Thirty-eight innovative drugs were approved in China during the first half of 2026, among which all 11 first-in-class therapies with novel targets and mechanisms were domestically developed. Meanwhile, the total transaction volume of out-licensing deals for Chinese innovative drugs reached nearly USD 110 billion in the same period.
On the 12th, a senior official from the Department of Drug Registration, National Medical Products Administration (NMPA) unveiled the latest performance report card for China’s innovative drug industry at the Changping Life Science Forum in Beijing.
Previous statistics released by NMPA showed that China granted approval to 76 innovative drugs in 2025, hitting a record high. Yet out of the 11 first-in-class medicines with novel targets and mechanisms approved that year, only four were homegrown.
In other words, the number of domestic first-in-class drugs (medicines with original targets and mechanisms) approved in the first half of this year has already surpassed the full-year tally of 2025, and the figure is expected to set another new annual record.
“The newly approved drugs in H1 feature numerous highlights. We have authorized the world’s first bispecific antibody-drug conjugate (ADC), the world’s first CAR-T therapy for solid tumors, the first global-first monoclonal antibody targeting both hepatitis B and hepatitis D, as well as China’s first domestically developed world-first radiopharmaceutical. These milestones mark China’s progress toward becoming a major powerhouse in innovative drug R&D,” the official stated.
Parallel to domestic breakthroughs, Chinese pharmaceutical innovation is gaining accelerating international recognition. Industry analysts had predicted 2026 would be a bumper year for pharmaceutical BD (Business Development) transactions involving Chinese novel drugs, an expectation now validated by official regulatory data.
NMPA figures put the full-year out-licensing transaction value of Chinese innovative drugs at USD 135.655 billion for 2025. That means the H1 2026 out-licensing scale has nearly matched last year’s total annual volume.
On the domestic market front, newly approved domestic novel drugs are also seeing faster commercial rollout.
Take the aforementioned world-first bispecific ADC for example. Developed by Chengdu-based biotech firm Baili Tianheng, the drug obtained conditional marketing approval via NMPA’s priority review pathway on June 22. According to Sichuan Release on July 8, less than one week after launch, the first batch of orders for this anti-cancer drug had been delivered to nearly 700 hospitals and pharmacies across over 200 cities nationwide.
In addition, Yicai noted the drug made it just in time to enter the formal review list for this year’s National Medical Insurance Negotiation (National Talks) for the national basic medical insurance catalog. The National Healthcare Security Administration (NHSA) disclosed that newly launched drugs account for the majority of varieties enterprises submitted for the dual catalog negotiations in 2026. A total of 343 new chemical entities approved within five years were filed under Eligibility Condition 1 for off-catalog varieties (excluding pre-submission candidates). “This demonstrates the vigorous development of China’s pharmaceutical sector, the continuous growth in newly launched medicines, and pharmaceutical companies’ high priority and active participation in catalog adjustments,” said NHSA.
A senior official from the Medical Insurance Management Department of NHSA told the forum that moving forward, the authority will continuously optimize the rules governing medical insurance catalog adjustments, advance a comprehensive real-world evidence evaluation system for medicines, strengthen evidence support, expand diversified payment channels, boost international exchanges to build consensus, and jointly establish unified evaluation standards. These measures will better support genuine and differentiated pharmaceutical innovation. (Outlook New Era)
Edit：Liu Zhiyu Responsible editor：Li Yulu
Source：https://www.yicai.com/
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