Beyondspring Pharmaceuticals Inc. literally sprang to life in June 2013 with a phase II cancer compound already in hand. In the second quarter, the company's lead compound, plinabulin, is set to enter a pivotal phase III trial in patients with non-small-cell lung cancer (NSCLC), a notoriously obstinate indication.
SHANGHAI – Hutchison Medipharma Ltd. (HMP) has gone from running a marathon to a sprint. HMP's pipeline has quickly grown from seven clinical trials to 16, 13 of which are phase Ib/II studies with 10 being in potential breakthrough therapy indications. This spurt of activity now puts HMP much closer to the finish line to deliver China's first world-class drug since artemisinin, an antimalarial that was discovered decades ago.
Hutchison Medipharma Ltd. (HMP), of Shanghai,, a unit of Hutchison China Meditech Ltd., said it completed enrollment in a phase II study of fruquintinib (HMPL-013) in non-small-cell lung cancer patients in China. The double-blind, placebo-controlled, proof-of-concept study is investigating the efficacy and safety of fruquintinib, HMP's investigational small-molecule inhibitor of vascular endothelial growth factor receptors.
Twi Pharmaceuticals Inc., of Taipei, Taiwan, appointed Tina Guilder president and CEO, and she will continue as president of Twi Pharmaceuticals USA, its subsidiary. The company named Calvin Chen special advisor to Guilder and he will remain president of Twi Biotechnology Inc.
HONG KONG – Paving the way for further growth of a $2 billion sector, the CFDA has published final regulatory guidelines for biosimilars. Included are standards for research, development and evaluation. Most importantly, the CFDA also gave clear instruction on the pathway, categorization and application material needed for biosimilar registrations.
Sucampo Pharmaceuticals Inc. is returning to R-Tech Ueno Ltd. all licenses for the eye drug unoprostone isopropyl in the wake of a phase III study in which the drug failed to meet its primary endpoint of improving mean retinal sensitivity in people with retinitis pigmentosa (RP) vs. placebo with statistical significance.
HONG KONG – Starting March 5, Japan's regulator suspended a subsidiary of Novartis AG from manufacturing or selling drugs, citing a string of unreported negative side effects patients suffered after using the company's drugs.
SHANGHAI – A trans-Pacific biotech – with labs in Zhangjiang Hi-tech Park in Shanghai, and offices in Hayward, Calif. – Micurx Pharmaceuticals Inc., has commenced enrollment for its U.S. phase II trial for MRX-1, an antibiotic to combat drug-resistant infections.
HONG KONG – New antibiotic agents are urgently needed to overcome the burgeoning problem of antimicrobial resistance (AMR) in infectious bacteria, but novel agents alone may not be sufficient to prevent a return to the dark days of the pre-antimicrobial era, an infectious disease specialist has warned.
RSS