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2019 ESMO Henlius Abstract Release


2019 ESMO Henlius Abstract Release

European Society for Medical Oncology (ESMO) is Europe’s leading medical oncology society, providing a professional network for its members and working with national societies across Europe. The ESMO Congress presents an invaluable opportunity for medical oncologists and other oncology professionals from the related fields. The 2019 ESMO annual congress will be held in Barcelona, Spain from 27th September to 1st October 2019. Some progressive data of two Henlius biosimilar products HLX01 (汉利康®, rituximab injection) and HLX02 ( a proposed trastuzumab biosimilar) will be disclosed at the congress.

Please see the displayed information below:

HLX02 BC1 P3 Study

Title: Efficacy and Safety of First China-Manufactured Trastuzumab Biosimilar HLX02 for Metastatic Breast Cancer: A Phase 3 Trial

Form: Invited poster discussion

Speaker: Bing-He Xu, M.D. Ph.D.

Time: 09:10 am, 29th Sept. 2019

Place: Cordoba Auditorium (Hall 7)

Poster ID: 309PD

(Full poster will be displayed at Hall 3)

HLX01 PopPK Study

Title: A New Population Model Validated Pharmacokinetic Similarity of HLX01 and Rituximab in B-Cell Lymphoma

Form: Poster display

Speaker: Yuan-Kai Shi, M.D. phD.

Time: 12:20 am, 27th Sept. 2019

Poster ID: 1080P

Place: Hall 4, Poster Display Area

About HLX02

HLX02, a proposed trastuzumab biosimilar, is the first China-develpoed trastuzuamb biosimilar investigated in a global setting. The HLX02 clinical program was developed in consultation with the China National Medical Products Administration (NMPA) and European Medical Agency (EMA) to support global development. We previously reported the clinical demonstration in a Phase 1 study (NCT02581748) of safety, tolerability and pharmacokinetic bioequivalence between HLX02 and trastuzumab sourced from China and European Union in 109 healthy males at the 2018 CSCO annual meeting. At the 2019 ESMO congress, we will report the interim analysis results of the global Phase 3 study comparing the efficacy and safety of HLX02 and trastuzumab in patients with metastatic breast cancer. The interim results were also accepted by EMA and the NMPA. HLX02 was currently under Marketing Authorization Application (MAA) and New Drug Application (NDA) review respectively.

About HLX01

HLX01 (汉利康®), the first-ever China-develpoed rituximab biosimilar, was approved by the China NMPA for the treatment of non-Hodgkin lymphoma (NHL) on February 20, 2019. It was concurrently developed as a novel drug for rheumatoid arthritis (RA) since the specified indication has not been approved in China. At the 2019 ESMO congress, we will describe the development and validation of a population pharmacokinetic (PopPK) model derived from the PK data of HLX01 and reference rituximab in the most sensitive and homogenous population of patients to assess PK comparability, and extrapolate the PK similarity based on data from Chinese patients to other races.

About Henlius

Henlius is a leading biopharmaceutical company in China that offers high-quality, affordable and innovative drugs to patients worldwide. Founded in 2010 and headquartered in Shanghai with two R&D centers in Taipei and California, Henlius has established and continues to expand its comprehensive product pipeline of biosimilars and bio-innovative drugs to treat tumors and autoimmune diseases.

Until now, in addition to one product launched commercially and two products under NDA/MAA review, Henlius has conducted over 20 clinical studies for 14 products and 6 combination therapies worldwide. HLX01, the first product of Henlius, has been granted approval by the NMPA as the first approved biosimilar in China. Moreover, HLX03 (adalimumab injection) and HLX02 have their NDA under primary review by the NMPA. HLX02 is the first biosimilar developed in China to enter a global multi-center phase 3 clinical trial in China, Poland, Ukraine and the Philippines. In June 2019, the MAA for HLX02 was accepted to review by EMA.