China’s drug regulator just announced a historic surge in new medicines. In 2025, a total of 76 innovative drugs received approval – the highest number ever recorded – and more than half of them are anti‑cancer treatments. The National Medical Products Administration processed over 20,000 drug registration requests, finishing nearly 19,400 of them, marking new highs in both applications and approvals. The approved drugs span 17 therapeutic areas, including infectious diseases, endocrinology, dermatology and eye care. Notably, 11 of the new medicines are “first‑in‑class,” targeting novel biological pathways, with four of those developed entirely in China, such as a breakthrough antibody‑drug conjugate for nasopharyngeal carcinoma. The report also highlighted major strides in orphan and pediatric medicines: 10 orphan drugs were approved, including the first innovative treatment for pulmonary fibrosis in a decade, and 138 pediatric drugs received clearance, expanding safe options for children. Scarce‑drug access improved too, with 174 registrations covering 33 essential medicines. Overall, anti‑tumor drugs dominated the pipeline, accounting for over 50% of clinical trial applications and nearly 42% of priority‑review submissions, underscoring China’s rapid shift from following global trends to leading them.
Read moreAt the 2026 DIA Drug Information Conference, a special forum brought together leading scientists from China, the U.S., Europe and Australia to discuss how basic research is being turned into new medicines faster than ever. Speakers highlighted that China’s new‑active‑substance pipeline has shrunk from an average of 9.5 years to just 3.6 years, with pre‑commercial biotech firms now launching nearly 70 % of clinical trials. The “basic + clinical” model – strong laboratory work paired with an efficient patient‑centric trial system – is credited with this speed. Experts also warned that artificial intelligence should be a workhorse, not a gimmick: AI is already helping scientists hit previously “undruggable” targets, cut trial‑and‑error, and create a two‑way data loop that feeds clinical problems back into the lab. International partners stressed that true progress comes from deep collaboration, combining China’s rapid execution, Europe’s cutting‑edge theory, and Australia’s regulatory expertise. The consensus was clear: when countries pool their strengths and let AI do the heavy lifting, the whole drug‑development pipeline can move faster, cheaper, and more patient‑focused.
Read moreDrug makers are launching more candidates than ever, yet the profit they earn from research and development has plummeted—from a 12‑15% return in the 2000s to just 3‑5% today. Experts say the biggest culprit is the growing complexity of clinical trials. Over the past decade, Phase III studies now require far more endpoints, stricter eligibility rules and an average of 301 procedures per participant, up from 187. This bureaucratic maze makes it harder to find volunteers, doubles dropout rates and stretches timelines, driving up costs and choking innovation. Kenneth Getz, a leading analyst, argues that no single fix will work. Instead, the industry needs a cultural shift: stop collecting data for its own sake and focus on the core purpose of meeting unmet medical needs. Tools like AI should simplify, not add layers of paperwork. A success story comes from China’s lung‑cancer research. Professor Lu Shun’s team turned the EGFR mutation—common in Asian patients—into a target that boosted five‑year survival from under a year to more than five years. Their work, spanning multiple generations of drugs and international collaborations, shows that precise targeting and streamlined trials can deliver real patient benefits. The takeaway? To revive pharmaceutical innovation, trials must become smarter, leaner and truly patient‑centric.
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