How To Make A Global First-In-Class Drug In China
The story so far of how an aspiring Western returnee researcher became a fully charged pharma entrepreneur in China’s wild world of drug innovation.
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Jiangsu Hengrui’s anti-PD-1 antibody is the latest to hit the immuno-oncology market in China, ensuring a fierce battle in pricing and reimbursement. Other recent new approvals include Pfizer’s antibacterial Zavicefta and a first-in-class topical treatment for psoriasis.
The successful IPO of China's drug innovation darling Betta may herald a new wave of capital inflow and renewed interest in new drug R&D in China, but hurdles to the pursuit of original research remain.
In what could be a blow to some aspiring developers eyeing the nascent but growing biosimilars market in China, new rules lay out when extrapolation of approved indications of reference biologics will be allowed, meaning this will not be automatic.