2009-11-27 04:52:06 -

National Cheng Kung University (NCKU), Taiwan signed a MOU with ScinoPharm Taiwan Ltd. on Nov. 24th. The NCKU President, Academician Michael M.C. Lai, attended together with Prof. Chyi-Her Lin, the Dean of the College of Medicine, Prof. Pin-Wen Lin, the Superintendent of the NCKU Hospital, Prof. Ih-Jen Su, the Deputy Superintendents of the NCKU Hospital, Prof. Ming-Jer Tang, the Vice

President of Academic Affairs, Prof. Jung-Chun Huang, the Associate Vice President for R&D, Prof.
Yung-Nane Yang, the Associate Vice President for R&D and the Division Head of University Development, and Distinguished Professor Shu-Hui Chen from Institute of Bioinformatics.

Dr. Jo Shen, the President and CEO of ScinoPharm Taiwan, also attended together with Dr. Hardy W. Chan, the Executive Vice President & Chief Scientific Officer of ScinoPharm Taiwan and the President of ScinoPharm Biotech and ScinoPharm Kunshan, China, Dr. Kuo-Hsi Cheng, the Vice President for Operations, Ms. Jessie Wang, the Director of Human Resource and Public Relationship, Ms. Min-Ling Cheng, Corporate Development Project manger, and Ms. Sabrina Wu, the Corporate Communications Manager.

According to the MOU, NCKU and ScinoPharm, Taiwan, both agree to encourage and promote cooperation in developing novel therapeutic agents and enabling technologies, as well as building competitive advantage in the knowledge-based industries in the greater China region and other territories. Moreover, they will also facilitate the relevant training of team members which are needed for the projects through exchanges of personnel on a mutually beneficial basis, and will explore opportunities for cooperation in any other areas of mutual interests.

“This is a good start between NCKU and ScinoPharm Taiwan Ltd. I hope to establish the university-industry cooperation and make a big breakthrough on the development of biotechnology industry in the future, which is one of the key industries for the future as declared by the Executive Yuan,” said President Lai.

Biotechnology and pharmaceutical industry has been developed for 20 years, and has especially made a big progress in the past 10 years. It is also one of the six emerging industries specially selected by the Executive Yuan for intensive development. Universities and higher education in Taiwan have produced many graduates with related majors every year. However, the unemployment rate is relatively the highest in biotechnology industry, compared to the other industries. Obviously, students’ trainings in universities could not fit into the demand of this industry. On the other hand, Taiwan has relatively succeeded in the upstream R&D of the biotechnology and pharmaceutical industries.

However, the fruitful R&D outcomes from the upstream could not be smoothly transferred to the downstream production in the biotechnology and pharmaceutical industries. Almost all scientists in the upstream R&D were trained from universities and did not learn corporate management in colleges, which led to miscommunication between the upstream R&D and the downstream production, and eventually the misfortune of the biotechnology and pharmaceutical industries. There is a common saying that the successful industries are almost those without any scientists’ involvement. Scientist did not know how to organize and operate the industry. This has posted quite a difficult task in Taiwan, especially in biotechnology area. Therefore, President Lai appreciated and praised that NCKU had the opportunity to collaborate with ScinoPharm Taiwan Ltd, which is considered as the top of Taiwan’s biotechnology and pharmaceutical industries.

“To be honest, without the cultivation and assistance of NCKU, there would be no ScinoPharm Taiwan Ltd today,” said Dr. Jo Shen. She appreciated the contribution and kind help of NCKU. There are so many employees from NCKU. Even more, the first two laboratories of ScinoPharm Taiwan were in the Chemical Engineering Buildings of NCKU. That is, the first-day-at-work of ScinoPharm’s senior employees in the company was indeed at NCKU. “NCKU has the opportunity to become the first biosimilar clinical center over the world. Both of us hope to establish the collaborative relationship in the exchange of students, education, and R&D. We also sincerely hope to have much closer relationship with NCKU especially in proteinomics and R&D in protein drugs,” said Dr. Jo Shen.

ScinoPharm Taiwan Ltd has the developmental technology with two more positions due to the coming of biosimilars. One is the productive equipment, and another is the biosimilar clinical center. The second one is very important for the industry line and needs to collaborate with NCKU through the standard operating procedure (SOP). “We hope that NCKU will lead the biotechnology industry over the top one around the world through the collaboration,” said Dr. Jo Shen.

About Biosimilar


(Full text available or see the Library of Congress website and search with H.R. 1548.)


Biosimilar or Follow-on biologics are terms used to describe officially approved new versions of innovator biopharmaceutical products, following patent expiry. Unlike the more common small-molecule drugs, biologics generally exhibit high molecular complexity, and may be quite sensitive to manufacturing process changes. The follow-on manufacturer does not have access to the originator's molecular clone and original cell bank, nor to the exact fermentation and purification process. Finally, nearly undetectable differences in impurities and/or breakdown products are known to have serious health implications. This has created a concern that copies of biologics might perform differently than the original branded version of the drug.

However, similar concerns also apply to any production changes by the maker of the original branded version. So new versions of biologics are not authorized in the US or the European Union through the simplified procedures allowed for small molecule generics. In the EU a specially-adapted approval procedure has been authorized for certain protein drugs, termed "similar biological medicinal products".

This procedure is based on a thorough demonstration of "comparability" of the "similar" product to an existing approved product. In the US the Food and Drug Administration (FDA) has taken the position that new legislation will be required to address these concerns. Additional Congressional hearings have been held, but no legislation had been approved as of December 2007. On March 17, 2009, the Pathway for Biosimilar Act was introduced in the House.

About generic drugs


A generic drug (generic drugs, short: generics) is a drug which is produced and distributed without patent protection. The generic drug may still have a patent on the formulation but not on the active pharmaceutical ingredient (API).

A generic must contain the same active ingredients as the original formulation. According to the U.S. Food and Drug Administration (FDA), generic drugs are identical or within an acceptable bioequivalent range to the brand name counterpart with respect to pharmacokinetic and pharmacodynamic properties. By extension, therefore, generics are considered (by the FDA) identical in dose, strength, route of administration, safety, efficacy, and intended use. The FDA's use of the word identical is very much a legal interpretation, and is not literal.

In most cases, generic products are available once the patent protections afforded to the original developer have expired.

When a pharmaceutical company first markets a drug, it is usually under a patent that allows only the pharmaceutical company that developed the drug to sell it. Generic drugs can be legally produced for drugs where.

1) the patent has expired, 2) the generic company certifies the brand company's patents are either invalid, unenforceable or will not be infringed, 3) for drugs which have never held patents, or 4) in countries where a patent(s) is/are not in force. The expiration of a patent removes the monopoly of the patent holder on drug sales licensing. Patent lifetime differs from country to country, and typically there is no way to renew a patent after it expires. A new version of the drug with significant changes to the compound could be patented, but this requires new clinical trials. In addition, a patent on a changed compound does not prevent sales of the generic versions of the original drug unless regulators take the original drug off the market.

This allows the company to recoup the cost of developing that particular drug. After the patent on a drug expires, any pharmaceutical company can manufacture and sell that drug. Since the drug has already been tested and approved, the cost of simply manufacturing the drug will be a fraction of the original cost of testing and developing that particular drug.

When generic products become available, the market competition often leads to substantially lower prices for both the original brand name product and the generic forms. The time it takes a generic drug to appear on the market varies. In the US, drug patents give twenty years of protection, but they are applied for before clinical trials begin, so the effective life of a drug patent tends to be between seven and twelve years.

About ScinoPharm Taiwan


ScinoPharm Taiwan Ltd. is a leading process R&D and API manufacturing service provider to the global pharmaceutical industry. With FDA-approved cGMP production facilities, ScinoPharm offers a wide portfolio of services ranging from custom synthesis for early phase pharmaceutical activities to brand companies as well as APIs for the generic industry. Combining cost-effective resources and productivity of Asia along with extensive regulatory know-how, ScinoPharm is uniquely positioned to serve global pharmaceutical R&D and manufacturing needs at any level and for any company in this sector. For more information please visit www.scinopharm.com : .

About National Cheng Kung University (NCKU).

NCKU is located in the ancient city of Tainan, the historical and ancient cultural capital city of Taiwan, which boasts more than 50 national relics sanctioned by the government and is approximately 250 kilometers south of Taipei. It is connected to all major cities in Taiwan by the recently initiated state-of-the-art Taiwan High Speed Rail. Further, this historical heritage is the pride of Tainan City and represents a rich cultural resource to NCKU. The technological sectors in the Southern Taiwan Science Park offer students at NCKU with a stage to apply what they have learned into practice.

With three quarters of a century of distinguished history, with well over 130,000 powerful alumni now dotting the globe, many have achieved supreme successes in arts, business, education, science, technology and healthcare and are ready and willing to assist the 22,000 academic selective students and 1200 academic faculty members. Currently, both have an international flavor, with enormous regional support, and there is a permeating culture of proactive intellectual growth on the world’s stage NCKU in Tainan, Taiwan, has evolved from its engineering genesis into a powerful and comprehensive research international university in the Asia Pacific.

Since NCKU’s establishment in 1931, it has developed into a research intensive and comprehensive university with integrated academic fields in nine colleges: Liberal Arts, Sciences, Engineering, Electrical Engineering & Computer Science, Planning & Design, Management, Social Sciences, Medicine, and Bioscience & Biotechnology. NCKU currently offers 40 undergraduate programs (excluding the Program of Bachelor’s Degree), 78 master’s degree programs, 54 doctoral programs and 20 master’s degree programs for working professionals.

Photos: www.cna.com.tw/postwrite/cvpread.aspx?ID=44525 :



National Cheng Kung UniversityJulia (Ying-Chen) Liu,
+886-6-275-7575 ext. 50042NCKU Press Officer yingchen@mail.ncku.edu.tw : mailto:yingchen@mail.ncku.edu.tw