In 2004, Zhongshan Hygene Biopharm Co., Ltd., (originally known as Shanghai Hygene Biopharm Co., Ltd.) was set up in Zhongshan National Health Base with registered capital of RMB 20 million. Business scopes: production and sales of genetic recombination products (recombinant human growth hormone for injection), as well as research of biological products.

Zhongshan Hygene Biopharm Co., Ltd. took about one year to complete the overall construction of the modernized factory in July, 2005. At present, the company has 1270㎡ of administrative offices and 1620㎡ of all-in-one workshop which is in accordance with the requirements of GMP, established and improved the production and operation management system, won the "Certificate of Pharmaceutical GMP," and "Drug Production License," issued by the State Food and Drug Administration and formally put into production. The company won the honor of “Guangdong Hi-tech Enterprise” in May, 2006 and “Guangdong Private Technology Enterprise” in November, 2006. After being put into production operation, the company achieved a remarkable business performance in the very year and became the rising star of China's biopharmaceutical industry.

Thus, the company, from the R&D and pilot test of genetic engineering drugs conducted by the former company in 1995 to the current success of industrial and commercial operation, has experienced a hone for 10 years, completed the accumulation process of technology and business management and stepped from the phase of “Three high, One long” (high input, high-risk, high-yield, long-cycle) into the high-growing phase of the enterprise.

 

The company's main product --" Recombinant Human Growth Hormone for Injection (rhGH)"—is a kind of gene recombinant protein drug, the registered trade mark of which is “Recombinant Human Somatropin for Injection”, the products are classified as the second category of new drugs of the country with independent property rights. Product specifications are 2.5IU / bottle, 4IU / bottle, 8IU / bottle, all of which won Drug Approval Permit No. and pharmaceutical production license issued by the State Food and Drug Administration in 2005.

 

The growth hormone is a kind of peptide hormone secreted by anterior pituitary (adenohypophysis), and human pituitary weighs about 0.5g, with a minimal amount of growth hormone. In 1955, the human growth hormone, which consist of 191 single-chain peptide of amino acids, was isolated from human pituitary for the first time; 24 years later, the first human growth hormone gene was cloned for the first time.

The main physiological role of human growth hormone is to promote the growth and development, and its receptors are distributed throughout all the tissues of the body. The main physiological functions of growth hormone are to promote the growth of cartilages, bones and cells, repair tissues and regulate metabolism. Its clinical applications are mainly reflected in five aspects: clinical short stature, clinical postoperative, anti-aging, clinical reproductive and clinical burning.

Recombinant Human Somatropin for Injection ® human growth hormone is a gene recombinant protein drug, composed of 191 amino acids, completely identical with natural human growth hormone in structure, having the same efficacy and having no adverse effects.

 

High-quality bio-pharmaceutical drug is bound to have high purity, high biological activity and high safety, and the company has advanced technology, process level, production equipment, as well as the management level to guarantee Recombinant Human Somatropin for Injection ® rhGH products of high purity, high biological activity and quality stability, but also to guarantee the safety and effectiveness of the medication.

Currently, the company adopts the most advanced secretory expression technology. The purity of the Recombinant Human Somatropin for Injection ® rhGH products reaches 99.9%, (the index stipulated by Chinese Pharmacopoeia is 99.5%),and the product activity reaches 100%. High-quality products not only reflect the level of the application of science and technology, but also make products successfully enter the international market to compete and acquire stable market share.

 

Recombinant Human Somatropin for Injection ® rhGH products compose of 191 amino acids, completely identical with natural human growth hormone in structure, the purity of the batch finished products reaches up to 99.9%, endotoxin is less than 1EU (less than 5EU for GB) which exceeds the purity of the products produced by the known domestic manufacturers, and the biological titer reaches nearly 100%. The "high purity, strong activity, and high titer" of the Recombinant Human Somatropin for Injection ® rhGH products have become an advantageous magic weapon for competition in the market which reflects the core technology and core competitiveness of the enterprise.

 

1. Business Strategy

The development goal of the company focuses on the establishment of a world-class R&D of bio-gene products and production base, centers on the core technology to create the core competitiveness of the enterprise. After undertaking the enterprise risks and industrialization risks alone, the enterprise has been equipped with good development conditions so that it can achieve future sustainable development through its capital operation.

 

2. Organization and Structure

The company has a set of complete organization and management systems and a staff of about 65 with 50% respectively going for administrative management, sales management and production system, and the fields involved include management, marketing, clinical pharmacology, biochemistry and genetic engineering, etc.

 

3. Management of Production and Quality

In quality management, the company has established an effective quality control guarantee system and operates in strict with GMP provisions. In production management, in the state of full capacity, the monthly output of “Recombinant Human Growth Hormone” is 1000g, and the annual output is 12000g, and at present 60% of the production capacity has been achieved.

 

4. Sales Management

The company sets up a marketing center for domestic sales and adopts the traditional model of pharmaceutical distribution agency. At present, six offices are set up respectively in Guangzhou, Shanghai, Tianjin, Wuhan, Xi'an and Beijing.