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XINBEI

ABOUT US

ABOUT US

XINBEI

Xinbei and Its Products

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Fuzhou XinBei Biochemical Industrial Co. Ltd (XinBei)is a high-tech company that develops and

manufactures Tachypleus Amebocyte Lysate(TAL)as well as related TAL accessory products. Our TAL

products not only meet the Chinese Pharmacopoeia standard, but also are in accordance with the U.s

harmacopoeia requirements

XinBei was founded by Chinese TAL pioneer researcher Youling Ding in 1995. In early 80s, Ms Ding

was one of the first researchers in China to successfully develop TaL and was awarded the top prize by the

Ministry of Health for her excellent work. Ms Ding spent several years studying and conducting research in

Japan under the guidance of Dr. Seizaburo Kanoh the head of osaka Division of the National Institute of

Health Science of Japan, who was an expert in endotoxin research. She also studied in the Department of

Molecular Biology of the Kyushu University( Fukuoka, Japan)under the guidance of international renown

biochemist Dr. Sadaaki lwanaga, specializing in reference standard endotoxin as well as the mechanism of

Limulus coagulation system. Ms Dings scientific papers were published in many international renowned

science journals. She also participated in the WHO collaborative calibration for international endotoxin

standard and brought her expertise back to China to help establish the 4th generation of the national

reference standard endotoxin 200707

During XinBei,s early years, we introduced advanced devices and production lines from Japan. In 1997

we received the dnug manufacture certificate from Fujian FDA and our TAL products received national drug

approval certificate. We were the first company in China to develop and manufacture high sensitive

quantitative TAL. In 1998 our products were tested by the National Institutes for Food and Drug Control and

the highest sensitivity could reach 0.0

In order to maintain our competitive advantage, we have been focusing on developing and

strengthening our R&D Department. Joining by researchers from overseas and graduates from a variety of

universities, we have developed new products and obtained several innovation patents as a result of our

excellent research activities. As an increasing number of drugs requiring endotoxin testing were added to

Chinese Pharmacopeia, we introduced Type P anti-interference TaL to meet the increasing market demand

Our 2nd generation TAL and 3rd generation chromogenic TaL were awarded Fuzhou Science and

Technology Progress Award 1st place, Fujian Science and Technoiogy Progress Award 2nd place, China

Cross-Straits Innovation Achievement Award and the 16th National innovation Display Gold Prize. Our 3rd

generation chromogenic TAL (with a maximum sensitivity of 0.005EU)has been used in clinical diagnosis to

help detect endotoxin in serum as well as certain types of body fluid. Our latest products, 4th generation

a specific TAL that only reacts to(1-3)-B-D-glucan. It is a highly sensitive, rapid diagnostic test that

(1-3)-B-D-glucan in serum to support the diagnosis of Invasive Fungal Disease. In addition we also

held several Endotoxin Detection Workshop nationwide and provided high levei of expertise in endotoxin

testing method for our customers

We participated in a variety of international conferences from time to time meanwhile we maintain

long-term collaborate relationship with research institutes such as Institute of Biochemistry and cell Biology

Chinese Academy of Science and established an Enterprise Academician Workstation in 2012. In addition

we often brought in international renowned TAL experts from abroad to give guidance to our research work

Over the past fifteen years, we were awarded the Nationai Innovation Funds three times and our tAl

products have been listed in <National Major New Products by five state ministries and commissions

Since 2004 XinBei has been certified as a high-tech enterprise by Fujian Institute of Science al

Technology. XinBei's current facility was built in 2011 with 2000 M2 in total floor space and the annual

production capacity of 10 million vials of TAL. the entire manufacture area is class 10, 000 with certai

Our mission is to provide superior products and service for our customers to ensure the safety of their

products. Our ultimate goal is to grow into an intemational leading manufacturer in endotoxin detection and

bring efficiency and productivity for the pharmaceutical and healthcare industry




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