Another Milestone: Hyperway Pharma’s Pan-KRAS Inhibitor Secures NMPA Clinical Trial Approval

On October 31, 2025, Hyperway Pharma’s independently developed pan-KRAS inhibitor, HBW-012462, received clinical trial approval from the National Medical Products Administration (NMPA), marking a significant milestone in the company’s pursuit of KRAS-targeted therapies. This achievement follows the clinical advancement of its KRAS G12D inhibitor, HBW-012336, and underscores Hyperway Pharma’s strategic foresight and robust R&D capabilities.

KRAS remains one of the most formidable targets in oncology drug development, driving treatment resistance in aggressive cancers such as pancreatic and colorectal cancer. Despite intense global investment, the unique protein structure of KRAS presents steep technical barriers, with only a select few companies achieving meaningful breakthroughs. As such, the successful development of KRAS inhibitors is widely regarded as a benchmark of true pharmaceutical innovation.

Anticipating both the urgent clinical need and vast market opportunity, Hyperway Pharma has built a comprehensive KRAS-focused R&D portfolio. Through differentiated development strategies, deep technical expertise, and agile execution, the company has advanced HBW-012336—a highly active, selective, and tissue-enriched oral KRAS G12D inhibitor—and HBW-012462—a pan-KRAS inhibitor—into clinical trials. These candidates hold strong therapeutic potential for KRAS-driven cancers, including pancreatic and colorectal malignancies.

With HBW-012462 now entering clinical studies, Hyperway Pharma is entering a new phase of competitive execution, where trial efficiency and quality will be key differentiators. To support this, the company has secured over 200 million CNY in Series B financing, providing substantial capital momentum for clinical advancement. Simultaneously, Hyperway Pharma has elevated its talent strategy, appointing Dr. Shunjiang Yu as Chief Medical Officer and Mr. Jinlong Hu as Vice President. Together, they bring complementary strengths in strategic planning and operational execution, reinforcing the company’s commitment to excellence in clinical development.

Jinlong Hu
Vice President, Hyperway Pharma

Mr. Jinlong Hu brings over 15 years of leadership in clinical development and operations, underpinned by a strong foundation in clinical medicine. He has held pivotal roles at leading domestic pharmaceutical innovators including Hengrui Medicine, Innovent Biologics, and Biokin Pharma, where he built and led high-performing teams and advanced complex clinical programs across oncology, immunology, and other therapeutic areas.

Renowned for his strategic acumen, Mr. Hu excels in designing scientifically rigorous clinical development plans and driving their execution with speed and precision. He has overseen or contributed significantly to dozens of innovative drug trials in China, with two successfully approved and commercialized.

Mr. Hu is also recognized for his excellence in organizational design and team management. He has built collaborative clinical teams from the ground up and led large-scale research operations exceeding 200 professionals, consistently delivering high-quality outcomes through standardized, system-driven approaches.

A seasoned expert in Good Clinical Practice (GCP) and regulatory compliance, Mr. Hu maintains deep, long-standing partnerships with top-tier clinical research organizations across China. His leadership continues to be instrumental in accelerating clinical timelines and elevating program quality for Hyperway Pharma’s pipeline of breakthrough therapies.