JPMorgan has issued a research report maintaining its "Overweight" rating on Hansoh Pharma (03692) with a target price of HK$50.
Merck (MRK.US) and Daiichi Sankyo (4568.JP) have voluntarily withdrawn the U.S. Biologics License Application (BLA) for their B7-H3 ADC drug ifinatamab deruxtecan (I-DXd) for previously treated extensive-stage small cell lung cancer (ES-SCLC). From a competitive timeline perspective, this represents an incremental positive for Hansoh Pharma/GSK's Ris-Rez.
The report notes that prior to the withdrawal, I-DXd's BLA had received priority review, with an original FDA PDUFA date of October 10, 2026. Future U.S. submission now depends on the ongoing Phase III IDeate-Lung02 study, which may complete enrollment in the coming months. Clinical trial registrations indicate a completion date around early 2028, meaning a new BLA could be submitted in early 2028.
This event weakens I-DXd's U.S. first-mover advantage and shifts focus more toward randomized Phase III overall survival (OS) and safety evidence. The bank believes that Ris-Rez has already reported positive OS data from the randomized Phase III ARTEMIS-008 trial in China and is being evaluated in GSK's global Phase III EMBOLD SCLC-301, with data readouts potentially in 2027/2028 and a potential U.S. submission falling around 2028, similar in timing to I-DXd's new submission.
According to WCLC'26 data, Ris-Rez demonstrated a median OS of 18.5 months versus 10.3 months for Topotecan in second-line and beyond ES-SCLC, with a hazard ratio of 0.46; median progression-free survival of 7.2 months versus 3 months; and an objective response rate of 58.3% versus 12.6%.
The bank notes that Ris-Rez's efficacy data appears to lead I-DXd's Phase II results, but differences in trial design and patient populations make direct head-to-head comparison inappropriate. Regarding safety, Ris-Rez showed a treatment-related interstitial lung disease incidence of 11.7% with no Grade 4/5 events, compared to 12.4% for I-DXd in Phase II, which included Grade >3 events.