Zai Lab, a Shanghai novel commercial stage biopharma, raised $261 million in a secondary offering. The company reported it held $68.7 million of cash on September 30, 2019 and spent $110 million on R&D in the first nine months of last year, a ...

 


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Zai Lab Raises $261 Million; Plans China NDA Filing for Ripretinib in Mid-2020

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

Zai Lab, a Shanghai novel commercial stage biopharma, raised $261 million in a secondary offering. The company reported it held $68.7 million of cash on September 30, 2019 and spent $110 million on R&D in the first nine months of last year, a near-doubling from 2018 due to new projects and ongoing clinical trials. Zai also announced it expects to submit a China NDA for ripretinib by mid-2020 to treat gastrointestinal stromal tumors. In late December, Zai reported China approval for Zezula, a PARP inhibitor and Zai's first drug to launch in China. More details....

Stock Symbol: (NSDQ: ZLAB)

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Roche's Kadcyla, a Breast Cancer Treatment, Is First ADC Approved in China

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

Roche announced Kadcyla has been approved in China as an adjuvant treatment for HER-2 positive breast cancer, the first antibody drug conjugate approved in China. In clinical trials, Kadcyla outperformed Herceptin, another Roche product that is now facing biosimilar competition. Kadcyla combines the HER2-targeting properties of Herceptin and the cytotoxic chemotherapy agent DM1. In a clinical trial, Kadcyla reduced the risk of invasive breast cancer recurrence or death from any cause by 50% compared to Herceptin. At three years, 88% of Kadcyla patients did not have a recurrence of their disease against 77% of Herceptin patients. More details....

Stock Symbol: (SWX: ROG)

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Beijing Hengsheng Medical Completes $6 Million Funding for Coronary Devices

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

Beijing Hengsheng Medical, a coronary medical device company, completed a $6 million Pre-A financing for its portfolio of drug-eluting stents, balloon catheters and accessories. The company has developed a drug-eluting balloon catheter with a proprietary "self-perfusion" technology that has begun late stage trials. HS Medical expects it will complete the clinical trial and apply for registration of the product in the first half of 2020, with a 2021 launch. The company says most balloon catheters in this class that are available in China come from foreign manufacturers. More details....

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Ascletis Approved to Start China Trial of PD-L1 in HBV Patients

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

Ascletis Pharma was approved to start China trials of its in-licensed PD-L1 in patients with chronic hepatitis B. One year ago, Ascletis acquired China rights to ASC22 from Suzhou Alphamab for hepatitis B and other viral conditions. Ascletis expects ASC22, a first-in-class, subcutaneously administered PD-L1 antibody, will be effective against HBV, which renders the immune system ineffective through T cell exhaustion. Ascletis has two other potential HBV treatments in pre-clinical development plus a marketed drug, Pegasys®. Ascletis plans to test ASC22 as a monotherapy and in combination with other drugs. More details....

Stock Symbol: (HK: 1672)

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China Medical In-licenses China Rights to Novel Anemia Drug from Zydus Cadila

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

China Medical System in-licensed China rights to a novel treatment for anemia from India's Zydus Cadila. Desidustat is an inhibitor of hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) that is aimed at treating anemia in patients with chronic kidney disease, including both dialysis and non-dialysis patients. CMS will be responsible for development and commercialization, plus registration and manufacturing of the drug in China. Desidustat is currently in Phase III trials. Zydus will receive an upfront payment, regulatory and sales milestones, plus royalties, though specific amounts were not disclosed. More details....

Stock Symbols: (HK: 0867) (BSE: 532321)

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