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MediLink Announces YL201 Granted Breakthrough Therapy Designation by FDA

June 23, 2025 — MediLink Therapeutics (“MediLink”), a clinical-stage biotechnology company, today announced that the United States Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to YL201 for the treatment of small cell lung cancer (SCLC). YL201 is an investigational B7H3-targeted antibody drug conjugate (ADC) developed based on MediLink’s proprietary TMALIN® (Tumor Microenvironment Activable LINker) technology platform.

2025-06-24

MediLink Therapeutics to Present Preclinical Data for Latest Innovations at AACR 2025

March 25, 2025- MediLink Therapeutics (“MediLink”), a clinical-stage biotechnology company, announces the presentation of preclinical data for two innovative ADC programs (YL217, a CDH17-targeting ADC, and YL242, a VEGF-targeting ADC) and its next-generation dual payload platform at the upcoming AACR Annual Meeting 2025. AACR will be held in Chicago, US April 25-30.

2025-03-26

MediLink’s YL217 received FDA Clearance of IND Application

February 1, 2025 — MediLink Therapeutics (“MediLink”), a clinical-stage biotechnology company, announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for YL217, an investigational antibody-drug conjugate (ADC) developed by MediLink. YL217 is the 11th ADC candidate entering into clinical stage developed based on MediLink’s proprietary TMALIN® technology platform.

2025-02-02

YL201 Received Another Breakthrough Therapy Designation for the Treatment of R/M NPC

January 20, 2025 — MediLink Therapeutics (“MediLink”), a clinical-stage biotechnology company, announced that the Center for Drug Evaluation (CDE) granted Breakthrough Therapy Designation to YL201, for the treatment of recurrent/metastatic nasopharyngeal carcinoma (R/M NPC). Previously, the Breakthrough Therapy Designation was also granted for YL201 by the CDE for the treatment of recurrent small cell lung cancer.

2025-01-20Learn more

MediLink Announces Collaboration with AstraZeneca to Explore the Combinational Potential of YL201 and Imfinzi®

Suzhou, China, Jan 14, 2025 -- MediLink Therapeutics (Suzhou) Co., Ltd. ("MediLink"), a clinical-stage biotech company, announced that a clinical collaboration has been established with AstraZeneca to explore the therapeutic potential in solid tumors, of the combination of MediLink's B7-H3-targeting antibody-drug conjugate (ADC) YL201 and AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi® ( durvalumab).

2025-01-14Learn more

MediLink Therapeutics Announces Strategic Partnership with Zai Lab to Develop a Novel LRRC15 Antibody-Drug Conjugate

SUZHOU, SHANGHAI and CAMBRIDGE, Mass., Jan 10, 2025 -- MediLink Therapeutics (Suzhou) Co., Ltd. (“MediLink”) today announced a new strategic collaboration and worldwide license agreement with Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) to use MediLink’s TMALIN® antibody-drug conjugate (ADC) platform for the development of a novel LRRC15 ADC, ZL-6201, consisting of an antibody discovered by Zai Lab.

2025-01-10Learn more

MediLink Announces YL201 Granted Orphan-Drug Designation by the US FDA

December 18, 2024 — MediLink Therapeutics (“MediLink”), a clinical-stage biotechnology company, today announced that the United States Food and Drug Administration (FDA) has granted Orphan-Drug Designation to YL201, for the treatment of small cell lung cancer (SCLC). YL201 is an investigational B7H3-targeted ADC, developed based on MediLink’s proprietary TMALIN® (Tumor Microenvironment Activable LINker) technology platform.

2024-12-18Learn more

MediLink successfully Held YL201 Investigator Meeting of a Phase III Study in Nasopharyngeal Carcinoma

December 1st, 2024 -- The investigator meeting of the phase III study in nasopharyngeal carcinoma for YL201, (a B7-H3 targeted antibody-drug conjugate), was held in Guangzhou, China. More than 70 experienced oncology experts from over 60 clinical sites (including many top oncologists from major academic cancer institutions across the country) attended the meeting to review and discuss the cutting-edge ADC technology in the treatment of nasopharyngeal carcinoma. The entire meeting was filled with an atmosphere of passion and a spirit of collaboration. YL201, a targeted antibody-drug conjugate is based on MediLink's TMALIN® platform and has received significant attention.

2024-12-02Learn more

MediLink Therapeutics B7H3 ADC-YL201 SCLC Phase III PI Conference, Guangzhou -More options for patients

On November 9, oncologists from more than 70 clinical research centers and experts from clinical trial institutions gathered in Guangzhou to participate in the multi-center, randomized controlled, open-label Phase III study of "Evaluating the efficacy and safety of YL201 for injection versus Topotecan hydrochloride for injection in patients with recurrent small cell lung cancer" organized by MediLink Therapeutics. Based on the availability of SCLC treatment in today's market and unmet clinical needs, in-depth exchanges and high-quality discussions were conducted regarding the design, preliminary clinical data, phase II study of YL201 and YL201-CN-302-01 research plan.

2024-11-09Learn more
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