China and the U.S. dual clinical approval, Yunnan Baiyao's first biological innovative drug welcomes a new milestone

On the evening of June 3rd, Yunnan Baiyao Group Co., Ltd. (hereinafter referred to as: Yunnan Baiyao, stock code: 000538.SZ) announced that the company recently received notification from the U.S. Food and Drug Administration (FDA) that its first therapeutic biopharmaceutical INB301 injection has obtained clinical trial approval from the U.S. FDA, with the indication for cancer cachexia. The drug received approval for clinical trial applications in both China and the U.S. in just over a month, showing rapid progress. According to the announcement, Yunnan Baiyao submitted the IND application for INB301 injection to the U.S. FDA on April 27, 2026, and received clinical trial approval on June 2. Previously, the domestic IND application for the drug was officially accepted by the National Medical Products Administration on February 24 and was included in the 30-day fast track for innovative drug review and approval, receiving domestic clinical approval on March 30. Cancer cachexia is a wasting metabolic disorder syndrome driven by host and tumor-derived inducing factors, accompanied by systemic inflammation, characterized by involuntary weight loss and persistent loss of skeletal muscle, which is difficult to reverse with conventional nutritional support. Clinical data shows that approximately 80%-90% of patients with advanced cancer experience symptoms such as weight loss and muscle wasting, severely affecting their quality of life and treatment tolerance; about 20% of patients with advanced cancer die directly from cachexia. According to Research Nester data, the global cancer cachexia market is expected to exceed USD 2.54 billion in 2025, estimated to be USD 2.65 billion in 2026, and is projected to exceed USD 4.02 billion by 2035. Currently, there are no approved targeted treatment drugs for cancer cachexia in both China and the U.S., indicating an urgent clinical need. INB301 injection precisely targets this significant unmet clinical need, and preclinical studies have shown good potential clinical value, promising to provide new treatment options for patients worldwide. To date, the company has invested approximately RMB 50.665 million in the research and development of this drug. As a leading traditional Chinese medicine enterprise, Yunnan Baiyao is accelerating its transformation into an innovative pharmaceutical company, insisting on leveraging both traditional Chinese medicine and innovative drugs. In 2025, the company achieved operating revenue of RMB 41.187 billion, with a net profit attributable to the parent company of RMB 4.865 billion, both setting historical highs, and the net operating cash flow reached RMB 4.6 billion. Ample cash flow enables the company to robustly promote the clinical research and development of its innovative pipeline, providing reliable support for short, medium, and long-term R&D pipelines. In 2025, Yunnan Baiyao's R&D investment reached RMB 423 million, a significant year-on-year increase of 21.51%; in the first quarter of 2026, R&D expenses increased by 27.72% year-on-year, continuously enhancing R&D capabilities. The company strengthens talent development by collaborating with several top domestic research institutions and universities, integrating industry-university-research resources, and relying on a dual-track mechanism of "external introduction + internal training," forming a high-level talent team led by academicians of the Chinese Academy of Engineering, recipients of the national "Ten Thousand Talents Program," and "National Outstanding Youth Fund" awardees, with over 60% holding master's or doctoral degrees, injecting lasting momentum into the company's long-term scientific and technological innovation development Continuous growth in R&D investment and a reserve of high-quality talent have become important levers for the company's dual-line layout, helping to improve and upgrade traditional Chinese medicine business, accelerate clinical transformation of cutting-edge innovation pipelines, and steadily fulfill the goals of innovative transformation and development