What behinds the blurred footing for China and Taiwan

Taiwan, China equals at WHA: Ma

05/10/2011 The China Post -- President Ma Ying-jeou yesterday said that the health ministers from Taiwan and China are on equal footing at the World Health Assembly (WHA). Ma's comment came as a clarification after a leaked World Health Organization (WHO) document shows that Taiwan is listed as a province of China. A letter sent out by WHO Secretary-General Margaret Chan last September to WHO members referred to Taiwan as "Taiwan Province of China," according to a report appearing in a local Chinese-language newspaper. In response, President Ma explained that Taiwan's minister of health will receive equal treatment as his Chinese counterpart at the WHA meeting, which will be held in Geneva, Switzerland on May 16-25."The invitation letter refers to our minister under the title 'Minister of Health,'" said Ma during his meeting with overseas Taiwanese representatives in the Presidential Office building yesterday morning. "China's minister attends the same meeting on equal footing with our minister," he added. Saying that such treatment is the first time in 38 years, Ma noted that it is a result of a closer cross-strait tie ever since he took office since 2008. This will be the third consecutive year since Ma assumed office that Taiwan has been invited to attend the annual world health conference as an observer under the title "Chinese Taipei." Since Taiwan is not a U.N. member, it was previously shut out of WHA until relations with China improved under Ma's "modus vivendi" approach.

MOFA to Lodge Protest with WHO  Meanwhile, the Ministry of Foreign Affairs (MOFA) yesterday said it will lodge a protest to the WHO over the apparent downgrading of the country's status. "Our government will never accept the political stance as shown in this document and we will seriously protest to the WHO over the matter," said Deputy Minister of Foreign Affairs Thomas Hou (侯平福) yesterday in a separate press conference held by the ruling Kuomintang (KMT) in the Legislative Yuan. Hou added that ever since the R.O.C was removed from the U.N. General Assembly in 1971, the U.N. has regarded Taiwan as part of China, an "inappropriate title" that the government has never accepted. But Hou noted that such controversy will not affect Taiwan's participation in the upcoming WHA meeting even though the opposition Democratic Progressive Party (DPP) has urged the government to withdraw as a protest. Another Deputy foreign Minister Shen Lyu-shun (沈呂巡) yesterday said that the ministry was drafting the official protest letter. The letter will be sent to the WHO via Taiwan's representative office in Geneva, he added. DPP Chairwoman Tsai Ing-wen, who also doubles as the party's presidential candidate, yesterday blasted the ruling administration for failing to pay attention to Taiwan's sovereignty. "This is a very serious matter which will have serious impact on Taiwan's international space in the future," she added. When asked to comment on the matter, Health Minister Chiu Wen-ta (邱文達) said he will lead the delegation to the meeting in Geneva as scheduled. He will not miss the rare opportunity to share Taiwan's expertise in the field while protecting the nation's sovereignty, Chiu added. He will protest if he is in any way mistreated or downgraded when he attends the meeting next week, he said.

Taiwan gives new impetus to World Health

05/10/2011  Taiwan Today   Taiwan, located at the nexus of Northeast and Southeast Asia, is the 18th largest economy in the world replete with vitality and a robust humanitarian spirit. Since being invited to the World Health Assembly in 2009, it has abided by the principle that disease knows no borders, enthusiastically joining efforts to safeguard world health. Taiwan does so as a responsible member of the international community, giving new impetus to programs at keeping the global village healthy. Taiwan has been steadfast in its support of international humanitarian aid and healthcare activities over the years. The central government and people have actively taken part in various worldwide medical aid and health exchanges. For example, Taiwan International Health Action has toured the globe offering emergency rescue and relief in recent years to disaster-stricken countries such as Haiti. Taiwan has also shared its experience and knowledge through Taiwan Health Center branches located in the Marshall Islands and Solomon Islands. As a member of the international community, Taiwan has accumulated a wealth of experience and enjoys advantages in the areas of national health insurance, medical technology and epidemic prevention and control. The U.N. World Health Organization chose "national health insurance" as the theme of its 2010 World Health Report, reflecting the global importance of setting up effective health insurance systems. Taiwan's national health insurance system has used relatively low premiums to cover outpatient and inpatient services since its implementation in 1995. With an insured rate of more than 95 percent, it has attained the objective of covering the entire populace and making access to medical care barrier free. It has also safeguarded the right of minority groups and the seriously ill and injured to medical treatment. As a key manufacturer of information and communication products for the world, Taiwan has a solid foundation for developing medical technology. It has developed world-class expertise in biochips, biomedical materials, biomedical informatics and medical and pharmaceutical engineering. This enables Taiwan to implement electronic medical record management and remote healthcare solutions, greatly boosting safety and treatment standards for patients while lowering costs. As the International Health Regulations of 2005 are implemented worldwide, Taiwan is now able to receive timely information on epidemics and food safety so it can help safeguard public health in the Asia-Pacific region. Taiwan is also playing its part in reporting information promptly and contributing resources and expertise to the establishment of a safety net for public health in the Asia-Pacific region and around the world. Taiwan will continue investing resources in various international world health activities, as well as participating in and promoting these initiatives. It shall also encourage local scholars, medical professionals and nongovernmental organizations to forge closer links with academic associations and groups in their respective fields. In addition, Taiwan will work to promote the U.N. Millennium Development Goals for medical cooperation to deal with prevention and control issues pertaining to transnational contagious and non-contagious diseases. This commitment demonstrates Taiwan's soft power and the new impetus it brings to programs protecting human health worldwide.

生技醫藥類研發成果聯合廠商說明會

為達成政府所推動之「臺灣生技起飛鑽石行動方案」整體目標，自民國100年起由國科會、經濟部、衛生署與原能會共同規劃推動「生技醫藥國家型科技計畫」，推動以新藥/新試劑/新治療策略/新興醫材探索研發為主之目標導向研究，期能落實研發成果進入臨床前及初期臨床試驗。生技醫藥類國家型橋接計畫配合政府強化研發能量之政策，協助推動生技醫藥國家型科技計畫研發成果產業化與商品化，除了生技醫藥類國家型科技計畫研發成果外，更擴大與國內各大學之技轉單位—臺灣大學、臺北醫學大學、成功大學、高雄醫學大學、臺北榮民總醫院、陽明大學，以及國家衛生研究院共同召開聯合廠商說明會，將上游之研發成果介紹給產業界，期望國內廠商早期參與合作或技術授權，以加速我國生技產業之提昇與發展。會議日期：2011年5月31日～6月1日（星期二、三）8:30 am – 5:00 pm 會場地點：南港軟體園區一期A棟2樓視訊會議中心（台北市南港區三重路19-10號2樓）報名方式：採用線上報名http://www.dcb.org.tw/en_msg.aspx?a=2&i=347聯絡人：李小姐 電話：(02) 2655-8633 ext. 8006報名截止時間：2011年5月23日前 本說明會歡迎國內生技醫藥產業參加，不收費用，並提供便餐及講義

 

議 程

2011年5月31日
時間	議題	主講/主持人
08:30 ~ 09:00	來賓報到
09:00 ~ 09:05	生技醫藥國家型科技計畫 總計畫主持人 致詞	臺大醫學院 楊泮池院長
09:05 ~ 09:10	生技醫藥類國家型橋接計畫 計畫主持人 致詞	生物技術開發中心 汪嘉林執行長
09:10 ~ 09:25	生技醫藥類國家型橋接計畫介紹	橋接計畫 王麗茹協同主持人
09:25 ~ 09:40	以微核醣核酸141抑制腸病毒71型的增殖與細胞病變	臺灣大學 俞松良
09:40 ~ 09:55	治療具NRG1缺陷個體之精神分裂症的負性症狀之方法	臺灣大學 符文美
09:55 ~ 10:10	鐵鉑奈米粒子在MRI/CT 雙模式分子顯影劑以及放射治療輔劑之應用	成功大學 謝達斌
10:10 ~ 10:40	Break
10:40 ~ 12:00	個案洽談
12:00 ~ 13:30	午餐時間
13:30 ~ 13:45	新穎長效型可注射式軟組織填補物	臺北醫學大學 楊正昌
13:45 ~ 14:00	高附加價值之體外檢測系統研發及其在流行性感冒病毒快速檢測之應用	成功大學 李國賓/楊松益
14:00 ~ 14:15	預防或治療慢性心衰竭之先導藥物370G	臺灣大學 蘇銘嘉
14:15 ~ 14:30	光動力殺菌組合物	臺灣大學 陳進庭
14:30 ~ 15:00	Break
15:00 ~ 17:00	個案洽談
2011年6月1日
時   間	議       題	主講/主持人
08:30 ~ 09:10	來賓報到
09:10 ~ 09:25	生技醫藥類國家型橋接計畫介紹	橋接計畫 王麗茹協同主持人
09:25 ~ 09:40	血液中循環癌細胞檢測晶片	臺灣大學 胡文聰
09:40 ~ 09:55	電腦微定位系統應用於經皮穿刺治療	臺灣大學 王兆麟
09:55 ~ 10:10	新穎性肝素親和性蛋白質藥物包覆與傳輸技術	臺北榮民總醫院 鄭宏志
10:10 ~ 10:40	Break
10:40 ~ 12:00	個案洽談
12:00 ~ 13:30	午餐時間
13:30 ~ 13:45	超音波藥物傳輸監測裝置	陽明大學 楊逢羿
13:45 ~ 14:00	小分子C型肝炎病毒抑制劑	國家衛生研究院 陳志豪
14:00 ~ 14:15	可定量各種PEG藥物的創新技術平台與商機	高雄醫學大學 鄭添祿
14:15 ~ 14:30	具抗糖尿病及新陳代謝疾病功能性天然物WYC-ADM	高雄醫學大學 張芳榮
14:30 ~ 15:00	Break
15:00 ~ 17:00	個案洽談

友華6月將展開Multikine(R) 9 國48中心臨床試驗 (Head and Neck癌症治療前用法)

Multikine®: A serum free lymphokine preparation derived from human buffy-coat mononuclear cells [buffy coat interleukins (BC-IL)], also named Leukocyte Interleukin, Inj. (LI), trade name Multikine, containing glycosylated interleukin-2 (IL-2) among other interleukins

CEL-SCI Corporation Receives Final Government Approval from Taiwan to Commence Phase III Clinical Trial of Multikine in Head and Neck Cancer

May 03, 2011 Eastern Daylight Time VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE AMEX: CVM) announced today that the Department of Health, Taiwan has issued an approval letter that allows enrollment of patients to begin in Taiwan in the Phase III clinical trial of Multikine®. The approval letter was issued by the Department of Health after manufacturing and stability data for the batches of Multikine that will be used in the trial in Taiwan were provided to them. The study in Taiwan is being run and paid for by CEL-SCI's partner, Orient Europharma. Seven clinical centers will be enrolling patients. Enrollment of patients is expected to start within the next month in Taiwan. CEL-SCI's Phase III trial of Multikine will be conducted in approximately 48 clinical centers in nine countries. CEL-SCI's other partner Teva Pharmaceutical Industries is conducting and paying for the trial at three clinical centers in Israel. The Phase III trial started in the United States in late December 2010 and in India in late April 2011. CEL-SCI's Phase III clinical trial is an open-label, randomized, controlled, multi-center study designed to determine if Multikine administered prior to current standard of care (surgery plus radiotherapy or surgery plus concurrent chemo radiotherapy) in previously untreated subjects with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity/Soft Palate (Head and Neck cancer) will result in an increased overall rate of survival, versus the subjects treated with standard of care only. CEL-SCI's 880 patient Phase III trial is expected to be the largest clinical study of head and neck cancer ever conducted. It is also the first trial in which immunotherapy will be administered before any other traditional means of care are attempted. This is significant because conventional cancer therapy weakens the immune system and likely compromises the benefits of immunotherapy. Phase II clinical trials of Multikine demonstrated that the product was safe and well-tolerated and eliminated tumors in 12% of the subjects less than a month into treatment. The Multikine treatment regimen was also shown to kill, on average, about half of the cancer cells in the subjects' tumors before the start of standard therapy. Follow-up studies of subjects enrolled in Phase II proof of concept study showed a 33% improvement in the survival rate of those treated with Multikine at a median of three and a half years following surgery. The U.S. Food and Drug Administration granted orphan drug status to Multikine in the neoadjuvant therapy of patients with squamous cell carcinoma of the head and neck.

About CEL-SCI Corporation   CEL-SCI Corporation is developing products that empower immune defenses. Its lead product, Multikine, is currently being tested in a global Phase III clinical trial that started in December 2010. In Phase II clinical trials Multikine was shown to be safe and well-tolerated and to improve the patients overall survival by 33 percent at a median of three and half years following surgery. Multikine is the Company's flagship immunotherapy developed as a first-line standard of care in treating head and neck cancer. CEL-SCI is also developing an immunotherapy (LEAPS-H1N1-DC) to treat H1N1 hospitalized patients and a vaccine (CEL-2000) for Rheumatoid Arthritis using its LEAPS technology platform. The LEAPS-H1N1-DC treatment involves non-changing regions of H1N1 Pandemic Flu, Avian Flu (H5N1), and the Spanish Flu as CEL-SCI scientists are very concerned about the creation of a new more virulent hybrid virus through the combination H1N1 and Avian Flu, or maybe Spanish Flu. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.

 

IMPAX new drug targets $800 million. restless legs syndrome market

IMPAX LABS : Impax Pharmaceuticals Provides an Update on Pipeline Candidate IPX159

05/10/2011 | Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. (NASDAQ: IPXL), announced the successful filing of an Investigational New Drug Application (IND) for IPX159 in Restless Legs Syndrome (RLS) and initiated a Phase I study. The Company will test multiple formulations of IPX159 in this Phase I study in healthy volunteer subjects. The Company plans to start a Phase IIb study in RLS patients in the fourth quarter of 2011 after selection of a preferred formulation. "We are pleased to announce progress in our neurology pipeline, with the start of the Phase I study of IPX159 and we look forward to continued development of this compound in RLS," said Suneel Gupta, Ph.D., chief scientific officer, Impax Pharmaceuticals.

About IPX159  IPX159 is an oral controlled-release formulation of a small molecule with a unique mechanism of action in RLS. IPX159 is a new molecular entity in the US. The compound has an established pharmacologic and safety profile for non-RLS use outside the US and Impax has completed a proof of concept study in RLS.

About Restless Legs Syndrome  Restless Legs Syndrome (RLS) is a condition characterized by an irresistible urge to move ones' limbs, most commonly the legs, to stop uncomfortable sensations and is associated with sleeping abnormalities, somnolence, pain and discomfort. There are about 25 million RLS sufferers in the US and an estimated current market size of $800 million.

About Impax Laboratories, Inc.  Impax Laboratories, Inc. is a technology-based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products. Impax markets its generic products through its Global Pharmaceuticals division and markets its branded products through the Impax Pharmaceuticals division. Additionally, where strategically appropriate, Impax has developed marketing partnerships to fully leverage its technology platform. Impax is headquartered in Hayward, California, and has a full range of capabilities in its Hayward, Philadelphia and Taiwan facilities. For more information, please visit the Company's Web site at: www.impaxlabs.com.

懷特C肝植物新藥於高醫進行臨床實驗

懷特C肝藥 獲衛署通過

2011年 05月11日 【台北報導】經濟部昨舉辦「生技起飛鑽石行動方案」成果發表會，其中，懷特生技與工研院研發的台灣自製的C肝植物新藥，目前已通過衛生署新藥臨床試驗申請，且在高雄醫大附設醫院進行人體臨床實驗，完成第1劑量評估，目前正進行第2階段臨床實驗。

生技創投基金將啟動 懷特肝藥是利用中草藥免疫調節的優勢，不但可以抑制C型肝炎病毒活性，未來若順利通過臨床三期，即可正式上市，並會在向美國申請FDT認證，未來商機龐大。 此外，經建會主委劉憶如昨午召開國發基金管理會議，討論「生技創業投資事業之審查及管理要點」，建立生技創投基金的投資規則，估計600億元規模的生技創投基金，最多可投資4成、約240億元協助發展生技產業。 據了解，一旦「生技創業投資事業之審查及管理要點」報院核定後，行政院就可據此遊戲規則，決定是否核定Taiwan Medtech Fund（TMF）生技創投基金個案。