China has recently approved a direct-acting antiviral (DAA) regimen from Bristol-Myers Squibb Co. (BMS) comprising the NS5A inhibitor Daklinza (daclatasvir) and the NS3 inhibitor Sunvepra (asunaprevir), for patients infected with genotype 1b chronic hepatitis C virus (HCV), marking the first market entry in the country for an all-oral HCV regimen.
China Direct-Acting HCV Drug Race Rapidly Gathering Pace
After the recent approval of its first all-oral hepatitis C regimen, the China FDA is striving to approve within a year more direct-acting antiviral (DAA) therapies to treat all genotypes of the disease, setting the stage for both multinational and domestic pharma firms to compete in the world’s largest HCV drug market.
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As biopharma derisks its business with China ‘rebalancing’ strategies, Syngene could convert majority of such pilots into full program contracts amid a challenging FY2025. The CRDMO also expects business discussions pertaining to a newly acquired US biologics site to mature into commercial opportunities.
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Two potentially first-in-class molecules signify Zai Lab’s renewed drive for the in-house discovery of drugs that it requires “to be innovative, differentiated and to have the potential to make a big difference for patients,” its global R&D head tells Scrip.
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CSPC’s SYS6010, the first monospecific EGFR-targeting antibody-drug conjugate in the clinic for advanced NSCLC, has shown Phase I promise, but could face close competition with another China-originated bispecific.
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Akeso explains the circumstances behind the release of preliminary overall survival data from a head-to-head Phase III trial with ivonescimab in lung cancer, which some investors viewed as disappointing.
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Funding cuts at the National Institutes of Health, big pharma’s US onshoring moves, GCC partnerships and talks with the Indian government to solve intellectual property challenges are discussed in an interview with Aragen’s CEO, who is also keenly watching the Trump administration’s moves on pharma tariffs
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Akeso explains the circumstances behind the release of preliminary overall survival data from a head-to-head Phase III trial with ivonescimab in lung cancer, which some investors viewed as disappointing.
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Novotech's CEO talks about rising interest for trials in regions with “regulatory agility” and “strategic insulation” from geopolitical complexity, especially among emerging and mid-sized biotech sponsors. Operational "reassessment” among some sponsors on exposure to China-based CROs/CRDMOs is another area he discussed.