On July 24, the national investigators' meeting for TAISHAN-303, a randomized, controlled, multicenter Phase III clinical study evaluating Tam-Peli (INN: Injection of Enkontamabtotamab YL201) versus investigator's choice of chemotherapy in patients with locally advanced or metastatic esophageal squamous cell carcinoma who have failed first-line therapy, was grandly held in Beijing. The study is sponsored by MEDILINK (Suzhou MEDILINK Therapeutics Co., Ltd.). The meeting was led by the leading principal investigators, Academician Yu Jinming of the Chinese Academy of Engineering and Professor Wang Linlin from Shandong First Medical University & Shandong Cancer Hospital and Institute, and brought together over 70 top domestic experts and scholars in the field of esophageal oncology, including Professor Meng Xiangjiao from Shandong Cancer Hospital and Professor Wang Qifeng from Sichuan Cancer Hospital, to share experiences, build consensus, and jointly contribute to the high-quality advancement of the YL201 Phase III clinical study in esophageal squamous cell carcinoma. Dr. Xue Tongtong, Founder, Chairman and CEO of MEDILINK, attended and delivered a speech, and Dr. Qin Xuke, Chief Medical Officer of the company, moderated the meeting.
On behalf of MEDILINK, Dr. Xue Tongtong extended sincere welcome and heartfelt gratitude to all investigators from across the country. He pointed out that esophageal squamous cell carcinoma is a highly prevalent malignancy in China, and patients with advanced disease have long faced a scarcity of treatment options. As a key candidate drug advanced through the company's independently developed TMALIN® core technology platform, the Phase III registration study of YL201 is a critical phase that will determine whether it can benefit patients at the earliest possible time. Dr. Xue expressed his hope that the participating experts would align on study understanding, exchange practical experience, and build a unified consensus. By comprehensively introducing the drug's mechanism and prior data, deeply discussing protocol interpretation and enrollment operations, and providing full-process supporting services from the company, MEDILINK would work in the same direction with all experts to overcome enrollment challenges. He emphasized that clinical trials carry the benevolence of physicians and the survival hopes of countless patients. Relying on the profound clinical expertise and rigorous scientific thinking of all experts, YL201 is expected to break through current treatment limitations and become a new therapeutic option for advanced esophageal squamous cell carcinoma, bringing new hope of longer survival and better quality of life to patients. He looked forward to the joint efforts of all parties to complete enrollment on schedule and with high quality, and to steadily advance the study to successful completion.
Academician Yu Jinming noted that China's international level and resource advantages in the field of esophageal cancer diagnosis and treatment are at the national forefront, and the country has the capability to complete the study with high quality. He stressed that all centers should uphold the principle of "quality is the bottom line, speed is life" to accelerate enrollment, and advance clinical research with high quality under compliance. He called for smooth channels of academic exchange and knowledge sharing, and for collaborative research efforts with a rigorous and scientific attitude, so that innovative scientific and technological achievements can benefit patients as soon as possible and contribute wisdom and strength to safeguarding people's health.
Dr. Qin Xuke reported on MEDILINK's development history and business operations, shared the encouraging news that YL201 is the first B7H3 ADC product globally to achieve positive Phase III results, and highlighted the company's independently developed and differentiated TMALIN® technology platform—a Tumor Microenvironment Activable LINker-payload ADC platform technology. This is a novel ADC platform technology with independent intellectual property rights owned by MEDILINK, which leverages dual cleavage mechanisms in the extracellular tumor microenvironment and intracellular lysosomes, and features high water solubility, high DAR homogeneity, high plasma stability, and tumor tissue enrichment.
Dr. Zhang Xian, Vice President of Clinical Medicine at the company, presented YL201's overall R&D plan and the latest clinical study data. Professor Meng Xiangjiao interpreted the clinical trial protocol and reported the current overall project progress. Professor Wang Qifeng shared best practices in efficient enrollment, safety management, and humanistic care in clinical research.
In her concluding remarks and outlook, Professor Wang Linlin stated that this meeting brought together the nation's top esophageal cancer research forces and clarified the scientific value and execution pathway of the Phase III clinical study in esophageal squamous cell carcinoma. She hoped that all centers would implement GCP at the highest standards, benchmark against international norms, strictly control the entire process of informed consent, screening, and follow-up, enhance the scientific rigor, precision, compliance, and authenticity of clinical data, and make every effort to advance the research so that cutting-edge scientific achievements can be transformed into better treatment options for patients as early as possible.
About Tam-Peli
Tam-Peli (YL201) is an ADC targeting B7-H3, developed using MediLink 's proprietary TMALIN® (Tumor Microenvironment-Activable Linker-payload) platform, which features a tumor-cleavable camptothecin-based linker-payload technology. In January 2026, Yilong Biomedical entered into an exclusive licensing agreement with Roche for the YL201 program, granting Roche exclusive global development, manufacturing, and commercialization rights outside mainland China, Hong Kong SAR, and Macau SAR. The two parties will jointly accelerate global R&D and regulatory filings, advancing development and commercialization across multiple solid tumor indications. Under the agreement, MediLink received an upfront payment and near-term milestones totaling $570 million, and is eligible for additional development, regulatory, and commercial milestone payments, as well as tiered royalties on net overseas sales.
Currently, YL201 is being evaluated in global clinical studies across multiple advanced solid tumor types. In China, YL201 has initiated three separate Phase III registrational trials for NPC, small cell lung cancer (SCLC), and esophageal squamous cell carcinoma (ESCC). Previously, YL201 has received five Breakthrough Therapy Designations from the NMPA's Center for Drug Evaluation (CDE) for indications including SCLC, NPC, ESCC, and pancreatic cancer, as well as a Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for SCLC. In addition, YL201 has been granted three Orphan Drug Designations by the FDA for SCLC, NPC, and ESCC.
About MediLink
Founded in 2020, MediLink is a clinical-stage biotechnology company focused on developing innovative conjugated drugs. The company has independently developed the differentiated TMALIN® technology platform, whose diversity and efficacy have been consistently validated through preclinical studies and ongoing global clinical trials across 14 ADC candidates currently in clinical stages. MediLink is dedicated to providing better treatment options for patients worldwide to address unmet medical needs. Headquartered in Suzhou, the company has R&D branches in Shanghai, Boston, and Singapore.
Medilink Announces Formal Acceptance by NMPA of Marketing Application for Tam-Peli (YL201) for Third-Line and Beyond Treatment of Nasopharyngeal Carcinoma
Null....