HONG KONG – In a surprisingly candid statement, the director of China’s Centers for Disease Control conceded that the efficacy of Chinese coronavirus vaccines is "not high" and may require improvements. Read More
HONG KONG – Covig-19, an anti-SARS-CoV-2 hyperimmune immunoglobulin therapy that Takeda Pharmaceutical Co. Ltd. developed alongside the Covig-19 Plasma Alliance, has failed to meet its endpoints in a global phase III trial. Read More
With shortages of the COVID-19 drug, remdesivir, being reported in several states in India, the country’s Central Drugs Standard Control Organization is calling on state regulators to “immediately initiate remedial action to ensure supply of remdesivir injection to public and private hospitals.” Read More
PERTH, Australia – The Australian government is recommending that Australians under 50 take the Pfizer Inc. COVID-19 vaccine due to the risk of rare blood clots associated with Astrazeneca plc’s COVID-19 vaccine (ChAdOx1-S). The move jeopardizes Australia’s vaccine rollout as it had planned for the majority of Australians to receive the Astrazeneca vaccine, which is being locally manufactured by CSL Ltd. Read More
Challenges to ongoing efforts to provide effective aid for hospitalized patients with COVID-19 continued April 8, with two new trial failures reported. A phase III trial testing the Olumiant (baricitinib) vs. placebo, both on top of standard of care, missed its primary endpoint of progression to non-invasive ventilation, invasive mechanical ventilation or death, said drugmakers Eli Lilly and Co. and Incyte Corp. A phase II trial testing Beigene Ltd.'s Brukinsa (zanubrutinib) vs. placebo in patients hospitalized with respiratory symptoms of COVID-19 also fell short, missing its co-primary efficacy endpoints of respiratory failure-free survival or reduction in days on oxygen. Read More
With less uncertainty surrounding the pandemic, the biopharma industry appears on track to shift efforts back to its internal programs and possibly meet, if not exceed, the record-breaking deal level of 2020. Strong financial markets, however, may continue to hold M&As down. Read More
The newly renamed Hutchmed (China) Ltd., previously known as Hutchison China Meditech Ltd. (Chi-Med), plans to sell $100 million of its American depository shares at $30.50 per ADS in a private placement to funds affiliated with Baring Private Equity Asia. Read More
HONG KONG – Onquality Pharmaceuticals LLC raised an additional $20 million from a series A+ financing round, bringing its amount of capital raised to $35 million. Read More
SHANGHAI – China’s regulatory environment has evolved to encourage drug innovation, but despite remarkable progress, mounting pricing pressure from the government and a weak insurance sector remain as barriers. Read More
Speaking during the 2021 China Pharmaceutical Innovation 100 Summit, industry insiders called for more regulatory talent and even an organizational revamp to clear innovative products faster and support the global development strategies of Chinese drugmakers. Read More
New and updated preclinical and clinical data presented by biopharma firms at the American Association for Cancer Research Annual Meeting, including: Gracell, Hummingbird. Read More
Biopharmas in Asia-Pacific raising money in public or private financings, including: ACM, Bionomics, Delta 4, Humanigen, Hutchison China Meditech, Icosavax. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific, including: Airway, Antengene, Beigene, Biontech, Cansino, Cytodyn, Gan & Lee, Generex, Huyabio, Immutep, Junshi, Mitoimmune, Nugenerex Immuno-Oncology, Pfizer, Resverlogix. Read More
