alkotinib (ZG0418) / Suzhou Zelgen - LARVOL DELTA

Alkotinib Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib (clinicaltrials.gov) - P2 | N=4 | Terminated | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd | N=104 ➔ 4 | Recruiting ➔ Terminated; Sponsor R&D Strategy Adjustment

Enrollment change • Trial termination • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Study of Alkotinib in Patients With Advanced Non Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=17 | Completed | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Recruiting ➔ Completed

Metastases • Trial completion • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ROS1

Alkotinib Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib (clinicaltrials.gov) - P2 | N=104 | Recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Trial completion date: Aug 2023 ➔ Aug 2024 | Trial primary completion date: Jun 2023 ➔ Jun 2024

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Study of Alkotinib in Patients With Advanced Non Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Trial completion date: May 2023 ➔ May 2024 | Trial primary completion date: Feb 2023 ➔ Feb 2024

Metastases • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ROS1

Alkotinib Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib (clinicaltrials.gov) - P2 | N=104 | Recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Trial completion date: Aug 2022 ➔ Aug 2023 | Trial primary completion date: Jun 2022 ➔ Jun 2023

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

A Phase I Study of Alkotinib in Patients With Advanced Non Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Trial completion date: May 2022 ➔ May 2023 | Trial primary completion date: Feb 2022 ➔ Feb 2023

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ROS1

A Phase I Study of Alkotinib in Patients With Advanced Non Small Cell Lung Cancer (clinicaltrials.gov) - P1; N=18; Recruiting; Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd; Trial completion date: May 2021 ➔ May 2022; Trial primary completion date: Feb 2021 ➔ Feb 2022

Clinical • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ROS1

Alkotinib Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib (clinicaltrials.gov) - P2; N=104; Recruiting; Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd; Not yet recruiting ➔ Recruiting

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

A Phase I Study of Alkotinib in Patients With Advanced Non Small Cell Lung Cancer (clinicaltrials.gov) - P1; N=18; Recruiting; Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd; Trial completion date: May 2020 ➔ May 2021; Trial primary completion date: Feb 2020 ➔ Feb 2021

Clinical • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • ROS1

To Evaluate the Effect of Food on the Pharmacokinetic Characteristics of Ocatinib Capsules in Healthy Subjects (clinicaltrials.gov) - P1; N=16; Completed; Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd; Not yet recruiting ➔ Completed; Trial completion date: May 2021 ➔ Dec 2019; Trial primary completion date: Jan 2021 ➔ Dec 2019

Clinical • Trial completion • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

A Phase I Study of Alkotinib in Patients With Advanced Non Small Cell Lung Cancer (clinicaltrials.gov) - P1; N=18; Recruiting; Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd; Trial completion date: Jan 2020 ➔ May 2020; Trial primary completion date: Sep 2019 ➔ Feb 2020

Clinical • Trial completion date • Trial primary completion date

To Evaluate the Effect of Food on the Pharmacokinetic Characteristics of Ocatinib Capsules in Healthy Subjects (clinicaltrials.gov) - P1; N=16; Not yet recruiting; Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd; Trial completion date: May 2020 ➔ May 2021; Trial primary completion date: Jan 2020 ➔ Jan 2021

Clinical • Trial completion date • Trial primary completion date

Alkotinib Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib (clinicaltrials.gov) - P2; N=104; Not yet recruiting; Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Clinical • New P2 trial

To Evaluate the Effect of Food on the Pharmacokinetic Characteristics of Ocatinib Capsules in Healthy Subjects (clinicaltrials.gov) - P1; N=16; Not yet recruiting; Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd; Trial completion date: Nov 2019 ➔ May 2020; Trial primary completion date: Oct 2019 ➔ Jan 2020

Clinical • Trial completion date • Trial primary completion date

Newly added product (clinicaltrials.gov) - P1, Non Small Cell Lung Cancer

Pipeline update