Recombinant Human Albumin Injection (Oryza Sativa) receives approval to initiate Phase III Clinical Trials in the United States
Recently, Healthgen’s proprietary, first-in-class drug, Recombinant Human Albumin Injection (Oryza Sativa), successfully has successfully completed a Type C meeting with the U.S. FDA. During the meeting, Healthgen reached a consensus on international multicenter Phase III clinical trial protocol and indications with U.S. FDA experts, including reviewers from the Center for Biologics Evaluation and Research (CBER) and American clinical experts.
The FDA experts characterized Healthgen’s Recombinant Human Albumin Injection (Oryza Sativa) as a “historic innovation” and expressed strong support for its global multicenter clinical trials, providing clinical practical guidance for execution. The FDA experts further confirmed that positive results of the international multicenter Phase III trialwould support approval of Recombinant Human Albumin Injection (Oryza Sativa) for all current clinical indications of human serum albumin, addressing unmet medical needs across all eligible patient populations.
On July 18, 2025, Recombinant Human Albumin Injection (Oryza Sativa) was approved by China National Medical Products Administration (NMPA), as the first recombinant human albumin injection ever authorized in China. This milestone achievement represents a breakthrough in China’s biopharmaceutical innovation, propelling China from technological follower to global leader in recombinant albumin technology while delivering a Chinese solution to worldwide blood product alternatives.
The global pharmaceutical market has grown increasingly competitive in recent years. Through international expansion and overseas market entry, Chinese biopharmaceutical firms can strengthen their global competitiveness while actively shaping the evolving pharmaceutical supply chain. Healthgen has initiated active preparations for its global multicenter Phase III clinical trial of recombinant human albumin injection in the near term.
