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
Mevion Medical Systems Announces CE Marking of the MEVION S250-FIT™ Proton Therapy System, Expanding Global Access to Compact Proton Therapy25.2.2026 09:00:00 EET | Press release
Mevion Medical Systems, the global leader in compact proton therapy, today announced that the MEVION S250-FIT Proton Therapy System has successfully completed the conformity assessment process and has received CE Marking under Regulation (EU) 2017/745 (EU MDR). This regulatory milestone enables the marketing, sale, and clinical use of the MEVION S250-FIT system throughout the European Union, building on the system’s existing U.S. FDA 510(k) clearance granted in September 2025. The MEVION S250-FIT is the first and only proton therapy system designed to fit into a standard radiation therapy vault. By enabling cancer centers to use their existing infrastructure, the MEVION S250-FIT dramatically reduces the cost, complexity, and timeline traditionally associated with proton therapy adoption. This opens a new pathway for hospitals and cancer centers across Europe to bring advanced proton treatment to their patients. “With both FDA clearance and CE Marking now in hand, the MEVION S250-FIT is
Bureau Veritas: Sector-Leading Organic Revenue Growth of 6.5% in FY 202525.2.2026 08:30:00 EET | Press release
Bureau Veritas (BOURSE:BVI): 2025 key figures1 › Full-year revenue of EUR 6,466.4 million, up 6.5% organically (with 6.3% organic growth in Q4). At constant currency, the growth was up 7.3% year-on-year and up 3.6% on a reported basis, › Adjusted operating profit of EUR 1,052.9 million, up 5.7% versus EUR 996.2 million in FY 2024, representing an adjusted operating margin of 16.3%, up 32 basis points year-on-year and up 51 basis points at constant currency, › Operating profit of EUR 992.4 million, up 6.3% versus EUR 933.4 million in FY 2024, › Adjusted net profit of EUR 631.4 million, up 1.7% versus EUR 620.7 million in FY 2024, › Adjusted EPS stood at EUR 1.42 in 2025, with a 2.8% increase versus FY 2024 (EUR 1.38 per share) and up 9.2% at constant currency, › Attributable net profit of EUR 588.0 million, up 3.3% versus EUR 569.4 million in FY 2024, › Free Cash Flow of EUR 824.2 million, up 3.9% organically and up 2.6% at constant currency, and cash conversion of 107%2, › Adjusted net
Azafaros Announces Publication of Preclinical Efficacy Data with Nizubaglustat in GM2 Gangliosidosis25.2.2026 08:00:00 EET | Press release
Azafaros, a company aiming to become a leader in lysosomal storage disorders (LSDs), focused on addressing especially neurological symptoms, today announced the publication of proof-of-concept preclinical data with its lead product, nizubaglustat, in GM2 gangliosidosis. The data, published in the 7 January issue of the Journal of Inherited Metabolic Disease in collaboration with the laboratory of Dr. Jagdeep Walia, Department of Pediatrics, Queen's University, Kingston, Canada, reinforce nizubaglustat’s potential to address unmet needs in rare LSDs and build on existing preclinical and clinical evidence. The preclinical study tested nizubaglustat in a mouse model in Sandhoff disease, a form of GM2 gangliosidosis with no approved treatments—alongside healthy control subjects. The research assessed how the drug’s exposure relates to its effects in the brain, demonstrating a significant increase in both survival (22%; 26 days) and assessments of movement and behavior at 16 weeks versus un
Galderma Announces Triple Approval of New State-of-the-Art Restylane ® Syringe in the EU, the U.S., and Canada, Reaffirming the Company’s Position at the Forefront of Injectable Aesthetics25.2.2026 08:00:00 EET | Press release
Galderma (SIX: GALD), today announced that regulatory authorities in the EU, the U.S., and Canada have approved a new state-of-the-art syringe for use with its NASHA® lidocaine range of Restylane products in multiple facial indications including the cheeks, nose, chin, jawline, tear troughs, nasolabial folds, marionette lines, as well as in the hands.1-3 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260224651688/en/ The syringe features a next-generation ergonomic design that enhances precision and control; includes an optimized syringe-needle connection with the new Terumo K-Pack Enhance™ needle; and offers a premium color-coded packaging and syringe design to support easy range navigation for practitioners.4-7, 9,10 It sets a new standard in Injectable Aesthetic devices and demonstrates Galderma’s unwavering commitment to driving innovation to meet the needs of both practitioners and patients. “Developing this new syringe
Verdict Expected Soon in Klarna’s $8.3 Billion Antitrust Lawsuit Against Google24.2.2026 20:09:00 EET | Press release
Klarna Group plc (NYSE: KLAR) announces that the Patent and Market Court of Sweden (Patent- och marknadsdomstolen) is expected to deliver its verdict on April 15, 2026 in the antitrust damages proceedings brought by Klarna’s subsidiary PriceRunner International AB against Google LLC and Google Ireland Limited. The trial, which ran from October 20 to December 19, 2025, concerned PriceRunner’s claim for approximately $8.3 billion in damages — the largest civil damages claim ever filed in a Swedish court. The Case The claim arises from Google’s abuse of dominance in online comparison shopping, as established by the European Commission in a binding 2017 decision and upheld without reservation by the Court of Justice of the European Union in September 2024. PriceRunner alleges that Google systematically demoted competing price comparison services in its search results while favouring its own Google Shopping product, causing sustained and quantifiable commercial damage to PriceRunner over mo
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