Actinium Pharmaceuticals' ATNM-400 Demonstrates Enhanced Anti-Tumor Efficacy
ATNM-400 Preclinical Data: Actinium Pharmaceuticals presented the first preclinical data for ATNM-400 in non-small cell lung cancer (NSCLC), showing superior efficacy with 3-5 times greater tumor growth inhibition compared to standard therapies.
Synergistic Activity: The combination of ATNM-400 with osimertinib resulted in complete tumor regression in all tested animals, indicating a strong synergistic effect that outperformed either treatment alone.
Improved Survival Rates: Data showed that combining external beam radiotherapy with osimertinib improved progression-free survival compared to osimertinib alone, supporting the clinical rationale for this combination therapy.
Targeted Therapy Potential: ATNM-400 demonstrated significant tumor growth inhibition in human lung cancer models, suggesting its potential as a promising treatment option for EGFR-mutant NSCLC.
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- Clinical Trial Results: The AMPLIFY Phase III trial demonstrated that 77% of patients treated with CALQUENCE plus venetoclax were progression-free at three years, compared to 67% for chemotherapy, indicating a significant potential to change treatment standards for chronic lymphocytic leukemia (CLL).
- FDA Approval: The combination therapy of CALQUENCE and venetoclax has been approved by the US FDA as the first all-oral, fixed-duration BTK inhibitor regimen, providing a new treatment option for CLL patients and enhancing their quality of life.
- Increased Treatment Flexibility: The 14-month fixed-duration design of this combination therapy allows physicians to tailor treatment plans according to individual patient needs and goals, thereby enhancing both flexibility and efficacy in treatment.
- Broad Market Potential: With approvals in the US, EU, Canada, and other countries, the CALQUENCE and venetoclax combination therapy is expected to drive AstraZeneca's market share growth in the hematology sector, further solidifying its leadership position in oncology.
- Surge in Deal Count: According to PharmCube, the Greater China region signed 186 cross-border licensing deals worth $137.7B in 2025, marking a nearly tenfold increase from 65 deals valued at $13.9B in 2021, highlighting the growing appeal of the Chinese market for global pharmaceutical companies.
- Industry Trend Analysis: As several blockbuster drugs face patent expirations, leading drugmakers increasingly rely on licensing deals to replenish their pipelines, with projections indicating a potential $200B revenue loss for the global pharmaceutical industry from 2026 to 2030, making China a crucial licensing market.
- Expansion of Deal Size: The average deal size in 2026 stands at $1.3B, reflecting a ~76% increase from 2025 and approximately six times the average size in 2021, driven by AstraZeneca's obesity drug deal worth up to $18.5B with CSPC Pharmaceutical and AbbVie's cancer drug deal worth up to $5.6B with RemeGen.
- Ongoing Attraction: So far in 2026, 38 deals have been reached with a total value approaching $49B, demonstrating the sustained interest of international pharmaceutical companies in the Chinese market, particularly under the pressure of patent expirations.
- Clinical Trial Results: The DESTINY-Breast05 phase 3 trial demonstrated that ENHERTU reduced the risk of invasive disease recurrence or death by 53% compared to T-DM1, indicating its potential as a new standard of care in early breast cancer treatment.
- Regulatory Progress: The European Medicines Agency has validated the marketing authorization application for ENHERTU, marking the commencement of the scientific review process, which is expected to expedite its availability for eligible patients in need of better treatment options.
- Patient Recruitment: The DESTINY-Breast05 trial enrolled 1,635 patients across Asia, Europe, and North America, showcasing the drug's broad applicability and potential market reach on a global scale.
- Future Development Directions: Additional regulatory submissions for ENHERTU are underway, including its combination with pertuzumab for the treatment of unresectable or metastatic HER2 positive breast cancer, highlighting its potential across multiple indications.

- Collaborative Drug Development: AstraZeneca and Bristol Myers Squibb are partnering with Switzerland-based Evinova to leverage its AI-native platform for drug development, aiming to enhance research efficiency and reduce costs.
- Cost Savings in R&D: Evinova claims its platform can deliver at least 5%-7% savings per study, which will significantly improve the economic viability of drug development and enhance the competitive edge of the partners in the market.
- Intelligent Clinical Design: Evinova's AI digitizer capability converts clinical study designs, protocols, and documents into machine-readable formats, improving data processing efficiency and accelerating the drug development timeline.
- Multi-Partner Collaboration Model: The platform's flexible architecture enables a multi-model partner approach, providing access to advanced AI models and deep enterprise expertise, fostering smarter operational insights and driving innovation in the industry.

Strategic Collaborations: EvinoVA has announced strategic collaborations with major pharmaceutical companies including Astellas, AstraZeneca, and Bristol Myers Squibb.
Focus on Clinical Development: These partnerships aim to advance EvinoVA's AI-native platform to accelerate global clinical development efforts.
- Policy Advocacy: FDA Commissioner Marty Makary stated in Washington that the agency plans to push for more prescription drugs to become over-the-counter (OTC) this year, aiming to improve drug accessibility and reduce healthcare costs, which could allow patients to obtain basic safe medications without a doctor's visit.
- Regulatory Streamlining: Legislation passed by Congress in November simplifies the regulatory process for transitioning prescription drugs to OTC status, including full, conditional, and partial switch pathways, which is expected to accelerate drug availability and enhance patient convenience in medication access.
- Increased Transparency: Makary emphasized that OTC sales would bypass insurers and pharmacy benefit managers, potentially lowering drug prices and increasing transparency, with cash prices for OTC medications possibly being lower than patients' copays for prescription drugs, thereby alleviating financial burdens on patients.
- Industry Pushback: The pharmaceutical industry has raised concerns about this policy, arguing that OTC drugs may not be covered by insurance, leading to higher costs for patients, and that the FDA lacks authority over drug pricing, necessitating thorough consultations with manufacturers before any transitions.








