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BioWorld - Thursday, May 29, 2025
Home » Authors » Shannon Ellis

Articles by Shannon Ellis

CFDA opens door for national approval of cell therapy trials as drugs

Jan. 9, 2018
By Shannon Ellis

SHANGHAI – The CFDA recently released "Guiding Principles for the Research and Evaluation of Cell Therapy Products" for trial implementation. This hotly anticipated move now adds cell therapies – such as stem cells and chimeric antigen receptor (CAR T) therapies – under the umbrella of CFDA reforms that are aligning China's drug regulations with global drug markets. The guidelines set out standards for the approval of clinical trials for cell therapies and opens the door to a viable path to commercialization of cell therapies to be regulated by the CFDA, much like other new drugs.


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Shenogen nabs China rights to Angiochem's paclitaxel-peptide drug conjugate to treat brain metastases from breast cancer

Jan. 5, 2018
By Shannon Ellis
SHANGHAI – Xinogen (Hong Kong) Pharma Co. Ltd., a subsidiary of Beijing Shenogen Pharmaceuticals Group, has negotiated a deal with Angiochem Inc., of Montreal, to develop and sell ANG-1005, a paclitaxel-peptide drug conjugate for the treatment of leptomeningeal carcinomatosis from breast cancer. The deal gives Xinogen rights for greater China.
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Zai to co-develop gastric cancer asset for China with Five Prime

Jan. 3, 2018
By Shannon Ellis
SHANGHAI – Zai Labs Ltd., of Shanghai, nabbed greater China rights for FPA-144, a first-in-class fibroblast growth factor (FGF) monoclonal antibody for gastric and gastroesophageal junction cancer being developed globally by Five Prime Therapeutics Inc., of San Francisco.
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China's Legend to partner with Janssen on anti-BCM CAR T; $350M cash, plus milestones

Jan. 2, 2018
By Shannon Ellis

SHANGHAI – Nanjing-based Legend Biotechnology Corp. has partnered with Janssen Biotech Inc., a subsidiary of Johnson & Johnson, to develop in CAR-B38M, a promising chimeric antigen receptor T-cell (CAR T) therapy for multiple myeloma that targets B-cell maturation antigen (BCMA).


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China's Legend to partner with Janssen on anti-BCM CAR T

Jan. 2, 2018
By Shannon Ellis
SHANGHAI – Nanjing-based Legend Biotechnology Corp. has partnered with Janssen Biotech Inc., a subsidiary of Johnson & Johnson, to develop in CAR-B38M, a promising chimeric antigen receptor T cell (CAR T) therapy for multiple myeloma that targets B-cell maturation antigen (BCMA).
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Zai to co-develop gastric cancer asset for China with Five Prime

Dec. 28, 2017
By Shannon Ellis
SHANGHAI – Zai Labs Ltd., of Shanghai, nabbed Greater China rights for FPA144, a first-in-class fibroblast growth factor (FGF) monoclonal antibody for gastric and gastro-esophageal junction cancer being developed globally by Five Prime Therapeutics Inc., of San Francisco.
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Beyondspring's plinabulin: A case study for impact of China's regulatory reforms

Nov. 29, 2017
By Shannon Ellis
SHANGHAI – When Beyondspring Pharmaceuticals Inc., a clinical-stage immuno-oncology biopharma started its U.S.-China development strategy for lead candidate plinabulin, getting a first-in-class drug past China's regulators was an unwieldy prospect, often taking years longer than the U.S. But after China's most recent round of regulatory reforms, things are looking up considerably.
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The impact of China's regulatory reforms: Conditional nods may shave clinical years

Nov. 28, 2017
By Shannon Ellis

SHANGHAI – When Beyondspring Pharmaceuticals Inc., a clinical-stage immuno-oncology biopharma started its U.S.-China development strategy for lead candidate plinabulin, getting a first-in-class drug past China's regulators was an unwieldy prospect, often taking years longer than the U.S. But after China's most recent round of regulatory reforms, things are looking up considerably. (See BioWorld Today, March 18, 2015.)


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China's Ark teams up with Calibr on COPD to breathe new life into HNE inhibitors

Nov. 15, 2017
By Shannon Ellis
SHANGHAI – Shanghai-based Ark Biosciences Inc., a virtual biotech, and the California Institute of Biomedical Research (Calibr), of La Jolla, an affiliate of The Scripps Research Institute (TSRI), one of the world's largest private biomedical research institutes, have partnered to develop preclinical assets for chronic obstructive pulmonary disease (COPD).
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China's Ark teams up with Calibr on COPD to breathe new life into HNE inhibitors

Nov. 15, 2017
By Shannon Ellis
SHANGHAI – Shanghai-based Ark Biosciences Inc., a virtual biotech, and the California Institute of Biomedical Research (Calibr), of La Jolla, an affiliate of The Scripps Research Institute (TSRI), one of the world's largest private biomedical research institutes, have partnered to develop preclinical assets for chronic obstructive pulmonary disease (COPD).
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