Application Number: 2026-15372

Submitted By: Precision Biotech Taiwan Corp.

Manufactured By: Precision Biotech Taiwan Corp.

Tradename: Precision Biotech-Human Umbilical Cord Mesenchymal Stem Cell Exosomes

[By Hui-Lin Zhou, Medical Correspondent]
      Precision Biotech, Taiwan’s leading cell therapy innovator, proudly welcomed a cross-disciplinary delegation from 13 prestigious Philippine universities, spanning the fields of medicine, agriculture, biotechnology, aviation, education, engineering, and maritime studies. This milestone visit not only marked a significant step in Taiwan’s expanding biotech diplomacy, but also highlighted the Philippines’ growing commitment to advancing regenerative medicine and cancer immunotherapy.

The visit showcased Precision Biotech’s strides in international outreach and reinforced Taiwan’s leadership in cancer immunotherapy and regenerative medicine across Asia. Through strategic academic alliances, Precision Biotech seeks to integrate scientific research, clinical practice, and educational resources to inject fresh momentum into the Asia-Pacific’s next wave of innovation in cell-based and precision medicine.

Mr. Yeh, General Manager of Precision Biotech (center, back row), joins representatives from 13 Philippine universities in a group photo, symbolizing a shared commitment to advancing global collaboration in cancer immunotherapy and regenerative medicine.

The delegation included vice presidents, deans, and research directors from institutions such as Bulacan Agricultural State College, Nueva Ecija University of Science and Technology, and the Philippine State College of Aeronautics—academic leaders with significant influence in research and policy-making in their respective sectors. During the multi-day program, Precision Biotech arranged a series of in-depth engagements, including a site visit to Taipei Medical University, underscoring Taiwan’s synergy between academia and the biotechnology industry.

During the conference, Philippine scholars expressed strong appreciation for Precision Biotech’s achievements in cancer immunotherapy, stem cell and exosome research, and anti-aging medicine. Of particular interest was the company’s pioneering work in exosome-based regenerative therapies, a rapidly emerging global field. Several universities signaled their intent to pursue preclinical research partnerships, launch joint faculty training programs, and explore student and talent exchange initiatives.

This dynamic exchange has laid a solid foundation for ongoing scientific and educational cooperation between Taiwan and the Philippines, signaling a new era of regional collaboration in the pursuit of advanced medical innovation

文章連結:英文:

 

 

精準生技公司2017年成立,主要發展主業有間質幹細胞、免疫細胞及外泌體三項之研發及臨床運用業務,董事長葉明功表示,公司每季均訂有目標,都能如期達標,持續締造新的里程碑。

葉明功觀察,幹細胞已淪為高度競爭的紅海市場,全球雖有業者取得藥證,也出現蛋塔效應般的併購或歇業現象。精準以免疫細胞治療為方向,技術及成本門檻較高,台灣僅5、6家業者,其中僅2、3家有進行臨床試驗往藥證申請發展,精準已完成臨床一期結案報告、臨床二期申請通過進行中。不同於業界採取自體細胞,精準發展異體免疫細胞治療,並實現規模化量產,業界唯一,發展前景佳。

精準生技董事長葉明功。翁永全/攝影
精準生技董事長葉明功。翁永全/攝影

葉明功認為,台灣具備發展生技醫療技術的優勢及應用潛力,加上醫生的配合度高,有潛力成為另一個護國產業。據統計,國內再生細胞公司多達200多家,37家申請GTP查驗,目前通過27件。精準為業界領頭羊,核心技術均為自行開發而非自國外引進,CAR-NK 及NK細胞凍存技術目前為國際領先技術,間質幹細胞之外泌體除已獲得IRB同意函可進行商用,並已標準化產程可達一次量產達50公升,遠高於目前的市場水準,外泌體無菌凍晶製劑已外銷到美國、澳洲及日本,樹立台灣製造進階為台灣創造的典範。

精準與美、日、澳洲大企業合作,採大聯盟作戰及系統整合,並且布局人口逾20億的東協市場。葉明功說,CIK自體免疫治療特管法自費治療的一個療程費用高達180萬,精準只要抓住1%高端消費族群,就能帶來可觀商機,呼籲台灣應朝發展成為國際醫療核心成為重要的再生治療促進健康島。

葉明功擔任公職25年,曾任食藥署署長。他自喻曾身為「裁判」,創立精準生技後,同步發展技轉及外銷,如今成為教練兼投手的角色,天明及尖端醫為近年的技轉實績。他在食藥署署長任內,致力推動新藥審查透明化及改善新藥審查效率的問題,共核發2張台灣首發新藥藥證,如今台灣首發新藥藥證已達15張。他表示,特管法除促使再生醫療加速發展外,更樂見再生二法及其子法明年公布施行後台灣再生醫療發展將更獨步全球創造卓越。

精準生技是第一家進駐台北生技園區公司,也榮獲2021年台北生技獎創新金獎等殊榮。內湖細胞工廠通過GTP認證,未來計畫在新竹設GMP廠,也評估到屏東南科生技園區發展。目前股本5,000多萬,去年營收9,000多萬,獲利4,000萬接近一個股本,年底將啓動A輪募資,每股1.5美元,募得1.5億美元以加速公司發展及臨床藥證研發。

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