Dizal Announces Global Exclusive License Agreement with AstraZeneca for Zegfrovy

On July 14, 2026 Dizal reported that it has entered into a global exclusive license agreement with AstraZeneca for Zegfrovy (sunvozertinib), a novel oral irreversible epidermal growth factor receptor (EGFR) inhibitor for patients with lung cancer. AstraZeneca will acquire worldwide rights to develop and commercialise Zegfrovy.

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Zegfrovy is approved in China and the U.S. for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy. Dizal recently announced results of the multinational Phase III WU-KONG28 study of Zegfrovy in first line NSCLC with EGFR exon20ins mutations. These data were presented as a Late-Breaking Abstract Oral Presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and simultaneously published in The New England Journal of Medicine. Supported by these results, a Supplemental New Drug Application for approval in the 1st-line setting has been submitted to the China’s Center for Drug Evaluation (CDE) and US Food and Drug Administration (FDA). The China’s CDE and US FDA have also both granted Breakthrough Therapy Designation to Zegfrovy in this setting.

Approximately 80-85% of lung cancer patients globally have NSCLC. About 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia, have EGFR mutations as a disease driver. Roughly one in four patients with an EGFR-mutated NSCLC mutation has a tumor with an exon 20 insertion mutation or other atypical mutation for which targeted treatment options are limited.

Dr. Xiaolin Zhang, Chief Executive Officer of Dizal said: "Zegfrovy is the only oral targeted therapy for EGFR exon 20 insertion non-small cell lung cancer approved in the US and China for patients following prior systemic therapy." As a leading global company with a strong lung cancer franchise, AstraZeneca will help ensure patients around the world can benefit from this innovation discovered by Dizal scientists in China."

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: "AstraZeneca is a leader in treating EGFR-mutated lung cancer, and we are eager to add Zegfrovy to our world-class portfolio of innovative medicines for patients whose tumours carry exon 20 insertion mutations. With this agreement, we will bring a differentiated, oral targeted treatment to these patients with limited options across the globe."

Financial considerations

AstraZeneca will make an upfront payment to Dizal of $600m and additional payments of up to $900m upon achievement of specific development, regulatory and sales-related milestones. Additionally, Dizal will receive tiered royalties on the global sales of Zegfrovy.

The transaction is expected to close in the second half of 2026, subject to customary closing conditions and regulatory clearances.

About Zegfrovy

Zegfrovy is an irreversible EGFR inhibitor targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. Zegfrovy is approved in the U.S. and China for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), whose disease has progressed on or after platinum-based chemotherapy. The approval in China is based on the results of the pivotal WU-KONG6 study in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. The U.S. approval is supported by WU-KONG1 Part B, a multinational pivotal study investigating the efficacy and safety of Zegfrovy in the same indication. The sNDA for previously untreated NSCLC with EGFR exon20ins has been submitted to China Center for Drug Evaluation (CDE) and US Food and Drug Administration (FDA), supported by WU-KONG28 study results. The China’s CDE and US FDA have also both granted Breakthrough Therapy Designation to Zegfrovy in this setting.

In addition, Zegfrovy also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations, as well as HER2 exon20ins. Zegfrovy showed a well-tolerated and manageable safety profile in the clinic. The most common drug-related TEAEs (treatment-emergent adverse events) were Grade 1/2 in nature and clinically manageable.

(Press release, Dizal Pharma, JUL 14, 2026, View Source [SID1234669213])

Anixa Biosciences Expands Global Patent Portfolio with Australian Patent Acceptance for Breast Cancer Vaccine Technology

On July 14, 2026 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that IP Australia has issued a Notice of Acceptance for a new patent related to Anixa’s breast cancer vaccine technology.

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This patent, exclusively licensed from Cleveland Clinic, will provide protection for the Company’s novel approach to breast cancer treatment and prevention in Australia. The patent is titled, "Vaccine Adjuvants and Formulations," and the co-inventors are Dr. Justin Johnson and the late Dr. Vincent Tuohy, both of Cleveland Clinic.

The acceptance further expands the international scope of Anixa’s intellectual property portfolio, reinforcing its leadership in the field of cancer immunotherapy. The Australian patent complements patents issued in the United States and other key global jurisdictions, including Europe, China, and Japan, among others, and represents an important step toward potential future regulatory approvals and commercialization efforts outside the United States.

In a recently completed Phase 1 trial, at Cleveland Clinic and funded by the U.S. Department of Defense, the vaccine met all major primary endpoints, was safe and well tolerated, and generated protocol defined immune responses in more than 74% of participants. These results support continued clinical development of the Company’s novel preventive and therapeutic breast cancer vaccine.

"This newly accepted patent continues the broad international recognition of the novelty and potential of our breast cancer vaccine," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "As we continue clinical development in the U.S., our growing international patent estate further strengthens our ability to pursue global opportunities and potentially partner with larger pharmaceutical companies for worldwide commercialization."

Breast cancer remains the most commonly diagnosed cancer among women worldwide, and while survival rates in Australia remain high, incidence rates have continued to increase. Despite significant advances in screening and treatment, there are currently no approved vaccines designed to prevent breast cancer.

Anixa’s breast cancer vaccine is based on immunizing against human α-lactalbumin, a protein associated with lactation that is aberrantly expressed in certain types of breast cancer. This "retired" protein strategy, developed at Cleveland Clinic and licensed exclusively to Anixa, aims to selectively prime the immune system to prevent tumor formation while avoiding harm to normal tissue, particularly in aggressive forms of the disease such as triple-negative breast cancer.

By reinforcing its global patent estate, Anixa is laying the groundwork for future international development and commercialization strategies. The Company’s broader vaccine platform also targets other high-incidence cancers and is designed to transform how the medical community approaches cancer prevention. If successful, the technology could represent one of the first preventive vaccine approaches targeting breast cancer.

(Press release, Anixa Biosciences, JUL 14, 2026, View Source [SID1234669214])

Phase II Trial of Cadonilimab(PD-1/CTLA-4) Combination Regimen Launches in the United States for Perioperative Treatment of Gastric Cancer

On July 14, 2026 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that it has entered into a collaboration with Memorial Sloan Kettering Cancer Center (MSKCC) to advance a Phase II clinical study evaluating a cadonilimab-based combination regimen for the perioperative treatment of locally advanced, resectable HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. Cadonilimab is the world’s first PD-1/CTLA-4 bispecific antibody developed by Akeso.

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The study is being led by Dr. Yelena Janjigian, a globally renowned expert in gastrointestinal malignancies at MSKCC. It is now actively enrolling patients across the United States.

This Phase II study will generate robust clinical evidence to support the future initiation of an international multicenter Phase III trial of the cadonilimab combination regimen for the perioperative treatment of GC/GEJ adenocarcinoma.

Cadonilimab and ivonescimab, as first-in-class bispecific antibodies with breakthrough global clinical value, have garnered significant attention and recognition from the international medical community. These innovative IO 2.0 therapies are increasingly favored by global partners as the preferred backbone for combination regimens and novel treatment paradigms across a wide range of cancers. Their global therapeutic value continues to be scientifically explored and realized through ongoing clinical data and new studies.

Building on cadonilimab’s unique dual-target synergistic mechanism, this Phase II study is supported by strong evidence from the Phase III COMPASSION-15 trial and previous Phase II neoadjuvant studies in gastric/GEJ adenocarcinoma.

Gastric cancer is the fifth most common malignancy worldwide, with nearly one million new cases annually. For patients with locally advanced, resectable gastric or gastroesophageal junction (GEJ) adenocarcinoma, standard perioperative FLOT chemotherapy achieves a 3-year overall survival rate of only 48%. Although the addition of PD-1 inhibitors to FLOT has become the new standard of care, the pathologic complete response (pCR) rate remains limited at approximately 19%, and nearly one-third of patients experience disease recurrence or death within two years. Dual PD-1/CTLA-4 inhibition has shown limited benefit due to overlapping toxicities and increased early mortality. A significant unmet medical need persists for more effective and better-tolerated treatment options.

As the first approved bispecific antibody for cancer immunotherapy, cadonilimab has demonstrated breakthrough clinical benefits across multiple pivotal studies and is now widely used in clinical practice. More than 12 registrational or Phase III studies of cadonilimab are currently underway globally, including two international multicenter registrational/Phase III trials led by Akeso.

In addition, Akeso is collaborating with INOVIO to explore a novel combination regimen using INOVIO’s DNA-based therapy for glioblastoma (GBM) at Dana-Farber Cancer Institute and Mass General Brigham. The Company continues to accelerate the global development of cadonilimab through strategic partnerships with leading therapeutics and institutions.

(Press release, Akeso Biopharma, JUL 14, 2026, View Source [SID1234669215])

Can-Fite Secures Australian Patent Allowance Supporting Namodenoson Development and Marketing in Liver and Pancreatic Cancer

On July 14, 2026 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a clinical-stage biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, reported that the Australian Patent Office has allowed Patent Application No. 2021290439 entitled "Treatment of Advanced Metastatic Cancer."

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The patent complements Can-Fite’s rapidly advancing oncology pipeline. Namodenoson is currently being evaluated in a pivotal Phase 3 study for advanced hepatocellular carcinoma following FDA and EMA protocol agreement. In pancreatic cancer, the Company recently completed a Phase 2a clinical study demonstrating an excellent safety profile together with encouraging survival outcomes and durable disease stabilization and is planning a Phase 2b study evaluating Namodenoson in combination with gemcitabine.

"This patent allowance further strengthens our global intellectual property portfolio surrounding Namodenoson and reinforces the long-term value of our oncology franchise," said Pnina Fishman, Ph.D., Chairperson and Chief Scientific Officer of Can-Fite BioPharma. "Importantly, the patent supports two of our most advanced oncology programs—hepatocellular carcinoma and pancreatic cancer—and extends protection for our innovative therapeutic approach in a major international market."

Namodenoson selectively targets the A3 adenosine receptor (A3AR), which is highly expressed in inflammatory and cancer cells. Activation of A3AR has been shown to induce apoptosis of tumor cells while sparing normal tissues, contributing to the compound’s favorable safety profile demonstrated across clinical studies.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is currently being evaluated in a pivotal Phase 3 trial for advanced liver cancer, concluded successfully a Phase 2a study in pancreatic cancer and enroll patients for a Phase 2b trial for the treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential expression may be one of the important factors that accounts for the excellent safety of the drug.

(Press release, Can-Fite BioPharma, JUL 14, 2026, View Source [SID1234669201])

Insilico Medicine and Bora Pharmaceuticals Announce Strategic Alliance for AI-Driven Drug Discovery and Development

On July 14, 2026 Insilico Medicine ("Insilico"; HKEX: 3696), a clinical-stage generative artificial intelligence (AI)-driven drug discovery company, reported a multi-target strategic alliance with Bora Pharmaceuticals Co., Ltd. ("Bora"; TWSE: 6472; OTCQX: BORAY), a global leader in pharmaceutical manufacturing.

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The proposed alliance will be governed by definitive agreements to be discussed and executed by Insilico and Bora and is designed to combine Insilico’s proprietary Pharma.AI platform, spanning target discovery, generative chemistry, and molecule optimization, with Bora’s global development, manufacturing, quality, and commercialization capabilities. By linking AI-enabled discovery with automation-driven development, manufacturing, and quality execution, Insilico and Bora aim to pioneer a next-generation drug innovation model that connects novel molecule design with the capabilities required to develop, manufacture, and deliver medicines to patients with unmet medical needs.

The alliance lays the foundation for a broad, multi-target collaboration framework, subject to the parties’ further discussion and execution of definitive agreements. If fully implemented, the potential value of the proposed collaboration could exceed US$2.5 billion. Insilico expects to support Bora in strengthening AI capabilities across its global workforce and enhancing AI literacy across the organization. The partnership is also expected to apply Insilico’s AI capabilities to improve efficiency across manufacturing, supply chain, distribution, and corporate operations. As the collaboration progresses, Bora and Insilico expect to further refine its scope, scale, and operating framework.

As part of the alliance, Insilico aims to accelerate Bora’s transition toward more AI-driven and automation-driven drug discovery and development capabilities by providing comprehensive research and development strategies and end-to-end AI solutions across global discovery and development workflows. Over time, the alliance will further explore opportunities to apply AI and automation-driven approaches across development planning, process optimization, pharmaceutical development, manufacturing readiness, and quality systems.

The proposed alliance reflects a shared vision that the next generation of biopharmaceutical innovation will be increasingly AI-native, data-rich, and automation-driven. In this new model, value will be created not only through the discovery and design of novel molecules, but also through smarter, more efficient translation of those molecules into high-quality development programs and, ultimately, medicines for patients. Insilico brings an AI-native discovery engine with demonstrated productivity across multiple therapeutic areas, while Bora brings deep experience in drug development, global manufacturing, quality systems, supply chain execution, and commercialization.

"Insilico Medicine has established itself as one of the world’s leading AI drug discovery companies by demonstrating that generative AI can identify novel targets, design novel molecules, and advance drug candidates into clinical development," said Bobby Sheng, founder, Chairman of Bora Group and CEO of Bora Pharmaceuticals. "This strategic alliance marks an important step in Bora’s evolution from a leading pharmaceutical development and manufacturing partner into a broader drug innovation ecosystem. By combining Insilico’s AI-native capabilities with Bora’s global expertise in formulation, CMC, regulatory development, scale-up, quality, commercial manufacturing, supply chain, and commercialization, we have an opportunity to create a truly integrated pathway from discovery to commercialization.

"AI is already transforming drug discovery, but its full potential will only be realized when that transformation extends across the entire development and manufacturing value chain. This is not simply about adding AI to existing processes; it is about reimagining how pharmaceutical products are developed, manufactured, and brought to patients. Together, we aim to build a scalable and repeatable model that can advance promising drug candidates more efficiently, positioning Bora at the forefront of AI-enabled pharmaceutical development and manufacturing, and establish a long-term growth platform through the development and commercialization of high-value proprietary assets."

"We are thrilled to partner with Bora, a visionary leader with world-class development and manufacturing capabilities and a strong commitment to AI-driven innovation," said Dr. Alex Zhavoronkov, founder, co-CEO, and CBO of Insilico Medicine. "Building on our collaborations with Takeda and SK Biopharmaceuticals in Asia-Pacific, this alliance with Bora further demonstrates Insilico’s commitment to partnering with leading biopharmaceutical innovators across the region. Insilico has built a powerful AI-native engine for target discovery, generative chemistry, and molecule optimization. Together with Bora, we aim to connect that discovery engine with the capabilities required to advance high-quality drug candidates through development, manufacturing, and potential commercialization, while also supporting Bora’s broader AI transformation. This alliance represents an important step toward demonstrating how AI-discovered medicines can be developed faster, more efficiently, and with greater scalability."

As an AI-native biotechnology company, Insilico is redefining the efficiency of preclinical drug development through its advanced AI and automation platform. While traditional early-stage drug discovery typically takes 2.5 to 4 years, Insilico has consistently reached preclinical candidate ("PCC") nomination in an average of just 12 to 18 months. Since 2021, the company has nominated 31 PCCs, 13 of which have received IND approval or clearance – a track record of speed and productivity that this alliance aims to pair with Bora’s development and manufacturing scale.

While expanding the practical applications of its technology in drug discovery and life science research, Insilico is also continuously enhancing the performance of its AI platform. Drawing on extensive experience and datasets from its training platform, the company has distilled thousands of benchmarks and integrated them into MMAI Gym. Serving as both a "trainer and benchmark" for scientific AI, MMAI Gym enables organizations to train models for domain-specific reasoning while rigorously evaluating their performance on real-world tasks, advancing the path toward pharma superintelligence. To date, Human Longevity and Liquid AI have collaborated with Insilico, joining as partners of MMAI Gym.

(Press release, Insilico Medicine, JUL 14, 2026, View Source [SID1234669216])