Izalontamab Brengitecan

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 global 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 academics 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 conducted in China increases the chances of success for the drug’s global trial, which launches this fall and is spearheaded by global partner Bristol Myers Squibb. 4. Leo ‘really strengthening’ pipeline with $435M deal for Tanabe rare skin disease drug awaiting FDA nod 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. 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)

Biokin Pharma’s iza-bren, a first-in-class antibody-drug conjugate partnered with Bristol Myers Squibb, has posted another positive phase 3 readout. The Panku-Lung01 lung cancer trial met its primary endpoint at an interim analysis, showing a significant progression-free survival benefit for iza-bren, Biokin said Tuesday in a securities filing (Chinese, PDF). The study in China tested the EGFRxHER3 bispecific ADC against platinum-based chemotherapy in patients with advanced EGFR-mutated nonsquamous non-small cell lung cancer following treatment with an EGFR tyrosine kinase inhibitor (TKI). A positive trend toward an overall survival improvement was also observed, according to Biokin. The phase 3 win from China boosts the chance of success for BMS’ global counterpart trial, Izabright-Lung01, a phase 2/3 trial launched in November 2025 and expected to read out in 2028. In both studies, patients are required to have progressed on a third-generation EGFR TKI. Previously, in a subgroup of chemo-naïve patients who had failed on a third-generation EGFR TKI, a phase 2 trial linked iza-bren to a median PFS of 12.5 months, according to data presented at the World Conference on Lung Cancer 2025. The New Jersey pharma is preparing to launch an ambitious phase 3 trial, Izabright-Lung02, in first-line EGFR-mutated NSCLC. The study, the fourth global phase 3 that BMS has outlined for iza-bren, will test the bispecific ADC in combination with AstraZeneca’s Tagrisso against either Tagrisso alone or its combination with chemo. Another set of phase 2 results shared at WCLC 2025 showed a 100% objective response rate for a combination of iza-bren and Tagrisso in first-line EGFR-mutated NSCLC. After a median follow-up of 12.8 months, the median duration of response and PFS had not been reached at that time. For reference, in the phase 3 Flaura2 trial, Tagrisso plus chemo registered an ORR of 77% in the same treatment setting. Iza-bren has been on a winning streak since BMS paid $800 million upfront to license the drug as part of a potential $8.4 billion deal signed in late 2023. For Biokin, Panku-Lung01 marks the fourth positive phase 3 trial the Chinese drugmaker has reported for iza-bren. The drug got its first regulatory approval in June when China’s National Medical Products Administration cleared it for recurrent or metastatic nasopharyngeal carcinoma following previous treatment with PD-1/L1 and chemo based on data from the Panku-NPC01 trial. The drug quickly added previously treated esophageal squamous cell carcinoma to its China label in July, thanks to positive PFS and OS results from the Panku-Esophagus01 study. In what could be iza-bren’s third indication, Chinese regulators are reviewing the drug for previously treated triple-negative breast cancer (TNBC). In the Panku-Breast02 trial, iza-bren significantly reduced the risk of death by 40% versus physician’s choice of chemotherapy, according to data presented at the American Society of Clinical Oncology annual meeting in June. BMS, taking a step further, has moved iza-bren into global phase 3 testing in first-line TNBC, as the Izabright-Breast01 trial in PD-(L)1-ineligible patients is projected to read out in 2028. Together, BMS and Biokin have launched 20 phase 3 or phase 2/3 trials for iza-bren globally or in China, according to Biokin. In both EGFR-mutated NSCLC and TNBC, iza-bren poses a threat to TROP2-targeted ADCs, including AstraZeneca and Daiichi Sankyo’s Datroway , Gilead Sciences’ Trodelvy and Merck & Co. and Kelun-Biotech’s sac-TMT . RELATED: ASCO: Bristol Myers’ $800M bispecific ADC aces China breast cancer study, putting TROP2 drugs on notice Getting ever more ambitious and potentially adding more pressure on TROP2 ADCs, Biokin is also initiating a phase 3 trial in first-line NSCLC. The China study, dubbed Panku-Lung05 , will evaluate iza-bren in combination with a PD-1xVEGF bispecific antibody—one of the hottest frontiers in oncology drug development—for squamous NSCLC. All the iza-bren advancement comes as Biokin is gunning for a double listing on the Hong Kong Stock Exchange after pulling the plug days before a planned IPO last November.