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China Reins In Cancer Drug Trials, Stressing Patient Needs and Benefits

Tougher Comparator Requirements

 
• By Dexter Jie Yan

China's drug regulatory authority is taking aim at strengthening randomized, controlled clinical trials conducted domestically for cancer drugs, leaving biotech stocks reeling from the proposed stricter requirements.

clinical trial progress
China’s CDE stipulates clinical value is determined by whether clinical needs can be met to maximize patients’ benefits • Source: Alamy

China’s Center for Drug Evaluation (CDE) is taking steps to rein in the nation’s exploding anticancer drug clinical trials, with a draft document that would require sponsors to conduct randomized controlled studies using best-in-class existing therapies as comparators, where these are available.

When choosing control drugs for such trials, the main focus should be on whether the study products represent the best...

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China’s BRL Gears Up For First UCAR-T Trial In Leukemia/Lymphoma

 
• By Xu Hu

Shanghai-based BRL Medicine is building a novel pipeline led by universal CAR-Ts. Its founder talks to Scrip about the benefits of this approach, China's potential advantages in the field and challenges faced by new ventures.

BeBetter, Trinomab Advance IPOs On China’s STAR Market In Firsts Since Policy Easing

 
• By Dexter Jie Yan

BeBetter becomes first unprofitable innovative drug maker to have application for an IPO on Shanghai's STAR Market cleared by China’s top securities regulator, while Trinomab becomes first among peers to have IPO filing accepted.

Chinese Biotechs Raise New Funds On Potential First-In-Class Assets

 
• By Dexter Jie Yan

Helped by their development of novel potential first-in-class therapies, Tcelltech, BioTroy and Xiaolu are among the Chinese ventures to have attracted new funding from investors over the past weeks.

GSK Gains Hengrui’s PDE3/4 Inhibitor, Options For 11 Early Assets In Potential $12bn Deal

 
• By Dexter Jie Yan

Deal Snapshot: The addition of Hengrui's HRS-9821, a China-originated fast-follower of Verona’s Ohtuvayre in chronic obstructive pulmonary disease, should enable GSK’s COPD therapy portfolio to stack up well against increasing competitors in the indication, including biologics and small molecules.

More from Focus On Asia

China’s BRL Gears Up For First UCAR-T Trial In Leukemia/Lymphoma

 
• By Xu Hu

Shanghai-based BRL Medicine is building a novel pipeline led by universal CAR-Ts. Its founder talks to Scrip about the benefits of this approach, China's potential advantages in the field and challenges faced by new ventures.

BeBetter, Trinomab Advance IPOs On China’s STAR Market In Firsts Since Policy Easing

 
• By Dexter Jie Yan

BeBetter becomes first unprofitable innovative drug maker to have application for an IPO on Shanghai's STAR Market cleared by China’s top securities regulator, while Trinomab becomes first among peers to have IPO filing accepted.

50% Levy On India And Brazil, US Tariffs Leave Global Trade, Forecasts In Disarray

 
• By Vibha Ravi

50% tariffs on US imports from India, a range on others, an uncertain outcome of Section 232 investigations of pharma and talk of BRICS tariffs are making forecasting for the pharma industry extremely difficult, Scrip finds in this infographic analysis