Zai, Novocure’s tumor treatment device granted innovative status



Shanghai-based biotech Zai Lab Ltd (NASDAQ: ZLAB) announced that its Optune device, based on Tumor Treating Fields (TTF) technology in-licensed from Israel-based partner Novocure (NASDAQ: NVCR), has been designated an “Innovative Medical Device” by the National Medical Products Administration (NMPA). Currently awaiting market approval from the agency, the designation is expected to accelerate the path to regulatory decision and allow a greater degree of communication between Zai and NMPA regulators.

The Optune product is a portable, non-invasive medical device for treatment of tumors based on the application of TTF, electric fields tuned to specific frequencies in order to disrupt cell division, inhibit tumor growth, and cause cancer cell death. The device is set for use in glioblastoma (GBM) patients alongside chemotherapy, and was approved in Hong Kong and launched to market in December 2018 for that indication. Optune was in-licensed from Novocure in a September 2018 deal, Zai Lab making a USD 15 million upfront payment for development rights to the technology in Greater China.

Reference:

Related news
Chinese biotech Zai Lab Ltd (Nasdaq.ZLAB) has decided it can’t do without a checkpoint inhibitor in its portfolio, signing up with US-based Incyte (Nasdaq.INCY) for Greater China development rights to the programmed death-1 (PD-1) inhibitor INCMGA0012.
The National Medical Product Administration (NMPA)’s Center for Drug Evaluation (CDE) website indicated that New Drug Application (NDA) filings for three products (encompassing six separate filings) have been awarded priority review status.
Germany-based pharma firm Boehringer Ingelheim is expanding the capacity of its Shanghai-based Contract Manufacturing Organization (CMO) site, named OASIS.
China-based biotech Zai Lab Ltd (Nasdaq.ZLAB) revealed that patient enrollment has now been completed in the firm’s pivotal Phase III clinical trial for Zejula (niraparib), a poly (ADP-ribose) PARP 1/2 inhibitor in-licensed from U.S. firm Tesaro Inc., (Nasdaq.TSRO).
  • 1547105476306
  • China
  • Drug
A group of Chinese R&D-based biotechs have in recent weeks gained central government support under the Major National Science and Technology Project for New Drug Research and Development program. According to company announcements, awards have been given to: - Antengene to reflect its development of ATG-008, a category 1 dual TOC1/2 inhibitor currently under Phase II/III study for advanced hepatocellular carcinoma (HCC); - BeiGene for PARP inhibitor BGB-290; - Acea Pharma for the third-generation EGFR inhibitor avitinib; - Zai Lab for development of the PARP inhibitor ZL-2306 (niraparib); - I-Mab for interleukin-6 (IL-6) trans-signaling blocker TJ301’s development in urothelial carcinoma; -&
Recent news
Taiwan-based firm TaiGen Biophamaceuticals Holdings Ltd picked up a milestone payment of USD 5 million from Yichang HEC Changjiang Pharmaceutical Co., Ltd, its co-development partner for the hepatitis C virus (HCV) therapy furaprevir in China.
Innovative Chinese biotech Nanjing Frontier Biotech announced that it plans to raise RMB 2.01 billion (USD 286 million) through an initial public offering (IPO) to the Science and Technology Innovation Board (STAR) hosted by the Shanghai Stock Exchange (SSE).
  • 1566271018353
  • China
Pharmaceutical major Amgen has transferred Dominican Republic-born Elvin Penn from its Mexico subsidiary to head its operations in Brazil.
A team of researchers in Argentina has identified tumor-supportive mechanisms derived from interactions between fibroblasts and anaplastic thyroid cancer cells, the most aggressive type of thyroid cancer with a worse prognosis for patients.
  • 1566206139500
  • Argentina
  • R&D
Shanghai-based Haihe Biopharma announced its latest in-licensing and partnership deal with the Shanghai Institute of Materia Medica (SIMM, affiliated to the Chinese Academy of Sciences) and Jinan University.
  • 1566205390010
  • China
  • Drug
GBI analysis reveals that Chile’s Institute of Public Health (ISP) last week published its approval of Austria-based Ever Pharma Jena’s Everpressin (terlipressin), a first-mover generic version of Switzerland-based Ferring’s hormone analogue Glypressin.
The China Securities Regulatory Commission (CSRC) released details of the administrative punishments it is levelling against senior executives at Kangmei Pharmaceutical Co., Ltd, in response to the discovery that the firm had fraudulently overstated its cash holdings from 2016 to August 2018 by over USD 12 billion.
Analytics Snapshot


Analytics Snapshot