On January 16, 2025 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported to have participated in the 43rd Annual J.P. Morgan Healthcare Conference (Press release, Innovent Biologics, JAN 16, 2025, View Source [SID1234649761]).
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During the conference, Dr. De-Chao Michael Yu, Founder, Chairman and CEO of Innovent, delivered a presentation highlighting 2025 as a pivotal year for significantly business growth and concreate steps in global innovation. These efforts will further strengthen the foundation for Innovent’s vision of becoming a global premier biopharma company.
Clear path to sustainable growth
Innovent has established itself as a leading brand in oncology, consistently gaining momentum with an expanding portfolio of synergistic products. Additionally, another key growth driver, the general biomedicine segment, features a highly competitive product lineup, poised to unlock the substantial opportunities in chronic disease areas.
The company remains confident in achieving its domestic product revenue target of 20 billion RMB by 2027. Alongside rapid business growth, Innovent continues to enhance operational efficiency through effective and lean management practices, ensuring sustainable and healthy operating model.
Focus on world-class technology platforms and key therapeutic areas
Innovent Academy, the company’s innovation engine, has built a world-class technology platform, encompassing ScFv engineering, T cell engager (TCE), VHH bispecific antibodies, Topo1i ADC, dual payload ADC, and antibody peptide conjugates (APC). These platforms have consistently delivered innovative molecules, providing a driving force for the company’s long-term development.
In particular, Innovent combines its world-class antibody engineering and multiple sets of differentiated linker payload technologies to create the TOPO1i ADC technology platform (SoloTx) and dual payload ADC technology platform (DuetTx), producing a pipeline of potential best-in-class (BIC) or first-in-class (FIC) ADC candidates.
The company has so far advanced 8 ADC candidates into clinic trials, supported by efficacy and safety data from over 600 patients, with multiple ADCs receiving breakthrough therapy designation (BTD). This further validates the differentiated advantage of the company’s ADC platform technology and its strong clinical execution.
Innovent continues to focus on high-potential therapeutic areas in oncology and general biomedicine. The "PD-1+precision therapies" pipeline strengthens its leadership in oncology, while the "IO+ADC" strategy is set to transform cancer treatment. Meanwhile, its general biomedicine pipeline covers next generation treatments for autoimmune, cardiovascular and metabolic, and ophthalmic diseases, aiming to elevate treatment standards for diverse patient populations.
Embracing new opportunities in global innovation
Innovent Academy’s advancements have paved the way for a globally competitive pipeline of next generation IO and ADC candidates. The company plans to expand into innovative ADCs, bispecific (multi-specific) antibodies, and next-generation autoimmune and CVM therapies for global development.
IBI343 (CLDN18.2 ADC): Phase 3 multi-regional clinical trial (MRCT) has been initiated in China and Japan for gastric cancer. Pancreatic cancer MRCT clinical Phase 1 data shows positive efficacy and safety signals in Chinese patients and has started patient enrollment in the U.S. Pivotal clinical trials are anticipated in 2025, subject to PoC validation.
IBI363：This first-in-class PD-1/IL-2α-biased bispecific antibody has shown promising Phase 1 clinical data, obtained from hundreds of patients in IO resistant non-small cell lung cancer (NSCLC), melanoma, and IO unresponsive "cold tumor" colorectal cancer (CRC). This points to its potential as the next generation IO cornerstone drug. Innovent is following up on the Phase 1b/2 expansion cohorts of these cancer types. Pivotal clinical studies in IO-resistant advanced squamous NSCLC and IO-naïve advanced melanoma are planned to launch in China in 2025, subject to PoC data and regulatory communication. A Phase 2 clinical study is ongoing in the U.S. and will further expand into cohorts for NSCLC, CRC, and melanoma.
IBI3009 (DLL3 ADC): Through global licensing collaboration with Roche, Innovent aims to accelerate the development of this potentially best-in-class DLL3 ADC for small cell lung cancer patients worldwide.
2025 outlook: unlocking growth opportunities
Looking ahead in 2025, the company anticipates a year of rapid growth, driven by six new drug launches and further advancements in commercialization across oncology and general biomedicine. Key highlights include:
Mazdutide (GCG/GLP-1): Expected approvals for weight loss and type 2 diabetes indications in the first and second half of 2025, respectively, will provide a best-in-class GCG/GLP-1 dual agonist drug offering robust weight loss and glucose reduction, substantial liver fat reduction as well as comprehensive metabolic benefits for the vast obese, overweight and diabetes population;
Teprotumumab (IGF-1R): Anticipated launch as China’s first anti-IGF-1R monoclonal antibody for thyroid eye disease (TED), addressing a 60-year treatment gap.
Picankibart (IL-23p19): Approval anticipated by late 2025. Picankibart is the first globally to report that over 80% of subjects achieved PASI 90 (≥90% improvement in psoriasis area and severity index) within 16 weeks of treatment. It also demonstrates clear advantages, including sustained long-term efficacy, effective in patients resistant to IL-17 inhibitors, and flexibility with seasonal dosing intervals. Picankibart is poised to deliver exceptional comprehensive benefits to psoriasis patients in China.
As the company advances key cornerstone products in its pipeline, we are actively expanding the development of mazdutide, teprotumumab, and picankibart into additional indications to maximize the portfolio’s value. Building on this solid foundation, next-generation candidates are gradually entering clinical development, aiming to address global challenges related to aging and chronic disease burden. These innovations focus on extending dosing intervals, oral delivery, and novel mechanisms of action.
Looking ahead to 2025, the company plans to submit NDAs or conduct ongoing registrational trials for seven drugs, while initiating pivotal or registrational trials for seven innovative pipeline candidates, pending PoC results. Additionally, molecules with global potential and novel mechanisms of action (MoAs) will progress into PoC and first-in-human studies. These efforts solidify Innovent’s vision of "growing into a global premier biopharma company."