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DRAGON GETS HUMAN G-CSF LICENSING RIGHTS EXCLUDING CHINA.


Dragon Pharmaceutical Inc. (TSX: DDD; OTC BB: DRUG), Vancouver, has entered into an agreement with Suzhou Suzhou, Soochow (both: s`jō`), or Wuxian (w Zhongkai Bio-Pharmaceuticals Company Limited ("Zhongkai") to in-license the exclusive right to commercialize its Recombinant Human Granulocyte
band-form granulocyte  band cell.


gran·u·lo·cyte (grny-l
 Colony Stimulating Factor ("rhG- CSF CSF - California Scholarship Federation
CSF - California State Fair
CSF - CAN (Controller Area Network) Standard Frame
CSF - Canadian Schizophrenia Foundation
CSF - Canadian Standard Freeness (property of woodpulp)
CSF - Cancer Slope Factor
CSF - Carcinogenic Slope Factor
CSF - Card Security Foil
CSF - Carrier Security Fee (maritime surcharge)
CSF - Casualty Staging Facility
CSF - Cat-Scratch Fever
CSF - Catastrophic System Failure
") product worldwide, excluding the People's Republic of China.

Using a non-mammalian cell fermentation technique (e.coli) with an in-house developed and patented purification process in the 6000m(2) Chinese State Food and Drug Administration ("SFD&A") cGMP-approved manufacturing facility in Suzhou, China, Zhongkai is one of the leading producers of rhG-CSF product, with approximately 16% market share in China, where competition is fierce with at least 20 other domestic producers. Dragon chose to in-license Zhongkai's rhG-CSF based on the company's evident superiority in compliance with cGMP, its well-documented processes, and the purity, safety, and efficacy of its product. Zhongkai's rhG-CSF is currently approved in China for oncology indication.

Human G-CSF G-CSF - Granulocyte Colony Stimulating Factor is a glycoprotein which regulates the production and release of functional neutrophils from the bone marrow. Myelosuppressive myelosuppressive /my·elo·sup·pres·sive/ (-su-pres´iv)
1. causing bone marrow suppression.
2. an agent that so acts.
 chemotherapy often upsets the patient's white blood cell
WBC
Any of the colorless or white cells in the blood that have a nucleus and cytoplasm and help protect the body from infection and disease through specialized neutrophils, lymphocytes, and monocytes. Also called leukocyte, white corpuscle.
 count, leading to febrile neutropenia neutropenia /neu·tro·pe·nia/ (noo?tro-pe´ne-ah) diminished number of neutrophils in the blood.

neu·tro·pe·ni·a (ntr
. The primary indications for rhG-CSF are in chemotherapy associated with the treatment of various cancers.

Zhongkai's product containing rhG-CSF causes marked increases in peripheral blood neutrophil counts within twenty four to thirty six hours. rhG-CSF functions within the body to stimulate production of more white blood cells, helping to reverse neutropenia so that cancer patients undergoing chemotherapy can continue with as near to normal white blood cell counts as possible. In some cancer patients, chemotherapy must actually be interrupted until neutropenia has been separately managed and brought under control, and in the case of certain tumor types, successful chemotherapy must be given according to a correct dosage and schedule.

"The competition is fierce in China with about 20 G-CSF products already in the market. As a result, we decided to partner with a leading producer in the market and focusing on developing the international market outside of China. This will bring much better economic value to Dragon without incurring significant risk in research and developing and the high investment to bring the drug into production" said Dr. Alexander Wick, president and CEO of Dragon. "This is an excellent opportunity for both Dragon and Zhongkai. Under the agreement, Dragon will leverage its regulatory approval knowledge and expertise from launching its own rh-Erythropoietin ("EPO") business internationally and will also utilize its existing licensing partnerships developed over time around the world to bring Zhongkai's rhG-CSF to the international market. A good quality, competitive bio-generic drug from China, like Zhongkai's rhG-CSF product, warrants the market exposure opportunities from both developing and developed countries. As a matter of fact, our international marketing and distribution partners have been quite keenly awaiting this product. Similar to Dragon's current strategy for the EPO product which has been approved in a number of developing countries and is in preparation to enter the European market, Dragon intends to commercialize the rhG-CSF initially in non-patented developing countries and will eventually extend the market coverage to developed countries upon expiry of the relevant patents. In the case of the European Union market, we believe that the relevant patents will expire in 2006 and by that time, we'll have an infrastructure, partnership and invaluable experience from launching our EPO product in the European Union market."

"This partnership with Zhongkai is part of our continued initiative to utilize our strengths and expertise in commercializing other in-house or in-licensed pharmaceutical products internationally. We have just announced entering into a letter of intent to merge with Oriental Wave Holding Ltd., on March 24, 2004, which would create a company that offers biotech generic drugs, chemical generic drugs and chemical intermediate produced in China competitively and marketed in China and international markets." said Dr. Wick. "We believe that the combined company will be ready to fully leverage the production infrastructure and sales network in China, diverse and proven product lines and distribution partnership around the world to make the combined company a serious player in the global pharmaceutical industry."

About Suzhou Zhongkai Bio-Pharmaceuticals Company Limited

Founded in 1996, Suzhou Zhongkai Bio-Pharmaceuticals Co. Ltd is a wholly owned subsidiary of Jiangsu Wuzhong Industrial Co. Limited. Zhongkai is currently engaged in research and development for two additional therapeutics: one recombinant drug, and the other with the development & refinement of an existing therapeutic based on Traditional Chinese Medicine.

About Dragon Pharmaceutical Inc.

Dragon Pharmaceutical Inc. is an international biopharmaceutical company headquartered in Vancouver, Canada, with a GMP production facility in Nanjing, China. Dragon's EPO is currently approved to treat anemia due to renal failure and for surgery patients in China, India, Brazil, Egypt and Peru. Additional regulatory submissions are in progress throughout Central and Eastern Europe, Asia, Latin America, the Middle East and Africa.

Dragon Pharmaceutical Inc. announced entering into a letter of intent to merge with Oriental Wave Holdings, Ltd. The proposed merger is subject to a number of conditions, including entering into a definitive agreement. If the merger is consummated, Dragon will be the surviving company and will be organized in three divisions: Chemical Drug division, Chemical Intermediate division and Biotech division with three existing cGMP manufacturing facilities and one under final construction.

For more information, call 604/669-8817 or 877/388-3784 or http://www.dragonbiotech.com.
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Publication:Worldwide Biotech
Date:Jun 1, 2004
Words:876
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