Company

Product

Description

Indication

Status

Date


Aivita Biomedical Inc., of Irvine, Calif.

Root of cancer

Autologous dendritic cells loaded with autologous tumor antigens from autologous self-renewing tumor-initiating cells

Solid tumors

Completed manufacturing quality consultation and clinical safety consultation with Japan's PMDA; will move forward to the final round of discussions focused on the clinical protocol

10/15/18

Innovent Biologics Inc., of Suzhou, China

IBI-308 (sintilimab) and IBI-305 (bevacizumab biosimilar)

Anti-PD-1 monoclonal antibody and anti-VEGF antibody

Non-small-cell lung cancer and hepatocellular carcinoma

China's National Medical Products Administration approved the IND for clinical development of the combination

10/15/18

JHL Biotech Inc., of Hsinchu, Taiwan

JHL-1149

Bevacizumab biosimilar

Several forms of cancer

China's National Medical Products Administration approved the phase I and phase III clinical trial applications for the biosimilar in several forms of cancer, including advanced non-squamous non-small-cell lung cancer, metastatic colorectal cancer, metastatic kidney cancer, advanced cervical cancer and recurrent ovarian cancer

10/15/18

Peptilogics Inc., of Pittsburgh

PLG-0206

Antimicrobial

Prosthetic joint infection and multidrug-resistant bacterial infections

Cleared by Australia's TGA to begin phase I testing

10/15/18

Teva Pharmaceutical Industries Ltd., of Jerusalem, and Celltrion Inc., of Incheon, South Korea

CT-P10

Biosimilar to rituximab

Non-Hodgkin lymphoma

FDA's Oncology Drugs Advisory Committee voted 16-0 to recommend approval of the biosimilar for 3 proposed indications: relapsed or refractory low-grade or follicular CD20-positive B-cell non-Hodgkin lymphoma; previously untreated follicular CD20-positive B-cell NHL in combination with first-line chemotherapy and for patients achieving complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy; and non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine and prednisone chemotherapy

10/10/18

Yisheng Biopharma Co. Ltd., of Beijing

Pika rabies vaccine

Vaccine using Toll-like receptor-3 immuno-modulating technology

Rabies

China regulators provided clearance to proceed with a clinical trial

10/9/18


Notes

The date indicated refers to the BioWorld Regulatory actions table in which the news item can be found.

For more information about individual companies and/or products, see Cortellis.