China's investigator-initiated trials, once praised for their speediness, have been drawn into scrutiny for a lack of transparency. AstraZeneca and Daiichi Sankyo's Enhertu earned a win in a phase 3 non-small cell lung cancer trial. Tanabe Pharma secured a $435 million payout for lobal rights to its dermatology rare disease treatment dersimelagon. And more.
1. After 2 undisclosed gene therapy deaths, can China’s alternative regulatory path still be trusted?
The high-speed regulatory pathway credited with fueling China’s biotech boom is under international scrutiny after several previously undisclosed deaths—beginning with two in young children with rare genetic conditions—were uncovered in a matter of weeks. China’s investigator-initiated trials (IIT) allow Chinese hospitals and academic to launch early-stage human trials under a separate regulatory pathway with less oversight than the traditional drug approval process. Fierce talked to experts about what the patient deaths and poor public disclosure could mean for the IIT system.
2. AstraZeneca touts Enhertu, Orpathys dual lung cancer wins amid bispecific failure
In a pair of phase 3 readouts for niche populations in non-small cell lung cancer, AstraZeneca and Daiichi Sankyo’s antibody drug conjugate Enhertu bested Keytruda in first-line HER2-mutant nonsquamous NSCLC, while its Huchmed-partnered Orpathys-Tagrisso combination outperformed platinum-based chemo in Tagrisso-pretreated EGFR-mutated disease. The wins, however, were overshadowed by a phase 3 flop from the investigational bispecific volrustomig, which failed to outdo Keytruda and chemo this week in first-line NSCLC patients whose tumors express PD-L1 at below 50%.
3. Biokin bispecific ADC iza-bren hits goal in lung cancer trial, boosting case for BMS’ global test
Biokin Pharma’s phase 3 trial for iza-bren, a first in-class antibody drug conjugate that targets both EGFR and HER3, met its primary endpoint in an interim analysis, demonstrating significant progression-free survival benefits. The success of the trial, done in China, increases the chances of success for the drug’s global trial launching this fall and spearheaded by global partner Bristol Myers Squibb.
Tanabe Pharma is set to receive $435 million in upfront and near-term milestone payments after a deal with Leo Pharma. In exchange, Leo gets global rights to dersimelagon, a treatment in development for the rare genetic dermatology conditions erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP). Tanabe announced a phase 3 win for the drug in both indications earlier this year and now awaits an approval decision from the FDA.
5. Sandoz strikes $322M biosimilars deal with Shanghai Henlius
Amid growing biosimilar opportunities, Sandoz has entered a collaboration with Shanghai Henlius and procured rights to three early development biosimilars. Per the deal, which could cover as many as 10 biosimilars, Sandoz is paying $100.5 million for the initial assets upfront, and up to $322 million if development milestones are achieved.
Other News of Note:
- Third death in China's popular but opaque trials revealed, this time in CAR-T (Endpoints)
- SK strikes settlement with MSN over future Xcopri generic: reports
- Kolon TissueGene shrinks workforce after pivotal osteoarthritis trial miss
- Contractor SK Pharmteco heralds completion of 2 API plants in Ireland
- Aurobindo unit, China API maker dinged in latest round of FDA warning letters
- China's top drugmaker Hengrui sees profit growth squeezed by bulk-buying programs (Reuters)
- Sino Biopharmaceutical rebrands to SBP Group (release)