IBI363 positioned as a promising next-generation IO therapy with Ph3 trials underway. Strong survival benefits and broad potential position IBI363 (PD-1/IL-2) as a potential blockbuster next-gen IO therapy-especially for IO- resistant and cold tumors. In sq-NSCLC, IBI363 (3mg/kg) achieved a highly competitive mPFS of 9.3 months, far exceeding docetaxel (3.9 months for sq- and 3.6 months for nsq-NSCLC). Its 12-month OS rate reached 70.9% in sq- NSCLC and 71.6% in nsq-NSCLC, outperforming AK112 + docetaxel, which reported a 65% OS rate in IO-resistant NSCLC patients (combined sq- and nsq-). IBI363 also shows promise in cold tumors, i.e. melanoma and MSS colorectal cancer (CRC), with encouraging data presented at ASCO (CMBI report, link). The pivotal Ph2 trial in first-line melanoma is expected to complete enrollment by year-end. Ph3 trials are on track to begin in 2H25, targeting IO- resistant sq-NSCLC and third-line MSS CRC, with Ph3 studies also planned in the US. Front-line indications represent broader opportunities, and Innovent expects to release Ph1b/2 PoC data for IBI363 in first-line NSCLC and MSS CRC in 2026. Further upside of IBI363 includes combination potential with ADCs and out-licensing opportunities. Separately, IBI343 (CLDN18.2 ADC) is advancing into Ph3 trial in PDAC, in addition to its ongoing Ph3 study in GC.
　　Robust pipeline of next-generation IO and ADC therapies. Innovent is building a strong portfolio of next-generation IO agents and ADCs, positioning itself at the forefront of IO-ADC combination strategies-a key trend in future oncology drug development. Beyond IBI363, Innovent is developing several innovative IO assets, including PD-1/IL-12, PD-L1/CD40, and multiple TCEs targeting GPRC5D/BCMA/CD3, DLL3/CD3, and CLDN18.2/CD3. IBI3003, a multiple myeloma TCE targeting GPRC5D/ BCMA/CD3, has shown superior efficacy with comparable tolerability to talquetamab (GPRC5D×CD3) and teclistamab (BCMA×CD3) in preclinical models. It also outperformed same- target TsAb JNJ-5322 in low antigen expression cell models. We see potential of IBI3003 to compete with CAR-T therapies. A Ph1 study of IBI3003 is ongoing. Innovent is also advancing a broad ADC pipeline, spanning monoclonal ADCs (i.e. CLDN18.2, HER2), bispecific ADCs (i.e. EGFR/B7H3, EGFR/HER3, PD-L1/TROP2), and dual-payload ADCs (i.e. CEACAM5). These assets are being developed with future IO combination strategies in mind. Notably, IBI3001 (EGFR/B7H3 ADC) demonstrated promising signals across multiple tumor models, and is in a Ph1 trial in China, Australia, and US.
　　Growing innovative pipeline in non-oncology. Innovent recently launched mazdutide, China’s first domestic dual-target GLP-1 drug for obesity, marking a significant milestone in its non-oncology portfolio. We expect IBI311 (IGF- 1R, for thyroid eye disease), IBI306 (PCSK9, for hypercholesterolemia) and IBI112 (IL-23p19, for psoriasis) to become important revenue drivers in its non- oncology portfolio. Innovent is also advancing a strong early-stage CVM pipeline, with assets such as IBI3032 (GLP-1 small molecule), IBI3012 (triple G), IBI3030 (PCSK9-triple G), and IBI3016 (AGT siRNA). In the autoimmune space, IBI356 (OX40L) and IBI3002 (IL-4Rα/TSLP) are in clinical development.
　　Maintain BUY. We are positive on the global potential of Innovent’s rich innovative pipelines. Innovent is on track to achieve EBITDA breakeven this year. Backed by smooth development of IBI363, we improved our possibility of success for the asset and raised our DCF-based TP to HK$102.95 from HK$94.74.