OBI Pharma, Inc. a clinical stage oncology company （4174.TWO）, today announced that the U.S. Food and Drug Administration （FDA） has cleared an investigational new drug （IND） application for OBI-902, to conduct a Phase 1/2 study. OBI plans to enroll patients with advanced solid tumors. This IND clearance represents a significant milestone for OBI-902, bringing forward a potentially best-in-class Trop-2 -targeted cancer therapy for patients with high unmet medical needs..

浩鼎生技股份有限公司（OBI Pharma, Inc.，股票代码：4174.TWO），一家处于临床阶段的肿瘤学公司，今天宣布美国食品药品监督管理局（FDA）已批准OBI-902的新药临床试验（IND）申请，将开展一项1/2期研究。浩鼎计划招募晚期实体瘤患者。此次IND批准代表了OBI-902的一个重要里程碑，为具有高度未满足医疗需求的患者带来了一种潜在的最佳Trop-2靶向癌症疗法。

OBI’s Chief Executive Officer, Heidi Wang, Ph.D. noted, “The impending OBI-902-001 clinical trial intends to evaluate the safety, pharmacokinetics, and preliminary efficacy of OBI-902 in patients with advanced solid tumors. We are very excited to begin dosing patients in our Phase 1/2 clinical study of OBI-902 later this year.” .

浩鼎生技总裁兼首席执行官王慧博士表示：“即将进行的OBI-902-001临床试验旨在评估OBI-902在晚期实体瘤患者中的安全性、药代动力学和初步疗效。我们非常高兴能在今年晚些时候开始对OBI-902的1/2期临床研究中的患者进行给药。”

OBI-902 is a novel Trop-2 ADC utilizing OBI’s proprietary GlycOBI® ADC enabling technology. At the 2025 American Association for Cancer  Research  （AACR） meeting, OBI presented data demonstrating enhanced linker-payload stability, favorable pharmacokinetics with superior and durable antitumor activities of OBI-902 in numerous in-vitro and animal studies compared to other Trop-2 ADCs 1, 2.

OBI-902 是一种新型的 Trop-2 抗体药物偶联物 (ADC)，利用了 OBI 专有的 GlycOBI® ADC 赋能技术。在 2025 年美国癌症研究协会 (AACR) 会议上，OBI 展示的数据表明，与其他 Trop-2 ADC 相比，OBI-902 在众多体外和动物研究中表现出增强的连接子-载荷稳定性、良好的药代动力学特性，以及优越且持久的抗肿瘤活性。

The Phase 1/2 clinical study is planned to begin enrolling patients in 2H 2025..

第1/2阶段的临床研究计划于2025年下半年开始招募患者。

About OBI-902

关于OBI-902

OBI-902 is a Trop-2-targeted antibody-drug conjugate （ADC） that carries a potent topoisomerase I inhibitor payload to kill tumor cells and with a drug-antibody ratio （DAR） of 4. Trop-2 is highly expressed in a variety of solid tumors such as breast, ovarian, gastric, and many other cancer types, rendering it an ideal target for cancer therapy..

OBI-902 是一种靶向 Trop-2 的抗体药物偶联物 (ADC)，其携带强效的拓扑异构酶 I 抑制剂有效载荷以杀死肿瘤细胞，并具有 4 的药物抗体比率 (DAR)。Trop-2 在多种实体瘤中高度表达，如乳腺癌、卵巢癌、胃癌及许多其他癌症类型，因此成为癌症治疗的理想靶点。

OBI-902 is a novel site-specific glycan-conjugated ADC using OBI’s proprietary GlycOBI® platform, which provides improved stability and enhanced hydrophilicity. OBI-902 demonstrated remarkable antitumor efficacy, improved pharmacokinetic characteristics, and a favorable safety profile in various animal models.

OBI-902 是一种新型的位点特异性糖链偶联抗体药物偶联物 (ADC)，利用 OBI 专有的 GlycOBI® 平台，具有更高的稳定性和增强的亲水性。OBI-902 在多种动物模型中展现出显著的抗肿瘤效力、改善的药代动力学特性和良好的安全性。

IND of OBI-902 was submitted to the U.S. FDA on March 31, 2025, and the IND was cleared on April 30, 2025..

OBI-902的IND于2025年3月31日提交给美国FDA，并于2025年4月30日获得IND批准。

OBI has licensed Trop-2 targeting antibody from Biosion, Inc. （www.biosion.com） since December 2021, holding exclusive rights worldwide except in China. OBI holds worldwide commercial rights to OBI-902, to the exception of the rights pertaining to the antibody in China.

自 2021 年 12 月以来，OBI 已从 Biosion, Inc. （www.biosion.com）获得靶向 Trop-2 的抗体许可，除中国外，拥有全球独家权利。OBI 拥有 OBI-902 的全球商业权利，但中国境内与该抗体相关的权利除外。

About GlycOBI®

关于GlycOBI®

OBI has developed a unique glycan-based ADC technology （GlycOBI®）, which is in a ‘Plug and Play’ format and compatible with any antibodies, linkers, and payloads in various DAR. Utilizing OBI’s proprietary enzymatic technology （EndoSymeOBI®） and linker technology （HYPrOBI™）, GlycOBI® generates site-specific homogenous ADCs with an efficient and scalable process under GMP conditions.

OBI开发了一种独特的基于糖链的ADC技术（GlycOBI®），该技术采用“即插即用”形式，兼容各种DAR中的任何抗体、连接子和载荷。利用OBI专有的酶技术（EndoSymeOBI®）和连接子技术（HYPrOBI™），GlycOBI®能够在GMP条件下通过高效且可扩展的工艺生成位点特异性均质ADC。

The conjugation process of GlycOBI® avoids disrupting the antibody structure and ensures the ADC has similar biophysical characteristics to the native antibody. Furthermore, OBI’s linker technology has improved conjugation efficiency of the payload, reduced aggregation propensity, which provides advantages on manufacturing ADC products.

GlycOBI® 的共轭过程避免了对抗体结构的破坏，并确保抗体药物偶联物 (ADC) 具有与天然抗体相似的生物物理特性。此外，OBI 的连接子技术提高了载荷的共轭效率，降低了聚集倾向，这为制造 ADC 产品提供了优势。

GlycOBI® has overcome the limitations of traditional ADCs and achieved better antitumor activity and stability in various in vivo animal studies..

GlycOBI® 已经克服了传统ADC的局限性，并在多种体内动物研究中展现出更好的抗肿瘤活性和稳定性。

About OBI Pharma

关于浩鼎生技

OBI is a clinical stage global oncology company that is headquartered in Taiwan and established in 2002. Its mission, together with its wholly owned subsidiary OBI Pharma USA, Inc., is to develop novel cancer therapeutic agents for patients with high unmet medical needs.

OBI是一家临床阶段的全球肿瘤学公司，总部位于台湾，成立于2002年。其使命是与其全资子公司OBI Pharma USA, Inc.共同开发新型癌症治疗药物，满足患者高度未满足的医疗需求。

OBI’s primary focus is the development of novel ADCs, including the first-generation cysteine-based TROP-2 ADC, OBI-992. Using the company’s proprietary ADC enabling technology, GlycOBI®, powered by EndoSymeOBI® and HYPrOBI™; OBI has created its second generation novel ADC pipeline, including monospecific: OBI-902 （Trop-2）, OBI-904 （Nectin-4）, Trastuzumab-ADC （HER2）, bi-specifics and dual payload ADCs.

OBI的主要重点是开发新型ADC，包括第一代基于半胱氨酸的TROP-2 ADC——OBI-992。利用公司专有的ADC使能技术GlycOBI®（由EndoSymeOBI®和HYPrOBI™支持），OBI创建了其第二代新型ADC管线，包括单特异性：OBI-902（Trop-2）、OBI-904（Nectin-4）、Trastuzumab-ADC（HER2），以及双特异性和双载荷ADC。

To broaden the applicability of the linker technology, HYPrOBI™, OBI further developed a next-generation ThiOBI® platform to enable irreversible cysteine-based conjugation.  Additionally, OBI’s pipeline also includes the first-in-class AKR1C3-targeted small-molecule prodrug OBI-3424, which selectively releases a potent DNA-alkylating antitumor agent in the presence of the aldo-keto reductase 1C3 （AKR1C3） enzyme that is highly expressed in tumors.

为了拓宽连接子技术的适用性，HYPrOBI™，OBI进一步开发了下一代ThiOBI®平台，以实现不可逆的基于半胱氨酸的偶联。此外，OBI的研发管线还包括首创的AKR1C3靶向小分子前药OBI-3424，它在醛酮还原酶1C3（AKR1C3）酶高度表达的肿瘤中，选择性释放一种强效的DNA烷基化抗肿瘤药物。

Additional information can be found at www.obipharma.com..

更多信息请访问 www.obipharma.com。

GlycOBI®, EndoSymeOBI ®, ThiOBI® are registered trademarks of OBI. HYPrOBI™ is a trademark under registration.

GlycOBI®、EndoSymeOBI®、ThiOBI® 是 OBI 的注册商标。HYPrOBI™ 是正在注册的商标。

Source: obipharma.com

来源：obipharma.com