Wang Juncai is observing the experimental data. Pictures provided by interviewees
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China News Service, Changchun, July 14 (Gao Long'an) Wang Juncai's mobile phone album contains a photo taken in September 2006: a pair of twin sisters with childlike faces looking a little shy at the camera. "They were 15 years old at the time and were only 1 meter tall, about half a meter different from normal children." Wang Juncai held his mobile phone in one hand and gestured at his waist with the other. "This is the first time I have come into contact with a patient with dwarfism . It is my eighth year in the industry."
Wang Juncai is the head of the process center/protocol process department of Changchun Jinsai Pharmaceutical Co., Ltd. "Many parents believe that their children's short stature is due to poor nutrition and insufficient physical exercise, and few would think of improving their height by supplementing growth hormone ." Wang Juncai said.
Wang Juncai’s company successfully launched China’s first recombinant human growth hormone powder injection and water injection in 1998 and 2005 respectively. "At first, we took the generic drug route. The technology and products are very mature, but they are limited to short-acting products. Patients have to inject drugs every day, which is very inconvenient." Wang Juncai said that patients need long-acting products more.
In the research and development of long-acting growth hormone, leading international companies started decades ago, but there has been no successful precedent in the field of practical application. "Growth hormone is essentially a naturally active protein secreted normally by the human body. It is easily degraded and cleared under physiological conditions. We need to find a way to maintain its blood concentration for a long time and retain its biological activity. "We also need to consider the safety of long-term use." Wang Juncai explained that the difficulty in developing long-acting growth hormone is here.
Wang Juncai is conducting drug ingredient analysis. Photo provided by interviewee
In 2002, Wang Juncai and his team began to invest in the research and development of long-acting growth hormone. They jumped out of the traditional solution and chose polyethylene glycol (PEG for short) link technology. PEG is a complex polymer , which is a key raw material for R&D and production. What kind of PEG is chosen and what kind of linking method is used directly determines the efficacy and safety of the product.
At that time, no domestic company had the ability to produce PEG, and the only way was to purchase it from abroad. "We bought 5 grams and spent 16,500 yuan, which was equivalent to one and a half years of my salary at the time." Wang Juncai said that they cherish the raw materials very much and are cautious in every experiment.
In order to solve the quality control problem, Wang Juncai and his team members worked hard for 4 consecutive months, working until 10pm every day, and completed the establishment of the first analytical method and standard for PEG-modified drugs in China. In the past 12 years, they have experienced countless attempts and failures, but they will gain something new every time. The safety and effectiveness of
drugs have been confirmed in clinical trials, and they have moved from the laboratory to the workshop production line step by step. In 2014, China's first long-acting recombinant human growth hormone passed relevant certification and was officially launched. In 2015, the "Development and Industrialization of Recombinant Human Growth Hormone Series Products" project won the National Science and Technology Progress Award second prize.
In recent years, Wang Juncai has been constantly trying to use new technologies to achieve self-production of key raw materials and iterative updates of product processes. He said that allowing more patients to use safe, effective and reasonably priced drugs is a topic that is always worth thinking about for scientific researchers. (End)
