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
Takeda’s Zasocitinib Delivered Rapid and Durable Skin Clearance in a Convenient Once-Daily Pill, Affirming Promise to Reshape Psoriasis Care28.3.2026 21:00:00 EET | Press release
Takeda(TSE:4502/NYSE:TAK)today announced new data from the two pivotal Phase 3studies of zasocitinib (TAK-279), a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis (PsO).1 Presented as a late-breaking abstract at the 2026 American Academy of Dermatology (AAD) Annual Meeting, these data show that convenient once-daily oral zasocitinib demonstrated rapid and durable skin clearance with a safety profile consistent with Phase 2b studies.1,2 “Our goal in psoriasis treatment is clear or almost clear skin, and previously this has been achieved primarily with injectable therapies,” said Melinda Gooderham, MSc, MD, FRCPC, dermatologist, SKiN Centre for Dermatology, Peterborough, Ontario, Canada, principal investigator for the Latitude PsO studies and presenting author. “These efficacy and safety results show it’s possible for a once-daily pill to deliver rapid, lasting skin clearance, highlighting the potential of zasoc
Incyte Announces New Positive 54-Week Late-Breaking Data for Povorcitinib in Hidradenitis Suppurativa at the 2026 American Academy of Dermatology (AAD) Annual Meeting28.3.2026 21:00:00 EET | Press release
Incyte (Nasdaq:INCY) today announced 54-week data evaluating the safety and efficacy of povorcitinib (INCB54707), an oral small-molecule highly-selective JAK1 inhibitor, from the pivotal Phase 3 STOP-HS clinical trial program in adult patients (≥18 years) with moderate to severe hidradenitis suppurativa (HS). The late-breaking oral presentation of these data is taking place at the 2026 American Academy of Dermatology (AAD) Annual Meeting, being held March 27-31, 2026, in Denver (Session: S034 – Late-Breaking Research: Session 2. Saturday, March 28, 2026, 1:00-4:00 p.m. MT). “The 54-week results from the STOP-HS program deliver compelling, long-term evidence supporting the potential of povorcitinib for patients with moderate to severe HS,” said Pablo J. Cagnoni, M.D., President and Global Head of Research and Development, Incyte. “Across both studies, povorcitinib demonstrated substantial and durable improvements over time in key measures of treatment success and meaningful clinical ben
AAD 2026: Late-Breaking Nemolizumab Data Demonstrate Clinically Meaningful Benefits for Children Aged 2 to 11 With Moderate-to-Severe Atopic Dermatitis28.3.2026 17:00:00 EET | Press release
Galderma (SIX: GALD) today announced new phase II data showing that nemolizumab was well tolerated and effective in children (aged 2 to 11 years) with moderate-to-severe atopic dermatitis, with a clinically meaningful and sustained reduction in skin lesions and itch for up to a year.1 Results will be presented in a late-breaking session at the 2026 American Academy of Dermatology (AAD) Annual Meeting. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260328320362/en/ Atopic dermatitis is the most common inflammatory skin disorder in children, yet treatment options in the moderate-to-severe pediatric setting are limited.5 The disease can have a significant impact on quality of life for both the patients and their loved ones, with persistent itch and recurrent skin lesions often disrupting sleep, school and relationships.5-8 “Atopic dermatitis can affect many aspects of children’s lives including schoolwork, emotional development
Angelalign Technology (6699.HK) Releases 2025 Results: Passion for Clinical Excellence Drives Worldwide Growth27.3.2026 21:56:00 EET | Press release
Angelalign Technology Inc. (6699.HK) (“Angel” or the “Company”) released its financial results for fiscal year 2025. During the reporting period, the Company continued to do well in both the global and China markets. Total case volume was 532,400, which increased 48.1%, revenue was USD 370.3 million, which increased 37.8%, and adjusted net profit was USD 43.8 million, which increased 63.0%. The results were driven by Angel’s passion for clinical excellence and its open and inclusive culture that empowers talented people to work together to meet customer needs, the Company said. Fox Hu, CEO of Angel, stated: “The clear aligner industry is complex and multidisciplinary. It requires top-tier technical and operational talent along with seamless collaboration among professionals from diverse geographies. Angel’s open and inclusive culture attracts professionals who share a passion for clinical excellence and a dedication to bringing outstanding products and services to customers. This melti
Axway Positioned as a Leader in the IDC MarketScape: Worldwide API Management 2026 Vendor Assessment27.3.2026 19:46:00 EET | Press release
Axway, a 74Software company (Euronext: 74SW) and global leader in federated API management and enterprise integration, has been named a Leader in the IDC MarketScape: Worldwide API Management 2026 Vendor Assessment.1 Axway Amplify securely connects, orchestrates, and automates data integration. Organizations in financial services, manufacturing, healthcare, and other industries rely on Amplify to modernize integrations and confidently unlock data to deliver superior digital services faster. The report notes: “The platform benefits from Axway’s long-standing experience in B2B integration, secure file transfer, and legacy connectivity, providing differentiated capabilities for organizations that need to expose and control APIs around core systems that are not cloud-native.”1 This multi-pattern expertise in security, integration, and federated governance — built during the early phases of the API-driven digital transformation — becomes especially critical as enterprises seek to govern dat
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