China’s Drug Approvals Surpass 2025 Total in H1 2026
China’s pharmaceutical innovation reached a historic milestone in the first half of 2026, with the number of domestically developed innovative drugs featuring new targets and mechanisms already exceeding the total for the entire year of 2025. According to data disclosed by the National Medical Products Administration (NMPA) at the Beijing·Changping Life Science Forum on July 12, the country approved 38 Class 1 innovative drugs in H1 2026, of which 11 drugs with new targets and mechanisms were all domestically developed — surpassing the full-year 2025 tally of 11 such drugs, of which only 4 were domestic, as reported by Xinhua News.
A Leap from ‘Fast Follower’ to ‘First-in-Class’
The data marks a qualitative shift in China’s pharmaceutical R&D capabilities. In 2025, China approved a record 76 Class 1 innovative drugs, but only 36% of new-target, new-mechanism drugs were domestic. In H1 2026, that figure jumped to 100%, signaling a transition from a “fast follower” model to genuine first-in-class innovation.
An NMPA official from the Drug Registration Management Department stated: “In the first half of the year, China approved the world’s first bispecific antibody ADC drug, the world’s first CAR-T drug for treating solid tumors, the world’s first monoclonal antibody targeting hepatitis B and D, and China’s first self-developed globally novel radiopharmaceutical. This marks China’s march toward becoming a major innovative drug R&D power.”
Global Firsts and Rapid Market Access
Among the most notable approvals was the world’s first bispecific antibody antibody-drug conjugate (ADC), developed by Chengdu-based biopharmaceutical company Baili Hengtian (百利天恒). Approved on June 22 via the NMPA’s priority review pathway, the drug reached nearly 700 hospitals and pharmacies across more than 200 cities within a week of approval, according to Yicai, citing Sichuan Release. The drug has also been included in the eligibility list for the 2026 National Reimbursement Drug List (NRDL) negotiations.
Other landmark approvals include the world’s first CAR-T therapy for solid tumors, the first monoclonal antibody targeting both hepatitis B and hepatitis D, and China’s first self-developed radiopharmaceutical with global novelty.
Out-Licensing Boom Signals Global Confidence
International recognition of Chinese pharmaceutical innovation is accelerating at an unprecedented pace. In H1 2026, the total value of out-licensing (BD) deals for Chinese innovative drugs approached approximately US$110 billion — reaching 80% of the full-year 2025 total of US$135.655 billion and double the full-year 2024 total, as reported by the Economic Information Daily.
This surge reflects growing global confidence in China’s R&D capabilities, with international pharmaceutical companies increasingly acquiring or licensing Chinese-developed novel drugs. What was once a sporadic flow of early-stage deals has matured into a regular US$100+ billion annual market.
Broader Innovation Pipeline Accelerates
A separate report from Jiemian (citing CCTV News) noted that China approved 43 innovative drugs in H1 2026 under a broader definition, representing a 59% year-on-year increase and approaching the full-year 2024 total of 48. This broader count includes China’s first domestically approved gene therapy product — for Hemophilia B — and a rare disease drug for immuno-metabolic conditions.
Policy Support for Genuine Innovation
Regulatory and reimbursement policies are evolving to sustain this momentum. The NMPA official outlined upcoming reforms, including optimizing cell and gene therapy reviews, piloting major change reviews for biologics and traditional Chinese medicine, advancing generic drug quality reforms, and introducing market exclusivity periods for pediatric and rare disease drugs.
Meanwhile, the National Healthcare Security Administration (NHSA) is refining its approach to drug reimbursement. An NHSA official stated: “Going forward, we will continue to optimize the adjustment rules for the medical insurance catalog, promote a real-world comprehensive evaluation system for medical insurance, strengthen evidence support, expand diversified payment channels, and jointly establish evaluation standards to better support genuine and differentiated innovation.”
Implications and Outlook
The H1 2026 data signals that China is no longer just the world’s largest pharmaceutical market — it is emerging as a source of truly novel therapeutics. The combination of regulatory reform, growing R&D investment, and international deal-making suggests that 2026 could be a record-breaking year for Chinese biopharma.
Key questions remain: Can this pace of innovation be sustained given the capital-intensive nature of drug development? How will China’s approval rates compare with the US FDA and EMA for the full year? And which domestic biopharma companies will emerge as the primary beneficiaries of this innovation surge? The second half of 2026 will provide critical answers.