73% CNS ORR! FDA Granted ODD to Utidelone Injectable (UTD1) From Biostar Pharma for the Treatment of Breast Cancer Brain Metastasis
73% CNS ORR! FDA Granted ODD to Utidelone Injectable (UTD1) From Biostar Pharma for the Treatment of Breast Cancer Brain Metastasis
SAN FRANCISCO, March 29, 2024 /PRNewswire/ -- Biostar Pharma, Inc., the U.S. subsidiary of Beijing Biostar Pharmaceuticals Co., Ltd. which is a synthetic biology driven biopharma company focusing on the development and commercialization of innovative oncology drugs, announced today that their core pipeline product utidelone injectable (UTD1) had been granted an Orphan Drug Designation (ODD) by the FDA for the treatment of breast cancer brain metastasis (BCBM).
舊金山，2024 年 3 月 29 日 /PRNewswire/-- 映星製藥有限公司是北京映泰製藥有限公司的美國子公司，該公司是一家以合成生物學爲導向的生物製藥公司，專注於創新腫瘤藥物的開發和商業化。該公司今天宣佈，其核心管線產品Utidelone Injectable（UTD1）已被美國食品藥品管理局授予孤兒藥稱號（ODD），用於治療乳腺癌腦轉移（BCBM）。
Up to 30% of metastatic breast cancer patients develop brain metastases (BM). Prognosis of patients with BM is poor and long-term survival is rare. Currently the survival duration of BCBM patients is very limited, with the median survival of only about 7.2 months, and even shorter for triple-negative breast cancer (TNBC) BM which is only 3.5 months. Macromolecular drugs usually cannot penetrate the blood-brain barrier (BBB), leading to low therapeutic efficacy. Therefore, local treatments including surgery and radiation therapy are currently considered the standard treatments for BCBM. As of now, there is only one drug approved for the treatment of BCBM globally, suggesting huge unmet medical needs [1].
高達30％的轉移性乳腺癌患者出現腦轉移（BM）。BM 患者的預後不佳，長期存活率很低。目前，BCBM患者的存活時間非常有限，中位存活期僅爲7.2個月，三陰性乳腺癌（TNBC）BM的存活時間甚至更短，僅爲3.5個月。大分子藥物通常無法穿透血腦屏障（BBB），導致治療效果低下。因此，包括手術和放射治療在內的局部治療目前被視爲BCBM的標準治療方法。截至目前，全球只有一種藥物獲准用於治療BCBM，這表明巨大的醫療需求未得到滿足 [1]。
Utidelone has the ability to cross BBB due to its unique physicochemical characteristic and insusceptibility to P-glycoprotein-mediated efflux. This ability has been well demonstrated by both preclinical and clinical studies. A phase II clinical trial of utidelone injectable in combination with etoposide and bevacizumab for HER2 negative BCBM patients (n=17) showed excellent central nervous system (CNS) overall response rate (ORR) and CNS clinical benefit rate (CBR) of 73% and 91%, respectively. Another phase II clinical trial of utidelone injectable in combination with bevacizumab for HER2 negative BCBM patients (n=46) demonstrated median PFS of 7.7 months and 12-month OS rate of 74.4%. The FDA granted ODD to utidelone injectable for the treatment of BCBM based on these promising data.
Utidelone由於其獨特的物理化學特性以及對P-糖蛋白介導的外流不敏感，因此具有穿越BBB的能力。臨床前和臨床研究都充分證明了這種能力。一項針對HER2陰性BCBM患者（n=17）的Utidelone注射液與依託泊苷和貝伐珠單抗聯合使用的II期臨床試驗顯示，中樞神經系統（CNS）總體緩解率（ORR）和中樞神經系統臨床受益率（CBR）分別爲73％和91％。另一項針對HER2陰性BCBM患者的Utidelone注射劑與貝伐珠單抗聯合使用的II期臨床試驗顯示，中位PFS爲7.7個月，12個月的操作系統率爲74.4％。根據這些令人鼓舞的數據，美國食品藥品管理局批准了奧德隆注射液用於治療BCBM。
Considering utidelone's excellent BBB-crossing capability and its therapeutic potential for brain tumors, Biostar Pharma also plans to advance the clinical studies of utidelone injectable for the treatments of other brain tumors such as lung cancer brain metastasis and glioma this year.
考慮到Utidelone卓越的BBB交叉能力及其對腦腫瘤的治療潛力，Biostar Pharma還計劃在今年推進用於治療肺癌腦轉移和神經膠質瘤等其他腦腫瘤的Utidelone注射劑的臨床研究。
About Orphan Drug
關於《孤兒藥》
An orphan drug is used to treat a rare disease that affects fewer than 200,000 patients in the US. Orphan drug development presents several major challenges including difficulties in patient recruitment, small market size and low return for the pharmaceutical companies. To encourage drug development for the benefit of rare disease patients, an ODD granted by the FDA provides many incentives such as tax relief on clinical trial costs, opportunity to apply for grants to support clinical trials, waiver of new drug application fee, acceleration for regulatory pathway, and the potential to receive 7 years of marketing exclusivity in the US market upon product approval.
孤兒藥用於治療一種罕見的疾病，這種疾病在美國影響不到20萬名患者。孤兒藥開發帶來了幾項重大挑戰，包括患者招募困難、市場規模小和製藥公司回報率低。爲了鼓勵開發有利於罕見病患者的藥物，美國食品和藥物管理局批准的ODD提供了許多激勵措施，例如臨床試驗成本的稅收減免、申請臨床試驗補助金的機會、免除新藥申請費、加快監管途徑以及產品批准後可能在美國市場獲得7年的市場獨家經營權。
About Beijing Biostar Pharmaceuticals Co., Ltd.
關於北京映泰製藥有限公司
Beijing Biostar Pharmaceuticals Co., Ltd. is an integrated biopharma company focusing on the development of first- and best-in-class innovative anti-cancer drugs with independent intellectual property through state-of-the-art technology platforms of combinatorial biosynthesis, microbial fermentation production and microbial drug formulation development. With an insight-driven strategy, experienced R&D teams, cGMP-compliant manufacturing facility and domestic commercialization capability, the company have built a balanced product pipeline, covering both lead product life-cycle expansion and early-stage projects development. Further information can be found on the company's website or by contacting our business development team at [email protected] on partnering with us.
北京映泰製藥股份有限公司是一家綜合性生物製藥公司，專注於通過組合生物合成、微生物發酵生產和微生物藥物配方開發等最先進的技術平台，開發具有自主知識產權的一流和一流的創新抗癌藥物。憑藉洞察力驅動的戰略、經驗豐富的研發團隊、符合CGMP標準的製造設施和國內商業化能力，該公司建立了平衡的產品管線，涵蓋了主導產品生命週期的擴展和早期項目開發。更多信息可以在公司的網站上找到，也可以通過 [email protected] 聯繫我們的業務開發團隊，了解如何與我們合作。
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[1] Source: Frost & Sullivan Analysis |
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[1] 來源：弗羅斯特沙利文分析 |
SOURCE Beijing Biostar Pharmaceuticals Co., Ltd.
來源：北京映泰製藥有限公司
譯文內容由第三人軟體翻譯。