On the 26th, Lotus Pharmaceutical announced that its independently developed bosutinib has been approved for market release by Taiwan’s Food and Drug Administration (TFDA). Bosutinib is a second-generation tyrosine kinase inhibitor (TKI) used in the treatment of chronic myeloid leukemia (CML). According to IQVIA data, Taiwan’s CML treatment market reached approximately US$100 million in 2023.

Bosutinib offers an effective second-line treatment option, specifically designed for adult patients newly diagnosed with Philadelphia chromosome-positive (Ph+) chronic phase CML, as well as those who have developed resistance or intolerance to prior TKI therapies.

The product received approval through Taiwan’s New Chemical Entity Category 2 (NCE-2) review pathway, reflecting TFDA’s strong recognition of its innovative mechanism of action and clinical efficacy.

CEO Petar Vazharov stated that with the growing number of CML patients and increasing demand for advanced treatment options, bosutinib will serve as a key addition to Lotus’s oncology portfolio, supporting the company’s long-term growth and delivering greater value to shareholders.

Resource: 美時獲台灣TFDA核准Bosutinib上市 搶攻1億美元CML市場

美時26日宣布，旗下自主研發的bosutinib獲得台灣TFDA上市核准。Bosutinib是一種第二代酪胺酸激酶抑制劑（TKI），用於治療慢性骨髓性白血病（CML）。根據IQVIA資料，2023年台灣CML治療市場規模約為1億美元。

Bosutinib提供一項有效的二線治療選擇，專為新診斷費城染色體陽性（Ph+）慢性期CML的成人患者，以及對先前TKI療法產生抗藥性或不耐受的患者所設計。

此產品是透過台灣「新藥二類（NCE-2）」審查途徑獲得核准，體現TFDA對其創新機轉與臨床療效的高度肯定。

總經理 Petar Vazharov 表示，隨著CML患者人數不斷增加與對進階治療需求日益殷切，bosutinib將成為美時腫瘤產品線中的關鍵補強，助力公司長期成長，並進一步為股東創造價值。 

5/27

StemCyte Receives Three Key FDA Designations to Accelerate Phase III Clinical Trial for Long COVID

StemCyte-KY announced on the 26th that its umbilical cord blood cell therapy, REGENECYTE, developed for the treatment of Long COVID, has received three critical acceleration designations from the U.S. Food and Drug Administration (FDA). These include the Regenerative Medicine Advanced Therapy (RMAT) designation, approval for charging under Expanded Access, and direct eligibility to apply for a pivotal Phase III clinical trial. With these recognitions, StemCyte has emerged as a global leader in cell-based therapies for Long COVID.

According to a 2024 report by Nature Medicine, more than 400 million people worldwide are affected by Long COVID, with annual global economic losses estimated at US$1 trillion. The most common symptom is fatigue (53.1%), followed by shortness of breath, joint pain, chest pain, cough, and altered sense of smell and taste. These lingering symptoms impact patients’ daily functioning and are often accompanied by cognitive and emotional disturbances. To date, no medications have been approved globally for the treatment of Long COVID, with most candidate therapies still in early-stage clinical development.

StemCyte CEO Tong-Young Lee stated that REGENECYTE demonstrated promising results in a completed Phase II clinical trial in the U.S. The primary efficacy endpoint showed that 85% of patients experienced significant improvement in fatigue after treatment, compared to 20% in the placebo group (P<0.01). Statistically significant differences (P<0.05) were also observed in fatigue severity, physical activity, pain, anxiety, and quality of life, highlighting the therapy’s potential for treating the multifaceted symptoms of Long COVID.

Lee explained that based on REGENECYTE’s clear efficacy and favorable safety profile, the FDA granted it an unprecedented triple acceleration pathway. First, the RMAT designation—equivalent to Breakthrough Therapy status—greatly expedites clinical development and the regulatory review process. Second, REGENECYTE was approved for Expanded Access with authorized charging, enabling the therapy to be used in clinical applications in the U.S. despite the absence of approved treatments, with detailed treatment information published on the company’s website. Third, the FDA has allowed StemCyte to bypass the lengthy trial design process and directly submit for a pivotal Phase III clinical trial, significantly shortening the timeline to regulatory approval.

REGENECYTE is currently the world’s only therapy for Long COVID to have demonstrated positive Phase II results and confirmed clinical efficacy, positioning it as a front-runner in regulatory approval for this indication. StemCyte plans to launch its Phase III trial this year, aiming to set a new record for the shortest approval timeline for a cell therapy drug. The company is also targeting rapid entry into the vast U.S. market and expanding REGENECYTE’s indications to include chronic fatigue syndrome and anti-aging therapies worldwide.

Resource: 永笙獲美FDA三項支持 加速推展「長新冠」三期臨床試驗