Recently, Yunnan Baiyao issued an announcement stating that its Investigational New Drug (IND) application for INB301 injection has been approved by the U.S. FDA, which agrees to conduct clinical trials for the intended indication of tumor cachexia.

The press release states that this is the company's first innovative therapeutic biological drug. Cancer cachexia is a complex metabolic disorder syndrome caused by malignant tumors, characterized by persistent skeletal muscle wasting that is difficult to reverse with conventional nutritional support.

Previously, the IND for INB301 injection was included in the 30-day fast track for innovative drug review and approval in China, and was approved by the NMPA in March 2026.

To date, the drug has obtained clinical trial approvals in both China and the United States, with a total R&D investment of approximately RMB 50.665 million.

As a leading Chinese medicine enterprise, Yunnan Baiyao has been accelerating the research and development of new drugs in recent years while optimizing and expanding its main business, thus broadening its development space through new tracks.

In 2025, the company's R&D investment reached 423 million yuan, a year-on-year increase of 21.5%, accounting for 2.64% of industrial revenue. In the first quarter of 2026, the company's R&D expenses increased significantly by 27.72% year-on-year, demonstrating its continuously improving R&D capabilities.

Currently, Yunnan Baiyao has established multiple innovative drug pipelines, seizing development opportunities in fields such as oncology and radiopharmaceuticals.
In the field of radiopharmaceuticals, the diagnostic radiopharmaceutical INR101 for PET imaging of PSMA-positive lesions in prostate cancer has initiated a Phase III clinical trial. Notably, this product completed a Phase I/IIa clinical trial in just six months, demonstrating excellent stability and safety.

The radiopharmaceutical INR102 is being used to treat PSMA-positive metastatic castration-resistant prostate cancer, and phase I/IIa clinical trials are being conducted concurrently.

In the field of biopharmaceuticals, the first innovative drug INB301 has completed preclinical pharmaceutical, toxicological, and pharmacokinetic studies, and its Investigational New Drug (IND) has been approved in both China and the United States.

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