New research shows that CAR‑T cell therapy, especially the BCMA‑targeted drug ciltacabtagene autoleucel (cilta‑cel), is emerging as the preferred treatment for patients whose multiple myeloma has come back or stopped responding to other medicines. In a large Phase 3 trial (CARTITUDE‑4), a single infusion of cilta‑cel gave patients a 30‑month progression‑free survival rate of 59 % and an overall‑survival rate of 76 %, with more than 99 % responding to treatment and 72 % achieving deep, MRD‑negative remissions. These results were better than standard therapies and also improved quality of life. By contrast, the bispecific antibody combo teclistamab + daratumumab (tec‑dara) also works well but requires regular monthly injections, carries a higher infection risk, and its benefit in patients already exposed to CD38 antibodies (like daratumumab) is still uncertain. Real‑world data suggest CAR‑T remains effective even after CD38‑targeted drugs, while tec‑dara’s performance in that setting is less clear. Experts now recommend using CAR‑T first when both options are available, reserving bispecific antibodies for later lines of therapy. The single‑dose approach reduces treatment‑related “time toxicity,” avoids the need for ongoing IVIG support, and may offer a path toward long‑term remission or even cure for many patients. Access and logistical hurdles remain, but for most eligible patients, CAR‑T is the default choice.
Read moreChina’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 moreOver the past two decades China has raced from Nobel‑level discoveries in stem‑cell science to bustling hospital clinics offering cell and gene therapies. A new set of rules released in March 2024 finally draws a line between “drugs” and “translatable biomedical technologies,” allowing highly personalized or rare‑disease treatments that lack a domestic drug counterpart to be classified as technology rather than medicine. This regulatory clarity has unleashed a flood of investigator‑initiated trials (IITs). From 2015 to the end of 2025 the number of IITs in China’s cell‑gene‑therapy (CGT) field jumped twelve‑fold to more than 1,300 projects, enrolling over 30,000 patients—far outpacing traditional registered trials. Major tertiary hospitals have responded by opening dedicated cell‑regenerative outpatient clinics and are eager to launch more IITs. While the promise is alluring—large‑scale indications could bring tens of millions of yuan in revenue for hospitals—the reality is mixed. Early hype suggested cures and anti‑aging miracles, yet systematic data on efficacy and safety remain scarce. Companies remain cautious; the technology pathway still involves lengthy approvals after costly R&D. Experts say the next decade will be defined by how quickly the industry can turn rapid IIT successes into vetted, affordable therapies for patients across China.
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