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
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230508005468/en/
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
Dominican Republic Drives Modernization of Electronic Passports Under the Leadership of the Thales - MIDAS Consortium26.3.2026 00:22:00 EET | Press release
The Presidency of the Dominican Republic, through the General Directorate of Passports, issued the country’s first electronic passport as part of its strategy to modernize and strengthen national security. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260324368065/en/ Passport of the Dominican Republic The new document was developed in partnership with Thales, world leader in advanced technologies for the Defense, Aerospace, Cybersecurity, and Digital sectors, and Midas Dominicana, a Dominican business group specializing in the comprehensive management of technology projects in the region. Together, both companies will guarantee the delivery of a passport that is more secure, reliable, and compliant with international standards. The project introduces and personalizes the country’s electronic passports, using advanced technologies to ensure the authenticity and protection of each document, while strengthening the national i
Dominican Republic Drives Modernization of Electronic Passports Under the Leadership of the Thales - MIDAS Consortium26.3.2026 00:22:00 EET | Press release
The Presidency of the Dominican Republic, through the General Directorate of Passports, issued the country’s first electronic passport as part of its strategy to modernize and strengthen national security. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260324368065/en/ Passport of the Dominican Republic The new document was developed in partnership with Thales, world leader in advanced technologies for the Defense, Aerospace, Cybersecurity, and Digital sectors, and Midas Dominicana, a Dominican business group specializing in the comprehensive management of technology projects in the region. Together, both companies will guarantee the delivery of a passport that is more secure, reliable, and compliant with international standards. The project introduces and personalizes the country’s electronic passports, using advanced technologies to ensure the authenticity and protection of each document, while strengthening the national i
Dominican Republic Drives Modernization of Electronic Passports Under the Leadership of the Thales - MIDAS Consortium26.3.2026 00:22:00 EET | Press release
The Presidency of the Dominican Republic, through the General Directorate of Passports, issued the country’s first electronic passport as part of its strategy to modernize and strengthen national security. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260324368065/en/ Passport of the Dominican Republic The new document was developed in partnership with Thales, world leader in advanced technologies for the Defense, Aerospace, Cybersecurity, and Digital sectors, and Midas Dominicana, a Dominican business group specializing in the comprehensive management of technology projects in the region. Together, both companies will guarantee the delivery of a passport that is more secure, reliable, and compliant with international standards. The project introduces and personalizes the country’s electronic passports, using advanced technologies to ensure the authenticity and protection of each document, while strengthening the national i
3D Systems Achieves Full-Scope EU MDR Certification, Accelerating European Launch of NextDent® Jetted Denture Solution Targeted for Summer 202625.3.2026 18:20:00 EET | Press release
3D Systems (NYSE: DDD) today announced it has received full-scope certification under the European Union Medical Device Regulation (EU MDR) 2017/745. The certification was attained on Monday, March 16, 2026. This milestone confirms that the Company’s quality system, technical documentation, and clinical evidence meet the most rigorous regulatory requirements in the medical device sector. With the MDR certificate in hand, 3D Systems will now introduce MDR-compliant product versions through a carefully coordinated, phased rollout across its dental product families and European markets. This approach ensures a smooth transition while maintaining uninterrupted product availability for customers and healthcare providers. The EU MDR certification immediately enables the introduction of innovative new materials and is a pivotal step for one of 3D Systems’ largest potential new product launches: the NextDent® Jetted Denture Solution. This solution forms the cornerstone of the Company’s ‘replac
Visa to Bring Privacy-Preserving Payments to Canton Network25.3.2026 18:00:00 EET | Press release
Visa (NYSE:V), a global leader in digital payments, today announced it will join the Canton Network as the first major global payments company to serve as a Super Validator, to help extend privacy‑preserving blockchain infrastructure to banks and financial institutions around the world. Visa will be one of 40 Super Validators on Canton. That move goes straight to a core challenge for financial institutions: the same transparency that gives blockchains their appeal can clash with privacy expectations financial institutions operate under. Canton Network, a blockchain built for regulated finance, has privacy built in from the beginning, so organizations can use shared infrastructure without exposing sensitive information. As a Super Validator, Visa will help clients who choose to run and secure operations on the Canton Network, applying the same trusted and reliable standards it uses to operate critical payment systems today. Institutions can experiment with and scale stablecoin payments,
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