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Friday, February 4, 2011

中國製藥導入新CGMP 藥企併購加速

GMP將導致行業大洗牌

《財經網》  20110131 新版GMP剛剛獲得國務院批准,下發在即。一位元全程參與新版GMP調研、起草、修改、上報等工作的藥監局課題組專家近日在接受記者採訪說,新版與1998GMP的重大區別是:在硬體上,對無菌製劑企業的要求有很大提高,更加強調生產過程的無菌、淨化要求。因此,無菌製劑企業需要投入大筆資金在硬體上進行改造,行業將面臨大洗牌,上市公司、龍頭企業、良性發展企業則有了很好的並購和擴張機會。無菌製劑生產所需的潔淨級別,新版參考了歐美CGMP(歐美等國家的動態藥品生產管理規範)的ABCD級別。我國的無菌製劑以前只是強調靜態,現在則"靜態""動態"都要達到要求的標準。因為無菌製劑的廠房和設備需要投入大筆資金進行改造,藥監局為了緩解對制藥企業的衝擊,除了新建車間須按照新版GMP建設,原有廠房將給予緩衝期。根據SFDA(食品藥品監督管理局)內部測算,國內1/3企業重建車間,購買國產高端設備需要投入300-500億元,低於上版GMP技改花費1500億元;但假設國內1/3企業在北京亦莊購置土地並重建車間,購買進口高端設備則需要2500億元。上述專家認為,一些原來基礎差的藥企,需要改造的費用就高一些,運營成本也高一些。但制藥企業無論大小,如果品種是贏利的話,是能支撐這個費用的。"很多效益好的企業都提前做,已經按新版建完了。北京賽生藥業剛建完的4條無菌線,花了2千多萬;先聲藥業08年新建一個凍幹車間,就是按可能的要出臺的新標準建的,當時花了6千多萬;廣東麗珠新建凍幹廠花了兩個億。新建比改造要省成本,"上述專家說。康緣藥業(600557.SH)品質管制部徐主任告訴記者,康緣凍乾粉車間是新建的不用改造。小容量無菌製劑是老車間,需要進行一些改造,初步估計是投入五六百萬的樣子,主要是空調等系統進行調整。徐主任參與了醫藥品質管制協會組織的企業徵求意見,"每個企業的投入不一樣,如果是老廠房,改造會大。當時有的企業說需要把廠房全部拆掉重建,需要投入幾千萬到幾個億,不過連雲港這幾家企業包括恒瑞在內,因為廠房大多是新建的,當時都說改造費用不大,基本能達到新版GMP的要求。"揚子江藥業一位副總告訴記者,揚子江570畝廠房是20062007年參照歐盟的標準新建的,當時花了幾千萬。新GMP出臺後改造花費大約需要花兩三千萬,一個注射劑車間需要投入500萬以上。從整體來看,GMP技改對上市公司衝擊不大,大多可通過自籌資金或增發來解決,尤其是一些近一兩年按歐盟或美國FDA的生產線建的,設備車間基本不需再做變動。通化東寶藥業股份有限公司(600867.SH)20104月份剛建好新廠房,是按歐盟標準建的;新版GMP徵求意見稿出來後,華潤三九(000999.SZ)建新基地也是按新標準建的;吉林敖東(000623.SZ)董事長李秀林說,他們準備得比較早,所以都是在計畫範圍內的;武漢健民藥業集團股份有限公司(600976.SH)在2010年就根據新GMP標準改造硬體設施,完善軟體,提高工藝標準,做人員培訓等工作。對於諾華等外資企業來說,新版GMP對其影響也小,因為他們建廠時就是按歐美標準建的,母公司設計時就是按CGMP設計的。外企建得較早的廠房,只要改造下硬體也就行了,投入也不大。新版GMP主要衝擊的是地方型中小企業,也為上市公司、龍頭企業提供了並購和擴張機會。新GMP對無菌製劑要求最嚴格,該領域的龍頭企業和良性發展企業受惠將最大,中藥注射劑的神威藥業(02877.HK)及大輸液的科倫藥業(002422.SZ),兩家公司均有擴張計畫,在新版GMP的刺激下,公司的市場份額還將提升。良性發展的、擁有好的贏利產品的中小企業也不容忽視。一些效益不好、目前還不想改造的企業,也找到了竅門:提前進行認證(藥企每5年認證一次),給自己留出應對時間,這樣改造的時間就可以拖後幾年。"未來有多少企業活下來,有多少被兼併,有多少退出不做認證,這些現在還不好統計。但有一點是肯定的,新GMP將促進由多小散低,走向大兼併大重組,"上述專家說。

台灣原料藥龍頭? 台耀經營策略不同於台灣神隆

兔年開春 生技業湧掛牌潮!台耀化學搶頭彩

鉅亨網2011-02-02兔年開春生技醫療業將湧現IPO掛牌熱潮!31日將原料藥的台耀化學(4746-TW)搶頭彩,率先掛牌上市,緊接著為3月中旬前上櫃專攻藥品及材料通路商的盛弘醫藥(8403-TW)321日上櫃植物新藥廠德英生技(4911-TW)、最後中天(4128-TW)轉投資的新藥研發廠合一生技(4743-TW),也預計3月底、4月初上櫃。其中原料藥廠的台耀先前興櫃股價一度衝破百元,近期維持高檔整理,上市蜜月期將挑戰上市櫃原料藥廠的股王地位。原料藥廠的台耀化學,目前主要產品包括防曬系列活性成分、維他命D衍生物及消炎止痛劑等,目前實收資本額6.09億元,去年該公司前三季營收18.44億元,稅後盈餘1.97億元,營收及獲利同步較前年同期成長46%,以當時加權流通在外股本估算,每股稅後盈餘3.24。此次籌資規模暫訂為4.9億元,取得資金主要將用於償還銀行借款。敏盛醫院子公司盛弘醫藥,主要業務包括藥材供應、委任經營健康管理及設備租賃,大股東為敏盛醫院,持股比例超過五成,公司目前實收資本額為3.81億元,上櫃預計增發4082張,發行後資本額將增至近4.22億元,籌資規模暫訂1.71億元。盛弘去年前三季營收9.47億元,年增39.5%,稅後盈餘8032萬元,年增率超過5成,以當時加權流通在外股本估算,每股稅後盈餘2.13。植物新藥廠德英目前實收資本額4.85億元,公司投入用於癌症治療輔助的SR-T100凝膠以完成國內二期臨床實驗,將再國內進行三期臨床並以國內二期數據向FDA申請二期臨床試驗。另外用於肝臟疾病治療的Hepanamin預計將於今年取得外銷專用許可證。德英2010年前31826萬元,稅後淨損394萬元,每股稅後淨損0.08

Weikang Bio-Technology(黑龍江維康科技) is preparing media campaign by $5.0 Million

Weikang Bio-Technology Announces Completion of $5.0 Million Private Placement

Weikang Bio-Technology Group Co., Inc. (OTC Bulletin Board: WKBT) ("Weikang" or the "Company"), a leading developer, manufacturer and marketer of Traditional Chinese Medicine (TCM), Western prescription and OTC pharmaceuticals and other health and nutritional products in the People's Republic of China, today announced the completion of its private placement offering for aggregate gross proceeds of $5.0 million (the "WKBT Offering").  A total of 520,831 units were sold in the WKBT Offering, with each unit comprised of (i) four shares of common stock, (ii) a three-year warrant to purchase one share of common stock at an exercise price of $3.60 per share (the "Series C Warrant"), and (iii) a three-year warrant to purchase one share of common stock at an exercise price of $4.80 per share (the "Series D Warrant"). In connection with the Offering, the Company issued a total of 2,083,324 shares of common stock, Series C Warrants to purchase up to 520,831 shares of common stock and Series D Warrants to purchase up to 520,831 shares of common stock.  Hunter Wise Securities, LLC acted as the Company's lead placement agent in connection with the Offering. "We are pleased to announce the successful completion of our private placement financing," said Mr. Yin Wang, Chairman and CEO of WKBT. "Weikang continues to advance as a U.S. publicly-traded company and now has a much more diversified shareholder base," said Chairman Wang. "The Offering will finance a media campaign utilizing print, radio and television to create further awareness of Weikang products in our markets." The Offering proceeds from today's completion of the $5.0 million placement and the Company's first financing for $2.5 million in January 2010 will meet WKBT's external investment requirement under the November 2007 FIE business license granted by the Heilongjiang Office of the State Administration for Industry and Commerce ("SAIC") which in March 2010 was extended until November 2027. WKBT's wholly-owned subsidiary Sinary Bio-Technology Holdings Group, Inc. is the 100% owner of Heilongjiang Weikang's registered capital. The securities offered in the private placement Offering have not been registered under the Securities Act of 1933, as amended, or any state securities laws, and unless so registered, the securities may not be offered or sold in the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act of 1933, as amended, and applicable state securities laws. The Company has agreed to file a registration statement covering the resale of the shares of common stock and shares of common stock issuable upon exercise of the Series C Warrants and the Series D Warrants issued in the private placement Offering.

About Weikang Bio-Technology Group Co., Inc.

Weikang Bio-Technology Group Co., Inc. is principally engaged in developing, manufacturing and distributing Traditional Chinese Medicine (TCM), and health and nutritional supplements in China, in compliance with requisite Chinese licenses and approvals. The Company is also expanding its business scope to develop, manufacture and distribute Chinese herbal extract products and GMP certified western prescription and OTC pharmaceuticals through its acquisition of Tianfang Pharmaceutical Co., Ltd.

Weikang Bio-Technology Group   

http://www.weikangbio.com;

http://www.hljweikang.com

台灣跨領域合作完成標靶診斷結合藥物控制釋放系統

研發治癌系統原型 成大醫材研發 成績亮眼

 2011/01/31 【台南訊】國立成功大學在醫療器材技術研發繳出漂亮成績 單,由電機系特聘教授楊明興領軍的前瞻治癌系統研發團隊 ,匯集了多項領域專業學者專家,成功研發大型前瞻治癌系 統第一代原型,包含頻率可調的「數位高周波儀與「三維磁控導管內視鏡系統,技術領先國際 成大校長賴明詔院士指出,此次該校發揮了團隊力量,由電 機系楊明興教授出面主導,邀集全校12位頂尖教授一起來參 與,利用教育部五年五百億的經費投入此次計劃的研發,並 順利研發出利用電磁波來做為癌症的診斷與治療的醫療器材 原型產品,成績相當亮麗。 成大電機系楊明興特聘教授表示,「三維可控的電磁熱生物醫學技術平台-腫瘤的影像、標靶、藥物釋放與熱灼治療術 計畫,創全國多項第一的紀錄,包含有:一、國內學術界首次高度跨領域整合,研發大型前瞻醫用治癌系統。前瞻治癌 系統研發團隊成員涵蓋成大電資學院、工學院、設計規劃學 院、生科學院及醫學院的相關頂尖教授,其中包括兩個工程系統整合設計子團隊、一個標靶奈米磁粒子設計子團隊,以 及兩個臨床應用醫師子團隊。 二、一開始即有資深醫師團隊,從臨床上最大量且最迫切需要新技術的應用層面,同步深入參與研發,也就是男性的泌尿系統腫瘤與女性的乳癌。 三、一開始就有企業集團同步大力投入,協助研發。 四、兩年內就能完成中小型動物實驗用的系統,可提供給參與的企業商品化,這比需要七至十年才能完成的人體臨床實用系統的商機還大。五、目前完成的頻率可調數位高周波儀與三維磁控導管內視鏡系統,在國際上屬於領先技術。六、卓越成果 獲得國際上乳房MRI的領導廠商AURORAPET的發明者美國 BROOKHAVEN國家實驗室的高度肯定,積極力邀參與乳房MRI PET系統整合研究及新一代PET的研發設計。

Sinovac’s (北京科興) bacterial vaccine platform creates pneumococcal, HIB and meningitis vaccines

Sinovac's (北京科興) bacterial vaccine platform creates pneumococcal, HIB and meningitis vaccines

Sinovac Biotech seeks SFDA approval to begin human trial for its proprietary Pneumococcal Polysaccharides Vaccines

Beijing  Wednesday, February 02, 2011, Sinovac Biotech Ltd. a leading provider of biopharmaceutical products in China, announced the submission of the applications to commence human clinical trials for its 23-valent and 24-valent Pneumococcal Polysaccharides Vaccines to the Chinese State Food Drug Administration (SFDA) on January 31, 2011. The preclinical studies were completed and showed good safety and efficacy profile in animal models. Sinovac independently developed the Pneumococcal Polysaccharides Vaccines (PPV) and will retain full commercialization rights to the vaccine upon approval. The supplied quantity of PPV was doubled in China over the past three years demonstrating the consistent increasing market demand. And the gap between demand and supply in Chinese market still exists. PPV remains relatively expensive in China due to the limited available products. The target population of PPV is children over 2 years old and adults in all age groups, especially the elderly over 65 years old. The current available 23-valent PPV have shown good protection effects after launching into the market. But due to the different epidemic characteristics of pneumococcal diseases in China, we also developed the 24-valent PPV to cover one more serotype of pneumococcus, which is one of the top three most prevalent pneumococcus bacteria in China, and therefore has the potential to provide more extensive vaccine protection to the Chinese population. Dr Weidong Yin, chairman & CEO, commented, "PPV is the first bacterial vaccine for which the Company has submitted the clinical trial application to the SFDA, representing our expansion of our R&D capabilities to include both bacterial and virus vaccines. The establishment of our bacterial vaccine development platform will accelerate the R&D for the pneumococcal conjugate vaccine and other types of bacterial vaccines in our pipeline, such as the HIB and meningitis vaccines. We consistently advance our R&D strategy to provide a greater number of high quality vaccine products aimed at preventing diseases in children and adults around the world." Pneumococcal diseases are a major public health problem all over the world. The etiological agent, Streptococcus pneumoniae (the pneumococcus) is surrounded by a polysaccharide capsule. Differences in the composition of this capsule permit serological differentiation between about 90 capsular types, some of which are frequently associated with pneumococcal disease, others rarely. Invasive pneumococcal infections include pneumonia, meningitis and febrile bacteraemia; among the common non-invasive manifestations are otitis media, sinusitis and bronchitis. At least 1 million children die of pneumococcal disease every year, most of these being young children in developing countries. In the developed world, elderly persons carry the major disease burden. Conditions associated with increased risk of serious pneumococcal disease include HIV infection, sickle-cell anaemia and a variety of chronic organ failures. Vaccination is the only available tool to prevent pneumococcal disease. The recent development of widespread microbial resistance to essential antibiotics underlines the urgent need for more efficient pneumococcal vaccines. Pneumococcal Polysaccharide Vaccine (PPV), is a vaccine used to prevent Streptococcus pneumoniae (pneumococcus) infections such as pneumonia and septicaemia. In the United States, PPV is recommended for adults 65 years of age or older, adults with serious long-term health problems, smokers, and children older than 2 years with serious long-term health problems. The World Health Organization recommendations are similar. The safety of the current polysaccharide vaccines in older children and non-pregnant adults is well documented. Sinovac's 23-valent PPV contains 23 different purified capsular polysaccharides prepared from the most prevalent and invasive strains of Streptococcus Pneumoniae, including serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F and 33F. 24-valent PPV contains 24 different purified capsular polysaccharides prepared from the most prevalent and invasive strains of Streptococcus Pneumoniae, including serotypes 1, 2, 3, 4, 5, 6A , 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F and 33F. Sinovac Biotech Ltd. is a China-based biopharmaceutical company that focuses on the research, development, manufacture and commercialization of vaccines that protect against human infectious diseases including hepatitis A, seasonal influenza, H5N1 (bird flu) pandemic influenza and H1N1 influenza and is developing a number of new vaccine products, including vaccines for pneumococcal conjugate, enterovirus 71 (EV71) (against Hand, Foot & Mouth Disease), Japanese Encephalitis, animal and human rabies, HIB and epidemic meningitis, chickenpox, mumps and rubella.

 

北京科興生物製品有限公司(SINOVAC BIOTECH CO.,LTD.)是由科興控股(香港)有限公司(Sinovac Biotech (Hong Kong) Ltd.)、北京北大未名生物工程集團有限責任公司合資組建的生物高科技企業。公司于2001年在北京中關村國家自主創新示範區註冊成立,註冊資本1.336億元人民幣。目前北京科興通過其控股公司在納斯達克全球市場上市(NASDAQSVA),是唯一一家在北美上市的中國疫苗企業。作為一家專業從事人用疫苗的研究、開發、生産和銷售的企業,並正在開創"讓世界兒童用上中國生産的疫苗"的新紀元。北京科興自成立之初就推出了我國第1支甲型肝炎滅活疫苗,填補了國內空白,緊接著全球第1SARS病毒滅活疫苗,中國第1支、全球第2支甲型乙型肝炎聯合疫苗,中國第1支與全球同步的大流行流感疫苗(人用禽流感疫苗),唯一不含防腐劑的國産流感病毒裂解疫苗以及全球第1支甲型H1N1流感疫苗相繼問世,且都擁有自主知識産權,為我國防治重大突發傳染病貢獻了巨大力量,其驕人成就世界矚目。在北京科興成立的短短數年間,胡錦濤、溫家寶、賈慶林、李克強、王岐山、回良玉、劉淇、吳儀、陳至立、郭金龍及國家相關委辦局領導都曾先後親臨視察,詳細了解北京科興的疫苗研發、生産、質量控制情況,傾聽疫苗研發進展。2009年北京科興被列入首批中關村國家自主創新示範區創新型企業,"科興"也被評為中關村十大品牌之一。北京科興憑藉持續的盈利能力和高速增長已經連續兩年入選德勤高科技、高成長中國50強(200844位,200937位),亞太區500強(2008189位,2009104位)和《福布斯》中國最具潛力中小企業榜200強(200952位,201023位,201124位),併入選2009中國最具競爭力境外上市公司10強。

中國醫療儀器與設備市場將達537億美元

中國醫療器械行業迎來黃金期 2015年產值將翻番

20110123: 中國經營報   據市場研究公司Frost & Sullivan預測,2015年,中國整個醫療儀器與設備市場預計將翻一番左右,達到537億美元。2009年至2011年,預計政府在醫療改革中共投入1240億美元,尤其是2011年作為"十二五"規劃的開局之年,將實現基本醫療保障制度的全面覆蓋,從而成為 中國醫療改革史上具有里程碑的一年。有資料表明,2011年,中國醫療健康行業規模將位居全球第三。而從全球第一的醫療行業展覽平臺MEDICAComPaMED展覽會2010年的資料來看,世界醫療行業也保持了平穩的發展。去年MEDICAComPaMED展覽會的規模都保持了增長,特別是中國展商的展覽規模逐年增長。這也反應了中國醫療行業近年來取得的發展和進步。作為中國醫療設備行業的一大盛會——2011年國際醫療儀器設備展覽會(CHINA MED2011),將於325日至27日在北京國家會議中心舉辦。CHINA MED2011由中國人民解放軍總後勤部衛生部、中國國際貿易中心股份有限公司、惠通興業國際展覽(北京)有限公司和杜塞爾多夫展覽(上海)有限公司共同主辦,幫助企業和醫院在中國醫療器械領域迎來黃金期的大環境下,抓住市場良機。

打造高端平臺,致力全球推廣CHINA MED首創於1989年,每年舉行一屆,規模逐年擴大,參展廠商不斷增加。CHINA MED既是展示世界醫療行業的視窗,也是國際醫療機構登陸中國的首站。CHINA MED作為國內首個通過國際展覽業協會(UFI)認證的國際醫療儀器設備展覽會,始終秉承國際化、專業化的宗旨,致力打造醫療儀器設備行業高端展示的商業平臺。為了幫助企業更好地把握新的市場機遇,主辦方大力推廣CHINA MED 2011。展會預計展覽面積30000平方米,展商約550家,觀眾約26000, 其中包括來自軍隊和各地方醫院的院長和設備科主任,且觀眾中不乏採購額在500萬以上的經銷商和代理商。在國內積極招商的同時,主辦方還充分利用展會的國際支援單位MEDICA及全球各大醫療資訊平臺的資源,在國際上推廣展會。據瞭解,目前特裝展區已經基本售罄,標準展位區的供應也頗為緊張。除此之外,主辦方官方網站也在為展商和觀眾提供24小時不間斷的線上服務,並不斷優化整體服務。從201041日起至1222日,網站的總訪問流量達到153947次,遠高於去年同期的119988次,同比增長28.30%。主辦方還設立了4006-234-578客服熱線,專門為觀眾和展商提供諮詢服務。這些服務獲得了展商和觀眾的肯定,絕大多客戶表示滿意。

彙聚新產品,鎖定熱門課題CHINA MED 2011的另一大看點,就是醫療行業各大知名企業將攜最新產品參展。到目前為止,東芝確定將展示最新適用於心血管疾病診斷的640切電腦斷層"Aquilion ONE",掃描速度更快,輻射劑量及顯影劑使用量更小,影像更清晰。美中互利將帶來美國Intuitive Surgical 公司由美國航太航空局等聯合開發的"達芬奇手術機器人"系統,作為目前世界上最為尖端的第三代手術機器人,它擁有世界上最靈巧的手腕,甚至可以完成常人難以完成的精准動作,比如能在狹小的空間內完成腔鏡外科醫生不可能完成的任務。作為全球最專業的放療設備生產商之一的瑞典醫科達公司,將突出展示其具有良好升級空間的數位直線加速器Compact,功能強大的Mosaiq腫瘤資訊管理系統,容積旋轉調強弧形治療技術(Vmat),腫瘤影像和治療的集成化解決方案Intuity,以及新一代腫瘤運動管理解決方案Symmetry等軟體。展會同期還將舉辦醫學影像、醫療衛生、臨床技術及招標採購等四大類20 多個現場活動。這其中"院長高峰論壇"是首次舉行,論壇將邀請醫院專家、國家財政部政府採購處領導對醫院經濟效益管理各方面相關問題展開討論,並現場觀摩醫院招標採購活動。為配合中國醫藥衛生事業"戰略前移,重心下移"的總指導思想和方針,CHINA MED2011與中國生物醫學工程學會將共同主辦"個人、家庭及社區健康資訊網路系統研討會",並專門邀請航空醫學研究所、解放軍總醫院、第四軍醫大學以及上海、瀋陽、無錫等地遠端資訊中心專家與行業人士進行探討與交流。

Sinopharm (國藥) invests $200 million on vaccines for the Vietnamese market

Sinopharm's M&A Extends Drug Distribution Network

Jan 29, 2011  |  author/source: Richard Daverman, PhD   Sinopharm Group (HK: 1099) will pay $198 million for a 60% stake of two units belonging to Le Ren Tang, a drug distributor and retailer with a 30% share in the Hebei market (see story). Le Ren Tang will transfer its distribution business and its stakes in four affiliate companies to Le Ren Tang Medicine Logistic, which will now be known as Sinopharm Group Le Ren Tang. Sichuan Kelun Pharmaceutical (SZ: 002422) will acquire 80% ownership of Guilin Dahua Pharmaceutical Co. Ltd. for $21.9 million (see story). Dahua produces bulk drugs and intermediates. Golden Meditech Holdings (HK: 801) raised $34.7 million by listing 90 million Depositary Receipts (TSE: 910801) on the Taiwan Stock Exchange (see story). Each unit consists of two shares of Golden Meditech's Hong Kong-listed stock. Golden Meditech, has its operations in mainland China. Bohai Pharmaceuticals Group (OTCBB: BOPH) brought in $1.87 million by placing 748,382 unregistered shares of common stock at $2.50 per share, a 23% premium to the previous closing price (see story). Apparently, no M&A activity is planned, as the company said it would use the funds for internal R&D.

Expanding Manufacturing  China National Pharmaceutical Group Corporation (Sinopharm), a state-owned company that is China's largest producer of pharmaceuticals, will invest $200 million to build a manufacturing facility in Vietnam's Hoa Lac Hi-Tech Zone, located about 30 km west of Hanoi (see story). The new plant will produce vaccines for the Vietnamese market. Tianyin Pharmaceutical (NYSE Amex: TPI) completed construction of its Jiangchuan macrolide facility in the Xinjin Industrial Development Area, near Chengdu, China (see story). The company says it expects the plant to add revenues during its 2011 fiscal year. In its Phase I state, the facility is capable of producing up to 240 tons of azithromycin API for domestic and international markets.

Market Forecast  Business Monitor International has increased its short-term forecast for the China pharma market, which includes both pharmaceuticals and TCM products, while it lowered its expectations for the longer term (see story). The business intelligence firm upped its compound annual growth rate for 2009-14 to 16.4%, a jump from 13.8%. But the company lowered its forecast for the size of the 2019 pharmaceutical market in China from $175 billion to $162 billion.

Trials and Approvals  Boston Scientific (NYSE: BSX) has started a China trial of its Promus™ drug eluting stent (see story). The double-blind test will enroll 500 patients in 15 sites across China. The goal of the trial, which is the first that Boston Scientific has conducted entirely within China, is to gain SFDA approval of the device. 3SBio Inc. (NSDQ: SSRX) was granted SFDA manufacturing approval of an extension of the TPIAO label to include treatment of idiopathic thrombocytopenic purpura (see story). The approval was a long time in the making, as 3SBio originally submitted its application in December 2008. Launched in 2006, TPIAO is a recombinant human thrombopoietin product that was originally approved to treat chemotherapy-induced thrombocytopenia, or platelet deficiency.

Distribution Agreements  First China Pharmaceutical Group (OTCBB: FCPG) will be the exclusive distributor for Esmolol Hydrochloride, a short and rapid-acting beta class II anti-arrhythmic used for temporary control of heart rate and blood pressure (see story). The manufacturer of the drug is Medisan Pharmaceutical Co. Ltd. First China projects initial sales of up to $1 million in its Yunnan Province base, which will grow as the company expands distribution through all of China.