助力创新药物出海+1！美迪西祝贺宜联生物B7H3 ADC授权罗氏   Bili...

近日，宜联生物，与国际医药巨头罗氏（SIX: RO, ROG; OTCQX: RHHBY）就靶向B7H3的抗体偶联药物（ADC）YL201项目达成一项新的独家许可协议。此次超5.7亿美元首付款及近期里程碑付款的重磅交易，不仅是对YL201项目巨大临床价值和市场潜力的高度认可，更是对宜联生物自主创新的TMALIN技术平台国际竞争力的有力证明。

美迪西助力

美迪西作为宜联生物的长期合作伙伴，为YL201项目提供了高效的FTE（全时当量）服务，助力客户实现目标分子的高效研发与优化，并参与了宜联生物TMALIN技术平台建设，完成了该平台中有效载荷C24，C57及连接子-有效载荷B81的首次合成，同时开发了从价廉易得原料出发、简洁高效地合成有效载荷C24的中间体片段的工艺路线，为TMALIN平台及后续ADC候选药物的开发奠定了坚实基础。

YL201项目：靶向B7H3的ADC

实现小细胞肺癌治疗突破

本次授权罗氏的YL201项目正是基于宜联生TMALIN平台开发的重点管线，为一款靶向B7H3的抗体偶联药物。

YL201的关键组成结构特异性结合

目前，YL201项目正在全球范围内开展针对多种晚期实体瘤的临床研究。在中国，YL201已进入用于小细胞肺癌和鼻咽癌适应症的两项III期注册性临床试验阶段。在二线小细胞肺癌患者中的早期临床数据已展现出优异的客观缓解率和生存获益。2025年6月，美国FDA授予YL201一项突破性疗法认证，用于治疗小细胞肺癌，此前，YL201已获得美国FDA授予的三项孤儿药资格认证，包括小细胞肺癌、鼻咽癌及食管鳞状细胞癌。这些进展预示着YL201有望为全球患者带来新的治疗希望。

TMALIN平台：以肿瘤微环境裂解技术

重塑ADC开发范式

宜联生物TMALIN技术平台是本次全球合作的核心基石。该平台通过独特的肿瘤微环境胞外酶切机制，克服了传统ADC技术的局限：其能够在肿瘤组织局部特异性释放有效载荷，大幅拓宽了抗体选择范围，并产生强效的旁观者效应，从而对异质性肿瘤具有突出治疗潜力。此外，基于TMALIN构建的ADC具备极高的循环稳定性、优异的理化性质与高均一性的定点偶联（DAR=8），显著提升了药物的安全性与开发成功率。

宜联生物产品管线

凭借突出的技术优势，宜联生物TMALIN平台已与罗氏、BioNTech、信诺维、和铂医药、复宏汉霖、再鼎医药等多家企业达成授权合作。截至目前，采用该平台的技术或产品授权已达10余项，并有13款相关药物进入临床研究阶段，6款药物授权出海。这一源自中国的原创ADC技术平台已获得全球药企的高度青睐，充分证明了其强大的国际竞争力与临床转化潜力。

美迪西ADC药物研发服务平台

已助力30+个ADC药物获批临床

在ADC药物研发领域，美迪西拥有多年实战经验与深厚技术积累，已搭建覆盖ADC Payloads合成、药物偶联、药效学评价、药代动力学评价及安全性评价的一站式临床前研发服务平台。截至2025年6月底，美迪西已成功助力30个ADC 药物获批临床，并有多个ADC项目在研。

美迪西创始人、董事长兼CEO陈春麟博士表示：“祝贺宜联生物创新药再次成功出海，达成这一里程碑合作。这不仅彰显了宜联生物在ADC领域的源头创新实力，也印证了中国创新药企在全球合作与技术输出方面能力的持续提升。作为宜联生物TMALIN平台发展的见证者与赋能者，我们深受鼓舞与荣幸，将持续深耕ADC临床前研发领域，不断升级一站式服务平台的技术能力，助力更多创新药物加速研发进程，共建开放、协同、高效的全球生物医药创新生态。”

关于宜联生物

宜联生物成立于2020年，是一家专注于开发创新型偶联药物的临床阶段生物科技公司。宜联生物已自主开发具有差异化的TMALIN技术平台，其多样性与疗效已通过13个处于临床阶段的ADC候选产品在临床前研究和正在进行的全球临床试验中得到持续验证。宜联生物医药专注于为全球患者提供更优治疗选择，以满足尚未被满足的医疗需求。公司总部位于苏州，并在上海、波士顿及新加坡设有研发分支机构。

Recently, MediLink Therapeutics entered into a new exclusive license agreement with Roche (SIX: RO, ROG; OTCQX: RHHBY), a global pharmaceutical giant, for YL201, an antibody-drug conjugate (ADC) targeting B7H3. This landmark deal, featuring an upfront payment and near-term milestone payments exceeding USD 570 million, not only serves as a strong recognition of the substantial clinical value and market potential of the YL201 program, but also stands as a compelling testament to the international competitiveness of MediLink Therapeutics’ proprietary TMALIN technology platform.

As a long-term partner of MediLink Therapeutics, Medicilion provided efficient Full-Time Equivalent (FTE) services for the YL201 program, facilitating the efficient R&D and optimization of the target molecule for the client, and also participated in the development of MediLink Therapeutics’ TMALIN technology platform. In addition to completing the synthesis of linkers and payloads for this platform, MediciLion developed a concise and efficient process route for synthesizing payload intermediates from inexpensive and readily available raw materials, laying a solid foundation for the TMALIN platform and the subsequent development of ADC drug candidates.

YL201 Program: A B7H3-Targeting ADC Breaking New Ground in Small Cell Lung Cancer Treatment

The YL201 program licensed to Roche is a key pipeline asset developed on MediLink Therapeutics’ TMALIN platform, which is an ADC targeting B7H3.

Structural Specific Binding of YL201’s Key Components

Currently, global clinical studies of YL201 are underway for multiple advanced solid tumors. In China, YL201 has entered Phase III registration clinical trials for two indications: small cell lung cancer (SCLC) and nasopharyngeal carcinoma. Early clinical data in patients with second-line SCLC have demonstrated impressive objective response rates and survival benefits. In June 2025, the U.S. FDA granted Breakthrough Therapy Designation (BTD) to YL201 for the treatment of SCLC. Prior to this, YL201 had already obtained three Orphan Drug Designations (ODD) from the U.S. FDA, covering SCLC, nasopharyngeal carcinoma, and esophageal squamous cell carcinoma. These advancements indicate that YL201 is poised to bring new treatment hope to patients worldwide.

TMALIN Platform: Reshaping ADC Development Paradigm with Tumor Microenvironment Cleavage Technology

MediLink Therapeutics’ TMALIN technology platform is the core cornerstone of this global collaboration. Through its unique extracellular enzymatic cleavage mechanism in the tumor microenvironment, this platform overcomes the limitations of traditional ADC technologies: it enables the localized and specific release of payloads in tumor tissues, significantly expands the scope of antibody selection, and generates a potent bystander effect, thereby exhibiting outstanding therapeutic potential against heterogeneous tumors. Furthermore, ADCs constructed based on the TMALIN platform possess high circulatory stability, excellent physicochemical properties, and highly homogeneous site-specific conjugation (DAR = 8), which markedly enhance the safety and development success rate of the drugs.

MediLink Therapeutics’ Pipeline

Leveraging its prominent technological advantages, MediLink Therapeutics’ TMALIN platform has entered into licensing collaborations with numerous companies including Roche, BioNTech, Evopoint , Harbour BioMed, Henlius, and Zai Lab. To date, more than 10 technology or product licensing deals based on this platform have been secured, with 13 related drugs advancing to clinical research phases and 6 drugs licensed for overseas markets. This original ADC technology platform originating from China has gained high recognition from global pharmaceutical enterprises, fully demonstrating its strong international competitiveness and clinical translation potential.

Medicilion’s ADC Drug R&D Service Platform: Enabling Over 30 ADC Drugs to Gain Clinical Approval

In the field of ADC drug R&D, Medicilon boasts years of practical experience and profound technical accumulation, having established an integrated preclinical R&D service platform covering ADC payload synthesis, drug conjugation,pharmacodynamic evaluation, pharmacokinetic evaluation, and safety evaluation. As of the end of June 2025, Medicilon has successfully supported over 30 ADC drugs in obtaining clinical approval, with multiple ADC programs currently under research.

Dr. Chunlin Chen, Founder, Chairman and Chief Executive Officer of Medicilon, commented: “We congratulate MediLink Therapeutics on the successful overseas expansion of another innovative drug and the achievement of this milestone collaboration. This not only demonstrates MediLink Therapeutics’ strength in original innovation in the ADC field, but also reflects the continuous improvement of Chinese biotech companies’ capabilities in global cooperation and technology export. As a witness and enabler of the development of MediLink Therapeutics’ TMALIN platform, we are greatly encouraged and honored. Medicilon will continue to deepen our focus on the preclinical R&D of ADCs, continuously upgrade the technical capabilities of our one-stop service platform, accelerate the R&D process of more innovative drugs, and jointly build an open, collaborative, and efficient global biopharmaceutical innovation ecosystem.”

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. Medicilon has built an integrated one-stop R&D platform covering drug discovery, CMC and preclinical studies, and has established service platforms in cutting-edge fields such as ADC, nucleic acids, peptides, CGT, PROTAC, and antibodies. Medicilon has established a quality system in compliance with international standards and has obtained GLP certifications from China's NMPA, the US FDA, the EU OECD, and Japan's PMDA, as well as AAALAC accreditation. Currently, Medicilon has nearly 80,000 square meters of R&D laboratories.

By the end of 2025, Medicilon has provided drug development services to over 2,000 clients worldwide, and has been involved in the research and development of 610+ new drugs and generic drug projects that have been approved for clinical trials with IND applications. For more information, please visit the company's official website at .cn.

(美迪西 动态宝)