How it started

In the nineties Jin Lei a brilliant Chinese pharmaceutical student, who graduated from Beijing University in 1985,  studied in the USA. In his free time he worked hard as a research scientist at Genentech, an American biotech company and one of the world’s leading producers of human growth hormones. His special interest where antibodies that bind to human growth hormones.

In 1994 he earned a PD in pharmaceutical chemistry from the university of California. After graduation, Mr. Jin, despite many offers for well paid jobs in the USA,  wanted to return to China to start his own biopharmaceutical company and help Chinese children by producing human growth hormone.

In 1997 Jin build a manufacturing lab, called GeneScience Pharmaceuticals Company,  in partnership with a state-owned company called “ Changchun High Tech Group “,and a year later they introduced their own patented human growth hormone, called Jintropin, named after Dr Jin. This new cheap and very effective growth hormone became very popular among anti-aging aspect, life extensionists and bodybuilders. Existing companies that made enormous amounts of money on this new and overpriced compound tried their best to discredit this much cheaper Chinese competitor.

GeneScience became  the proprietary rights by the Chinese government to use the “Secretion Technology” which means they where the only company that  could manufacture 191 aa (amino acids) recombinant human growth hormone by secretion technology in China. They owned the Chinese patent rights and sued every company that claimed otherwise. The fact that the Chinese government had invested $9 million in this company, most certainly had a major influence on the Chinese decision to grant GeneScience the exclusive rights to use this technology. All  other Chinese growth hormone was still manufactured using inclusion body technology and therefore possessed a 192 aa sequence. As you can read in our last article about Chinese growth hormone, 191 aa rhGH is by far superior on the 192 aa version. Genetech had an international patent on 191aa manufacturing secretion technology and GeneScience has been sued by Genentech USA,  for  stealing its technology when Jin Lei was working for them when he was studying in USA, but the international patent had expired. The present situation on the Chinese market is that all Chinese manufactured growth hormone is191 aa except Kexing's product.

Two Hygene companies

Mr Lin, Jin’s main technical man and co founder of GeneScience, had differences of opinion about GeneScienses future development, Lin left GeneScience, in 2002.  He developed the production process of Jintropin mainly by himself, and he promoted it as the best HGH in china. When he left the company, Lin was awarded with 6% shares of GeneScience.

He was invited to become the general manager of Hygene Pharmaceutical company and established his own brand "Hygetropin". Hygene was founded in Zhongshan city in May 2005 and was expanding very quickly.  Lin marketed his brand Hygetropin® just like he had done with Jintropin® before and it became a similar success story. In 2007,  prior to Olympic Games, the USA blackmailed China to cooperate in a major crackdown on international trafficking in steroids and other illicit bodybuilding drugs  known as “Operation Raw Deal” . Jin Lei and GeneScience where charged by the USA, the USA was asking for his extradition to the USA but the proud Chinese nation refused just like they had refused to extradite Kenneth Chen before. The American government seized $3.4 million from the New York branches of two Chinese banks linked to GeneScience.

Still the Chinese government did some concessions and they limited the production and export of peptides and pharmaceutical ingredients. Because of all this Lin  had to leave Hygene and Hygene changed its name to Zhongshan Hygene(Biohygene). Lin left Biohygene and withdrew all his techniques from Biohygene.  After that Biohygene's GMP was cancelled by the Chinese FDA (SFDA).  Lin possessed the licence on the brand name Hygetropin® and therefore Biohygene was no

longer able to use this name. They renamed there growth hormone Hygene®. To summarize in June 2007 the Hygene Pharmaceutical company was split into two different companies. Lin kept the Companies name Hygene and his former associates changed their companies name in  Zhongshan Hygene Biopharmaceuticals Co, Ltd. Since August 2007 the box of Hygetropin® bears an anti-counterfeit sticker on the kit boxes and "Hygetropin 8iu" printed on the top. The box without the sticker has the circular symbol.

The quality

On the left we posted a graphic of RP-HPLC (reversed phase HPLC). On the graphic, the main peak is corresponding to the activity.   This method is according to European Pharmacopoeia.

First, the activity was tested by using little animals. This was strongly protested by animal welfare organizations. Then, the WHO asked some labs to seek the relationship between HPLC and the activity. After  experimenting, scientists concluded that the result of the RP-HPLC  well corresponded to  the activity as tested on little animals . Then , in pharmacopoeia, changes where made that the  activity was no longer tested on small animals, but instead by RP-HPLC.

Before we continued our second article about growth hormone we asked our members which brand they wanted us to analyse. The majority choose for Hygetropin which was extremely popular at the time also due to an absence of counterfeits of this brand.

For our first article on growth hormone we had performed analyses on Jintropin and blue tops. We had also asked the toxicological department of the university of Gent to analyse these two samples on peptide pollutions and both items where very pure and clean..

On the different discussion forums members questioned the quality of the Chinese growth hormone. Some people still consider China as a developing country with an underdeveloped industry, but I can assure you that the majority of the manufacturing pharmaceutical companies is producing on the highest possible level with sophisticated equipment, techniques and employees. The few recent scandals, due to personal greed, should not effect our general opinion about the Chinese products.

On the internet on many discussion forums all over the world, bodybuilders, anti-agenists and life extentionists wondered about the quality and legitimacy of Hygetropin® . As we already mentioned in the start of this article. Mr Lin owns the patent on his brainchild. The only legitimate Hygetropin ® therefore is the version with the anti-counterfeit sticker. The Zhongshan is also certificated as you can see on fig 5.

The counterfeit

What about the Hygetropin without the sticker and with the circular symbol (the logo belonging to Zhongshan BioHygene)? This cheap item flows the European market.

A major board (www.ergogenics.org ) claimed to have analysed this version and said it contained Albumin !!!They did not specify the kind of albumin. Many bodybuilders in the know remembered a scandal on supposed IGF-1 LR3 that was stabilised with BSA (bovine serum albumin) and not meant for “in vivo” use. The BSA is mostly fetal bovine calf serum. Albumin is the main fraction in blood but blood also contains more proteins then just albumin, and could cause a n immune response. Albumin is normally added 5-10mg/ml as a stabilising agent.

Lots of faithful users of the counterfeited Hygetropin mailed us after they had read the posting on ergogenics.org , most of them where very worried. Albumin can be easily detected as a fat band around 67 kDa by SDS-PAGE. We decided to sent a sample to the laboratory to find out for sure. It turned out that there was no trace of albumin visible, and  the sample seems to be highly pure (only one band visible, fig 6).

The how and what.

Growth hormone is very popular and as we wrote in the beginning of this story almost all Chinese growth hormone is produced by the same technology. That means that they are all fishing in the same pond. Some brands are very popular others unknown. We know now one of this companies is counterfeiting Hygetropin®. We feared in the first that it would be a bad counterfeit, but as you can see by the analysis that fear was not grounded.

I was told  that real Hygetropin® uses a  kind of sugar as stabilising agent and not manitol. In order to stand out in the present growth hormone market the companies have to provide quality. This means that they try to manufacture a product with a high activity and with as little as possible HGH related contaminants.

Because the production process is the same, the specific activity is therefore also the same. The bioactivity can be detected by HPLC as we mentioned in the beginning of this article. It is said that 8IU Hygetropin® equals 9.6IU Jintropin®. Because they add more HGH in their product. Some R&D departments are experimenting with HGH that is PEGylated to prolong their activity. Next time we will inform you further about the quality .

As usual Hygetropin added a new item to their products an box that contained 10 vials with growth hormone 10 iu. Original they used the engraved tops. All of a sudden the colour and text of the tops changed. Again the members of our forum (seen the counterfeits below) where confused and thought they had bought perhaps some counterfeits. A mail to Dr Lin ended this confusion.

Our company have changed our 10iu top as yellow. You can check from our website //www.hygetropin.cn/important.htm. The pictures for the new top you can see from //www.hygetropin.co/introductio...ntm%20rhgh.htm and from //www.hygetropin.co/indications...getropintm.htm.

Until next time….ronny…