CHINA HEALTH SCIENCES NEWSLETTER
Vol. 4 , No. 20 - January 2, 2004
TOPICS THIS ISSUE:
- Chinese State Food and Drug Administration Accepts LAM Pharmaceutical's Submission for Approval
- Celsion Announces Formation of Development Joint Venture in China
- China Works out New Device to Detect Genetically Modified Products
- Chinese biotechnology company retains New York communications agency
Chinese State Food and Drug Administration Accepts LAM Pharmaceutical's Submission for Approval
LAM Pharmaceutical Corp, a biomedical company focused on the development and commercialization of novel wound healing and transdermal drug delivery systems, announced recently that the Chinese State Food and Drug Administration ("SFDA") has accepted LAM's submission for the approval of its patented LAM IPM Wound Gel(TM) -- SFDA file number Imp-03-1457. The completion of the approval submission culminates several months of dedicated work by both LAM's Chinese regulatory advisors and LAM staff.
Joseph Slechta, President and Chief Executive Officer of LAM, commented, "The acceptance of the approval submission for our IPM Wound Gel represents a crucial step in our regulatory initiative in China. We anticipate receiving the final SFDA approval to market the Gel during the first quarter 2004. We are presently negotiating distribution and marketing agreements for the vast Chinese market. We are confident that the impending SFDA approval for our Gel will enable us to conclude these negotiations and commence the launch of the Gel into the Chinese market."
Mr. Ma Qun, the senior consultant responsible for LAM's SFDA submission, added, "My colleagues and I have worked closely with LAM coordinating the Chinese SFDA approval process. We are very excited about the prospects for LAM IPM Wound Gel(TM) as it enters the Chinese marketplace. Diabetic patients and other serious ulcer sufferers will no doubt welcome the relief provided by LAM's excellent wound healing product."
(Source: PR Newswire)
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Celsion Announces Formation of Development Joint Venture in China
Celsion Corporation recently announced that it has established a joint venture to develop its technologies and distribute its products in Greater China with Asia Pacific Life Sciences Group Limited, a group of Hong Kong-based investors.
Dr. Augustine Cheung, Celsion's President and Chief Executive Officer said, "We are excited to have established a presence in China. We believe that the growing healthcare industry and evolving regulatory climate in China currently are very receptive to new technologies for the treatment of cancer and other serious diseases. In this environment, the opportunity for our tumor targeting, heat-activated liposome and gene products for cancer treatment could be significant. Additionally, the Chinese medical community historically has been interested in heat as a therapeutic modality, especially for the treatment of cancer. Over the last several years we have built a network of China-based scientists, clinicians and thought leaders in the field of heat-based therapies who now anticipate a new focus on heat-based treatments in cancer care. Through our joint venture with Asia Pacific Life Sciences Group Limited, we expect to continue the process of demonstrating the efficacy of our technology, which has already produced very promising results in animal studies, in treating a wide variety of cancers and localized infectious and inflammatory diseases.
"In the short term, we expect that the pre-market approval of our Microfocus BPH 800 Microwave Urethroplasty (TM) System will be expedited in China once we receive approval from the FDA to market the system in the United States. Such an approval will enable the rapid roll-out of the system in Greater China and the early generation of revenues."
(Source: Business Wire)
China works out new device to detect genetically modified products
Amid consumer concerns over transgenic crops, Chinese scientists have worked out a device that can tell in 50 minutes if a farm produce has been genetically modified. The reagent box, independently developed by a bio-technology center under the Shanghai Academy of Agricultural Sciences, can screen out transgenic soybean, rape, corn and other agricultural products.
The device is very close to similar products on the global market in terms of sensitivity and accuracy, but is only half their price, according to sources with the State Administration for Entry-Exit Inspection and Quarantine, one of its first users. Researchers with the academy say the reagent box has been put into mass production, and 1,000 to 2,000 pieces are being produced each month.
Though the effects of transgenic technology is still debated by scientists around the world, an official with the State Environmental Protection Administration has warned that China has the world's fourth largest area of transgenic crops, after the United States, Canada and Argentina. Currently, genetically modified crop growing areas in China exceed 650,000 hectares and six genetically modified plants, including soybean and rice, have been approved.
(Source: Xinhua News Agency)
Chinese biotechnology company retains New York communications agency
American Oriental Bioengineering Inc. (AOBO) has retained The Ruth Group, based in New York, as its investor relations and financial communications agency. The Ruth Group will work to increase awareness among investors and the business media of American Oriental Bioengineering's corporate focus and growth strategy.
Shujun Liu, chief executive officer of American Oriental Bioengineering, commented, "Given our leadership position in China as a primary biotechnology company focused on the use of soybeans in supplemental and medical research, the strategic initiatives we have underway, and our efforts to increase shareholder value, it made sense to retain The Ruth Group, a top financial communications firm.
"Given our rapid growth and our optimistic outlook, it is now crucial that we partner with a professional agency to maximize the opportunities ahead of us. Management can now focus on new product development and proper penetration into market. We also continue to evaluate several acquisition opportunities. The Ruth Group's history working with dozens of NASDAQ, NYSE, and Amex listed companies and its vast experience working with leading companies in China, such as SINA (SINA) and ChipPAC (CHPC), will prove valuable as we enter the next phase of our growth."
(Source: Drug Week)
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