COVID19快篩試劑 售300萬劑….無妄之災

藍質疑動物藥商接快篩標案 弘朗生物科技聲稱無妄之災 209 張薷、林和生、程炳璋／連線報導 2022年5月10日繼高登環球生醫有限公司被爆出，以資本額200萬元承攬衛福部16億元的快篩試劑採購案後，國民黨立法院黨團總召曾銘宗再揭露，「弘朗生物科技」前身是動物用藥公司，成為衛福部授權緊急採購快篩試劑的廠商，資本額僅330萬元，卻取得政府400萬劑、3.8億元政府標案，公司竟設立在一間農舍裡，質疑是「高登2.0」。國民黨團書記長萬美玲質疑，弘朗生技公司設在民宅，還以330萬元資本額拿下政府3.8億元的採購案，政府有義務說清楚講明白。國民黨立委洪孟楷在臉書指出，除了高登環球公司，剩下的9家投標廠商中，「新富偉生物科技股份有限公司」被踢爆是綠友友，「因思銳國際股份有限公司」之前是遊戲業，代理線上遊戲，「難道又是小吃店傳奇翻版？」弘朗生技公司地址登記於屏東縣潮州鎮，記者實際走訪發現，從鬧區轉往巷道內的民宅老厝鐵門深鎖，探詢鄰居後獲悉，此處少有人出入，被問到是否經營生技公司時，對方直接揮手答道「應該不可能啦！只是把公司掛名在這裡的！」一旁鄰居也說，此處住的都是親戚，其中有住在台南的、假日才會回來老家。弘朗生技公司另一處地址則在台南市歸仁區，外觀卻是一戶民宅，田姓女住戶出面表示，「這裡只是幫忙連絡公司事務的辦事處」；網路查詢電話則為一家會計師事務所，客服人員僅承認弘朗是其客戶。弘朗生技公司市場開發經理部經理林俊宏坦言，潮州登記處是負責人的古厝，由於公司客戶主要是醫院、診所及藥局，多是由業務對接出貨，根本沒人會在公司出入，當初也是方便才會登記在此。林無奈表示，弘朗做生意都有所本，2020年4月新增可販售醫材項目通過後，去年6月開始進口韓國鼻腔快篩試劑，至今已售出300萬劑。他也解釋，要將表面財務搞得漂亮也可以，不過就是流於形式，何不認真把事做好？認為整件事情就是無妄之災。

(JHL Biotech Sentenced) 涉嫌超過1.01億美元（約新台幣27.9億元）電信欺詐

涉竊取美商業機密、電信詐欺28億 喜康生技2創辦人提交認罪協議 新頭殼newtalk | 張如嫻 綜合報導 發布 2021.08.31台灣生物製藥公司「喜康生技」（JHL Biotech，後改名為伊甸生醫）兩名創辦人先前因竊取商業機密、電信詐欺等罪嫌，遭美國聯邦大陪審團起訴。美國司法部 26日表示，兩人已提交認罪協議，承認共謀竊取美國生技巨頭公司基因泰克（Genentech）商業機密，及涉嫌超過1.01億美元（約新台幣27.9億元）電信欺詐的罪行。加州檢調辦公室在新聞稿指出，喜康生技創辦人兼執行長喬石瑞（Racho Jordanov）與另一名聯合創辦人林穗虹（Rose Lin）密謀竊取商業秘密和電信欺詐，兩人都已向法官遞交書面認罪協議。根據認罪協議，喬石瑞與林穗虹 2012 年在台灣成立喜康生技，該公司主要從事蛋白質藥物製造銷售及生物相似藥研發。2011至2019年間，喬石瑞利用從基因泰克竊取的商業機密，降低成本並快速開發、生產基因泰克生物仿製藥品。2014 年 1月，林穗虹招募當時基因泰克的首席研發長林贊茜（Xanthe Lam），祕密擔任喜康生技的配方主管，她的丈夫與另外兩名前同事也都涉嫌參與竊取機密，並擔任喜康生技的顧問。今年6月喬石瑞與林穗虹也正式被起訴，遭指控共謀盜取基因泰克的商業機密、電信詐欺、國際洗錢和妨礙司法公正罪；7 月林贊茜與丈夫則向法院認罪，根據夫妻兩人提交的認罪協議，2013 年他們祕密將基因泰克的生物製藥、暢銷抗癌藥物等技術配方，洩露給喜康生技。起訴書指出，喜康生技將基因泰克的數據與標準作業程序據為己有，藉此向投資者募集數百萬美元的資金，還與法國跨國製藥公司賽諾菲（Sanofi）建立夥伴關係，獲賽諾菲以電匯方式向喜康生技支付的 1.01 億美元預付款。喜康生技對此表示，對公司員工之不當行為深表遺憾，董事會並積極配合調查，自願提供公司內部資料以求透明，與基因泰克達成無賠償金之和解並撤回訴訟，中止與創辦人之聘雇合約，對創辦人追償公司損害、懲處其他相關涉案員工、並進行調整公司研究開發計畫等措施，美國司法部基於喜康生技之合作，於 2021 年 6月已達成相關公司法人不起訴協定。

Former CEO And COO Of JHL Biotech Sentenced For Conspiring To Steal Trade Secrets And Commit Wire Fraud Exceeding $101 Million

Department of Justice, U.S. Attorney's Office, Northern District of California Tuesday, March 15, 2022 SAN FRANCISCO – Racho Jordanov, the co-founder and former Chief Executive Officer of JHL Biotech, and Rose Lin, another of the company's co-founders and former Chief Operating Officer, were sentenced today for their respective roles in conspiring to commit trade secret theft and wire fraud, announced United States Attorney Stephanie M. Hinds, Internal Revenue Service ̶ Criminal Investigation (IRS-CI), Special Agent in Charge Mark H. Pearson, and Federal Bureau of Investigation, Special Agent in Charge Craig D. Fair.Jordanov was sentenced to a term of imprisonment of twelve months and one day, to be followed by a term of supervised release of 36 months, a condition of which shall be to serve nine months in home confinement.Lin was sentenced to a term of imprisonment of twelve months and one day, to be followed by a term of supervised release of 36 months.The sentences were handed down today by the Hon. William Alsup, Senior U.S. District Judge. Both defendants pleaded guilty to the charges on August 24, 2021. According to the plea agreements, in 2012, Raco Ivanov Jordanov, also known as "Racho" Jordanov, 74, of Rancho Santa Fe, Calif., and Rose Lin, also known as Rose Sweihorn Tong, 73, of South San Francisco, Calif., co-founded JHL Biotech, Inc., a biopharmaceutical startup in Taiwan.Between 2011 and 2019, Jordanov, as President and CEO of JHL Biotech, obtained and possessed confidential, proprietary, and trade secret information from Genentech, and used it to accelerate the timeline for and to reduce the costs of JHL Biotech's development and production of Genentech biosimilars and to enhance JHL Biotech's ability to meet various regulatory requirements related to the same. By various means, Jordanov obtained for JHL Biotech's use many confidential and proprietary documents from Genentech without authorization, some of which contained trade secret information. In so doing, he worked with multiple people within JHL Biotech to possess and use confidential, proprietary, and trade secret information he knew JHL Biotech was not authorized to have. According to the plea agreement, Jordanov hired former Genentech employees to work at JHL Biotech, several of whom he learned surreptitiously brought, without authorization, confidential and proprietary documents with them from Genentech to JHL Biotech.The company used only some of the stolen documents, but Jordanov tolerated this practice by the employees of JHL Biotech and made no effort to discourage its employees from using the documents or information they brought with them.The employees Jordanov hired provided the Genentech documents and information to JHL Biotech, which, at times, allowed the company to cheat, cut corners, solve problems, provide examples, avoid further experimentation, eliminate costs, lend scientific assurance, and otherwise help JHL Biotech start-up, develop, and operate its business secretly using the intellectual property and scientific know-how taken from Genentech.Jordanov admitted that he suspected that some or all the stolen information was brought to JHL Biotech in violation of relevant Genentech non-disclosure agreements and employment contracts, but he made no effort to verify whether that was true. In January 2014, Lin arranged for Xanthe Lam, a Principal Scientist working full-time at Genentech, to secretly work as the head of formulation for JHL Biotech.Lin encouraged JHL Biotech scientists to ask Xanthe Lam for assistance or information when they ran into problems.Throughout this time, Lin knew that Xanthe Lam continued to work for Genentech and was not authorized to work for JHL Biotech.Lin also knew that Xanthe Lam did not want Genentech to learn of her work for JHL Biotech.Lin agreed to pay Xanthe Lam's consultancy fee through her husband, Allen Lam.To further conceal Xanthe Lam's work for the company, JHL Biotech did not enter a direct contract with Xanthe Lam.Instead, it always paid her through Allen Lam.Lin agreed to conceal Xanthe Lam's work for JHL Biotech because Lin knew Genentech would not permit Xanthe Lam to work for another biotech company.Lin also directed JHL Biotech employees to use Allen Lam's JHL email address to email questions to Xanthe Lam.Lin also instructed JHL Biotech employees to refer to Xanthe Lam as "Allen" in these email communications. In early 2014, Lin learned that JHL Biotech employees were using confidential and proprietary documents, taken without authorization from Genentech, to create a set of JHL Biotech standard operating procedure ("SOPs").JHL Biotech needed SOPs to apply for the initial Good Manufacturing Practices or "GMP" certification of its manufacturing facility by the Taiwan Food and Drug Administration or "Taiwan FDA."Lin was in charge of the process for ensuring that JHL Biotech met the deadlines set for the GMP certification process.In that role, Lin was copied on emails where JHL Biotech employees discussed using Genentech documents to create JHL Biotech's SOPs. Ultimately, 90-100 SOPs were generated in this way. Lin knew the JHL Biotech employees did not have the right to use Genentech's documents and that their actions constituted theft from Genentech. Between 2014 and 2018, Jordanov sometimes personally used and instructed others to use confidential, proprietary, trade secret Genentech documents and information relating to Genentech's complex technology transfer procedures and processes.He used Genentech's confidential and tech transfer documents in the development, construction, and operation of new facilities for JHL Biotech including its manufacturing facility in Wuhan, China.Jordanov instructed the employees to whom he sent the documents not to share them with others inside the company.Later, in September of 2018, after the criminal investigation had begun, the JHL employee Jordanov tasked with using the Genentech tech transfer documents was instructed by Jordanov to delete the email from Jordanov and its attachment and Jordanov instructed the employee to tell others at JHL Biotech to do the same. In early-December 2016, Jordanov and Lin met with representatives of Sanofi S.A., the multi-national French pharmaceutical company, for approximately one week, during which they reviewed the strategic partnership agreement to be entered into by Sanofi and JHL Biotech.During this week-long meeting, Jordanov and Lin reviewed each section of the prospective partnership agreements in detail.Some of the sections of the agreements involved JHL Biotech representing to Sanofi that it had developed and was conducting its biosimilar operations without infringing the intellectual property rights of other companies or using other companies' proprietary information.Jordanov and Lin did not disclose their possession and use of stolen Genentech documents to Sanofi, and instead, Jordanov signed the partnership agreements on behalf of JHL Biotech.By concealing these facts, Jordanov and Lin made it appear, falsely, that JHL Biotech had developed its own, or had lawfully obtained, the intellectual property that the biotech company used when, in fact, JHL Biotech had relied upon intellectual property, including confidential, proprietary, and trade secret information that it stole or received without authorization to obtain regulatory approval for its clinical trials, and build out its manufacturing capability. Jordanov and Lin knew that if they had not concealed these facts, Sanofi would not have agreed to the corporate transaction and invest approximately $80 million in JHL Biotech securities pursuant to the subscription agreement and approximately $21 million pursuant to Biologics Products Options Agreement (BPOA) for a total investment by Sanofi in JHL Biotech of approximately $101 million. On June 1, 2021, a federal grand jury indicted Jordanov and Lin, charging both defendants with the following charges: (1) conspiracy to commit theft of trade secrets and wire fraud, in violation of 18 U.S.C. § 371; (2) wire fraud, in violation of 18 U.S.C. §§ 1343 and 2 (three counts each defendant); (3) international money laundering, in violation of 18 U.S.C. § 1956(a)(2)(A) (nine counts against Jordanov and five counts against Lin); and (4) conspiracy to obstruct justice, in violation of 18 U.S.C. § 371.In addition, the indictment charges Jordanov with two counts of theft of trade secrets, in violation of 18 U.S.C. §§ 1832(a)(1)(2)(3) and 2; and charges Lin with one additional count of making false statements to a government agency, in violation of 18 U.S.C. § 1001(a)(2).Pursuant to the plea agreements, both defendants pleaded guilty to count one of the indictment, conspiracy to commit theft of trade secrets and wire fraud. The remaining charges were dismissed at sentencing. On July 7, 2021, in a related case, United States v. Xanthe Lam and Allen Lam, Case No. 18-cr-0527 WHA, both Xanthe Lam and Allen Lam pleaded guilty to, among other offenses, conspiracy to commit theft of trade secrets by stealing confidential, proprietary, and trade secret information from Genentech and giving it to JHL Biotech. Assistant U.S. Attorneys Adam A. Reeves and Claudia A. Quiroz are prosecuting the case with the assistance of Beth Margen and Kathy Tat.The prosecution is the result of an investigation by the Internal Revenue Service ̶ Criminal Investigations and the Federal Bureau of Investigation.

2個月 民眾進口自用COVID-19快篩

擬開放民眾進口快篩自用　陳時中：成效自負、不得販售 2022年05月10日【記者賴玟茹／臺北報導】本土中共病毒（COVID-19）疫情持續升溫，快篩實名制供不應求，放寬國人自行輸入呼聲頻傳。指揮中心指揮官陳時中10日表示，擬開放2個月時間讓民眾進口自用快篩，雖不限廠牌、不用通過緊急使用授權（EUA），但成效自負、不得販售，也不適用於任何防疫規定。根據衛福部現行規定，民眾從國外購買自用快篩試劑須由食藥署逐案審查，且須繳交2千元行政規費。國民黨主席朱立倫近期建議，政府「開放自主進口合規快篩」、「快篩資訊便民查詢」、「合法合理採購機制」。陳時中表示，政府從未禁止廠商進口，只是有一定輸入程序，因應民眾需求，未來擬鬆綁相關規定約2個月，也可能取消2千元行政規費的規定，屆時民眾進口自用的快篩試劑可不限廠牌，也不用通過食藥署緊急使用授權，但成效自負、不得販售，也不得適用任何防疫相關規定。疫情升溫，有民眾表示，曾經確診後又再度染疫。指揮中心發言人莊人祥表示，自今年初統計至今，總計再度染疫確診者有268例，不過無法評估是再度染疫，或為染疫一段時間後的時陰時陽。

9日單日口服藥量破千　使用量創新高 至於口服藥物使用情況，指揮中心醫療應變組副組長羅一鈞表示，9日使用量明顯成長，共發出819人份輝瑞口服藥、默沙東口服藥物則開出218人份，為使用口服藥以來單日人數最高一天，其中輝瑞有423份，是由醫院、醫院負責的集中檢疫所開出，另300多份則是經過視訊診療與居家照護判斷、開出處方箋後，由藥局開出，藉由到宅送藥或家人代領發出。

提升效率　簡化藥物使用表單 指揮中心逐步簡化送藥到宅流程。羅一鈞表示，早上已發出新公文，即日起簡化口服抗病毒藥物使用表單，分別為病人治療同意書、藥物申請與領用檢核表，及口服藥物切結書。羅一鈞說明，因為新冠口服藥沒有藥害救濟，因此需要事前告知病人相關優劣，將從紙本同意書，改為加註相關字樣即可；藥物申請與領用檢核表則改為免填、免繳回，改以健保代碼做領用紀錄；病人治療紀錄表也簡化成非必填，改由病患住院或照護後續團隊處理。

國外19廠牌快篩試劑已通過食藥署緊急授權 根據食藥署資料顯示，通過緊急使用授權專案輸入快篩試劑共19款廠牌，以美國與韓國製造為大宗，另有德廠亞培（Panbio）及另款中國製BD家用新型冠狀病毒抗原快速檢測套組。經查，這款中國製快篩是由新加坡商必帝公司台灣分公司引進，製造地點在中國江蘇，5月3日才取得EUA，尚未確認是否已在市面販售，價格也不明。儘管產品說明書上所列的產地不一定等於原產地，但製造地標示為中國仍顯得敏感。據了解，快篩通過EUA審查的主要標準是以安全性等品質項目為重，而非產地。另有7件為國內核准專案製造的快篩試劑，福爾威創、飛確 RV2、台塑生醫、凌越、速可安、長興等6款，其中飛確 RV2占2件。

保瑞15億元 購伊甸生醫蛋白藥業務

保瑞買下伊甸生醫在台CDMO資產 跨入大分子藥物代工 2022/05/10 17:51〔記者陳永吉／台北報導〕保瑞藥業（6472）宣布成立子公司保瑞生技，該公司將以大分子生物藥CDMO（委託開發暨製造服務）為主要業務，保瑞生技並公告以5千萬美金（約新台幣15億元）取得伊甸生醫CDMO業務在台資產，包括台灣廠房、實驗室與全數人才庫，同時與伊甸生醫簽訂MSA（Master Service Agreement）代工協議，也就是伊甸生醫既有客戶與產品一併由保瑞生技承接。保瑞表示，透過此次策略性的收購，將讓保瑞集團快速跨足大分子細胞治療領域，拓展CDMO全球事業版圖。保瑞生技將以蛋白質藥物（又稱生物藥）CDMO為定位，看好該公司的市場潛力，台新健康基金與泰福（6541）創辦人趙宇天也投資挹注保瑞生技未來發展。保瑞指出，本案不僅是收購原伊甸生醫CDMO硬體設備與資產，更具指標性意義的是保瑞將取得包含生產蛋白質藥物的細胞株開發、上下游製程開發、分析及品管檢驗規格建立、細胞庫製備等國際級生物科技技術，更含括未來商業化生產協議。保瑞發言人陳世民指出，該廠具備四個500公升生物反應器，已通過歐盟品質授權人（QP）稽核和衛福部食藥署審核通過，並已完成多個國際委託合作案，具備完整CDMO能力，保瑞將可提供一站式的上下游開發，包含細胞株開發、製程開發、分析方法開發、劑型設計與品質控制檢測服務等，為客戶生產臨床和商業量產藥物。除了收購資產，保瑞生技並與伊甸生醫簽訂產品代工協議，伊甸自有產品與既有客戶之訂單合約，將全數轉移保瑞生技承接，將依產品專利到期日規劃兩階段產品線開發，目前開發中已有品項將進入一期與三期臨床，保瑞生技將擁有開發中新藥未來上市量產的優先代工權利。保瑞藥業今同步公布Q1財報，合併營收11.17億元，年減18.27%，稅後淨利1.79億元，EPS為2.62元。保瑞表示，今年Q1由於受到國際航運塞港、缺櫃的影響，導致出貨遞延，以致營收稍受影響，預期今年第2季後即恢復正常；保瑞也公告4月營收為4.49億元，較去年同期增8.5%。

登興櫃: 綠茵 營收6.93億/純益1.69億 保健代工原料 (康普森/鋒揚生醫)

生技股新兵來了　綠茵生技明登興櫃、認購價60元！記者吳康瑋／綜合報導國內疫情持續延燒，帶動各生物科技產業公司加速申請掛牌及加速產品研發的腳步，對此，櫃買家族於本周將有一檔新兵，保健食品代工原料研發生產OEM／ODM大廠綠茵生技（6846）將於明（19）日登錄興櫃，成為今年第16家興櫃掛牌的公司，興櫃認購價為60元。綠茵主要從事保健食品及原料之研發、製造、銷售，為國內少數自行開發保健食品原料之廠商，在中部科學園區及台中工業區設有生產基地，生產植物系與微生物系原料素材；團隊秉持創新研發、改善大眾健康的精神，以成為台灣生技保健邁向國際的領航者為目標，全力開發台灣特色保健原料，目前已擁有多項具特色及潛力的保健食品原料。據了解，綠茵旗下「康普森生技」及「鋒揚生醫」皆為團隊100％持有之子公司，其中康普森的主要業務為海外保健食品品牌原料之代理與銷售；鋒揚則以提供保健食品配方設計的客製化製造及銷售為主；而目前團隊透過集團化分工，全力發展保健食品原料研發、製造到配方設計、成品開發等服務，更積極深耕多國市場。綠茵為2012年7月18日所設立，其實收資本額為2.44億元，董事長吳嘉峰同時兼任總經理，截至今（2022）年3月31日，董事持股比例為46.04%。根據公開資料顯示，公司去（2021）年市場結構為內銷占比87%、外銷佔比13%，而在營收部分，去年營業收入達6.93億元，稅前純益1.69億元，每股盈餘5.46元，這次申請登陸興櫃，主辦輔導券商為福邦證券，認購價為60元。