AstraZeneca’s Daiichi Sankyo-partnered antibody-drug conjugate Enhertu has made it onto China’s national insurance program despite the star med being a part of an ongoing investigation in the country.
Enhertu was among 91 new additions to China’s National Reimbursement Drug List (NRDL) effective at the start of 2025, Chinese authorities announced (Chinese) last week. Of the new entrants, 89 went through pricing negotiations in October. Drugmakers that won those spots offered on average a 63% discount, a level that was in line with previous years, according to (Chinese) the National Healthcare Security Administration.
Enhertu’s placement on the NRDL comes at a delicate time for AZ as Leon Wang, who until recently served as the company’s China and international business head, was put under investigation, along with AZ’s former China oncology leader Eva Yin.
AZ has said the company believes Chinese authorities are looking into allegations that employees had illegally imported Enhertu and cancer immunotherapy Imjudo from Hong Kong to the mainland and that they had broken the law with patient data collection.
The NRDL development marks a bittersweet experience for AZ in the country. A few years ago, a hefty discount on the company’s blockbuster EGFR lung cancer med Tagrisso—under the NRDL program—contributed to a rare decline of the British pharma’s China business. Afterward, the unit bounced back as volume growth started to compensate for the price cut.
Enhertu won its initial China nod in early 2023 as a treatment for previously treated HER2-positive breast cancer and later added HER2-low breast cancer, HER2-positive gastric or gastroesophageal junction cancer and HER2-mutant non-small cell lung cancer (NSCLC) to its list of approved uses.
Besides Enhertu, Roche’s blockbuster ADC Polivy, a diffuse large B-cell lymphoma treatment, also secured a spot on China’s national insurance plan.
However, Gilead Sciences couldn’t make a deal for its TROP2-directed ADC Trodelvy after another try with the NRDL. That means the U.S. biotech lost an opportunity to dig a firmer foothold as competition builds in the market. Local firm Kelun-Biotech’s rival drug, sacituzumab tirumotecan, just won a matching nod in China for patients with advanced triple-negative breast cancer. And AZ and Daiichi’s application for their datopotamab deruxtecan is also under review by Chinese authorities.
Trodelvy and Pfizer’s leukemia ADC Besponsa were among 28 drugs that entered price negotiations but failed to strike an accord with the NRDL, according to local media reports. That number translated into an overall negotiation success rate of 76% for meds not previously included on the NRDL.
Other therapies didn’t even make it to the negotiation table. These include four CAR-T therapies that were eligible to be considered, according to local media reports.
CAR-T therapies cost much less in China compared with the U.S. However, their list prices—at above 1 million Chinese yuan (roughly $137,650)—are still viewed as too expensive for the NRDL compared with a widely cited ceiling of 300,000 yuan annually that the NRDL is willing to pay for any single drug.
As national reimbursement appears out of reach in the foreseeable future, Gilead in September walked away from its cell therapy joint venture with Fosun Pharma, handing full control over the CD19 CAR-T Yescarta in China to its local partner.
Other important additions to the NRDL include Roche’s fast-growing eye med Vabysmo plus its HER2 combo Phesgo and newer flu med Xofluza. Bristol Myers Squibb’s oral psoriasis med Sotyktu, Johnson & Johnson’s blockbuster multiple myeloma antibody Darzalex and Takeda’s first-in-class cytomegalovirus drug Livtencity are also among those that landed on the NRDL.
From domestic companies, Akeso’s PD-1/VEGF bispecific antibody ivonescimab, which recently beat Merck’s Keytruda in a head-to-head China phase 3 trial in first-line, PD-L1-positive NSCLC, has also secured reimbursement from the NRDL. While Akeso awaits a decision from China’s drug reviewers on that use, the drug’s current indication is only for second-line EGFR-mutant nonsquamous NSCLC. If approved, a first-line NSCLC indication would require a separate price negotiation to be included in the NRDL.
Akeso’s other bispecific product, a PD-1/CTLA-4 med called cadonilimab that's approved in China for cervical cancer, also made it onto the NRDL this time.