MedPath

Clinical Trial News

Ivonescimab Demonstrates Superior Efficacy in Phase III Lung Cancer Trials, Positioning for Global Regulatory Approvals

Drug Approval
  • Ivonescimab, a PD-1/VEGF bispecific antibody, achieved a 48% reduction in progression-free survival risk compared to chemotherapy in EGFR-mutated NSCLC patients.
  • The drug outperformed pembrolizumab in head-to-head comparison with median PFS of 11.14 months versus 5.82 months in PD-L1-positive NSCLC.
  • Akeso has secured two NMPA approvals in China for 2025, while Summit Therapeutics prepares BLA filing for U.S. market entry.
  • The projected $500 million market opportunity reflects growing adoption across Asia-Pacific region with 15% CAGR expected through 2033.

KYAN Technologies' Ex Vivo Platform Demonstrates Clinical Utility in Relapsed/Refractory Non-Hodgkin Lymphoma

Precision Medicine
  • KYAN Technologies' Optim.AI™ platform achieved 74.5% accuracy in predicting clinical response in a prospective study of 117 relapsed/refractory non-Hodgkin lymphoma patients published in JCO Precision Oncology.
  • Patients treated with platform-guided combinations showed 59% objective response rates and three-fold improvement in progression-free survival compared to prior treatment lines.
  • The study represents the largest published cohort using an ex vivo functional precision medicine platform in lymphoma, demonstrating statistically significant survival benefits over salvage therapy (P = 0.0191).
  • The platform tests hundreds of clinically relevant drug treatments simultaneously on live tumor cells, providing oncologists with real-time, patient-specific treatment guidance.

Robles BioCeutics Partners with Innovigen to Scale Production of Senolytic-Enhanced Skincare

  • Robles BioCeutics has entered a strategic manufacturing partnership with Innovigen to scale production of its flagship product GlowSelle™, which combines senolytic compounds with stem cell-derived growth factors for regenerative skincare.
  • The collaboration focuses on refining and manufacturing formulations that target senescent "zombie cells" while stimulating natural skin regeneration through growth factors produced under injury-mimicking conditions.
  • This partnership represents a significant step toward commercializing advanced biotechnological skincare, leveraging Innovigen's GMP production expertise to ensure consistent quality and regulatory compliance.
  • The agreement includes comprehensive manufacturing services and explores co-development opportunities for next-generation regenerative dermatology products.

Delhi High Court Rules Against Roche in Pertuzumab Patent Disclosure Case, Clarifies Section 104A Requirements for Biologics

Monoclonal AntibodyOncology
  • The Delhi High Court denied F. Hoffmann-La Roche's request to access Zydus Lifesciences' manufacturing process for their Pertuzumab biosimilar, ruling that Roche failed to meet mandatory requirements under Section 104A of the Patents Act.
  • The court established that Section 104A can be invoked at interim stages of patent litigation and prevails over general discovery provisions under the Commercial Courts Act.
  • The ruling clarifies that "identical product" requirements under Section 104A cannot be diluted for biological drugs, even though absolute replication is scientifically difficult.
  • The decision impacts ongoing patent disputes in India's biosimilar market, particularly for cancer treatments where regulatory reference to branded biologics does not automatically imply process infringement.

GSK Secures $12.5 Billion Deal with Hengrui for COPD Drug and 11 Additional Programs

  • GSK has entered into agreements with Chinese pharmaceutical company Hengrui worth up to $12.5 billion for exclusive global rights to develop 12 innovative medicines, including a potential best-in-class COPD treatment.
  • The deal centers on HRS-9821, a PDE3/4 inhibitor in clinical development for chronic obstructive pulmonary disease that has demonstrated potent bronchodilation and anti-inflammatory effects in early studies.
  • GSK will pay $500 million upfront and potentially $12 billion in milestone payments, with Hengrui leading development of 11 additional programs through Phase I trials before GSK can exercise options.
  • The collaboration spans therapeutic areas including respiratory, immunology, inflammation, and oncology, representing a significant milestone in China's growing presence in global pharmaceutical development.

China Approves XPOVIO for Second-Line Multiple Myeloma Treatment Based on Phase III BENCH Trial

Drug Approval
  • China's NMPA has approved XPOVIO (selinexor) in combination with bortezomib and dexamethasone for adult multiple myeloma patients who have received at least one prior therapy.
  • The approval is based on the Phase III BENCH trial involving 154 Chinese patients, which demonstrated superior efficacy compared to standard bortezomib-dexamethasone treatment.
  • XPOVIO is the world's first approved orally-available selective XPO1 inhibitor and marks the third approved indication for the drug in China.
  • The drug has already been approved in ten Asia-Pacific countries and included in national insurance schemes in five markets.

OSR Holdings Acquires Korean Non-Invasive Glucose Monitoring Pioneer Woori IO

  • OSR Holdings has signed a term sheet to acquire Woori IO, a South Korean company developing non-invasive glucose monitoring technology using near-infrared spectroscopy.
  • Woori IO's proprietary platform eliminates the need for needles, sensors, or skin penetration, offering a truly non-invasive alternative to current continuous glucose monitors.
  • The company has completed proof-of-concept studies with Korea University Hospital and plans to enter larger confirmatory trials for regulatory approval in Korea.
  • The blood glucose monitoring devices market is expected to exceed $40 billion by 2030, with non-invasive and wearable monitoring systems driving major growth.

CUHK Develops Magnetic Microcatheter for Precise Treatment of Acute Ischemic Stroke

  • Researchers at The Chinese University of Hong Kong have developed the first sub-millimeter Magnetically Actuated Soft Rotatable-tipped Microcatheter (MSRM) for treating acute ischemic strokes.
  • The device features a soft, rotatable tip guided wirelessly by external magnetic fields, enabling precise navigation through complex blood vessels while delivering clot-dissolving drugs and mechanically breaking down clots.
  • Testing in human placenta blood vessels showed the MSRM caused minimal cell damage compared to traditional guidewires, with its low rotation speed of 2-8 Hz reducing trauma to delicate brain vessels.
  • The all-in-one design eliminates the need for tool exchanges during procedures, potentially offering new treatment options for distal-to-medium vessel occlusions that account for 25-40% of acute ischemic strokes.

Roche Launches Clinical Trial for Trontinemab to Prevent Alzheimer's Disease

  • Roche announced plans to test Trontinemab, an experimental drug designed to delay or prevent Alzheimer's disease symptoms in at-risk individuals.
  • The drug features enhanced blood-brain barrier transport technology to improve brain delivery compared to existing treatments.
  • This trial represents part of Roche's expanding Alzheimer's development program amid recent competitive advances by Eli Lilly's Kisunla.
  • Current approved Alzheimer's treatments target amyloid beta plaques but carry risks of brain swelling and bleeding with high costs.

Colorcon Opens State-of-the-Art Film Coating Manufacturing Facility in Malaysia to Strengthen Asia-Pacific Supply Chain

  • Colorcon has inaugurated a new 200,000 square-foot film coating manufacturing facility in Johor, Malaysia, employing 30 people initially and serving as the production hub for the Asia-Pacific region.
  • The state-of-the-art facility features cutting-edge technology and energy-efficient systems, reinforcing Colorcon's commitment to industry innovation, quality, and environmental stewardship.
  • This strategic investment strengthens Colorcon's global supply network for film coatings and positions the company to better anticipate market growth and meet evolving customer demands in the rapidly growing Asia-Pacific pharmaceutical market.
  • The facility represents one of several development projects in Colorcon's pipeline to support their mission of being "everywhere our customers need us to be" while contributing to Malaysia's emergence as a high-value pharmaceutical manufacturing hub.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.