Business Wire

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

9.5.2023 09:00:00 EEST | Business Wire | Press release

Share

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.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

For media and partnership inquiries:
J. Michael French
SVP, Corporate Development
michael.french@zionpharma.com
+1.703.338.1972

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

The Estée Lauder Companies Announces Partnership with Profound to Expand AI Visibility Across Its Global Brand Portfolio14.9.2026 19:32:00 EEST | Press release

The Estée Lauder Companies Inc. (NYSE: EL) today announced a global strategic partnership with Profound, the category-defining AI marketing platform, advancing its ambition to be prestige beauty’s leader in AI-native discovery. The partnership will provide the company with visibility into how its full portfolio of brands is represented across leading generative AI platforms, as well as opportunities to optimize that representation. This partnership establishes the company as the first in prestige beauty to deploy Profound’s capabilities globally across the company’s full portfolio and operationalize Generative Engine Optimization (GEO) and AI marketing at scale. As consumers increasingly turn to ChatGPT, Gemini, and other AI assistants to discover products, compare recommendations, and seek personalized beauty advice before a purchase, The Estée Lauder Companies is partnering with Profound to define the next era of beauty discovery. This partnership will equip the company with a unifie

AMAALA Yacht Club Opens, Putting the Red Sea on the Global Yachting Map14.9.2026 19:00:00 EEST | Press release

Red Sea Global (RSG), the regenerative tourism developer, has announced that AMAALA Yacht Club has officially begun operations, marking a major milestone in establishing the Saudi Red Sea as a new global destination for luxury yachting, sailing and marine tourism. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260914160771/en/ AMAALA Yacht Club, the new luxury yachting destination on Saudi Arabia’s Red Sea coast. Nestled within AMAALA Marina Village, the AMAALA Yacht Club is now welcoming founding members and visiting yachts to moor and explore the destination. Located approximately 2,000 nautical miles from Monaco, the club provides a new winter destination for the world’s luxury sailing community, which traditionally migrates from the Mediterranean to the Caribbean or Indian Ocean from October. Positioned closer to the Mediterranean than the Caribbean, AMAALA offers an attractive winter cruising hub and a strategic gateway

Behind the Stage Lights: How Students Learned to Trust Their Voices with Doha Debates14.9.2026 16:40:00 EEST | Press release

During high school years in Model United Nations, Dahlia Al-Ansari learned to argue on behalf of a country she was assigned to represent. But when Doha Debates invited her to join a town hall debate in Toronto this July, she faced an unfamiliar challenge: sharing her own beliefs about a timely issue. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260914150232/en/ Students from Qatar, Canada and Mexico during their visit to the University of Toronto as part of the Doha Debates Town Hall experience in Canada. (Photo: AETOSWire) An 18-year-old biological sciences student at Carnegie Mellon University in Qatar, Al-Ansari hadn’t traveled to defend a predetermined position. Instead, she discovered that she was there to think critically, express her own viewpoint and remain open to diverse perspectives. This shift required her to navigate uncharted waters, but “I’m happy that it did,” she says. “It’s showing me the importance of sp

Matt Shafer Joins Golub Capital as Head of Golub Equity Continuation Partners14.9.2026 16:30:00 EEST | Press release

Golub Capital (“the Firm”) today announced the appointment of Matt Shafer as Managing Director and Head of the Firm’s GP-led private equity secondaries strategy, Golub Equity Continuation Partners (“GECP”). In this role, he will be responsible for leading the continued growth and development of the strategy and helping expand the Firm’s equity investment capabilities. Matt will work closely with Greg Cashman, Vice Chair and Co-Head of Golub Capital’s Sponsor Finance practice, to expand Golub Capital’s activity in this growing market. Shafer brings nearly three decades of global experience as an investor, financier and advisor working with private equity firms. He was most recently Head of Capital Solutions and U.S. Private Equity at Northleaf Capital Partners. In this role, Shafer helped lead the firm’s private equity investment activities, including secondaries, co‑investments and structured capital. Prior to Northleaf, he was Partner and Head of Americas Private Equity at Vision Capi

HealthCap Invests in AMRA Medical to Accelerate Global Growth in Quantitative MRI14.9.2026 16:19:00 EEST | Press release

AMRA Medical today announced an investment from HealthCap, one of Europe’s leading life science venture capital firms. This milestone marks a significant step in AMRA’s growth, underscoring market confidence in the company’s vision to transform the measurement and understanding of muscle and fat. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260914838191/en/ HealthCap Invests in AMRA Medical to Accelerate Global Growth in Quantitative MRI HealthCap’s backing comes as quantitative MRI gains vital importance in understanding how fat distribution and muscle composition influence disease, treatment response, and patient outcomes. Built on over 15 years of research, AMRA’s proprietary methods move beyond conventional metrics—like weight, and BMI and muscle function tests—to provide the standardized, automated data from advanced muscle and fat imaging necessary for modern clinical research. With its deep scientific expertise and

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye