Biohyalux - Bloomage BioTechnology

Bloomage BioTechnology Corporation Limited is an international group company committing itself to bio-pharmaceutical development. With almost 10 subsidiaries engaged in pharmaceutical production, sales and investment, it has listed on Hong Kong Stock Exchange (stock code: 00963.HK) on October 3, 2008.

Bloomage Freda Biopharm Co., Ltd., the main subsidiary of Bloomage BioTechnology Corporation Limited, is a high-tech enterprise focusing on HA production for over 20 years. As the biggest professional HA raw material producer, the company provides safe, stable and reliable HA raw material to famous pharmaceutical, cosmetic and health food enterprises around the world. The HA raw material sales of the company accounts for 20% of global market share, and 60% of domestic market share. The reason for such achievements is the company’s continuous R&D and innovation, as well as its high attention to the quality management system.

With over two decades effort in R&D, the company has made two key scientific breakthroughs filliping international and domestic gaps.

*In 1990, fermentation was successfully employed in HA production domestically for the first time. As a revolutionary technical innovation during the industrialization process of HA, it not only realized the scale production of HA but also improved its quality.

*In 2011, the company realized industrialized oligomeric HA (Hyatrue HA™) production via enzyme digestion for the first time in the world; in the same year, Hyatrue HA™ was launched, providing a kind of HA raw material with complete structure and supporting transdermal absorption.

As the specialist in research, development and manufacture of HA products for over 20 years, the company is the largest & most successful supplier in the global HA raw material market by maintaining the highest pharmaceutical standards available; For our dermal fillers, we set the same high standards to ensure a high quality and safe range of products.

Qualification and certificates
HA Raw Materials:

According to the requirements of ISO 9001 Quality Management System Standard and Good Manufacturing Practices (GMP) for Pharmaceutical Products, the Group has established a consolidated set of production procedures, along with a standardized and comprehensive record of quality. The Group is the country’s firstmanufacturer to receive permission to manufacture pharmaceutical adjuvant (F20040001) with sodium hyaluronate by fermentation and the only manufacturer to produce Active Pharmaceutical Ingredients (H20113379, H20133147) with sodium hyaluronate by fermentation, and has also obtained the HA bulk drug GMP Certificate. Our injection grade sodium hyaluronate (API) is manufactured according to the ICH Q7 requirements, and its quality complies with the standards of both the European and the Japanese Pharmacopoeia. It has so far received the CEP from the European Union, the DMF registration from United States and the DMF registration from South Korea, and has also passed the on-site audits of both US FDA and South Korea FDA.

At the same time, the Group is the chief drafter of the industrial standard for hyaluronic acid used in cosmetics in China, and our cosmetics grade hyaluronic acid products obtained the ECOCERT certificate for organic ingredients in cosmetics in 2011. Since 2004, the Group took the lead in launching the registration of new resource food for hyaluronic acid in domestic, and we became the first authorized manufacturer in the country to produce hyaluronic acid as the new resource food since September 2008. In 2011, our food grade hyaluronic acid products gained two international certificates in succession, which are the Kosher Certificate and the Halal Certificate for food products.

End products:
“BioHyalux” modified sodium hyaluronate gel for injection is a domestic pure HA dermal filler used for facial cosmetic surgery injections, which is the only product of its kind to receive approval from the China Food and Drug Administration (CFDA). Being the most preferred material for Minimally Invasive Cosmetic Surgery, hyaluronic acid helps to improve the skin, slow skin aging, smooth out wrinkles, plump the lips and shape up the face, etc. The use of HA is safe, effective, painless, convenient and natural when compared with plastic surgeries and other cosmetic injections.