訊聯生技(1784)今(7)日舉行線上直播業績發表會，2019年營收較2018年成長，連續兩年獲利，主要是因應細胞治療應用需求升溫，連帶推升成人脂肪幹細胞、免疫細胞業務成長翻倍，此外訊聯新近取得化妝品製造GMP查廠認證，預計將為成長增添動能。在訊聯細胞委託研究/製造的業務方面，繼美國藥廠委託之後，近期也有歐洲藥廠洽詢。

高齡化浪潮，慢性病、癌症、退化性關節炎、骨質疏鬆症等發病率攀升，再生醫學因而成為當今許多國家最重點扶植的生醫領域之一，據Trends Market Research報告指出，全球組織工程及再生醫療市場預計2023年將達到1099億美元，2018年到2023年複合年增長率(CAGR)為34.8％。訊聯生技總經理劉天來表示，全球高齡化趨勢，連帶推升成人脂肪幹細胞、免疫細胞業務，2019年相較2018年成長達191.25%，展望未來，訊聯將持續拓展細胞治療應用範圍的戰略。

近期新冠肺炎肆虐全球，考驗企業的韌性，劉天來表示，訊聯20年來走過SARS及2008年金融風暴，觀察及對應這波疫情的影響與趨勢有三，第一就是間質幹細胞(MSC)的臨床應用加速。目前新型冠狀病毒(COVID-19) 確診已飆破130萬，死亡人數超過7萬，重症多數會出現嚴重肺損傷，並導致急性呼吸窘迫症候群(ARDS)，而ARDS致死率高達52.4%，儼然是COVID-19重症病患死亡的最大原因之一。在全球還沒研發出疫苗和特效藥前，國際上使用間質幹細胞治療新冠病毒引起的急性呼吸窘迫症候群(ARDS)、各種肺損傷的臨床研究，至少已達10件，如法國、巴西NestCell®、約旦。而澳洲再生醫學公司Mesoblast也已申請在澳洲、歐、美及中國使用間質幹細胞投入治療COVID-19引起的ARDS。

訊聯2005年即成立間質幹細胞庫，投入免疫調節、呼吸道疾病相關研究15年，包括2008年移植物對抗宿主疾病(GvHD)、2010年早產兒支氣管肺發育不全，以及5年前展開的人體試驗，用以降低流感或肺炎、嚴重肺損傷及敗血症導致的ARDS，證實間質幹細胞能降低發炎、改善肺損傷及肺纖維化，相關論文近日發表於國際重症醫學期刊《Critical care medicine》後，引起海外醫療單位的高度關注，尋求訊聯提供間質幹細胞協助治療肺損傷的可能性，例如馬來西亞、日本、越南、巴拿馬等地。劉天來表示，疫情嚴峻，訊聯以台灣優先為前提，積極對抗戰疫，目前訊聯建置的間質幹細胞庫足以供應130萬人使用，只要有醫療需求並符合各國規範，隨時都能成為台灣繼口罩之後、輸出海外的醫療資源，及時救援不成問題。

其次，近年全球細胞療法發展加速，以幹細胞做為臨床測試的需求也增加。劉天來指出，訊聯具有20年珍貴的細胞資源及豐富細胞處理經驗，並具備執行4次經過GTP(人體細胞組織優良操作規範)訪查臨床案件的優勢，細胞製備/代工的商機有機會呈現兩位數百分比成長。

第三是疫情提高民眾預防保健的意識，劉天來表示，臍帶血含有零歲的多樣免疫細胞，預留免疫細胞多樣性，為實現精準醫療的第一步。訊聯目前已擁有國際臍帶血暨骨髓資料庫（BMDW）最大亞洲臍帶血庫，相當擁有台灣最豐富的零歲免疫細胞庫。越來越多父母為孩子同時留下臍帶間質幹細胞和臍帶血，占第一季新生兒幹細胞服務的44%。

Recently, the acute respiratory distresssyndrome (ARDS) has attracted much attention, especially due to pneumoniacaused by the novel coronavirus (COVID-19 / SARS-CoV-2) that has spreadthroughout the world. Currently, there are more than 1,460,000 affected patientsin the world, and the death toll surpasses 80,000. COVID-19 not only mutatesrapidly, but also invades aggressively and can persist in the body for morethan 53 days. It can cause pneumonia and systemic viral infections in affected patients.Most of the severe cases have severe lung injury which can lead to ARDS. ForCOVID-19 patients that develop ARDS, the mortality rate can be as high as 52.4%.ARDS is one of the leading causes for COVID-19-related mortality. As thepandemic continues amidst the lack of available treatment and vaccine, and thelengthy time required to develop such, the number of critically ill patientswill no doubt rise rapidly. COVID-19 has proven to be a global health threatwithin a short time period. The fight is real and time is crucial. At acritical moment like this, mesenchymal stem cell (MSC) treatment has become anew option to fight diseases.

A newly published article in an internationally acclaimed journal in the fieldof critical car, “Critical Care Medicine”, reported on a 4-year human clinical trial by a Taiwanese medicalteam that uses umbilical cord mesenchymal stem cells (UCMSC) to treat ARDS. Theclinical trial showed that the allogeneic transplantation of UCMSC has good allograftcompatibility and is safe, and can be considered as a potential valuabletreatment option for ARDS caused by viruses or other factors in the future.During this critical fight against a virus, the study results are quiteexciting!

There have been at least ten clinicaltrials internationally, such as in France, Brazil (NESTCELL^®) and Jordan, onthe use of MSC to treat ARDS caused by COVID-19 or various lung injuries.Furthermore, an Australian regenerative medicine company, Mesoblast, has alsoapplied for the use MSC to treat COVID-19 related ARDS in Australia, Europe, theUnited States and China.

BIONETCorp. is a Taiwan-based international company established 20 years ago involvedwith cell therapy and regenerative medicine. In 2005, BIONET Corp. has establishedthe Mesenchymal Stem Cell Bank and has since then dedicated research efforts tostudy immunomodulation and respiratory diseases. For the past 15 years, BIONETCorp. has participated in multiple studies, including graft-versus-host disease(GvHD) in 2008, and bronchopulmonary dysplasia in premature infants in 2010. Fiveyears ago, a human clinical trial was initiated to study utilizing MSC to treatsevere lung injury and sepsis caused by influenza, pneumonia, and ARDS. It wasconfirmed that MSC can reduce lung injury and inflammation, and improve infiltration caused by pulmonary fibrosis. Thestudy and its findings were recently published in the international criticalcare journal "Critical Care Medicine", and has attracted greatattention from overseas medical units, such as from Malaysia, Japan, Vietnam,Panama and other countries, seeking collaboration opportunities with BIONETCorp. to provide MSC to assist in the treatment of lung injury. The recentCOVID-19 pandemic is a major global health threat. BIONET Corp. expressed that withtheir Mesenchymal Stem Cell Bank having sufficient storage units to treat 1.3million patients. BIONET Corp. expressed they will work with local governmentand local teams to meet the medical needs of Taiwan. While at the same time,serve global citizens as international medical demands arise. Just like the exportsof face masks, MSC and other cell therapy can be exported to serveinternational patients. A timely global medical rescue for COVID-19 patients isforeseeable.

TheTaiwan medical communities have an extensive experience in treating lung injurieswith stem cells. The Taiwan government also has rigorous and well-establishedregulations overseeing the use of cell therapy. BIONET Corp. has devoted 15years into MSC-related research. BIONET’s Mesenchymal Stem Cell Bank is also oneof the largest in the world. With both experience under its belt, BIONET Corp.has valuable resources to support the global fight. Combining the knowledge andresources of medical communities, government and industry, it will surely be agreat power for the global fight against new viruses and influenza in thefuture. Just as soldiers are committed to defending their homeland, we in thelife sciences are eagerly looking forward to contributing our efforts to theglobal community.

Additionalinformation：

CritCare Med. 2020 Mar 13. doi: 10.1097/CCM.0000000000004285.

Read more：

○ Acer's chairman nominates George Huang as successor

○ Firm helps hemophilia carrier have healthy child

○ Mesenchymal stem cell transplant greenlighted for clinical test