YL201 / MediLink, Roche - LARVOL DELTA

YL201-INT-102-02: A Study of YL201 in Combination with Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors (clinicaltrialsregister.eu) - P1/2 | N=35 | Not yet recruiting | Sponsor: Medilink Therapeutics (Suzhou) Co. Ltd.

New P1/2 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Phase III Study Evaluating YL201 Versus ICC in 2L ESCC (clinicaltrials.gov) - P3 | N=440 | Not yet recruiting | Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.

New P3 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

A Study YL201 in Patients With Selected Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=990 | Active, not recruiting | Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

A Study of YL201 in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=118 | Not yet recruiting | Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.

New P1/2 trial • Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor • Thoracic Cancer

A B7H3-targeting antibody-drug conjugate in advanced solid tumors: a phase 1/1b trial. (PubMed, Nat Med) - P1, P1/2 | "YL201, a novel B7H3-targeting ADC, leverages a tumor microenvironment activable linker-payload platform, coupled with a novel topoisomerase 1 inhibitor via a protease-cleavable linker...Phase 3 clinical trials for patients with SCLC and NPC have already been initiated. ClinicalTrials.gov identifiers: NCT05434234 and NCT06057922 ."

Journal • P1 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Hematological Disorders • Interstitial Lung Disease • Leukopenia • Lung Adenocarcinoma • Lung Cancer • Nasopharyngeal Carcinoma • Neutropenia • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • CD276

YL201, a novel B7H3-targeting antibody-drug conjugate (ADC), in patients (pts) with advanced solid tumors: Results from a first-in-human phase I study (ESMO 2024) - P1, P1/2 | "YL201 has demonstrated encouraging efficacy in heavily pretreated advanced solid tumors with manageable safety and tolerability profile."

Clinical • Metastases • P1 data • Lung Cancer • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • CD276

MediLink Therapeutics ("MediLink") today announced that it has entered into a new collaboration and exclusive licensing agreement with Roche…for the development and commercialization of YL201, an investigational novel antibody-drug conjugate (ADC) asset targeting B7H3 across numerous solid tumor types. (PRNewswire) - "Under the terms of the agreement, MediLink will grant Roche an exclusive license to develop, manufacture, and commercialize YL201 worldwide, excluding the mainland of China, the Hong Kong Special Administrative Region, and the Macau Special Administrative Region. MediLink will receive upfront and near-term milestone payments of US$ 570 million, together with additional development, regulatory, and commercial milestone payments, as well as tiered royalties on net sales of YL201 outside of China, once approved."

Licensing / partnership • Esophageal Squamous Cell Carcinoma • Nasopharyngeal Carcinoma • Small Cell Lung Cancer

A Study of YL201 in Combination With Toripalimab and With or Without Cisplatin in Nasopharyngeal Carcinoma. (clinicaltrials.gov) - P1/2 | N=202 | Recruiting | Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.

New P1/2 trial • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

A Study of YL201 and Ivonescimab (AK112) in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=260 | Recruiting | Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Study of YL201 and Ivonescimab (AK112) in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=260 | Not yet recruiting | Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.

New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

YL201-INT-101-01: A Study of YL201 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=312 | Recruiting | Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. | Phase classification: P1 ➔ P1/2 | N=196 ➔ 312

Enrollment change • First-in-human • Phase classification • Oncology • Prostate Cancer • Solid Tumor

Yilian Biopharmaceuticals' YL201 Receives Breakthrough Therapy Designation from the U.S. FDA (Yilian Biopharma Press Release) - "Suzhou Yilian Biopharmaceutical Co., Ltd...announced today that YL201 has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of small cell lung cancer (SCLC)."

Breakthrough therapy • Small Cell Lung Cancer

DeLLphi-310: Study of Tarlatamab in Combination With YL201 With or Without Anti-programmed Death Ligand 1 (PD-L1) in Participants With Extensive Stage (ES) Small Cell Lung Cancer (SCLC) (clinicaltrials.gov) - P1 | N=200 | Recruiting | Sponsor: Amgen | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

YiLian Biopharmaceuticals YL201 Phase I Study Results Published in Nature Medicine [Google translation] (bydrug.pharmcube.com) - P1/1b | N=287 | NCT05434234 | Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. | "This is a global multicenter, open-label Phase I/Ib clinical trial, divided into dose escalation (Phase I) and dose expansion (Phase Ib), including patients with extensive-stage small cell lung cancer (ES-SCLC), nasopharyngeal carcinoma (NPC), non-small cell lung cancer (NSCLC), etc....Among 72 evaluable patients with extensive-stage small cell lung cancer (ES-SCLC), the objective response rate (ORR) reached 63.9%, the disease control rate (DCR) reached 91.7%, and the median progression-free survival (mPFS) was 6.3 months....Among 70 evaluable patients with nasopharyngeal carcinoma (NPC), the objective response rate was 48.6%, the disease control rate was 92.9%, the median progression-free survival was 7.8 months, and the median duration of response was 8.4 months."

P1 data • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Small Cell Lung Cancer

(DeLLphi-310): Study of Tarlatamab in Combination With YL201 With or Without Anti-programmed Death Ligand 1 (PD-L1) in Participants With Extensive Stage (ES) Small Cell Lung Cancer (SCLC) (clinicaltrials.gov) - P1 | N=200 | Not yet recruiting | Sponsor: Amgen

New P1 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Intracranial efficacy of YL201, a novel B7-H3-targeting antibody-drug conjugate (ADC), in patients (pts) with small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC) (ELCC 2025) - P1, P1/2 | "YL201 shows durable intracranial antitumor activity in SCLC and WT NSCLC pts with CNS metastasis at baseline, supporting further investigation of YL201 in these pts."

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Study YL201 in Patients With Selected Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=990 | Recruiting | Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. | N=640 ➔ 990 | Trial completion date: Oct 2027 ➔ Oct 2028

Enrollment change • Trial completion date • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Phase III Study of YL201 in Recurrent or Metastatic Nasopharyngeal Carcinoma (clinicaltrials.gov) - P3 | N=400 | Recruiting | Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

A Phase III Study of YL201 in Relapsed Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=438 | Recruiting | Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Yilian Biopharma Announces Collaboration with AstraZeneca to Explore Combination Potential of YL201 and Durvalumab [Google translation] (vbdata.cn) - "Yilian Biopharma is collaborating with AstraZeneca to explore the potential of YL201 and Durvalumab in combination for the treatment of solid tumors, and has initiated a Phase I/Ib study to evaluate its safety, efficacy and pharmacokinetics. YL201 is an antibody-drug conjugate targeting B7H3, and has accumulated efficacy and safety data."

Commercial • New P1/2 trial • Oncology • Solid Tumor

Domestic new drugs have a breakthrough!…Class I new drugs have been included in the breakthrough therapy [Google translation] (Sohu.com) - "On January 8, the official website of the China Food and Drug Administration (CDE) announced that four domestically produced Class I new drugs were to be included in the breakthrough therapy category, which attracted widespread attention...drugs are...YL201 (Yilian Biopharma), IBI343 (Innovent Biologics)...YL201, developed by Yilian Bio, is an antibody-drug conjugate (ADC) targeting B7-H3, mainly used to treat recurrent or metastatic nasopharyngeal carcinoma...Innovent Biologics' IBI343 is an ADC targeting CLDN18.2, developed specifically for advanced pancreatic ductal adenocarcinoma."

Breakthrough therapy • Nasopharyngeal Carcinoma • Pancreatic Ductal Adenocarcinoma

YL201 was granted orphan drug designation by the US FDA (Yilian Biotech Press Release) - "Suzhou Yilian Biopharma Co., Ltd...today announced that its self-developed antibody-drug conjugate YL201 has been granted Orphan-drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of small cell lung cancer (SCLC). YL201 is an ADC drug targeting B7H3 based on Yilian's self-innovated TMALIN technology platform."

Orphan drug • Small Cell Lung Cancer

Yilian Biopharma initiates Phase III clinical trial of B7-H3 ADC for the treatment of small cell lung cancer [Google translation] (163.com) - "On November 14, the Drug Clinical Trial Registration and Information Disclosure Platform showed that Yilian Biopharma launched a multicenter, randomized, controlled, open-label Phase III study to evaluate the efficacy and safety of YL201 for injection versus topotecan hydrochloride for injection in patients with recurrent small cell lung cancer (SCLC)....The primary endpoint of the study is to evaluate the overall survival (OS) of YL201 versus topotecan hydrochloride for injection in patients with relapsed SCLC who have failed initial platinum-based therapy."

Trial status • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

YL201-INT-101-01: A Study of YL201 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=196 | Recruiting | Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. | Trial completion date: Jul 2025 ➔ Oct 2027 | Trial primary completion date: Jul 2024 ➔ Apr 2027

Metastases • Trial completion date • Trial primary completion date • Oncology • Prostate Cancer • Solid Tumor

YiLian Biopharma’s ADC cancer drug to be included in breakthrough therapy category [Google translation] (bydrug.pharmcube.com) - "On October 24, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration announced that Yilian Biopharma's YL201 for injection is planned to be included in the breakthrough therapy category, and the proposed indication is recurrent small cell lung cancer that has failed initial platinum-containing treatment."

Breakthrough therapy • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor