On June 2, 2026, the innovative biological drug INB301 injection, developed by the Central Research Institute of Yunnan Baiyao Group (hereinafter referred to as the "Central Research Institute"), officially obtained Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA). Previously, the product had received clinical trial approval from the China National Medical Products Administration (NMPA) on March 30, 2026. The consecutive successful clinical reviews by the drug regulatory agencies of both China and the United States for INB301 injection marks a key advancement for Yunnan Baiyao in its global innovative drug strategy, achieving a significant breakthrough in "dual application" between China and the U.S.Aligning with international standards and setting a new benchmark for Sino-US dual reporting"Dual application in China and the US" is an important indicator of an innovative pharmaceutical company's R&D strength and its ability to align with international standards. The fact that INB301 injection received clinical trial approvals from both the NMPA and FDA in a short period fully validates its international compliance with pharmaceutical control (CMC) quality standards, the completeness of preclinical research data, and the scientific rationality of its clinical trial protocol. This approval not only demonstrates Yunnan Baiyao's ability to fully align its R&D system with international standards but also sets a precedent for "dual application in China and the US" for the group's innovative pipeline, accumulating valuable experience and laying a solid foundation for the global R&D layout of subsequent products.Authoritative regulatory recognition solidifies the foundation for global R&D security.The FDA is known for its stringent regulatory standards and high review thresholds, and its Investigational New Drug (IND) approval is a crucial and authoritative endorsement of the safety and efficacy of investigational drugs. This FDA approval of INB301 injection signifies that key aspects such as the drug's mechanism of action (MoA), pharmaceutical research, toxicological data, and clinical trial protocol have all been recognized by the FDA and successfully passed reviews across various professional disciplines. This not only significantly reduces the uncertainty of subsequent clinical development but also provides a solid scientific basis for advancing simultaneous multi-center clinical trials globally.Targeting clinical gaps, the market and value potential are vast.INB301 injection is intended for the treatment of cancer cachexia. Cancer cachexia is a complex metabolic disorder syndrome caused by malignant tumors, characterized by persistent skeletal muscle wasting that is difficult to reverse with routine nutritional support. Clinical data show that approximately 80%-90% of patients with advanced cancer experience symptoms such as weight loss and muscle atrophy, severely impacting their quality of life and treatment tolerance; about 20% of patients with advanced cancer die directly from cachexia. Currently, there are no approved targeted treatments in China and the United States, highlighting an urgent clinical need. INB301 injection precisely addresses this significant unmet clinical need, and preclinical studies have demonstrated promising potential clinical value, potentially providing a new treatment option for patients worldwide.From a inheritor of traditional Chinese medicine to an innovator in modern pharmaceuticals, Yunnan Baiyao is continuously advancing its international and digital transformation towards innovative drugs. The approval of its INB301 injection's IND (Investigational New Drug) application in both China and the US is not only a milestone in the company's innovative R&D process but also a new starting point for its global expansion. In the future, Yunnan Baiyao will continue to uphold its mission of "protecting life and health," accelerating the globalization of its high-quality innovative pipeline with a forward-looking vision and an open and collaborative approach, and promoting the accessibility of original Chinese innovative drugs for patients worldwide.Contributed by: Academia Sinica

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