Recently, Shanghai Henlius Biotech, Inc. has completed its first Phase III study of HLX01(Rituximab Injection), investigating its efficacy in direct comparison with MabThera® (sourced from Mainland China) for patients with CD20-positive diffuse large B-cell non-Hodgkin’s lymphoma (DLBCL，the most common type of non-Hodgkin’s lymphoma). The top-line results met its primary efficacy endpoint for overall response rate (ORR) and secondary endpoints (safety, immunogenicity and pharmacokinetics profiles).
“We did not observe substantial efficacy and safety differences in previously untreated patients with CD20-positive diffuse large B-cell non-Hodgkin’s lymphoma treated with either HLX01-CHOP or MabThera®-CHOP,” said Yuan-Kai Shi, M.D., Ph.D., the principal investigator in the multi-center trial and professor of medical oncology at the Cancer Institute and Hospital of the Chinese Academy of Medical Sciences in Beijing, China. “If approved, HLX01 should have a positive, meaningful impact on the lives of patients who are not able to afford to treat with this devastating disease.”
HLX01 is the first monoclonal antibody (mAb) developed by Henlius, indicated for patients with Non-Hodgkin's Lymphoma (NHL) and Rheumatoid Arthritis (RA). Its originator drug rituximab was the first mAb approved by the U.S. FDA for the treatment of CD20-positive non-Hodgkin’s lymphoma. In 2000, rituximab was imported into China as MabThera®, as a single therapy or combined with CHOP to treat NHL. In 2014, the pre-clinical study results of HLX01 was accepted by the China Center of Drug Evaluation (CDE), allowing three clinical trial approvals (Phase Ia/Ib/III studies to be conducted in a step-wise approach) with its phase III study started in 2015. In 2017, HLX01 received “Drug Manufacturing Certificate” and submitted New Drug Application (NDA) to CFDA, which soon assigned HLX01 into its priority evaluation list in early 2018, making HLX01 potentially the first approved biosimilar in China.
Henlius has completed IND filings of 11 products with 16 indications, and 4 biosimilar mAb of these are in late-stage development currently. “We are pleased to report on our first proposed biosimilar mAb with positive study results. These results reinforce the potential of our rituximab (HLX01) in providing a safe yet effective treatment for patients,” said Scott Liu, Ph.D., President and CEO, Shanghai Henlius Biotech, Inc. “As a global leader in biosimilar and novel biologics rooted in China, and with one of the richest global portfolios in Oncology and Immunology, we are committed to providing high-quality and affordable treatments for the millions of patients with cancer and immune disorders around the word today and in the future.”
About HLX01-NHL03 Study
HLX01-NHL03 was a multi-center (over 33 clinical sites across China), double-blind, randomized, parallel-control Phase III study conducting to evaluate the efficacy, safety, immunogenicity and pharmacokinetics profiles of HLX01 and MabThera® in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) chemotherapy regimen for the treatment of previously untreated patients with CD20-positive DLBCL. It is an important study to demonstrate biological similarity of HLX01 and MabThera®. In the HLX01-NHL03 study, 402 participants (182 females and 220 males) aged 21 to 77 years old with approximately one-third of the study participant population was aged > 60 years (median age: 55.0) and nearly three-fourth of the study participant population had stage II or III of DLBCL were randomized to receive either HLX01-CHOP or MabThera®-CHOP. All participants received up to six 3-week treatment cycles of CHOP and 375 mg/m2 of HLX01 or MabThera® on day 1 of each treatment cycle.
About Henlius
Shanghai Henlius Biotech, Inc., a joint venture company founded by Fosun Pharma and a team of overseas scientists in December 2009, specializes in the discovery, development, manufacturing and commercialization of high-quality biological therapeutics to treat a range of chronic and often life-threatening diseases. Henlius has advanced a robust pipeline consisting of biosimilar, bio-better and novel mAbs for oncologic and auto-immune disorders. As of today, Henlius has established an integrated global product development platform including research and development centers in Shanghai (China), Bay Area (U.S.A) and Taipei (Taiwan China), EU-GMP QP accredited manufacturing facilities and commercial operations in Shanghai, China. To meet the upcoming demands of research and commercial manufacturing, Henlius signed an official investment agreement with Shanghai Songjiang District Government in late 2017 to build the second biological manufacturing center in Songjiang District, Shanghai.
As of now, Henlius has completed IND filings of 11 products with 16 indications, and 4 biosimilar mAbs of these are in late-stage development currently. Apart from biosimilars, Henlius has been devoting continuous efforts in developing novel monoclonal antibodies in a timely fashion. Its first three innovative products HLX07, HLX06 and HLX10 have already acquired clinical trial approvals from Mainland China, Taiwan China, and the United States and some have already been recruiting patients in Taiwan China. We truly believe that Henlius has now become the unicorn among newly up-growing pharmaceutical companies with an estimated market value of over RMB 10 billion.