Taiwan imports GM lab mice from mainland China

 Genetically modified lab mice from mainland China's Nanjing University are ready to contribute to biomedical research in Taiwan. (Courtesy of NARL) Publication Date：12/12/2012 Source： Taiwan Today Taiwan's National Applied Research Laboratories signed an agreement Dec. 11 with Nanjing University allowing the import of genetically modified lab mice from mainland China.The NARL noted that such mice were already available from Europe, the U.S., Australia and Japan, while their import from mainland China had been prohibited. Taiwan's global supply network for these laboratory rodents is now complete, the institute added.Genetically modified mice play a key role in biomedical research, especially in connecting laboratory experimentation with clinical applications, the NARL said, making them essential for research institutions and pharmaceutical plants.With the agreement, local researchers will be able to obtain the genetically modified lab mice they need for experimental work in translational medicine related to metabolic disorders, coronary blood vessels, obesity, diabetes, autoimmune diseases and Alzheimer's disease, the NARL said.The completion of Taiwan's linkage with the global supply network for genetically modified mice will bring more attention to Taiwan's original research and increase opportunities for collaboration, according to the NARL.Cryopreservation of mice embryos in its Rodent Model Resource Center helps safeguard research results, prevents redundant development of genetic modifications, and can save an estimated NT$35 million (US$1.2 million) annually in expenses from raising live mice, while sparing the lives of 20,000 lab mice and eliminating the need for 4,000 cages, the institute said.

 

Taiwan’s amended Patent Act set to take effect

 The new-look Patent Act is set to strengthen protections while increasing convenience for inventors and designers. (Courtesy of TIPO) Publication Date：12/13/2012 Source： Taiwan Today The amended Patent Act will come into force Jan. 1, 2013, according to the Intellectual Property Office (TIPO) under the ROC Ministry of Economic Affairs.The revised act will be more compliant with international standards, with more expansive protection for design patents and increased flexibility in application procedures, TIPO said Dec. 12.Major changes regarding application include permission to apply for a patent for an invention that has been disclosed in a publication provided the submission is made within six months of the disclosure, and the limitation of applications in foreign languages to Arabic, English, French, German, Japanese, Korean, Portuguese, Russian and Spanish.In terms of patent examination, the time limit for an applicant to request modifications to the invention description, claims or drawing was removed, while provisions for final notification and correction of mistranslations were added.Patent rights for designs have been expanded to cover icons, graphic user interfaces, generative designs and sets of related items.The amended act clearly requires intent or negligence in the infringement of a patent before damages may be claimed, while related regulations adopt the internationally accepted patent exhaustion doctrine.Compulsory licensing will apply "where the patented invention is exploited noncommercially in the public interest, in response to national emergency or other circumstances of extreme urgency," TIPO explained. New articles covering compulsory licensing when pharmaceutical products are needed to help other countries treat epidemics were also added.TIPO will no longer have the power to invalidate patents itself, and invalidation requests may be filed against one or more individual claims within a patent.The new version incorporates 159 amendments, with 108 articles revised, 36 added and 15 deleted. Eight regulations and five examination standards were also adjusted to bring them in line with the revised law.The text of the amended act and related regulations are available on its website, TIPO said.

Patent cliff to compel global pharma to turn into biotechnology

` Source: IRIS (24-DEC-12) Bio-technology drugs differ from conventional drugs in the sense that they are developed using living cells. Conventional drugs, on the other hand, are chemically synthesized. While biotech drugs are difficult to develop and manufacture, they are often more effective. This is especially true in therapeutic areas like oncology, where conventional drugs perform poorly."Despite the fact that biotech drugs have so far been overshadowed by conventional drugs, we see the patent cliff (and the absence of new conventional drugs) will compel global pharma majors to seriously turn to biotechnology," Sudarshan Padmanabhan, analyst, HDFC Securities.Meanwhile, a biotech patent pipeline worth +USD 75 billion is expiring over the next 6-7 years, comparable to that of conventional drugs. Price erosion in bio-generics will be much lower than conventional generics, as manufacturing barriers will prevent 'generic flooding' post patent expiry. Gilead's acquisition of Pharmasset for a whopping USD 11 billion in 2011 is indicative of the interest that conventional drug makers have in the biotech space, Padmanabhan said.As the US, EU and other countries grapple with ways to cut healthcare expenditure, they are likely to be more accommodative towards bio-generics. The US has recently released draft guidelines for launching bio-generics. While this does not mention any specific time-lines, it shows the intent of the USFDA to ultimately adopt and promote bio-similars, he opined.Recent trends suggest that even companies outside the pharmaceutical world are willing to commit high stakes. In 2011, Samsung entered into a JV with Quintiles (90% owned by Samsung) to form Samsung BioLogics, aiming to provide contract manufacturing for bio-similar drugs. It also paid USD 255 million for 85% stake in a JV with Biogen Idec later that year. Several M&A deals have been struck globally, in pursuit of newer opportunities. While biotechnology has an alluring appeal, there are several barriers. The cost involved in developing bio-similars ranges from USD 20-100 million (excl plant cost), while conventional generics it is USD 1-4 million. Failures abound. Merck was forced to acknowledge that a novel yeast-based protein (Glycofi) that it acquired in 2006 could not produce a bio-similar with structural similarity to the innovator product. After paying USD 400 million to buy Glycofi, Merck termed the project as a 'junk' version of erythropoietin.Disclaimer: IRIS has taken due care and caution in compilation of data for its web site. Information has been obtained by IRIS from sources which it considers reliable. However, IRIS does not guarantee the accuracy, adequacy or completeness of any information and is not responsible for any errors or omissions or for the results obtained from the use of such information. IRIS especially states that it has no financial liability whatsoever to any user on account of the use of information provided on its website.

 

生技類股上櫃審查程序與認定原則 !!!!!

生技業發展 產官描繪藍圖【經濟日報╱記者黃文奇】 2012.12.26 03:02 am

大陸商機大 產值快速成長 李欣 （康聯控股執行長）康聯控股執行長李欣指出，由於老齡化風潮席捲，大陸生技醫療市場在2020年以前可望躍居全球第2大，未來大陸製藥和家庭照護醫材市場產值，都將快速成長，3年內將達到1,262億美元（約新台幣3.66兆元）規模。李欣12月19日受邀出席勤業眾信舉辦「醫療生技產業企業化與轉型實務面面觀」研討會，並針對「中國大陸醫療生技產業發展實務經驗」進行專題分享。他指出，由於大陸生技政策回溫，專利藥物陸續到期的狀況下，大陸食品藥品監管局（SFDA）鼓勵該藥企前5名「首仿」藥物（即原廠藥物到期後首波完成學名藥查驗登記者）藥價可獲優待。但SFDA也要求大陸的學名藥（仿製藥）標準必須和專利藥「評價一致」。李欣指出，由於大陸學名藥審核日趨嚴格，將造成大陸藥企的洗牌效應，演變為大者恆大、強者恆強的局面。李欣指出，以中國大陸市場而言，因應十二五規劃，政府大力投入帶動了產業成長，除了藥品市場，家用醫療器械市場的快速增長也很可觀，尤其是當人口老齡化時，慢性病需要日常護理，以社區和家庭為主醫療模式都有利於家用醫療器械的長期發展。李欣認為，老齡化讓大陸的家用醫材市場不脫市場快速膨脹的局面；他指出2年前大陸家用醫療器械市場產值約人民幣130億元，每年的成長率約27%，未來幾年成長速度上看三成。李欣評估，不僅大型企業集團間的競爭將更加激烈，中小型藥品流通企業也會主動併入大型企業，共用品牌資源，以應對激烈的市場競爭。

台灣前景俏扶植百億大咖 洪輝嵩 （經濟部工業局民生化工組長）醫療生技產業近來在資本市場掀起掛牌熱，整體產業的前景也備受投資人矚目；經濟部工業局民生化工組長洪輝嵩表示，經濟部將於未來10年扶植至少3家營收突破300億元、至少5家達百億元的生技公司。洪輝嵩於12月19日受勤業眾信會計師事務所邀請，於「醫療生技產業企業化與轉型實務面面觀」研討會中，針對「生技類股上櫃審查程序與認定原則」進行專題演講。洪輝嵩指出，目前生技被歸類為科技類，上櫃前須由經濟部工業局民生化工組召集專案小組進行審查。在申請審查條件中，除了可享有擬科技類股「免受成立年限、獲利能力之限制」外，洪輝嵩提醒想要申請上櫃的生技企業，審查條件中「技術前瞻性、市場價值」為關鍵，且審查人都是產學界的專家中的一時之選，企業絕不可抱持輕忽心態。他指出，專家們會針對開發產品的臨床數據、市場潛力等進行各方審驗，若臨床數據低於一般標準，則可能面臨退件不審；其審查嚴謹程度，不下於國際大廠、衛生單位的查驗。洪輝嵩表示，國內當前生技產值約2,400億元，年複合成長率約6%，但經濟部則希望能扶植生技產業年成長率達到9% 。因此，經濟部將以10年為期，扶植國內生技公司至少5家營收名列百億俱樂部，其中至少3家規模在300億元以上；洪輝嵩表示，經濟部將持續引進大型創投公司，投資生技產業；並帶領廠商走上國際，協助企業開發差異化產品，讓企業可以快速成長。【2012/12/26 經濟日報】

 

台灣生技股 本夢比先出局?? 終究回歸EPS !!!

短線High過頭，生醫類股跌跤 2012-12-26 【時報-台北電】果真High過頭？生醫族群在昨日耶誕節中因櫃買中心對基亞 (3176) 、合一 (4743)祭出「預收款券」處置，每30分鐘撮合一次下，多頭氣勢崩潰，類股在大盤上漲逾百點中一枝獨綠。不過，市場認為，該族群籌碼尚未失控，主管機關的「關警閉」動作，是否會變成「創意條款」備受矚目。 多空交戰激烈的生醫類股，由於短線過熱，昨日幾乎是一片慘綠，包括基亞、合一、盛弘、合世、(又又)美、晶宇等多達6檔個股跌停鎖死，總計上市生技類股跌幅1.5％，上櫃生技類股跌幅2.6％，是今年首見的「奇慘」現象。市場主力認為，生醫類股昨日是一蹶不振，但從這些近年強勢的新藥股和近來漲勢較凶的輪動股來看，大部分都是呈現上漲有量、下跌量縮現象，表示籌碼面並未失控。而基本面方面，製藥業有旺季效應、PIC/S光環，醫材業則因生技產業發展條例由新藥放寬至二類醫材，配合立法院將修正藥事法，預期明年醫藥和醫材業都可望享受較高健保價，而兩岸醫藥合作臨床也還如火如荼進行下，題材面預計仍將持續發酵。另外，以資金面來看，由於電子業景氣堪慮，部分資金潮已逐步挪向生醫族群，激勵生醫類的成交量能已達1成以上，而產業面的逐步成氣候，也吸引企業集團願意加碼投資，加上資本市場活絡，不少生醫公司都趕搭掛牌潮下，前仆後繼的動能也讓該類股生生不息。備受市場關注的生醫類股，在遭受警示下，合一生技昨日公佈，自結11月營收162萬元，稅前虧損695萬元，單月每股虧損0.05元，累計10、11月稅前虧損2,043萬元，較去年同期虧損擴大41.93％，每股稅前虧損0.16元。（新聞來源：工商時報─記者杜蕙蓉／台北報導）