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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.

2025-01-20

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).

2025-01-14

MediLink Therapeutics Wins the 2024 Endpoints 11 Award

Boston, USA, September 26, 2024 -- The annual most valuable biotech selection by Endpoints News, "The Endpoints 11 award", was announced. MediLink therapeutics (“MediLink”) was selected as one, and the only one from China, of the E11 2024 award recipients.

2024-09-27Learn more

MediLink presents YL201 (B7H3 ADC) at ESMO 2024, with over 6-months PFS in SCLC, and showing pan-tumor benefits

The first publication of clinical data for YL201, featured in an oral presentation at ESMO 2024. Encouraging antitumor activity of YL201 in multiple solid tumor types, including SCLC, NPC, and wild-type NSCLC, from Phase I escalation and expansion results. In extensive-stage SCLC patients, ORR was 68.1% and mPFS was 6.2 months.

2024-09-14Learn more

MediLink Therapeutics announces a multi-target TMALIN® ADC technology platform license agreement with BioNTech

MediLink Therapeutics (Suzhou) Co., Ltd. ("MediLink"), a clinical-stage biotech company, today announces a new strategic collaboration with BioNTech SE (Nasdaq: BNTX, "BioNTech"), a next-generation immunotherapy company pioneering novel therapies for cancer and other serious diseases, under which BioNTech will receive an exclusive option to an exclusive global license to apply MediLink’s TMALIN® antibody-drug conjugate (ADC) platform, for several novel targets chosen by BioNTech.

2024-05-27Learn more

MediLink announces the first patient dosed with YL211

SUZHOU, CHINA, May 2, 2024 -- MediLink Therapeutics (“MediLink”) today announced that the first patient has been successfully dosed with YL211 in a phase I study in the US. MediLink and Roche had previously entered into a worldwide collaboration and license agreement on YL211. Following the execution of this agreement, the Investigational New Drug (IND) application for YL211 has been cleared by the U.S. Food and Drug Administration (FDA), and a phase I study to assess the safety, pharmacokinetics and preliminary efficacy of YL211 in patients with advanced solid tumors has been initiated subsequently.

2024-05-02Learn more

MediLink Therapeutics presents its platform and pipeline progress at AACR 2024

MediLink Therapeutics will present its next-generation TMALIN ("Tumor Microenvironment Activable LINker-payload”) platform and preclinical results of YL205, a novel antibody drug conjugate targeting NaPi2b, at the American Association for Cancer Research 2024 meeting (AACR 2024), which takes place April 5-10 in San Diego, United States. Presented studies are as follows:

2024-04-07Learn more

MediLink Therapeutics Announces Worldwide Collaboration and License Agreement with Roche to develop next-generation ADC in Oncology

SUZHOU, CHINA, January 2nd, 2024 -- MediLink Therapeutics (“MediLink”), announced today that it has entered into a worldwide collaboration and license agreement with Roche (SIX: RO, ROG; OTCQX: RHHBY) on the development of a next-generation antibody-drug conjugate candidate YL211, targeting c-Mesenchymal epithelial transition factor (c-Met) against solid tumors.

2024-01-02Learn more

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