浩鼎(Optimer) 乳癌疫苗新藥 5億元增資(US 17.8 million)為臨床試驗

浩鼎生技 將在台上市

【2011/02/10 經濟日報】 台灣浩鼎生技董事長張念慈昨（9）日表示，為了發展乳癌新藥，已完成5億元增資，目標今年底完成二期臨床試驗，台灣浩鼎也將在台申請上市。2002年成立的台灣浩鼎生技，原本是美商Optimer製藥在台子公司，透過5億元增資，除了Optimer持股比重降到五成外，其餘參與增資的公司，還包括富邦、潤泰、永豐餘等大型集團，還有玉山金控及全球策略創投。張念慈表示，去年12月中旬起，台灣浩鼎研發的乳癌新藥OPT-822，在台灣展開第二／三期臨床試驗，預計投資4億元收取350名病患。若是今年底之前二期臨床有不錯的成果，公司不排除在台灣申請掛牌。張念慈說明，乳癌新藥OPT-822的技術來源，是中研院的研究成果，透過相同的技術來源，台灣浩鼎未來也將推出第二代乳癌新藥及醣晶片。張念慈強調，近年來新藥在國際市場授權趨勢已有改變，早期台灣不少新藥只要完成二期臨床試驗，就可與國際大藥廠談判授權。張念慈呼籲，近兩年國際大藥廠只青睬做完三期臨床試驗的新藥，以台灣現有資本市場熱中生技產業的情況來看，台灣的投資人應有足夠的資金實力，支持各生技公司將其新藥完成三期臨床試驗，如此才能創造更高的市場價值。

 

2011台灣生技熱

生技股抗跌 買進賺短線

2011-02-10 工商時報 台股連續兩日下挫，昨（9）日更是跌104點，回測9,000點整數關卡。觀察各類股表現，生技族群由於股價修正時間長，昨日走勢相對抗跌，東洋（4105）、太醫（4126）等漲幅都逾2％，太醫更是攻上漲停。法人認為，生技股走勢沉寂已久，看好短線可成為抗跌族群，酌量佈局認購權證可提升獲利。 東洋以7,000萬元獲台灣動科所基因轉殖豬生產「人類第九凝血因子」技術平台。該公司表示，將藉此投入研發治療血友病的蛋白質新藥，並同步在兩岸進行人體試驗，最快2015年可望上市。 林榮錦表示，利用「人類第九凝血因子」做成藥品，台灣市場規模約2億元，大陸200億元，全球約1,200億元，但目前各藥廠的技術是透過生物反應劑來培養，此技術台灣已落後，但以基因轉殖豬的乳汁來反應台灣是首創，因此，很有機會成為國際頂端。 近期東洋在回測季線守穩後，股價重拾漲勢，昨日大漲2.47％。短線看好東洋可留意國泰VK（700970），目前價外5.57％，有效槓桿8.1倍，且成交量大，無流動性風險。 太醫受惠國際大廠轉單和大陸營運成長，去年EPS達6.73元的歷史新高。展望今年，太醫今年外銷可維持成長動能，預期大陸市場維持4~5成的高成長幅度，日本、歐洲、美國代工訂單穩定成長。法人認為，太醫今年營收可望成長2成，全年EPS約7.5元。近2日三大法人也聯手買超太醫900張，推升太醫昨日股價攻上漲停價112.5元，可挑選連結太醫的寶來P5（700975），實質槓桿近2倍，成交量也較大。

台股吹寒風 生技股暖呼呼 〔記者陳永吉／台北報導〕台股加權指數跌逾百點，生技股成為最佳避風港，不論上市、上櫃生技指數，全部以紅盤作收，搭配冬季旺季效應，生技股元月營收表現不弱，法人表示，若大盤持續表現不佳，生技股短線有機會再走高。目前已公告的生技醫藥股元月營收，已有精華（1565）創下歷史新高，太醫（4126）、曜亞（4138）則寫下歷史次高，永信（1716）則為有史以來元月最高紀錄，另外旭富（4119）、聯合骨科（4129）、泰博（4736）也較去年同期成長，僅五鼎（1733）出現明顯衰退。精華1月營收2.85億元，較去年同期成長29.35%，也較前一個月2.84億元微增，為連續第11個月寫下營收新高紀錄，精華去年兩次擴產，3月以後營收逐月走高，而今年3月公司新產能擴產也將到位，屆時單月營收將突破3億元大關，啟動新一波成長動能。太醫元月營收為1.18億元，較去年同期成長15.8%，僅較去年12月的歷史新高小幅減少，不過因為太醫以外銷為主，台幣升值將影響其毛利率，使得太醫股價過去兩個月跌跌不休，昨天雖然台幣一度升破29元大關，但太醫逆勢漲停，股價出現跌深強彈。曜亞元月營收為9,384萬元，較去年同期成長16%，也較去年12月增加19%，僅低於去年9月創下的營收新高紀錄，由於公司目前正積極進軍中國市場，法人預估公司今年業績有機會穩定成長。至於血壓計廠商泰博元月營收維持1.6億元以上高檔，較去年同期增加18%，法人指出，泰博經過去年一年品牌及代工策略的調整陣痛期，目前營運逐步上軌道，估計本季非合併營收可望有4.7-4.9億元水準，季減5%以內，表現淡季不淡。

台灣佳醫投資中國博愛眼科連鎖受阻!

佳醫董事會通過暫緩投資北京太平洋博愛醫療管理顧問案(補公告)

2011/02/10 證交所重大訊息公告(4104)佳醫-補充公告：董事會通過-暫緩透過轉投資第三地區現有公司再投資大陸公司。(代重要子公司Excelsior Healthcare Co.,Ltd.一併公告) 1.事實發生日:2011/02/09  2.本次新增（減少）投資方式:本公司原透過子公司Excelsior Healthcare Co.,Ltd.轉投資北京太平洋博愛醫療管理顧問有限公司(以下簡稱北京太平洋)以間接取得大陸地區博愛眼科連鎖機構，因江西炙療康復醫院業務發展尚待評估，予以暫緩。  3.交易數量、每單位價格及交易總金額:投資金額：人民幣28,000仟元(依10/20匯率4.6505計約新台幣130,214仟元)。  4.本次新增投資大陸被投資公司之公司名稱:北京太平洋博愛醫療管理顧問有限公司。  5.前開大陸被投資公司之實收資本額:人民幣17,373,260.74元。  6.前開大陸被投資公司本次擬新增資本額:不適用。  7.前開大陸被投資公司主要營業項目:醫療管理的諮詢服務。  8.前開大陸被投資公司最近年度財務報表會計師意見型態:保留意見(轉投資公司未按權益法核算)。 9.前開大陸被投資公司最近年度財務報表淨值:人民幣16,861,254.28元。 10.前開大陸被投資公司最近年度財務報表損益金額:人民幣-137,390.63元。 11.迄目前為止，對前開大陸被投資公司之實際投資金額:美金242萬元。 12.迄目前為止，投審會核准赴大陸地區投資總額（含本次投資）:美金25,670,000元(依02月08日匯率29.16計約新台幣748,537仟元)。 13.迄目前為止，投審會核准赴大陸地區投資總額（含本次投資）占最近期財務報表實收資本額之比率:78.60% 14.迄目前為止，投審會核准赴大陸地區投資總額（含本次投資）占最近期財務報表總資產之比率:14.46% 15.迄目前為止，投審會核准赴大陸地區投資總額（含本次投資）占最近期財務報表股東權益之比率:16.91%  16.迄目前為止，實際赴大陸地區投資總額:美金2,620,000元(依02月08日匯率29.16計約新台幣76,399仟元)。 17.迄目前為止，實際赴大陸地區投資總額占最近期財務報表實收資本額之比率:8.02%  18.迄目前為止，實際赴大陸地區投資總額占最近期財務報表總資產之比率:1.48%  19.迄目前為止，實際赴大陸地區投資總額占最近期財務報表股東權益之比率:1.73%  20.最近三年度認列投資大陸損益金額:98年：新台幣-4,838仟元；97年：新台幣-290仟元；96年：新台幣-195仟元。21.最近三年度獲利匯回金額:0元。22.交易相對人及其與公司之關係:不適用。23.交易相對人為實質關係人者，並應公告選定關係人為交易對象之原因及前次移轉之所有人（含與公司及相對人間相互之關係）、移轉日期及金額:不適用。24.交易標的最近五年內所有權人曾為公司之實質關係人者，尚應公告關係人之取得及處分日期、價格及交易當時與公司之關係:不適用。25.處分利益（或損失）:不適用。26.交付或付款條件（含付款期間及金額）、契約限制條款及其他重要約定事項:不適用。27.本次交易之決定方式、價格決定之參考依據及決策單位:不適用。28.經紀人:不適用。29.取得或處分之具體目的:不適用。30.本次交易董事有異議:否31.本次交易會計師出具非合理性意見:否32.其他敘明事項:本投資案原於第九屆第六次董事會(99.10.20)通過並授權董事長處理相關事宜，因江西炙療康復醫院業務發展尚待評估，故予以暫緩。

ShangPharma (尚華醫藥), an ambitious CRO follows WuXi Pharma Tech biz model

ShangPharma opens Fengxian facility

18-Jan-2011 ShangPharma has opened a multi-purpose pharmaceutical development cGMP manufacturing facility in Fengxian, China, and started operations on the initial phase of production. The pharma and biopharma research and development (R&D) outsourcing company, said its state-of-the-art facility will be named China Gateway Pharmaceutical Development Company and will operate as a wholly owned subsidiary of the firm. The expansion will enable ShangPharma to boost its service offerings in process and formulation R&D, analytical method development and validation and current good manufacturing practice (cGMP) manufacturing of drug intermediates and active pharmaceutical ingredients (APIs) for preclinical development and clinical trials. A ShangPharma spokesperson said: "With the newly added capacity in the Fengxian plant, the company will be able to support its clients' projects all the way through Phase II and into Phase III development." The contract research organisation (CRO) added that further plans may be made to expand the manufacturing facilities to 460,000 sq ft if it experiences a strong demand for commercial manufacturing of FDA – or EMEA – approved drugs. Last year, ShangPharma raised $87m (€65m) through an IPO on the New York Stock Exchange, of which the firm planned to spend $15m on the new Fengxian site. Some of these proceeds have been spent on equipping the Fengxian facility with a pilot plant boasting six separate bays with reactor capacities of 200 to 3,000 litres, as well as other specialty bays for high temperature, cryogenics, and highly toxic and pressurized reactions such as hydrogenation.

Clean room suites and R&D lab  Additionally, ShangPharma said there are two clean room suites rated at class 100,000 for isolation, 10 kilo-lab suites for non-cGMP and cGMP manufacturing, alongside an R&D laboratory for analytical, formulation and process development activities. According to the China-based firm, there is an area of the new facility dedicated to analytical support, and testing of raw materials, intermediates and final products will also be carried out at the site. A separate quality assurance (QA) department has been added to allow the company to ensure materials are manufactured to keep in line with standards set out by cGMP guidelines.

US Chinese Anti Cancer Association facilitated liver metastasis biomarkers cooperation between Peking University & Aushon BioSystems

Aushon BioSystems and Peking University Cancer Hospital Collaboration to Focus on Predictive Diagnostic Biomarkers for Liver Metastases of Colorectal Cancer

Feb 8, 2011 Aushon BioSystems, Inc., a leading provider of multiplex immunoassay products and services announced that it has signed a letter of intent to enter into a diagnostic development collaboration with Peking University Cancer Hospital ("PUCH"), Beijing, China. The primary goal for the collaboration is to develop predictive diagnostic markers for liver metastases of colorectal cancer utilizing Aushon's proprietary suite of protein biomarker detection technologies, and stratification biomarkers for radio-chemotherapy patients. As part of this collaboration, PUCH and Aushon will further negotiate an agreement to grant Aushon exclusive rights In North America and Europe to certain intellectual property generated from the collaboration for diagnostic applications. The research will be conducted under the leadership of Dr. Jin Gu, MD, FACS, Peking University Cancer Hospital, Peking University. Prof. Gu is a world-renowned expert and clinician on colorectal cancer and liver metastasis. He leads a team of scientists and physicians investigating the mechanisms of colorectal cancer metastasis including the identification of biomarkers to predict which patients may develop metastatic disease in liver. Dr. Gu has established a vast library of patient samples, as well as extensive clinical and post-surgery follow-up data that he and his staff have accumulated over the past several years. "We look forward to the opportunity to collaborate with Aushon on this critical clinical research program," said Dr. Gu. "Aushon's technology has already received widespread market acceptance with leading pharmaceutical companies due to its proven reliability and performance in late stage clinical trials, and has the key attributes we identified for a multiplex diagnostic platform. We are very optimistic that this partnership will lead to the discovery and development of predictive diagnostic markers for primary colorectal cancer metastases in liver, and establishment of new treatment strategies to improve outcomes for our patients." "We're extremely excited that Dr. Gu and his exceptional team at the Peking University Cancer Hospital have selected Aushon as a partner for their project," said Joe Blanchard, COO of Aushon. "We believe Aushon's technology and expertise are ideally suited for this diagnostic development program and expect that this will be the first of several such technical collaborations with Peking University Cancer Hospital and other leading research institutions in Asia". The collaboration was initiated and facilitated by the US Chinese Anti-Cancer Association (USCACA). "This collaboration marks another important milestone for USCACA in promoting US-China collaborations in cancer research, drug development, and patient care," remarked Dr. Li Yan, Managing Director of USCACA and adjunct professor at PUCH. "I am thrilled to see PUCH taking a leadership position in the area of personalized medicine, and look forward to the successful results of their collaboration with Aushon." Aushon also recently announced its partnership with LightArray Biotech, a drug development service company located in Wuxi, China. This partnership enables Aushon to provide its multiplex biomarker products and services to pharmaceutical clients in China.