RX208 / Suzhou NeuPharma, Fosun Pharma - LARVOL DELTA

Henlius HLX208 Phase II Clinical Study Recruits Patients with Advanced Melanoma [Google translation] (Sina Corp) - "This study has been approved by the National Medical Products Administration with approval numbers 2018L02616 and 2018L02617, and has been approved by the ethics committee, and is currently recruiting subjects."

Trial status • Brain Cancer • Melanoma • Oncology • Skin Cancer

Henlius HLX208 tablet clinical trial approved [Google translation] (new.qq.com) - "On August 2, according to the official website of CDE, Henlius' HLX208 tablet clinical trial was approved, and it plans to conduct research on the treatment of BRAF V600 mutation advanced melanoma."

New trial • Melanoma • Oncology • Skin Cancer • Solid Tumor

Study on Food Influence and Drug-drug Interaction of HLX208 Tablets in Chinese Healthy Subjects (clinicaltrials.gov) - P1 | N=20 | Completed | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Completed | N=52 ➔ 20 | Trial primary completion date: Sep 2023 ➔ Dec 2023

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

Mass Balance Study of [14C]HLX208 in China Healthy Subjects (clinicaltrials.gov) - P1 | N=6 | Completed | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Completed

Trial completion

HLX208, a novel BRAF V600E inhibitor, in adult patients with Langerhans cell histiocytosis and/or Erdheim-Chester disease harbouring BRAF V600E mutation (ESMO Asia 2023) - P2 | "No treatment-emergent AEs leading to death occurred. Conclusions HLX208 showed promising efficacy in adult patients with LCH and/or ECD harbouring BRAF V600E mutation, with a manageable safety profile."

Clinical • Oncology • Solid Tumor

Henlius Announces Upcoming Mini Oral Presentation and Five Posters at the ESMO Asia 2023 (Henlius Press Release) - "From 1 to 3 December 2023, the European Society for Medical Oncology Asia (ESMO Asia) Congress will be held in Singapore. At this congress, Henlius will share the latest results of clinical trials of several products, including anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (serplulimab), HLX208 (BRAFV600E small molecule inhibitor), HLX07 (anti-EGFR mAb), and HLX26 (anti-LAG-3 mAb). Notable among them is the updated analysis of HLX208-LCH/ECD201 study, the phase 2 study of HLX208 in adult patients with Langerhans cell histiocytosis and/or Erdheim-Chester disease harbouring BRAFV600E mutation...and the results from this updated analysis were selected for a mini oral presentation. Moreover, results from the Asian subgroup of the pivotal phase 3 study (ASTRUM-004) of serplulimab in treating squamous non-small cell lung cancer (sqNSCLC)...will be presented in the form of a poster presentation....The company will also present data from four other clinical studies in poster..."

Clinical data • Non Small Cell Lung Cancer

The Efficacy of HLX208 (BRAF V600E Inhibitor) With Cetuximab for Metastatic Colorectal Cancer (mCRC) With BRAF V600E Mutation After First-line Treatment (clinicaltrials.gov) - P2 | N=50 | Active, not recruiting | Sponsor: Shanghai Henlius Biotech | Recruiting ➔ Active, not recruiting | Trial completion date: Aug 2023 ➔ Jan 2025 | Trial primary completion date: Aug 2022 ➔ Jun 2024

Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

The Efficacy and Safety of HLX208 in Advanced Anaplastic Thyroid Cancer (ATC) With BRAF V600 Mutation (clinicaltrials.gov) - P1/2 | N=25 | Active, not recruiting | Sponsor: Shanghai Henlius Biotech | Recruiting ➔ Active, not recruiting | Trial primary completion date: May 2023 ➔ Jun 2024

Enrollment closed • Metastases • Trial primary completion date • Endocrine Cancer • Oncology • Solid Tumor • Thyroid Gland Anaplastic Carcinoma • Thyroid Gland Carcinoma

HLX208 (BRAF V600E Inhibitor) in Combination With Trametinib in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=220 | Recruiting | Sponsor: Shanghai Henlius Biotech | Trial completion date: Jun 2024 ➔ Jun 2025

Combination therapy • Metastases • Trial completion date • Oncology • Solid Tumor

The Efficacy and Safety of HLX208 in Adult Langerhans Cell Histiocytosis (LCH) and Erdheim-Chester Disease (ECD) With BRAF V600E Mutation (clinicaltrials.gov) - P2 | N=25 | Active, not recruiting | Sponsor: Shanghai Henlius Biotech | Recruiting ➔ Active, not recruiting | Trial completion date: May 2024 ➔ Oct 2024 | Trial primary completion date: Nov 2022 ➔ Jun 2024

Enrollment closed • Trial completion date • Trial primary completion date • Langerhans Cell Histiocytosis • Rare Diseases

The Efficacy and Safety of HLX208 in Metastatic Colorectal Cancer (mCRC) With BRAF V600E Mutation (clinicaltrials.gov) - P2 | N=25 | Active, not recruiting | Sponsor: Shanghai Henlius Biotech | Recruiting ➔ Active, not recruiting | Trial completion date: Feb 2025 ➔ Jun 2025 | Trial primary completion date: Jul 2023 ➔ Jan 2024

Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Study on Food Influence and Drug-drug Interaction of HLX208 Tablets in Chinese Healthy Subjects (clinicaltrials.gov) - P1 | N=52 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

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

A phase 2 study of HLX208, a BRAFV600E inhibitor, in adult patients with Langerhans cell histiocytosis and/or Erdheim-Chester disease harboring BRAFV600E mutation. (ASCO 2023) - P2 | "In summary, HLX208 was safe and well tolerated, and showed promising efficacy in patients with LCH and/or ECD. Clinical trial information: NCT05092815."

Clinical • P2 data • Langerhans Cell Histiocytosis • Oncology • Rare Diseases • Solid Tumor

Mass Balance Study of [14C]HLX208 in China Healthy Subjects (clinicaltrials.gov) - P1 | N=6 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

New P1 trial

Shanghai Henlius Biotech Says Hlx208 Granted Breakthrough Therapy Designation By NMPA (Kalkine Media) - "HLX208 GRANTED BREAKTHROUGH THERAPY DESIGNATION BY CENTER FOR DRUG EVALUATION OF NMPA."

Non-US regulatory • Oncology

A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of HLX208+HLX10 in NSCLC With BRAF V600E Mutation (clinicaltrials.gov) - P1/2 | N=49 | Recruiting | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Recruiting

Enrollment open • IO biomarker • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

A phase 1b/2 study of HLX208 (a BRAF V600E inhibitor) in combination with trametinib in patients with advanced solid tumours (ESMO-TAT 2023) - No abstract available

Clinical • Combination therapy • Metastases • P1/2 data • Oncology • Solid Tumor

A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of HLX208+HLX10 in NSCLC With BRAF V600E Mutation (clinicaltrials.gov) - P1/2 | N=49 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

IO biomarker • New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

"State-owned Enterprise Red Chip" Henlius (2696) Approved for Clinical Trial of Combination Therapy for Solid Tumors [Google Translation] (Anue Juheng) - "Henlius (02696) announced that recently, HLX208 (BRAF V600E inhibitor) combined with Henseyer and related combination therapy, that is, HLX208 combined with Henseyer combined with cetuximab or Trametinib, a Phase 1b/2 clinical trial application for the treatment of BRAF V600E or BRAF V600 mutation-positive advanced solid tumors, has been approved by the State Drug Administration, and relevant clinical trials are planned to be carried out when conditions are met."

New P1/2 trial • Oncology • Solid Tumor

A Phase II Clinical Trial to Evaluate HLX208 in Advanced Solid Tumor Patients With BRAF V600 Mutation (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

New P2 trial • Oncology • Solid Tumor

A Phase II Clinical Trial to Evaluate HLX208 in Advanced Melanoma Patients With BRAF V600 Mutation (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Shanghai Henlius Biotech | Trial completion date: May 2024 ➔ Aug 2024 | Trial primary completion date: Apr 2023 ➔ Aug 2023

Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor • BRAF

The Efficacy and Safety of HLX208 in Metastatic Colorectal Cancer (mCRC) With BRAF V600E Mutation (clinicaltrials.gov) - P2 | N=25 | Recruiting | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Recruiting

Enrollment open • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

HLX208 (BRAF V600E Inhibitor) in Combination With Trimetinib in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=220 | Recruiting | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Recruiting | Initiation date: Sep 2021 ➔ Jan 2022

Combination therapy • Enrollment open • Trial initiation date • Oncology • Solid Tumor

A Phase II Clinical Trial to Evaluate HLX208 in Advanced Non-small Cell Lung Cancer Patients With BRAF V600 Mutation (clinicaltrials.gov) - P2; N=20; Recruiting; Sponsor: Shanghai Henlius Biotech; Not yet recruiting ➔ Recruiting

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

The Efficacy and Safety of HLX208 in Adult Langerhans Cell Histiocytosis (LCH) and Erdheim-Chester Disease (ECD) With BRAF V600E Mutation (clinicaltrials.gov) - P2; N=25; Recruiting; Sponsor: Shanghai Henlius Biotech; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Langerhans Cell Histiocytosis • Rare Diseases