Thursday, October 7, 2010

Taiwan_(台灣獨家!!) 台灣東洋與美國Nasdaq上市公司BioDelivery Sciences合作減少癌病人疼痛問題

TTY Biopharm is the leading pharmaceutical company specialized on oncology in Taiwan. With recent optimistic new about securing health authority sales approval for  oral drug TS1 for gastric cancer patients in Taiwan, this newly partnership with US company is polishing and sharpen the future development in Taiwan and China.

 

BioDelivery Sciences Announces Commercial Partnership for BEMA Fentanyl in Taiwan -BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced a license and supply agreement with TTY Biopharm Co., Ltd., for the exclusive rights to develop and commercialize BEMA Fentanyl (marketed as ONSOLIS in the U.S.) in the Republic of China, Taiwan. The agreement results in potential milestone payments to BDSI of up to $1,300,000, which includes an upfront payment of $300,000. In addition, BDSI will receive an ongoing royalty based on net sales.  “We are very pleased to have TTY as our commercialization partner for Taiwan to introduce BEMA Fentanyl into this rapidly growing market,” said Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI. “TTY has a strong market presence in Taiwan and a significant product portfolio in oncology, making BEMA Fentanyl an excellent fit for their organization.” TTY will be responsible for the regulatory filing of BEMA Fentanyl in Taiwan as well as future commercialization in that territory. BEMA Fentanyl is approved in the U.S. and Canada, under the trade name ONSOLIS, for the treatment of breakthrough pain in opioid-tolerant adult patients with cancer. BEMA Fentanyl is licensed to Meda for all territories with the exception of Taiwan and South Korea. In South Korea, BEMA Fentanyl is licensed to Kunwha Pharmaceutical Co.

 

中天_切割蛋白質抗體事業 (biz game ! When it is scarce and valuable, it polished your brand. But time changes, it sound of tarnishing the finance report !!)

 As mentioned how important IP right by China Premier, it is ironic that Chinese pharmaceutical company, GeneScience Pharmaceutical, pleaded guilty on distribution of illegal human growth hormone in US. Even this protein drug has lots off-patent follow-on(s), foreign companies still hobble launch the first in class drugs in China market. But, compromised, the appealing huge China market still lure profit –hungry investors.
5 highlight news
China_China Premier Wen Jiabao pledges to protect intellectual property 


China_維生素C市場危機又起上市公司紛紛停產保價度難關

China_金賽藥業(GeneScience Pharmaceutical)承認賣禁藥 罰款USD:7.5M !!

Taiwan_中天 切割蛋白質抗體事業

Taiwan_醫美部門爭氣 友華9月很風光
China Premier Wen Jiabao pledges to protect intellectual property
2010-10-08 (China Daily) China will take substantial measures to protect intellectual property rights and to improve the country's investment climate to attract more foreign investors, Premier Wen Jiabao said on Oct 7 after a meeting with Italian Prime Minister Silvio Berlusconi."The competition around the world is the competition of intellectual property," Wen said. "We will initiate more administrative and legal measures to protect intellectual property and broaden education in society on the need to protect intellectual property."I usually tell our entrepreneurs and researchers that protecting intellectual property is a noble type of morality. We cannot leaf through documents without permission, even if the documents are just lying on the table, let alone plagiarize them," Wen said.In regard to the investment environment in China, Wen said all foreign enterprises will enjoy the same level of treatment as their Chinese counterparts."We consider Italian companies that invest in China as our own enterprises, which means they will receive the same fair and equal treatment in bidding for specific government procurement," Wen said. Prime Minister Berlusconi expects that by 2015 the value of annual bilateral trade between China and Italy will reach $100 billion. His remarks were echoed by Wen. "However, we will still need to make a lot of effort to achieve this goal," Wen said. Italy holds special attraction for China. Compared to other countries, Italy has advantages in the areas of environmental protection, creativity and design, small- and medium-sized businesses, tourism services, as well as its own culturally creative industries, Wen said.Chinese Minister of Commerce Chen Deming said: "We have provided thousands of square meters in the Changning district of Shanghai to exhibit Italian products. People living in the Yangtze River Delta can obtain a glimpse of various Italian brands through this window. The area and the population in the delta almost equal that of Japan. The purchasing power there is also very strong, Chen said, adding that if this type of exhibition proves to be successful and beneficial to both countries, it can be duplicated elsewhere. Paolo Zegna, president of the Italian employers' federation Confindustria, said: "China is the most popular destination for Italian investors. The market there is more and more open and promising. And our engagement in China is of strategic importance, not some short-term plan. We hope to firmly establish our presence in China." He applauded the Shanghai Expo as "a great success for Italy" because so many Chinese people get to know about exquisite Italian brands.
The 10 agreements signed during Wen's visit to Rome on Oct 7 include energy and technology. In 2004, Wen visited Italy for the first time, when trade volume between the two countries was $10 billion. Wen is due to visit Turkey after he departs from Italy.

維生素C市場危機又起上市公司紛紛停產保價度難關

2010年10月08日 08:14:17  來源: 證券日報據了解,今年9月,包括東北制藥、華北制藥等五大維生素C生產廠家召開協調會,停止對外長單報價,並宣布從9月20日開始停產保價。國家發改委適時提出限令,整控維C行業。而目前國內VC市場明顯出現了變化,VC產品報價部分有上升趨勢,VC市場是否迎來轉機?維C生產上市公司又將有怎樣的表現和受到何種影響?停產保價 拯救維C市場中國維C產業早已出現了產能過剩、無序競爭等亂象,停產保價成為度過危機的希望。中國醫藥保健協會相關人士告訴記者:“維C生產企業嚴重產能過剩,存在重復建設問題。如果不及時應對,到2012年我國維C不僅導致產能過剩,還將引發出口的新一輪惡性競爭,屆時可能出現全行業虧損。”早在價格和成本雙重重壓之下,原本國際上維C兩大生產企業DSM(帝斯曼)和BASF(武田巴斯夫)不斷停產,維C生產能力逐漸集中到了中國5大企業:東北制藥、華北制藥、石藥集團、江山制藥和魯維制藥。據了解,這5大企業產量總和超過10萬噸,佔據了全球90%以上的市場份額。然而2006年初,華北制藥集團維爾康藥業就停產30天,緊接著江山制藥、石家莊制藥集團維生藥業停產、東北制藥也岌岌可危紛紛停產。近幾年,由于維C在國際原料藥市場動蕩定情況下站穩腳跟,連續保持相對平穩的價格,維持國內價格在90元/公斤、國際出口價格維持在10美元/公斤的高位。高利誘惑使得包括沈陽同聯集團、河南華星藥廠、山東天力藥業、安徽泰格生物等一批化工、生物醫藥企業紛紛興建維C項目,一時間,全國包括已建、在建和規劃的維生素產能超過7.5萬噸。遠遠超過銷量,產能嚴重過剩。迫于價格不穩定壓力,五大維C巨頭的聯盟早早成立,一度通過控產護價來度過險關,然而不幸的是低門檻的維C投資熱浪不斷襲來拍打,以致于生產聯盟措手不及。今年9月,五大維C生產廠家召開協調會,停止對外長單報價,並宣布從9月20日開始停產保價。上市公司年報將受到影響相關分析人士指出,維C為行業生產上市公司貢獻了相當一部分的凈利潤,維C價格波動必然對上市公司的業績影響非常大。根據東北制藥2009年年報,該年度公司實現銷售收入50.94億元,同比增長10.49%;實現營業利潤5.32億元,同比增長7.57%;實現利潤總額5.84億元,增長16.95%;實現屬于母公司的凈利潤4.76億元,同比增長33%。東北證券分析師宋晗分析預計,東北制藥2009年維C實現銷售收入14億元。佔總收入的四分之一。而從華北制藥年報可發現,2009年該公司實現主營業務收入48億元。其中,維生素類營業收入13.74億,營業成本5.5億元,利潤約為8.24億。維C更是為其貢獻了60%的凈利潤。由此,此次停產對于生產維C上市公司的影響可謂不容忽視。上述醫藥保健協會人士表示:“從理論上講,維C停產產量減少導致價格上去,對企業效應來說利好,如果效果不理想,價格上不去,會附帶產生成本費用,對于企業來說無疑是增加負擔。”發改委一紙限令解救危機目前,我國醫藥大宗原料藥已佔據國際市場重要地位,維C以出口為主,近年來產品嚴重供大于求,低價惡性競爭,產業規模缺乏有效調控和監管。同時,在價格惡性競爭的情況下,國際部分國家對我國產品實施反傾銷,嚴重影響產業發展。今年3月7日,全國人大代表、石藥集團董事長蔡東晨提交了5項議案。在一份題為《關于控制大宗醫藥原料藥及中間體產業規模、規范市場競爭秩序的建議》中,蔡東晨建議,有關主管部門將青霉素等部分原料藥的出口改為配額管理,以抑制日益惡化的原料藥產業低價競爭。2009年12月30日,國家發改委產業司副司長李寧寧更直接表態,上述5家企業就佔據了全球維C市場90%以上的份額,要將維C納入到需要加強引導控制的產業中。由于維C產能的極度膨脹,使中國可能重蹈過去多次出現的維C價格大大低于生產成本的局面,其後果不僅徹底葬送中國具有國際競爭力的維C行業,而且還將導致企業破產倒閉、職工下崗失業、銀行不良貸款增加等一係列經濟社會問題。發改委早已表示要將維C產業納入調控范圍,限制日益擴張的維C產能。國家發改委會同工信部等多部委出臺嚴控措施,規范維C產業的發展,首先將嚴格執行國務院頒布的投資管理政策,停止審批和建設內外資新增維C項目,對于已建、在建和已批未建的項目進行清理整頓。其次,嚴格生產許可證的審查和發放,對違規企業已頒發生產許可證的要依法撤回;對維C出口繼續實施出口許可證管理,並抓緊制定出口商品合規生產認證制度,規范經貿流通秩序;通過實行行政問責制,建立資訊發布制度等措施,引導企業加強自律,維護產業健康持續發展;對違紀違規、瀆職失職的行為進行嚴肅的行政處理。據了解,目前,由工業和資訊化部牽頭制定的《關于加快推進醫藥行業結構調整的指導意見》正廣泛徵求意見,預計不久將會發布另一份與行業結構調整相關的文件——《維C行業準入條件》。出口配額管理和停產保價是此次發改委提出的救市兩個重點。出口配額管理,是指我國商務管理部門針對部分重要產品、資源型產品的出口實行的一種管理方式。行業分析師認為,實行出口配額相關細則有待明確,現在推出出口配額管理和停產保價,雖然目的在于限制中國維C行業產能過剩,對維C價格有一定助漲,由于維C的價格已接近歷時最低點,接近企業生產成本。雖然在發改委的限令之下,維C市場有所轉暖,短期內維C的價格漸有上漲,但是要讓維C的價格長期保持在比較高水準,依舊比較艱難。
金賽藥業(GeneScience Pharmaceutical)承認賣禁藥 罰款USD:7.5M !!
(2010年10月08日)總部設在中國長春的金賽藥業(GeneScience Pharmaceutical)及公司負責人金磊,與美國法庭達成認罪協議,承認向美國非法出售人體生長激素,同意繳付750萬美元(約5,850萬港元)。當局相信,在美國檢獲的非法人體生長激素,近90%來自該公司。美國緝毒署於07年,在27個州大舉打擊用於體育的非法藥物,揭發金賽藥業多年來透過網頁及電郵,非法輸及銷售生長激素,當局在行動檢獲1,140萬劑違法藥物,拘捕逾120人。該公司出售的禁藥名為Jintropin,主要用於增生肌肉,但該藥從未獲美國食品及藥物管理局(FDA)許可,因此不能在當地出售。當局相信,美國境內近90%成非法銷售的生長激素,均來自該公司。居於上海的藥廠總經理金磊在判刑當天沒有出庭,他原本同時被控洗黑錢及走私等罪名,但後來與美國羅德島地區法院達成和解協議,只要承認較輕的售賣未經註冊藥物罪名,將被判緩刑5年。金賽藥業及金磊的450萬美元(約3,510萬港元)資產被沒收,並要捐出300萬美元(約2,340萬港元),資助旨在打擊體育界使用非法藥物的﹁反禁藥公平競爭基金」。 美國《紐約時報》報道,該公司之前亦因走私,被罰款270萬美元(約2,106萬港元)。七十年代興起人類生長激素(human Growth Hormone,H.G.H.)是一種肽類激素,可以促進發育,以及細胞增殖。自七十年代起被體育選手廣泛使用,之後被國際奧林匹克委員會及美國大學體育協會列為禁藥。

中天 切割蛋白質抗體事業
2010.10.08【經濟日報╱記者李至和/台北報導】中天生技(4128)昨(7)日召開股東臨時會,通過將蛋白質抗體庫事業體分割,獨立成為新公司「盛泉生技」。 未來中天將利用這座抗體庫,創造十項以上可授權藥廠的新藥,授權金潛在利益上看20億元。 中天今年前九月營收3.66億元,年增250.61%。昨天中天股價收54.5元、下跌0.7元。 中天與上海大潤發合作效益發酵,在8月首批保健品出貨帶動下,連兩月營收均大幅成長。 法人分析,中天擴大與大潤發合作有助推升營收,第四季應有機會出現單月營收破億元,全年每股稅後純益上看1元。 中天計劃將旗下新藥研發中心有關癌症、病毒感染的抗體新藥及其相關偵檢試劑業務,分割移轉給百分之百持有的泉盛生技,分割後泉盛生技資本額5億元。 中天董事長路孔明說,全球抗體市場主要分為自體免疫、癌症與病毒感染兩大市場,估計各市場規模達200億美元,成長速度也很快,中天未來將專注在自體免疫抗體市場,泉聖則主攻癌症與病毒感染抗體研發。 中天今年在抗體研發上已有重大進展,路孔明指出,目前以找出約50株重要的治療性抗體,正在逐一篩選中,到年底前可望篩出五株以上治療性與診斷性抗體,估計每株抗體授權金約在2億元。 中天關係企業已有合一生技、合一生機園、上海中天生技及大陸生技,隨著泉盛生技的成立,中天旗下關係企業已達到五家。 其中合一生技已進入上櫃前的預審,最快年底有機會掛牌,合一生機園也計畫明年下半年申請掛牌,上海中天也要在三年內掛牌。
醫美部門爭氣 友華9月很風光
2010-10-08【記者杜蕙蓉/台北報導】友華生技(4120)在通路擴展與季節性推廣活動刺激,醫學美容保養品、嬰幼兒及成人保健食品9月營收表現亮眼,也推波單月營業額2億3千8百萬元,年增率14.4%。友華累計前三季營收24.36億元,年增率4.94%。友華9月營收以醫學美容事業部門成長率40.79%躍居各部門之冠,原因主要是與連鎖藥妝通路康是美策略合作,配合該通路醫美活動的檔期,推出獨家且限量的醫學美容保養品,旗下娜芙(NOV)系列產品之防曬隔離霜,已成為該通路上半年醫學美容產品暢銷商品之一。

China: Sichuan University_high prevalence of oral cancer in Taiwan & China. HIF-1α/2α serve as drug targets seperately.

Clin Cancer Res. 2010 Oct 1;16(19):4732-41.

Hypoxia inducible factor 1{alpha} and hypoxia inducible factor 2{alpha} play distinct and functionally overlapping roles in oral squamous cell carcinoma.

 
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