Shenzhen's BGI Genomics reported the US issued an Emergency Use Authorization for its RT-PCR kit for detecting SARS-CoV-2. The company says its test kit provides qualitative detection of SARS-CoV-2 in bronchoalveolar lavage fluid (BALF) and throat ...
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Shenzhen's BGI Genomics Approved to Launch SARS-CoV-2 Test in the US

Written by Richard Daverman, PhD, Executive Editor, Greg B. Scott.

Shenzhen's BGI Genomics reported the US issued an Emergency Use Authorization for its RT-PCR kit for detecting SARS-CoV-2. The company says its test kit provides qualitative detection of SARS-CoV-2 in bronchoalveolar lavage fluid (BALF) and throat swabs. Results are available within three hours, the company said. The test was approved for China use on January 26, followed by CE-IVD marking for European use on March 2. Currently, BGI can manufacture 600,000 reactions per day and is scaling up to meet global demand. More details....

Stock Symbol: (SHZ: 300676)

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Fosun Long March's COVID-19 Test Approved in China

Written by Richard Daverman, PhD, Executive Editor, Greg B. Scott.

Shanghai Fosun Long March Medical Science, a wholly-owned in vitro diagnostics subsidiary of Fosun Pharma, was granted emergency approval to launch its novel coronavirus nucleic acid detection kit in China. The company said it based the test on its speedy test reagents for Type A&B flu and common respiratory viruses. Earlier this month, Fosun Long March received CE certification to market the test in Europe. More details....

Stock Symbols: (SHA: 600196; HK: 02196)

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CStone Files Taiwan NDA for Precision-Med GIST Candidate

Written by Richard Daverman, PhD, Executive Editor, Greg B. Scott.

Suzhou CStone Pharma filed an NDA in Taiwan for avapritinib, a precision therapy for gastrointestinal stromal tumors (GIST). The candidate is indicated for adult patients with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations. Avapritinib produced an ORR of 84% in the patient population against a 0% ORR for other TKI drugs. In 2018, CStone in-licensed greater China rights to avapritinib in a $386 million, three-drug deal with Blueprint Medicines of Cambridge, MA. More details....

Stock Symbols: (HK: 2616) (NSDQ: BPMC)

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China's Asieris Pharma Lands $14 Million for Genito-Urinary Tumor Treatments

Written by Richard Daverman, PhD, Executive Editor, Greg B. Scott.

Asieris Pharma, located in Taizhou's China Medical City, raised $14 million in a C round to advance its genito-urinary tumor treatments. Its lead candidate, a novel treatment for non-muscular invasive bladder cancer, has completed China Phase III trials and a US Phase I trial. Unlike other treatments for the condition, usually bladder resection, APL-1202 is convenient, painless and does not cause damage to the urethra. A repurposed oral inhibitor of MetAP2, APL-1202 is a 50-year-old wide spectrum antibiotic that had been shown to have an anti-angiogenesis effect. More details....

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Innovent Acquires China Rights to Novel Immunoncology Candidate from Alector

Written by Richard Daverman, PhD, Executive Editor, Greg B. Scott.

Suzhou Innovent Bio acquired China rights to an anti-SIRP-alpha antibody from Alector, a South San Francisco biotech. AL008 is designed to inhibit the ability of macrophages to interfere with the immune response around tumors. It antagonizes the CD47-SIRP-alpha pathway by degrading the inhibitory receptor on macrophages while engaging Fc gamma to promote immuno-stimulatory pathways, increasing the immune attack on the tumor. In pre-clinical studies, the molecule has shown activity in myeloid and lymphoid cancers. Innovent will lead China development of the molecule and have manufacturing rights. More details....

Stock Symbol: (HK: 01801)

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More Recent Articles

Written by Richard Daverman, PhD, Executive Editor, Greg B. Scott.


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