New Strategies Needed As China Shakes Up Drug Classes?

In a fundamental shakeup of chemical drug classifications in China, foreign imported products are now in a class of their own while domestic drugs will be considered generics unless they are NCEs or have new formulations or indications. The changes are set to change the competitive landscape in profound ways, industry observers predict.

BEIJING - Like a stone being thrown into a pool of calm water, the China FDA released on March 9 “Document 51, Reform Plans for Chemical Drug Registration”, stirring up immediate reactions from the pharma industry.

Although the CFDA had in late 2015 decided to narrow the definition of "new drugs", the agency provides further details...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from China

US Tariff Overhang Weighs on Chinese API Exports

 

Chinese API exports to the US fell by 24% year-on-year to $255m in May, when the US and China called a truce in a previously escalating trade war.

Chinese Developers Showcase Potentially Differentiated Weight Loss Assets At ADA

 
• By 

Multiple Chinese firms presented at this year’s ADA meeting, with a focus on weight reduction efficacy for mostly early clinical stage assets. While limited information was given on lean mass preservation, several companies are progressing drugs and combos to address this need.

China Signals Restarting IPOs For Unprofitable Biotechs

 

The China Securities Regulatory Commission has proposed a new “growth tier” for the STAR Market of the Shanghai Stock Exchange, to reinstate the market’s listing standards for unprofitable firms.

Innovent Builds Metabolic Pipeline While Retaining Oncology Backbone

 
• By 

Innovent presented data on multiple pipeline assets at ASCO, including promising OS results for its first-in-class anti-PD-1/IL-2α-bias bispecific. The Chinese firm is also continuing to build out its metabolic disease portfolio and consider its partnering strategies, its CEO tells Scrip.

More from Focus On Asia

Battle For Obesity Market Shifts Gears in India: Will Wegovy Trump Mounjaro?

 

Novo Nordisk debuts Wegovy in India, gears for pole position in obesity. The Danish group’s leadership doesn’t appear too perturbed about the head start for Lilly’s Mounjaro or the imminent arrival of generic semaglutide next year.

Bitcoin Player Parataxis To Acquire Bridge Biotherapeutics After IPF Failure

 
• By 

After the failure of its lead asset in a Phase II trial earlier this year, Korea's Bridge Biotherapeutics has accepted an acquisition offer from bitcoin group Parataxis.

Chinese Developers Showcase Potentially Differentiated Weight Loss Assets At ADA

 
• By 

Multiple Chinese firms presented at this year’s ADA meeting, with a focus on weight reduction efficacy for mostly early clinical stage assets. While limited information was given on lean mass preservation, several companies are progressing drugs and combos to address this need.