China’s First Plant-Based Human Serum Albumin Injection Receives Priority Review forMarket Approval
Wuhan, China – A groundbreaking development in the pharmaceutical industryhas emerged from China, with Wuhan HeYuan Bio-Technology Co., Ltd. (HeYuan Bio) receiving approval for its New Drug Application (NDA) fora plant-derived recombinant human serum albumin injection (Oufumin). This innovative drug, classified as a Class I therapeutic biological product, has been granted priority reviewstatus by the National Medical Products Administration (NMPA).
The decision to prioritize Oufumin’s review stems from its potential to address a critical need in China’s healthcare system. The country currently faces a significant shortage of human serum albumin,relying heavily on imports to meet the annual demand of approximately 1,000 tons. Oufumin’s approval could significantly reduce this dependence on foreign sources, making this essential medication more accessible to the Chinese population.
HeYuan Bio, a high-tech enterprise specializing in plant-derived recombinant protein expression technology, developed Oufumin using cutting-edge molecular medicine techniques. The company’s intelligent production line has already secured a drug manufacturing license, ensuring the quality and safety of this innovative treatment.
This is a significant milestone for HeYuan Bioand for the development of plant-based biopharmaceuticals in China, said a spokesperson for the company. We are committed to providing patients with safe and effective treatment options, and we believe that Oufumin has the potential to revolutionize the way human serum albumin is produced and delivered.
The priority review status granted to Oufumin signifies the NMPA’s recognition of its potential to address a critical public health need. This accelerated review process will expedite the drug’s path to market, bringing much-needed relief to patients and healthcare providers alike.
Background:
HeYuan Bio’s journey to develop Oufumin was supported by a strategicinvestment from BeiDa Pharmaceutical, a leading Chinese pharmaceutical company. BeiDa’s expertise in the full innovation drug chain has been instrumental in advancing Oufumin’s clinical research and industrialization.
HeYuan Bio has established a comprehensive industrialization and quality assurance system for plant-based biopharmaceuticals in China. The company’sunique plant expression system and two technology platforms – OryzHiExp (rice endosperm cell protein expression platform) and OryzPur (protein purification platform) – have positioned it as a leading center for plant-based drug research and development internationally.
Looking Forward:
The approval of Oufumin represents a significant stepforward for China’s biopharmaceutical industry. It demonstrates the country’s commitment to developing innovative treatments and reducing its reliance on imported medications. As the drug progresses through the approval process, it holds the promise of improving the lives of countless patients in China and beyond.
References:
- BeiDa Pharmaceutical
*Wuhan HeYuan Bio-Technology Co., Ltd. - National Medical Products Administration (NMPA)
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