China is speeding up the development and approval of cutting‑edge cell and gene therapies. On July 3, the National Medical Products Administration released a draft plan to streamline reviews, and the Center for Drug Evaluation issued new technical guidelines for 2026. The measures focus on cancer and rare diseases, encouraging global collaboration and multi‑center trials. Key points include: therapies that meet the new criteria will enter a 30‑day fast‑track review; breakthrough drugs with novel targets get priority full‑cycle support; and the time to approve major manufacturing changes for marketed products drops from 200 to 130 working days. The impact is already visible. According to Insight Database, more than 700 new drugs saw progress in the first half of 2026, with 61 gaining their first regulatory approval, 59 filing marketing applications, and 84 moving into Phase III trials. Domestic leader Hengrui Medicine tops the list, advancing 30 candidates, while CSPC, Sinopharm, Qilu, AstraZeneca, 3S, Hisun, Fosun, Hansoh, Changchun Gaoxin and Innovent Biologics also made the top‑ten. Overall, China’s innovative‑drug market reached a historic $99.7 billion, marking the strongest half‑year performance ever recorded.
Read moreChina’s biotech scene is buzzing. On July 8, Sino Biopharm announced a deepened partnership with GSK that gives it exclusive rights to sell two world‑leading inhalers – Flutiform and Anoro – across mainland China. The deal expands Sino’s focus from liver medicines to chronic lung diseases, with GSK keeping regulatory and branding duties while Sino handles import, distribution and hospital promotion. Both inhalers together have generated more than $23 billion in global sales. In the same week, Sino’s subsidiary Chia Tai Tianqing struck a licensing pact with AstraZeneca for its own PDE3/4 inhibitor, TQC3721. The agreement promises up to $200 million upfront and could deliver as much as $1.9 billion in milestones and royalties if the drug reaches the market. The news comes amid a wave of growth in China’s innovative‑drug sector. Haisike Pharma reported a 500% jump in first‑half net profit, driven by strong domestic sales and a surge in out‑licensing deals that brought in billions of yuan. The H‑Share Innovative Drug ETF (159570) rose nearly 2%, lifted by gains in Sino Biopharm, Innovent, CSPC and others. Industry analysts note a 36% rise in new drug trial registrations and a 33% increase in licensing transactions year‑over‑year, signaling a rapid move toward overseas commercialization. Together, these developments highlight China’s accelerating push to become a global hub for cutting‑edge medicines.
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