). ZN-A-1041 was designed to be blood-brain-barrier-penetrant, and has the potential to treat or prevent the onset of brain metastases in patients with HER2-positive metastatic breast cancer. Up to 50% of patients with HER2-positive metastatic breast cancer will develop brain metastasis during the course of the disease.

“Our agreement with Roche is the culmination of a tremendous team effort to deliver a potentially best-in-class therapy for patients with HER2-positive breast cancer, particularly in the field of brain metastasis by virtue of the high blood-brain barrier permeability of this asset,” stated Zack Cheng, M.D., Ph.D., Chairman, CEO and Co-Founder of Zion Pharma Limited. “Within five years, we have gone from company formation to first-in-human, to finding a partner in Roche, who has the resources and expertise to bring ZN-A-1041 to patients with few other therapeutic options,” Dr. Cheng continued.

Dr. Ding Zhou, Ph.D., CSO and Co-Founder of Zion Pharma Limited added, “We are pleased that Roche recognizes the potential of our asset for advancing the standard of care with regards to brain penetrable compounds in HER2-positive breast cancer.”

“We are excited to enter this partnership with Zion to further develop this innovative treatment option for people with HER2-positive breast cancer. This partnership builds on Roche’s legacy and expertise in the treatment of HER2-positive breast cancer and supports our pursuit of advancing science by combining external innovation with our in-house capabilities to address areas of high unmet patient needs,” said James Sabry, Global Head of Pharma Partnering.

After a transition period, Roche will be responsible for the further development, manufacturing, and commercialization of ZN-A-1041 globally. Zion will receive up to $70 million USD in upfront and near-term milestone payments pending achievement of certain milestone events. Zion will also be eligible for up to $610 million USD in additional payments following achievement of certain development, regulatory, and sales-based milestone events by ZN-A-1041, as well as tiered royalties on sales.

About ZN-A-1041

ZN-A-1041 is an orally administered selective tyrosine kinase inhibitor targeting the Human Epidermal Growth Factor Receptor 2 (HER2). ZN-A-1041 was designed to be blood-brain-barrier-penetrant. The ongoing Phase 1 trial is being conducted at multiple sites in the U.S. and China. Additional details will be presented at the poster sessions during the American Society of Clinical Oncology Annual Meeting in June 2023.

About Zion Pharma Limited

Zion Pharma is a private, clinical stage biotech company focused on the development of novel, small molecule, anti-tumoral agents. Founded in 2018, the company’s research headquarters are in Suzhou with additional research operations in Shanghai. The company is applying an innovative drug discovery approach, capitalizing on its DMPK expertise, to develop a pipeline of proprietary first-in-class/best-in-class compounds focused on therapeutic targets which drive tumor inhibition, including ataxia telangiectasia mutated (ATM), Kirsten RAt Sarcoma (KRAS G12D) and SMARCA2 (BRM). Additional information about Zion Pharma is available at www.zionpharma.com.

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