Eisai Co. Ltd., of Tokyo, and Merck & Co., of Kenilworth, N.J., received breakthrough therapy designation from the FDA for Eisai's multiple receptor tyrosine kinase inhibitor Lenvima (lenvatinib) in combination with Merck's anti-PD-1 therapy Keytruda (pembrolizumab) for the treatment of advanced or metastatic renal cell carcinoma. This is the second breakthrough therapy designation for Lenvima and the 12th for Keytruda. Read More
SAN FRANCISCO – A shifting regulatory climate and an increasing push for innovation combined with a staggering amount of capital is expected to significantly increase the rate of cross-border dealmaking between China firms and U.S.-based and multinational companies, experts predicted during the Chinese American Biopharmaceutical Society meeting last week. Read More
The findings of a new study by Swedish and Chinese researchers into a novel photosensitization-based drug-release system could bring about broad changes in the delivery of cancer therapies, with millions of patients worldwide potentially benefiting from this research. Read More
SAN FRANCISCO – Exuberance over China's ascendant biopharma sector formed a near-deafening roar at the 6th Annual Wuxi Global Forum last week, where Ruyi He, chief scientist of the CFDA's Center for Drug Evaluation (CDE), spoke to the accelerating pace of the Republic's regulatory reform. In the past few years, he said, not only has the agency embraced a growing body of guidelines from its regulatory agency peers but has also gone on a hiring spree aimed at boosting efficiency at the agency, which has labored under criticism in past years. Having jumped from 600 CDE reviewers to 800 in just the last year, he said that the agency is now aiming to reach a total of 1,600 reviewers by 2020. Read More
HONG KONG – KBP Biosciences Co. Ltd. closed a $76 million series A financing to, among other things, advance its lead asset, KBP-5074, a mineralocorticoid receptor antagonist for cardiovascular disease entering phase IIb studies. The cash will also support moving its headquarters to the U.S. Read More
HONG KONG – CSPC Pharmaceutical Group Ltd., of Shijiazhuang, China, has made plans to acquire a 39.56 percent stake in Wuhan YZY Biopharma Co. Ltd. in a deal worth up to ¥356 million (US$54.6 million). Read More
