Chinese biotechs are bracing for lengthy delays as the nation’s unwaveringly stringent restrictions continue to cause barriers to on-site inspections from the US FDA. Hard-hit domestic firms are proposing a "quarantine bubble" like that used during the Beijing Winter Olympics to put back on track the field checks necessary for obtaining biologics approvals.
With the Chinese government showing few signs of lifting stringent restrictions on international travel, the country’s drug makers are increasingly bearing the brunt of overseas approval delays due to the requirement to receive on-site facility inspections from foreign regulators including the US Food and Drug Administration.
The newest entrant to this growing list might be BeiGene, Ltd. The Beijing-based biotech is anticipating an FDA decision...
An employee of Astellas faces three and a half years in prison after sentencing by a court in China on espionage charges.
Big pharma is increasingly looking east to restock its pipelines, a process that is helping to forge a new generation of mid-sized R&D-based companies in China and is reflected in their stock price performance.
The list of small-cap companies with the fastest-rising share prices so far this year is dominated by Chinese companies, underscoring their growing contribution to the global biopharma ecosystem.
Four Chinese companies have won approvals in China, the first anywhere, for novel drugs for diffuse large B-cell lymphoma, certain types of non-small cell lung cancer and influenza A.
Aside from several sizable global out-licensing deals, South Korean bioventures saw a cancellation of other alliances, updated their pipelines with losses and gains and reported clinical trial progress in the second quarter, while domestic IPO sentiment also improved.
Glenmark’s managing director talks about IGI’s billion dollar-plus deal with AbbVie, ISB-2001’s striking data, the BEAT platform, other "exciting" pipeline assets and the "blood, sweat and tears" to get to this stage.
Four Chinese companies have won approvals in China, the first anywhere, for novel drugs for diffuse large B-cell lymphoma, certain types of non-small cell lung cancer and influenza A.
