Medicovestor, Inc., a biotechnology company advancing next-generation antibody-drug conjugates (ADCs), announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ADoBind MC001, its lead candidate for the treatment of pancreatic cancer.

Medicovestor公司是一家致力于推进下一代抗体药物偶联物（ADCs）的生物技术公司，该公司今天宣布，美国食品药品监督管理局（FDA）已授予其治疗胰腺癌的主导候选药物ADoBind MC001孤儿药资格（ODD）。

Pancreatic cancer is among the most aggressive and fatal malignancies, with a five-year survival rate under 10% and limited treatment advances over the past decades. ADoBind MC001 is designed to address this high unmet need through a new class of chemoimmunotherapy ADCs that combine potent tumor targeting with immune system engagement..

胰腺癌是最具侵袭性和致命性的恶性肿瘤之一，其五年生存率低于10%，且过去几十年治疗进展有限。ADoBind MC001旨在通过一类新型的化疗免疫疗法ADC来满足这一高度未满足的需求，这类ADC结合了强大的肿瘤靶向能力和免疫系统激活作用。

“We are proud to receive Orphan Drug Designation for ADoBind MC001,” said Dr. Seah Lim, CEO of Medicovestor. “This recognition underscores the potential of our platform to push the boundaries of what ADCs can do—especially in cancers that have historically resisted treatment.”

“我们为ADoBind MC001获得孤儿药资格感到自豪，”Medicovestor首席执行官Seah Lim博士表示，“这一认可凸显了我们的平台在突破ADC药物治疗极限方面的潜力，特别是在那些历来难以治疗的癌症领域。”

Adobind: A New Frontier in Adc Innovation

Adobind：抗体偶联药物创新的新前沿

While full preclinical data remains confidential, ADoBind MC001 integrates multiple proprietary enhancements to antibody structure, payload delivery, and tumor engagement—creating a distinct class of ADCs that go beyond conventional approaches.

虽然完整的临床前数据仍属机密，但ADoBind MC001整合了抗体结构、载荷递送和肿瘤结合的多种专有增强技术，创造了一类超越传统方法的ADC。

Key differentiators include:

关键区别包括：

Further data will be shared at upcoming scientific meetings and in select investor and partner briefings.

更多数据将在即将召开的科学会议以及部分投资者和合作伙伴简报中分享。

About Orphan Drug Designation

关于孤儿药指定

The FDA grants Orphan Drug Designation to investigational drugs intended for the treatment of rare diseases affecting fewer than 200,000 people in the U.S. Benefits include seven years of market exclusivity upon approval, tax credits, fee waivers, and potential eligibility for expedited review pathways..

美国食品药品监督管理局（FDA）授予用于治疗美国境内患病人数少于20万人的罕见疾病的在研药物孤儿药资格。其优势包括获批后七年的市场独占期、税收抵免、费用减免，以及可能符合快速审查通道的资格。

What’s Next

接下来是什么

Medicovestor is currently progressing ADoBind MC001 through IND-enabling studies, with a Phase 1 clinical trial expected to begin in early 2026.

Medicovestor 公司目前正在通过新药临床试验申请（IND）相关研究推进 ADoBind MC001，预计将在 2026 年初开始一期临床试验。

About Medicovestor, Inc.

关于Medicovestor公司

Medicovestor, Inc. is a biotechnology company developing novel antibody-drug conjugates through its proprietary ADoBind and ADoTope platforms. By reimagining how antibodies function within the tumor microenvironment, Medicovestor aims to unlock transformative therapies for solid tumors with high unmet needs..

Medicovestor公司是一家生物技术公司，通过其专有的ADoBind和ADoTope平台开发新型抗体药物偶联物。通过重新构想抗体在肿瘤微环境中的作用方式，Medicovestor旨在为具有高度未满足需求的实体瘤解锁变革性疗法。