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

Boomi Named a Leader and Secures Highest Score in the Strategy Category in Adaptive Process Orchestration Software Evaluation28.9.2026 18:45:00 EEST | Press release

Boomi™, the data activation company for AI, today announced it has been named a Leader in The Forrester Wave™: Adaptive Process Orchestration Software, Q3 2026. The report evaluated 13 providers, and Boomi achieved the highest score in the strategy category. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260928931590/en/ Boomi Named a Leader and Secures Highest Score in the Strategy Category in Adaptive Process Orchestration Software Evaluation According to the report, Boomi’s “above-par roadmap is driven by a strong internal innovation process that embraces partner input and customer feedback, while recent investments focus on supporting client data sovereignty and control in geographies where sovereignty matters.” The report also cites Boomi's vendor-neutral control plane for agentic automation as allowing it to extend into the process automation market, an approach reinforced by recent acquisitions, such as Lunar.dev, an

Azalea Vision Enrolls First Patient in Proof-of-Concept Study Evaluating Novel Optical Aperture for Keratoconus and Presbyopia28.9.2026 17:27:00 EEST | Press release

Azalea Vision, a Belgian healthtech company building the first medical-grade smart contact lens, today announced that it has enrolled the first patient in its NOA proof-of-concept study. The study marks the start of Azalea’s clinical program, following its selection for the European Innovation Council (EIC) Accelerator. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260928982998/en/ Novel Optical Aperture smart lens The study is conducted at Visser Contact Lenses (Netherlands) and the University Hospital Antwerp (UZA, Belgium). It evaluates a contact lens with a precisely positioned aperture, the optical principle at the core of Azalea’s adaptive smart lens, to reduce higher-order aberrations in keratoconus and to improve near vision in presbyopia. “For people living with keratoconus and presbyopia, better optical solutions can make a real difference in everyday life. We are proud to take part in this first clinical step and

CORRECTING and REPLACING SES Launches Cash Tender Offer28.9.2026 16:42:00 EEST | Press release

Please replace the release with the following corrected version due to multiple revisions to dates. The updated release reads: CORRECTING and REPLACINGSES Launches Cash Tender Offer THIS ANNOUNCEMENT RELATES TO THE DISCLOSURE OF INFORMATION THAT QUALIFIED OR MAY HAVE QUALIFIED AS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE 7(1) OF THE MARKET ABUSE REGULATION (EU) 596/2014. NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN OR INTO OR TO ANY PERSON LOCATED OR RESIDENT IN, OR AT ANY ADDRESS IN, THE UNITED STATES OF AMERICA, ITS TERRITORIES AND POSSESSIONS (INCLUDING PUERTO RICO, THE U.S. VIRGIN ISLANDS, GUAM, AMERICAN SAMOA, WAKE ISLAND AND THE NORTHERN MARIANA ISLANDS), ANY STATE OF THE UNITED STATES OF AMERICA OR THE DISTRICT OF COLUMBIA (THE UNITED STATES) OR TO ANY U.S. PERSON (AS DEFINED IN REGULATION S OF THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED (THE SECURITIES ACT)) OR IN OR INTO ANY JURISDICTION WHERE IT IS UNLAWFUL TO RELEASE, PUBLISH OR DISTRIBUTE THIS ANNOUNCEMEN

Incognito Software Systems Launches NEXA, an AI-Enabled Solution for Automated Broadband Operations28.9.2026 16:00:00 EEST | Press release

Incognito Software Systems, a leading global provider of service orchestration, device management, and network intelligence solutions, today introduced NEXA, an AI-driven network intelligence and automation platform that enables broadband service providers to turn operational data into action. NEXA unifies network, device, service, and subscriber data in a single intelligence layer, delivering real-time and predictive insights that help service providers identify issues sooner, better understand the subscriber experience, and take faster, more informed action across their operations. As service providers seek to differentiate beyond connectivity, subscriber experience has become a critical competitive advantage. However, networks have evolved into complex service platforms that span access, edge, customer premises, apps, and third-party systems, making it difficult to detect and resolve issues quickly. NEXA addresses this challenge by combining cross-platform observability with AI-enab

Volante Technologies and Circle advance stablecoin payment and settlement capabilities for financial institutions28.9.2026 16:00:00 EEST | Press release

Volante Technologies, the global leader in Payments as a Service (PaaS), today announced a strategic collaboration with Circle Internet Group, Inc. (NYSE: CRCL) (“Circle”), a leading internet financial platform company and the issuer of USDC1 through its regulated entities, to help financial institutions integrate stablecoin payment and settlement capabilities into their existing payment operations. Through the collaboration, Volante is bringing USDC workflows into its AI-powered Payments Platform, enabling financial institutions to evaluate how stablecoin activity can operate alongside existing payment rails, operational controls, and on- and off-ramp requirements - without requiring a separate digital asset stack. Volante clients, which include four of the top five global corporate banks and seven of the top 10 U.S. banks, will be able to evaluate key workflows, including minting, redemption, beneficiary wallet registration, funding, notifications, and wallet-to-wallet payment execut

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