Oncotelic与美迪西在核酸药物、纳米制剂等领域达成战略合作

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2月25日，全球领先的RNA疗法制药企业Oncotelic Therapeutics（OTCQB: OTLC）及其合资公司GMP生物技术有限公司全资子公司Sapu Bioscience, LLC（Oncotelic持有45%股份），与上海美迪西生物医药股份有限公司（股票代码：688202.SH）宣布达成战略合作。

此次合作旨在通过美迪西一站式生物医药临床前综合研发服务平台，5年加速推进Oncotelic和SAPU20件新药临床试验申请（IND）项目，目前多个新型抗癌药物IND项目正在积极推进中。

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Oncotelic：全球领先的RNA疗法制药企业

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Oncotelic在肿瘤药物开发领域已深耕37年，专注于RNA疗法与小分子药物的研发创新，尤其在罕见儿科癌症领域取得了丰硕的研究成果。通过合资企业形式，Oncotelic获得多项罕见病疗法认定，包括针对DIPG的OT-101、针对黑色素瘤的CA4P及针对AML的OXi 4503。此后，Oncotelic收购PointR Data Inc.，转型为AI驱动的生物制药公司；获AL-101开发权，计划用于治疗帕金森病、勃起功能障碍等，不断拓展其研发管线与治疗领域。

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美迪西：全球新药临床前研发服务赋能者

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美迪西，作为中国少有的一站式生物医药临床前研发服务平台，始终站在国际技术前沿，成功搭建了涵盖ADC、核酸、PROTAC、抗体、多肽、疫苗以及细胞与基因治疗等多个领域的新分子药物研发服务平台。截至2024年底，美迪西已助力约520件IND项目获批临床、60件IND项目实现中美双报获批，积累了丰富的中美欧多国申报的成功经验。

聚焦核酸药物、纳米制剂等领域

美迪西助力Oncotelic5年推进20个IND项目

此次合作不仅是Oncotelic和SAPU在新型癌症疗法领域前瞻战略布局与深度研发信念的深刻体现，也是各方创新愿景高度契合、优势资源深度整合的典范。

根据战略协议，美迪西将依托一站式生物医药临床前综合研发服务平台，为Oncotelic和SAPU提供包括药物发现、药学研究（原料药、制剂）、临床前研究（药效、药代、安评）等在内的一站式临床前研发支持，5年助力Oncotelic和SAPU加速推进20个新药项目的IND申报，涵盖核酸药物和纳米制剂等创新药物，为全球新药研发注入崭新的活力与创新动力。

Vuong Trieu 博士

Oncotelic和SAPU董事长&CEO

“此次合作将为我们的开发项目带来革命性的变革。美迪西一站式生物医药临床前综合研发服务平台对于加速SAPU和Oncotelic药物研发进程至关重要。我们期待与美迪西继续深化合作，携手推动创新抗癌药物更快进入临床阶段。”

陈春麟博士

美迪西创始人、董事长&CEO

“非常荣幸能够与Oncotelic和SAPU达成战略合作。我们将依托在新药研发领域所积累的研发技术和国际经验，为Oncotelic和SAPU提供一站式临床前研发服务，携手并进，共同加速新药研发的进程，为全球病患开辟新的治疗选择。”

关于Oncotelic

Oncotelic Therapeutics（前身为Mateon Therapeutics, Inc.）最初于1988年在纽约州成立，名为OXiGENE, Inc.，1992年重新在特拉华州注册，2016年更名为Mateon Therapeutics, Inc.，并于2020年11月更名为Oncotelic Therapeutics, Inc.。公司致力于利用其在肿瘤药物开发领域的深厚专长，以改善癌症患者（尤其是罕见儿科癌症）的治疗效果和生存率。通过旗下持有45%股权的合资企业GMP Biotechnology Limited，Oncotelic已获得多项罕见儿科疾病认定：针对弥漫性内生型桥脑胶质瘤（DIPG）的OT-101疗法、针对黑色素瘤的CA4P疗法，以及针对急性髓系白血病（AML）的OXi 4503疗法。2019年11月，Oncotelic收购了PointR Data Inc.，旨在打造一家由人工智能驱动的生物科技公司。此外，公司于2021年第四季度获得了AL-101（用于鼻内递送阿扑吗啡）的开发权，计划将其应用于帕金森病、勃起功能障碍、女性性功能障碍及性欲减退症的治疗。这些疾病均影响着庞大患者群体，存在迫切的临床需求。有关AL-101的详细信息，请参阅公司于2024年4月12日向美国证券交易委员会（SEC）提交的2023年度10-K表格报告。

关于美迪西

美迪西（股票代码：688202.SH）成立于2004年，总部位于上海，致力于为全球制药企业、研究机构及科研工作者提供全方位的临床前新药研究服务。美迪西的一站式综合服务以强有力的项目管理和更高效、高性价比的研发服务助力客户加速新药研发进程，服务涵盖医药临床前新药研究的全过程，包括药物发现、药学研究及临床前研究。至2024年底，美迪西已为全球超2000家客户提供药物研发服务，参与研发完成的新药及仿制药项目已有约520件IND获批临床，与国内外优质客户共同成长。美迪西将继续立足全球视野，聚力中国创新，为人类健康贡献力量！

右滑查看中文版

AGOURA HILLS, Calif., February 25, 2025– Oncotelic Therapeutics, Inc. (OTCQB:OTLC). Oncotelic Therapeutics Inc., a leader in RNA-based therapeutics, including its subsidiaries (“Oncotelic”) and including Sapu Bioscience, LLC (“SAPU”), a wholly owned subsidiary of GMP Biotechnology Limited in which Oncotelic is a 45% owner, is pleased to announce a strategic partnership with Shanghai Medicilon Inc. (“Medicilon”) (stock code: 688202.SH). Through this collaboration, Oncotelic and SAPU will utilize Medicilon’s industry-leading rapid IND development platform to support up to 20 Investigational New Drug (IND) projects. Six of these INDs are ongoing and are focused on next-generation anticancer agents.

Oncotelic and SAPU's partnership with Medicilon is poised to significantly accelerate the development of our innovative oncology pipeline. This collaboration reflects our strategic move to strengthen our position as a leader in novel cancer therapies.

Enabling Rapid Growth: Medicilon’s integrated platform for drug discovery, pharmaceutical research, and preclinical development will expedite the regulatory pathways for Oncotelic’s and SAPU’s upcoming IND submissions.

Portfolio Expansion: This initiative will initially focus on the current six INDs but has the potential to extend up to 20 projects, reflecting the depth of Oncotelic’s and its affiliates’ R&D programs.

Dr. Vuong Trieu

Chairman and CEO of Oncotelic and SAPU

“This partnership is poised to be  a game-changer for our development programs. The ability to access a rapid IND-enabling platform is crucial for accelerating SAPU’s and Oncotelic’s development programs. We look forward to continued success working with Medicilon as we advance innovative anticancer agents to the clinic.”

Dr. Chen Chunlin

Chairman,Founder and CEO of Medicilon

“We are excited to partner with Oncotelic and SAPU and contribute our international experience in drug R&D. We are a comprehensive, one-stop services organization, from early discovery to IND registration, built to accelerate the translation of Oncotelic and SAPU’s pipeline into new therapeutic options for patients.”

About Oncotelic

Oncotelic (f/k/a Mateon Therapeutics, Inc.), was formed in the State of New York in 1988 as OXiGENE, Inc., was reincorporated in the State of Delaware in 1992, and changed its name to Mateon Therapeutics, Inc. in 2016, and Oncotelic Therapeutics, Inc. in November 2020. Oncotelic is seeking to leverage its deep expertise in oncology drug development to improve treatment outcomes and survival of cancer patients with a special emphasis on rare pediatric cancers. Oncotelic has rare pediatric designation for Diffuse Intrinsic Pontine Glioma (“DIPG” through OT-101) through its 45% joint venture, GMP Biotechnology Limited, melanoma (through CA4P), and Acute Myeloid Leukemia (“AML” through OXi 4503). Oncotelic also acquired PointR Data Inc. in November 2019 to build an AI driven biotechnology company. Further, Oncotelic acquired AL-101, during the 4th quarter of 2021, for the intranasal delivery of apomorphine. We intend to develop AL-101 for the treatment of Parkinson Disease, erectile dysfunction, female sexual disorder and hypoactive sexual desire disorder. All these ailments have a very large population suffering from them and there is a need for treatments for each. For more information on AL-101, refer to our 2023 Annual Report on form 10-K filed with the SEC on April 12, 2024.

About Medicilon

From its inception in 2004, Shanghai Medicilon Inc. (stock code: 688202.SH) has been committed to providing comprehensive R&D services to pharmaceutical companies, research institutions, and any organizations working in the preclinical space. By the end of 2024, Medicilon has provided drug development services to over 2,000 clients worldwide, and has been involved in the research and development of 520 new drugs and generic drug projects that have been approved for clinical trials with IND applications.

(美迪西)