The road to domestic implant-grade PEEK replacement From 2007 to 2024, from the pilot project of Jiangbian Chemical in Changzhou to the full production of Shandong Junhao Phase II, it marks that we have gone through nearly 20 years in the PEEK industry chain. From small-scale trials and pilot tests to today’s 6-cubic-meter domestic largest PEEK polymerization unit, we continue to break through technical bottlenecks and improve product quality. AKSOPEEK brand story From PEEK industry to medical field replacement, we have always been committed to breaking the foreign monopoly and achieving localization. In 2018, we officially established the medical implant grade AKSOPEEK brand. AKSO means the goddess of health in ancient Greek mythology, expressing our hope to promote medical development and human health. The brand mainly covers AKSOPEEK, AKSOPEEK HA, AKSOPEEK CF, AKSOPEEK LCF and other implant brands. Professional R&D team and R&D equipment From project development to formal production, it took 2190 days, a R&D team of hundreds of people, and tens of millions of R&D investment. In August 2023, we became the first domestic implant grade PEEK independent synthesis production enterprise registered in the NMPA master file. The filing includes implant-grade particles, plates, rods, 3D printing filaments and other product forms.
In March 2024, AKSOPEEK officially obtained the first registration certificate for Class III implantable PEEK applications issued by NMPA. This means that domestic substitution has taken a formal step. In October 2024, AKSOPEEK® medical implant-grade PEEK officially completed the FDA’s MAF master file filing. As of November 2024, more than 20 domestic companies have used AKSOPEEK to register Class III products, covering typical PEEK product applications in neurosurgery, orthopedics, cardiovascular and other fields.
From initial suspicion to trial and then to trust, the road of domestic implant PEEK replacement is tortuous, but we have achieved initial results. In the future, we will continue to work hard, continue to develop good PEEK products with gratitude and awe, and contribute our own strength to promote the development of my country’s medical device industry.