begins phase III study of JHL1101 on large B-Cell Lymphoma

Must Read

Explained: What gaming options are open for low-spec desktops and laptops

Even if you purchase a low-spec desktop PC or laptop, it’s never a barrier to enjoying some form of gaming

Microsoft partners with Accenture to host virtual startup challenge in India

Microsoft 100X100X100 program that focuses to bring 100 companies and 100 early and growth startups will collaborate with Accenture Ventures Open Innovation program to host Accenture Ventures Challenge

SAP eyes India’s MSMEs with ‘Global Bharat’ program

With the aim to focus on MSMEs market in India, SAP has launched 'Global Bharat' program with Nasscom, UNDP and Pratham

JHL Biotech said that the first patient at has been successfully randomized in the Phase III study of JHL1101 to treat diffuse large B-cell lymphoma (DLBCL).

The Phase III study is a multinational, randomized, double-blind, positive-controlled, parallel group clinical study.  It compares the efficacy and safety of JHL1101 in combination with CHOP (J-CHOP) versus rituximab in combination with CHOP (R-CHOP) in patients with previously untreated diffuse large B-cell lymphoma. CHOP is the standard chemotherapy treatment for diffuse large B-cell lymphoma. The study is being conducted in Europe, , and other parts of Asia.

JHL1101, a biosimilar product to rituximab which is a monoclonal antibody targeting CD20, is being developed by JHL Biotech for the treatment of non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), and rheumatoid arthritis (RA).

After completion of similarity assessment in quality attributes and preclinical, a pharmacokinetic (PK) study is being conducted in RA patients in Europe.  Earlier this year, the Chinese regulatory authority approved the clinical trial application of the Phase III study.

“Rituximab is an important biologic for the treatment of lymphoma and rheumatoid arthritis. Unfortunately, it is very expensive for patients and healthcare payers. JHL1101 would provide an affordable treatment for these patients,” said , CEO, JHL Biotech. “This is a significant milestone for JHL, and a step forward in our goal to become a global leader in developing, manufacturing, and commercializing biologics.”

In addition to JHL1101, JHL has several other biosimilars currently in or expected to be in clinical trials. These include:

  • Bevacizumab biosimilar, JHL1149, used for the treatment of several cancers, the most common of which are metastatic colorectal cancer, non-small cell lung cancer, and ovarian cancer, as well as cervical cancer, renal cell carcinoma, and glioblastoma. Pharmacokinetics study in Europe has been conducted. Received clinical trial approval for Phase III in China in 2018.
  • Dornase alfa biosimilar, JHL1922, to manage symptoms of cystic fibrosis. Pharmacokinetics study in Europe has been conducted. Expected Phase III trial in Europe in 2019.
  • Trastuzumab biosimilar, JHL1188, to treat breast cancer. Expected pharmacokinetics study in Australia in 2019.

(This story has not been edited by Tech Observer staff and is auto-generated from a syndicated feed.)

Subscribe to receive the day's headlines from Tech Observer straight in your inbox

Leave a Reply

*The moderation of comments is automated and not cleared manually by techobserver.in. Embedding of any link and use of abusive or unparliamentary language are prohibited.
- Advertisement -

Latest in TECH

- Advertisement -SAP Hana

Related Articles