Last month, the production line of Jiangsu Yingke Biological Pharmaceutical Co., Ltd for “Lentinan” API which has been granted national new version GMP certification formally started production. This production line is the first API production line being granted national GMP certification and launched into production in the pharmaceutical zone. After production starts, its annual output value will top 100 million yuan.
Led by Yang Yue’e, Executive Vice President of Yingke Biological, the reporter put on cleanroom garments, and cap, shoe cover before walking into Yingke Biological’s API production line to make explorations.
From sorting, washing, extraction, separation, concentration, alcohol precipitation, drying, to final cleaning, this API production line is divided into eight functional zones, which are closely linked to each other, and occupies the 4th floor of Yingke Biological Building, with over 3000 sqm. A group of fully dressed staff members were attentively selecting Shiitake.
“Excluding sorting, the remaining steps are handled by automated equipment.” Yang Yue’e said, the API production line specially manufactures API “Lentinan” extracted from Shiitake, making preparations for the production of Lentinan injection for adjusting immunity by the enterprise.
“This year we plan to manufacture 5 kg of ‘Lentinan’ API, which can be used to produce 1 million ‘Lentinan’ injections in 5 mg specification.” said Men Yunlong, Director of Yingke Raw Material Workshop, due to factors such as advanced technology and stringent production requirement, in the past, there were only two manufacturers of Lentinan injection in China. Today, Yingke Biological has become the third manufacturer of this drug nationwide, its production capacity far surpasses the other two.
“Apart from API production line, we also constructed three injection production lines.” According to Yang Yayong, Production Vice President of Yingke Biological, Yingke Biological’s large volume injection production line, small volume injection production line and freeze dry powder injector production line have all been completed, in June this year they will receive national new version GMP certification. By that time, we can manufacture energy drug, anesthetic drugs, and anti-cancer drugs etc.
“Wherein, energy drug is our key product.” Yang Yayong disclosed, Yingke Biological is leading the industry in the R&D and production of energy drugs in China, many energy drug products are very mature. For instance, Lentinan injection is an energy drug directly transferred from Guangzhou Headquarters Pulekang Group to CMC for production, after production starts the annual output value of this product alone will top 100 million yuan.
Now, Yingke Biological is applying for production license of a new generation of Medium and Long Chain Propofol Emulsion. This product is also a kind of energy drug for improving immunity, and is dedicated to serving stomach and intestine tumor operation victims, meanwhile it also applies to patients lacking fatty acid. At present, only four manufacturers in China that manufacture this product, all of them are foreign invested manufacturers, their annual total sales topped 30 billion yuan. Yingke Biological will shatter the monopoly of this product by overseas manufacturers to become the only domestic manufacturer of Medium and Long Chain Propofol Emulsion in China.
“There are also amino acid nutrient fluid and so on, there are many products.” Yang Yayong said, the reason that Yingke Biological had recorded outstanding performance in energy drug aspect is that Yingke Biological has its own R&D team, it also set up dedicated “Energy Engineering Lab”. This year, this Lab was approved by the Provincial Development and Reform Commission to become a provincial level lab, next year it will be further upgraded to state level lab to become the only energy engineering lab in China.
“It is expected that in 2015, the four production lines can be launched into production simultaneously, the output value will then top 1 billion yuan.” Yang Yayong said, in addition to going all out to build China’s only “Energy Engineering Lab” in CMC, Yingke Biological will focus on developing 6 tinib type anti-cancer targeted new drug to benefit more patients.
Taizhou Daily Page A1, April 5, 2014