藥華P1101 (黃正谷/詹青柳/林國鐘) 美國迎戰INCYTE, 歐洲迎戰Novartis, Jakafi /Jakavi (ruxolitinib)

藥華藥首度參加美血液學會 加速新藥上市進度 鉅亨網 2015/08/27 19:11 興櫃新藥廠藥華醫藥(6446-TW)將首度獲邀參加血液疾病國際知名醫師會議「2015美國區血液增生疾病會議」，總經理黃正谷表示，在這場為期二天的會議上，將有自己的專屬攤位，可詳細向與會醫師介紹P1101在PV治療上的臨床結果和進展，提升醫師對此新藥的用藥意願，加速新藥上市進度。黃正谷進一步指出，國際大型藥廠最擅長且有效的行銷新藥手法就是於國際醫學會議擺攤或贊助相關疾病研討會，特別是能在會議中請來重要意見領袖的站台，直接提供他們更多相關的臨床研究或產品訊息，藉由與這些意見領袖的分享討論，有效提升新藥的曝光度及醫師的用藥意願。因此接下來的半年內，藥華藥將積極透過醫學會議或贊助主辦血液疾病論壇，為P110新藥上市後的行銷布局預先暖身。正谷表示，即將在美國登場的「2015美國區血液增生疾病會議」，便是由血液增生疾病權威醫生主持，每年參與出席的醫界精英多達數百人，擁有醫學與生物學雙博士學位，現任職於德州MD安德森癌症中心，長期專注於骨髓增殖性疾病領域之研究，且持續主導多項治療MPN新藥物的臨床試驗。黃正谷強調，P1101已完成三期臨床收案，目前正進行受試者療程階段及數據資料整理，由於BESREMi®的臨床設計為第一線用藥，副作用低、安全性高、耐受性也佳，根據AOP提供的資料顯示，以每2周注射一次，在給藥12周後，病人JAK2基因突變狀況即大幅減少，而若把治療滿一年的第二期臨床受試者，改為延長為每4周注射一次，其結果證實仍能維持療效，並達到整體副作用更為降低的目的。P1101將有機會成為全球治療PV疾病的第一個治癒型的新藥。

藥華PK美廠 搶申請藥證  2015-08-31 02:32:17 經濟日報 記者黃文奇／台北報導 分享藥華PK美國千億藥廠INCYTE，新藥拚明年首季上市申請。藥華醫藥總經理黃正谷表示，公司旗下抗真性紅血球增生症（PV）的新藥P1101為一線用藥，最快明年初即可向歐美藥品主管機關，包括歐洲EMA、美國FDA，遞件申請藥證。藥華進度最快的產品P1101，所聚焦的PV疾病在全球商機達百億美元，而法人指出，P1101為PV的第一線首選用藥，可望治療PV達75%病人，遠優於INCYTE已在美國上市的PV第二線新藥「Jakafi」，極具市場寡占性。藥華成立於2000年，由現任董座詹青柳、全球策略長林國鐘一手創立，聚焦罕見血液疾病、肝炎、腫瘤等門檻較高適應症的新藥研發。產品線分五大疾病領域，16種適應症，其中五項產品已進入臨床三期，並以P1101抗PV適應症進度最快。P1101為長效型新一代干擾素，沒有傳統干擾素的副作用，業界認為，這將能大幅提升病人與醫生的使用意願，為未來上市銷售加值，而藥華授權的歐洲夥伴AOP，目前已經在歐洲完成260人的臨床三期收案，數據最快年底即將公布。藥華於2009年將P1101歐洲等地區的商化權利授權給奧地利藥廠AOP，並以用於治療罕見血液增生疾病，授權區域包含歐洲、中東、前蘇聯獨立國， 而保留上述地區以外的製造、銷售權利；該產品目前都被美、歐認定為孤兒藥，因此未來上市後，將獨占七到十年的獨賣權與溢價（補助）空間。目前，藥華的主要對手INCYTE的PV二線用藥已經在美上市，該產品適應症以PV為主、骨髓纖維化為輔，今年首季銷售額度約2億美元（約新台幣64億元），法人預估，該產品今年有機會賣破6億美元，明年即向8億到10億美元邁進，登上重磅級大藥的行列。據悉，INCYTE的Jakafi今年初准用於PV適應症，該公司股價立即從1月初的80美元，一直攀升到6月間的120美元。雖然因全球股災而上攻力道趨緩，但仍維持在110到120美元區間，市值超過200億美元（超過新台幣6,000億元）。

閱讀祕書／真性紅血球增生症（PV） 真性紅血球增生症（PV）是一種罕見血液疾病，美國約有20萬個病人，歐洲則超過17萬人，目前平均一個療程達7.5萬美元，以20萬人的美國潛在市場估算，遠逾百億美元。PV的致病的原因為骨髓造血細胞長期不正常地製造過多的紅血球細胞，造成血液過於黏稠，常伴隨白血球與血小板數量也增加。血液循環上的問題包括血栓，也可能會轉變成骨髓纖維化或血癌，常見的症狀包含頭痛眩暈、眼結膜充血、視力障礙、血壓增高、皮膚泛紅，嚴重可能導致不正常的血小板功能、脾腫大、全身動靜脈栓塞、骨髓纖維化、和轉化成急性骨髓性白血病等併發症狀。（黃文奇）

Incyte Reports 2015 Second-Quarter Financial Results and Updates Shareholders on Key Clinical Programs.  $142 million of 2015 second-quarter net product revenues from Jakafi® (ruxolitinib), representing 69 percent growth over the same period last year. 2015 guidance for Jakafi net product revenues increased to range of $560 million to $575 million, driven by strong underlying demand. Positive results from two pivotal trials of baricitinib in rheumatoid arthritis presented at EULAR. Multiple abstracts presented at ASCO and EHA, demonstrating continued progress across broad clinical portfolio

August 04, 2015 07:00 AM Eastern Daylight Time  WILMINGTON, Del.--(BUSINESS WIRE)--Incyte Corporation (Nasdaq: INCY) today reported 2015 second-quarter financial results, including revenue from Jakafi."The commercial performance of Jakafi in Q2 2015 was very strong, confirming both underlying growth from the myelofibrosis indication and an acceleration in Jakafi growth from the launch in patients with uncontrolled polycythemia vera" The Company highlighted the continued momentum in the commercialization of Jakafi in the U.S., as well as progress being made across its clinical portfolio, including the results of two pivotal trials of baricitinib that were presented with Eli Lilly and Company ("Lilly") at the 2015 European League Against Rheumatism (EULAR) meeting in June. In addition, positive proof-of-concept results from the novel:novel combination of Incyte's PI3Kδ inhibitor INCB40093 and JAK1-selective inhibitor INCB39110 in B-cell malignancies were presented at both the 2015 American Society of Clinical Oncology (ASCO) and European Hematology Association (EHA) annual meetings in the second quarter of 2015."The commercial performance of Jakafi in Q2 2015 was very strong, confirming both underlying growth from the myelofibrosis indication and an acceleration in Jakafi growth from the launch in patients with uncontrolled polycythemia vera," stated Hervé Hoppenot, Incyte's President and Chief Executive Officer. "Recent data presented from our product candidates, and the progress we are making in recruiting multiple clinical trials, further illustrate the strength and diversity of our development portfolio." Jakafi is approved by the U.S. Food and Drug Administration for treatment of people with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea. Jakafi is also indicated for treatment of people with intermediate or high-risk myelofibrosis (MF), including primary MF, post–polycythemia vera MF, and post–essential thrombocythemia MF.

2015 Second-Quarter Financial Results

 

Revenues For the quarter ended June 30, 2015, net product revenues of Jakafi were $142 million as compared to $84 million for the same period in 2014, representing 69 percent growth. For the six months ended June 30, 2015, net product revenues of Jakafi were $258 million as compared to $154 million for the same period in 2014, representing 68 percent growth. For the quarter and six months ended June 30, 2015, product royalties from sales of Jakavi® (ruxolitinib) outside of the United States received from Novartis, the Company's collaborator, were $17 million and $33 million, respectively, as compared to $12 million and $22 million, respectively, for the same periods in 2014. For the quarter ended June 30, 2015, contract revenues were $3 million as compared to $3 million for the same period in 2014. For the six months ended June 30, 2015, contract revenues were $31 million as compared to $13 million for the same period in 2014. The $18 million increase in contract revenues for the six months ended June 30, 2015 compared to the same period in 2014 relates to an increase in milestone payments earned from Novartis. For the quarter ended June 30, 2015, total revenues were $163 million as compared to $100 million for the same period in 2014. For the six months ended June 30, 2015, total revenues were $322 million as compared to $189 million for the same period in 2014.

 

Ruxolitinib (INC424, INCB18424, trade names Jakafi and Jakavi, by Incyte Pharmaceuticals and Novartis) is a drug for the treatment of intermediate or high-risk myelofibrosis, a type of myeloproliferative disorder that affects the bone marrow. It is also being investigated for the treatment of other types of cancer (such as lymphomas and pancreatic cancer), for polycythemia vera, for plaque psoriasis, and for alopecia areata. Ruxolitinib is a Janus kinase inhibitor with selectivity for subtypes JAK1 and JAK2 of this enzyme. Ruxolitinib inhibits dysregulated JAK signaling associated with myelofibrosis. JAK1 and JAK2 recruit signal transducers and activators of transcription (STATs) to cytokine receptors leading to modulation of gene expression. The phase III Controlled Myelofibrosis Study with Oral JAK Inhibitor-I (COMFORT-I) and COMFORT-II trials showed significant benefits by reducing spleen size and relieving debilitating symptoms. In November 2011, ruxolitinib was approved by the U.S. Food and Drug Administration (FDA) for the treatment of intermediate or high-risk myelofibrosis based on results of the COMFORT-I and COMFORT-II Trials.

Side effects Immunologic side effects have included herpes zoster (shingles; 1.9%) and case reports of opportunistic infections. Metabolic side effects have included weight gain (7.1%). Laboratory abnormalities have included alanine transaminase (ALT) abnormalities (25.2%), aspartate transaminase (AST) abnormalities (17.4%), and elevated cholesterol levels (16.8%). Other common adverse events are anemia (low red blood cell count) and thrombocytopenia (low blood platelet count). Grade 3 to 4 anemia occurs in up to 45% of patients and grade 3 to 4 thrombocytopenia occurs in 10% to 15% of cases, and requires medical intervention to return to near-baseline levels.

 

Novartis' Jakavi gets yes in Europe  MARCH 17, 2015 10  PHARMATIMES REPORTER  Novartis' Jakavi gets yes in Europe  Novartis has been given the green light in Europe for Jakavi to treat a rare blood cancer. Specifically the drug, a JAK 1 and 2 tyrosine kinase inhibitor, has been approved by the European Commission for the treatment of adults with polycythemia vera who are resistant to or intolerant of hydroxyurea. PV is a rare and incurable blood cancer associated with an overproduction of blood cells that can cause serious cardiovascular complications, such as blood clots, stroke and heart attack. It roughly affects one to three people per 100,000 globally. Approximately 25% of patients with PV develop resistance to or intolerance of hydroxyurea and are considered to have uncontrolled disease."The European Commission's approval of Jakavi is encouraging news for patients," said Dr Claire Harrison, study investigator and consultant hematologist, Guy's and St. Thomas' NHS Foundation Trust, London. "Jakavi will fill an unmet need as the first treatment shown to significantly improve hematocrit, as well as symptom control and reduce spleen size in patients with polycythemia vera resistant to or intolerant of hydroxyurea." The approval of Jakavi (ruxolitinib) is based on data from the pivotal Phase III RESPONSE clinical trial demonstrating that a significantly greater proportion of patients achieved the composite primary endpoint of hematocrit control without use of phlebotomy and spleen size reduction, key measures of disease control, when treated with Jakavi compared to best available therapy. In the study, a 50% or more improvement in PV-related symptoms was seen in 49% of Jakavi-treated patients compared to 5% of patients treated with best available therapy."The approval of Jakavi in polycythemia vera underscores what's possible in today's era of precision oncology research," said Bruno Strigini, president, Novartis Oncology. "Jakavi specifically targets the JAK-STAT pathway, which regulates blood cell production and is known to play a key role in the underlying mechanism of this disease, bringing patients and physicians a new way to treat polycythemia vera."

Incyte Reports 2015 Second-Quarter Financial Results

澳優乳業 主席YAN Weibin (顏衛彬)…迎戰中國乳製品挑戰

澳優乳業股份有限公司2015中期毛利及毛利率分別增長約7.3%和3.0個百分點 香港2015年8月26日電 /美通社/ -- 業務摘要 (截至2015年6月30日) 自家品牌業務收入約人民幣531.6百萬元，按年增長約29.6%。該增長主要因集團改變策略，將業務重心由利潤率相對較低的私人商標及合約製造業務，轉移至利潤率較高的自家品牌業務 作為自家品牌業務之一的牛奶製品收入增長約10.1%至約人民幣291.5百萬元，羊奶製品佳貝艾特系列產品收入增長約73.7%至約人民幣235.9百萬元 毛利約為人民幣290.1百萬元，增長約7.3% 毛利率約為31.8%，增長約3.0個百分點 集團與 Dutch Dairy Investments B.V. 訂立股份購買協議，以收購 Ausnutria Hyproca B.V. (「澳優海普諾凱」)餘下49.0%股權，代價約470.3百萬港元 集團與晟德大藥廠股份有限公司(「晟德大藥廠」)及其他八間機構完成強制性全面現金要約，晟德大藥廠成為公司單一最大股東 澳優乳業股份有限公司 (「澳優」或「公司」，聯同其轄下附屬公司，統稱「集團」；股份編號：1717.HK)，一間生產設備主要設於中國及荷蘭的嬰幼兒配方奶粉公司，今日公佈截至2015年6月30日止六個月(「回顧期內」) 未經審計的中期業績。 回顧期內，集團收入約為人民幣912.3百萬元，減少約2.6%。收入減少的部分原因是因為集團改變策略，將業務重心由利潤率相對較低的私人商標及合約製造業務，轉移至利潤率較高的自家品牌業務。而自家品牌業務的收入增長了29.6%至約人民幣531.6百萬元。 集團毛利約為人民幣290.1百萬元，增長約7.3%。毛利率則約為31.8%，增長約3.0個百分點。隨着集團在中國銷售自家品牌產品（主要為銷售佳貝艾特系列產品）之比重持續上升，使集團得享自家品牌產品毛利率較其他產品線為高之優勢，推動了毛利及毛利率增長。 因為集團為應對日趨激烈的市場競爭，以及配合集團長遠的發展策略，於其他海外市場推出及推廣佳貝艾特系列產品，令銷售及營銷費用有所增加。然而隨着投放的額外銷售及分銷開支的到位，佳貝艾特系列產品在中國的銷售額增長了71.9%，並已成為集團增長最快的品牌之一。 集團主席顏衛彬先生表示：「過去幾年，中國政府推出了一系列新政策，在這些新政策的推動下，本集團旗下所有品牌已獲授相關進口批准，本集團的所有海外廠房亦已成功登記，成為受認可的海外乳製品生產商。我們認為，中國的乳業市場，也是本集團最主要的市場，於未來幾年將是充滿挑戰。為了應對即將到來的挑戰，同時也為了滿足嬰幼兒營養品的長期增長及需求，我們採取了一系列措施，以確保集團長期穩定的可持續發展。」 2015年5月，晟德大藥廠連同其他八間機構與集團一前任股東訂立了買賣協議，以收購澳優合共197,368,600股股份。該買賣協議引發了強制性要約，並已於2015年8月6日完成，晟德大藥廠現為集團單一最大股東。集團相信，晟德大藥廠的支持將有利於集團日後發展，而憑藉晟德大藥廠的管理專長，集團將為股東締造長遠價值。 同時，集團於回顧期內繼續加強整合上游及產品的多元化，進一步加強嬰幼兒配方牛奶粉的發展，並專注於嬰幼兒配方羊奶粉。其中，集團收購澳優海普諾凱餘下49.0%股權已獲股東決議，並計劃於月底完成。澳優海普諾凱具備自荷蘭牧場收集新鮮羊奶到供應成品羊奶的完整產業鏈，是世界領先的羊奶製品生產商之一。截至2015年6月30日，澳優海普諾凱擁有三間廠房及一間在建廠房，均設於荷蘭。除此之外，為進一步增加澳優海普諾凱在中國以及全球嬰幼兒配方羊奶粉市場的份額，澳優海普諾凱繼續在營銷及宣傳佳貝艾特系列產品上分配更多資源，以增強市場知名度。 產品研發一直是集團的發展重點。除集團自身於增強研發實力方面的不懈努力，集團還與北京大學醫學院繼續合作，共同研發母嬰奶粉，履行與其訂立的10年戰略合作協議。 與此同時，集團亦意識到客戶關係的重要性，並為加強運營和客戶關係管理，大力開發信息技術系統，推出了多項手機應用程式，並以綫下店及公司客服中心相結合的方式，著力發展顧客及會員服務。 展望未來，顏先生表示：「我們相信，作為集團的主要市場，中國乳業市場於來年依然面臨重重挑戰。但集團加強了產業鏈、客戶服務能力以及銷售網絡等方面的建設。我們對集團業務於中國市場的增長特別是與客戶間關係的提升而感到高興。同時。集團將繼續整合上游資源，豐富產品多元化，增加荷蘭產能，致力於建立世界領先的嬰幼兒配方羊奶粉生產商地位。同時繼續投資研發，增強內部研發實力，並與其他行業參與者及研究中心建立戰略合作關係，並加強 IT 系統。憑藉我們建立的良好基礎，包括堅實的荷蘭生產基地，以及中國及海外的龐大分銷網絡以及自身的顧客服務能力，尤其是荷蘭廠房升級改造完成後，我們相信集團將實現進一步的業績增長，為集團股東創造最大價值。」 關於澳優乳業股份有限公司 澳優乳業股份有限公司是一間生產設備主要設於中國和荷蘭，從事研發、奶源收集、加工、生產及包裝乳製品等活動，並於中國、歐洲、北美、中東、俄羅斯及獨聯體及其他海外市場從事營銷及銷售活動的嬰幼兒配方奶粉公司。澳優於中國內地的廠房為內地第一批成功取得生產許可證換證的廠房；於新政策下，荷蘭子公司的下屬工廠亦為首批成功獲發海外產品進口許可證的海外嬰幼兒配方奶粉製造商之一。

Ausnutria Hyproca in Europe The Netherlands is our home base; our factories and head office are located here. We supply our Dutch and international clients with private label baby formula from the head office in Heerenveen. We are also active in many European countries, with the sale of our CBM goat milk ingredients. The global CBM market is also supplied from the Netherlands, as are the majority of the European markets for our Kabrita goat milk products. The sale of our Kabrita goat milk infant formula in Russia and other CIS countries takes place via a joint venture in Moscow.

Rich history in the dairy industry  The Ausnutria Hyproca history spans more than 100 years. The modern-day Ausnutria Hyproca is a company with great experience in the production of infant formula and other types of dairy products, in Ommen, Leeuwarden and Kampen.

Hyproca Dairy l Ommen The history of the factory in Ommen dates back to 1897, when it was founded by Mr. Kramer. It was named the "De Vechtstreek", a name still proudly born by the company premises. In 1910 a group of farmers decided to create a co-operative and bought the factory. It was the first factory with complete and continuously operating butter making facilities. As milk production grew in the Netherlands, the factory was expanded and extra activities added. Milk powder has been produced in Ommen since 1928. In 1996, the factory was sold to the Hyproca Dairy Group, which is now Ausnutria Hyproca, and continued under the name Hyproca Dairy. Nowadays, Hyproca Dairy is a professional dairy factory which not only produces own brand products but also supplies various large international companies with top-quality dairy ingredients.

Lypack and Lyempf l Leeuwarden and Kampen The origins of the factories in Leeuwarden and Kampen lie in 1912, when Lijempf (Leeuwarden Ice and Milk products Factory) was founded . The development of formula for baby and toddler nutrition was started back in 1938. In 1973, Lijempf was taken over by Royal Wessanen, and from that point on concentrated on the export of infant formula under the Bebelac brand name. As the number of international contacts increased, the factory name was changed to Lyempf. In 1993 Lyempf was taken over by Nutricia. Six years later, the Hyproca Dairy Group, currently known as Ausnutria Hyproca, purchased the factory in Leeuwarden, which now has been named Lypack. In 2011, the takeover of the Kampen factory reunited the Leeuwarden and Kampen factories. Nowadays, the production of infant formula is the core activity of the two factories, both under the own brand name and based on private label and contract manufacturing.

Mr. YAN Weibin ("Mr. Yan"),顏衛彬 aged 49, was appointed as the executive Director on 8 June 2009 and was elected Chairman of the Board on 7 June 2013. Mr. Yan is a shareholder and director of Brave Leader Limited and Ausnutria Holding Co Ltd, the substantial shareholders of the Company, and also a director of a number of the Company's subsidiaries, including Ausnutria China and Ausnutria Hyproca. He joined the Group since the establishment of Ausnutria China in September 2003. Mr. Yan is responsible for leading the Board and making sure it works effectively and discharges its responsibilities and that all key and appropriate issues are discussed by the Board in a timely manner. Mr. Yan is also primarily responsible for the overall corporate strategy, planning and business development of the Group. Mr. Yan graduated from Hunan University with a degree in bachelor of engineering and MBA. Mr. Yan has been a director of Yuan Longping High-tech Agriculture Co., Ltd*（袁隆平農業高科技股份有限公司） ("Longping High-tech"), a company whose shares are listed on the Shenzhen Stock Exchange, from 2004. He was Longping High-tech's chief officer from 2004 to April 2010, the vice chairman and the chief financial officer from April 2010 to December 2011, the chief executive officer and chief financial officer from December 2011 to June 2012 and has become the vice chairman since June 2012. Mr. Yan resigned as the chief executive officer and the chief financial officer (remains as the vice chairman) of Longping High-tech in June 2012.

Mr. LIN Jung-chin ("Mr. Lin"), aged 60, was appointed as the executive Director on 12 December 2014. Mr. Lin is a shareholder and director of Center Laboratories, Inc. and Bioengine Capital Inc., both being the substantial shareholders of the Company. Mr. Lin is mainly responsible for the overall corporate strategy, planning and business development of the Group. Mr. Lin graduated with a bachelor degree in pharmacy from Taipei Medical University and was rewarded an honorary doctor in medical by Taipei Medical University in 2010. Mr. Lin also serves the chairmanship of several companies listed on the Emerging Stock Market in Taiwan, namely Center Lab, Medeon Biodesign, Inc., Mycenax Biotech Inc. and TPG Biologics, Inc. He also holds the directorship or as a member of the senior management of over ten companies. Mr. Lin has extensive experience in directing the reorganisation and restructuring of enterprises. He is actively engaged in the investment planning and integration of the biotechnology industry.

Mr. Bartle VAN DER MEER ("Mr. van der Meer"), aged 69, was appointed as the executive Director and Chief Executive Officer on 7 June 2013. Mr. van der Meer is one of the founders of Ausnutria Hyproca. He indirectly held 49% equity interests in Ausnutria Hyproca through the shareholding in Dutch Dairy Investments B.V. and has been involved in the strategic management since the establishment of Ausnutria Hyproca in 1994. He has also been a member of the board of directors and chief executive officer of Ausnutria Hyproca since 2012. Mr. van der Meer is primarily responsible for managing and executing the Group's overall business directions and corporate operation decisions. He graduated with a business administration degree in the Netherlands with a major in banking in 1966. He worked for Rabobank, a multinational banking and financial services group in the Netherlands for more than 25 years. He is serving as the executive director of PMH Investments B.V., a private equity which owned 46.55% equity interests in DDI, and Vegelin Group B.V. since 1994. Mr. van der Meer has been the chairman of supervisory board of sc Heerenveen NV (a soccer club which plays in the premier division in the Netherlands) since 1998 to 2012, and a member of Foundation Accell Group (a company listed on Euronext Amsterdam (formerly known as Amsterdam Stock Exchange) since 1998.

Ms. NG Siu Hung ("Ms. Ng"), aged 46, was appointed as the executive Director on 19 September 2009. Ms. Ng is primarily responsible for the Group's investor relations. She studied applied english language at Changsha University and graduated at The University of Westminster, the United Kingdom with a master of arts degree in human resource management. She was the representative of a computer network company and then, a manager of a trading company for about 2 years. Ms. Ng has been a director of Hunan Yukai Real Estate Development Co., Ltd*（湖南宇凱房地產有限公司）since 2004. She is the officer of Public Relations of Hunan XinDaXin Co., Ltd*（湖南新大新股份有限公司）.

OTC雙跨藥品(處方藥&非處方藥) 退出醫保兩難!

OTC退出医保目录将是未来趋势2015-08-04 08:43:00京华时报 近日，一条"OTC（非处方药）可能全部退出新医保目录"的新闻在业内引发震动。不过，7月24日，人力资源和社会保障部新闻发言人李忠在新闻发布会上回应称，这一消息并不属实。 尽管官方已经辟谣，但是关于"OTC该不该退出医保目录"的讨论却依然在发酵，很多人关心的是将来OTC会不会退出医保目录，退出后对老百姓有何影响？

退出是未来趋势 OTC英文全称是Over The Counter，中文名叫非处方药。据了解，2009年国家版医保目录中总计有2151个药品，其中属于OTC的产品共有556个品种药品，涉及化学药品200种，中成药356种。这556个OTC药品的去留，引发了大家的关注。此前有媒体报道，"即将启动的下一轮医保目录更新的工作中，或将作出历史上最为重大的调整，目录中现有的OTC药品品种或将全部退出"。也有媒体称，虽然具体退出进度未有统一意见，但可以确定的是"新医保目录不会增补新的OTC药品种进入"。 不过，7月24日，人力资源和社会保障部新闻发言人李忠在新闻发布会上回应称，这一消息并不属实。"下一轮基本医疗保险药品目录的调整工作并未启动。" 虽然官方已经辟谣，但未来OTC药品是否会退出医保目录呢？ 国家卫计委全国合理用药监测系统专家孙忠实指出，非处方药是和处方药相比，相对安全的药品，属于患者可以自购自用的药物。在国外，大部分非处方药都是自费的。"我认为，非处方药退出医保目录，这是一个未来的趋势，但不会一下子全部退出，可能是逐渐地分批地清退。" 据了解，在不少发达国家的医保体系中，就将非处方药退出医保目录，如美国也曾对医保购买OTC药品有诸多限制，2011年奥巴马的《平价医疗法案》规定只有拿到医生处方才能用"弹性消费账户"和"健康储蓄账户"购买OTC药品，这瞬间引发了对于医保自由购买权的捍卫与抗议。虽然2013年恢复了这两个账户自由购买OTC的权利，但传统医保账户却只允许消费处方药。

为医保基金减负 很多人不明白，非处方药为什么要退出医保目录呢？对此，孙忠实指出，这是为了减轻国家的开支和负担。 记者了解到，《2014年度人力资源和社会保障事业发展统计公报》显示，2014全年城镇基本医疗保险基金总收入9687亿元，支出8134亿元，分别比上年增长17.4%和19.6%。医保基金增长速度已低于支出速度。 同时，《中国医疗卫生事业发展报告2014》预测，2017年城镇职工基本医疗保险基金将出现当期收不抵支的现象，到2024年，将出现基金累计结余亏空7353亿元的严重赤字。医保基金正面临越来越大的支付压力，多省份统筹基金结存偏离"满足6-9个月支付需求"的红线。业内人士分析，从这个角度来说，OTC退出医保目录，有助于减轻医保基金的压力。 OTC该不该退出医保目录？这一热点话题也在网上引发了正反两方大讨论。有观点认为，通过将OTC药品从医保目录中清退这种方式，并不能实际减缓医保基金压力的问题。他们认为，OTC药品不能报销，患者就会通过走去医院就诊的报销流程，反而加重了医保资金的压力。原本可以自己在医保定点药房买药的消费者，为了省钱会涌向医院看门诊，也会令现在本就人满为患的看病难问题雪上加霜。 针对此观点，孙忠实指出，随着社会文化发展，人们的素质也会相应提高，等发展到了一定程度后，大部分人就不愿为了看个普通感冒花费巨大的时间精力成本，跑去医院就诊开药，而会自己去楼下药店自费买个非处方药，这也符合卫计委提出的"小病不进医院"的目标。

双跨药品再引关注 在OTC是否该退出医保目录的大讨论中，此前一直不为人所熟知的"双跨药品"也成为讨论的焦点。 所谓"双跨"药品，就是指既作为处方药又作为非处方药的药品。数据显示，我国现有OTC产品近4800个，其中接近一半是双跨产品。在2300多个双跨产品中，中成药双跨品种为2000多个。 据了解，我国的非处方药都是从处方药转化而来的。某些药作为处方药时有多个适应证，有些适应证患者能够自我诊断和自我药疗，在三限（限适应症、限剂量、限疗程）的规定下，将此部分适应证作为非处方药，可以安全地用于患者的小伤小病；而患者难以判断的部分仍作为处方药，于是，"双跨"药品应运而生。 如果OTC退出医保目录，那么，这些双跨药品该何去何从？ 此前，关于双跨药品的身份之争由来已久，不少专家呼吁取消"双跨"品种，但这遭到了不少医药企业的强烈反弹。 孙忠实指出，如果有一天OTC全部退出医保目录了，那国家相关部门也可以让企业选择，药品要么按照处方药存在，要么依照OTC品种存在。确定药品的唯一身份，也更利于老百姓安全用药。 京华时报记者夏文