Faricimab

AUSTIN, Texas--(BUSINESS WIRE)--Ollin Biosciences, Inc. (Ollin), a clinical-stage biotech advancing best-in-disease therapies for vision-threatening diseases, today announced final 20-week study completion data from its randomized, head-to-head Phase 1b JADE clinical study comparing OLN324, a higher-potency, smaller-format, higher-molar dose VEGF/Ang2 bispecific antibody, to faricimab (Vabysmo®), in patients with diabetic macular edema (DME) or wet (neovascular) age-related macular degeneration (wAMD). Final results released today include favorable durability data for OLN324 compared to faricimab and new anatomic data showing faster, greater, and more durable control of wAMD pigment epithelial detachments (PEDs). Topline data from the Week 12 primary endpoint readout, previously announced in January 2026 and presented at the Angiogenesis, Exudation, and Degeneration symposium in February 2026, demonstrated OLN324, compared to faricimab, delivered superior anatomic outcomes in DME, including faster and greater retinal drying and more patients achieving absence of DME; equivalent retinal drying compared to faricimab in wAMD; rapid and sustained gains in vision in both DME and wAMD that were numerically better than faricimab; and had a favorable safety profile with no cases of intraocular inflammation. Final 20-Week Study Completion Data Highlights In the JADE trial, which enrolled 164 U.S. patients with either DME or wAMD, all patients initially received three monthly doses of OLN324 or faricimab. Thereafter, they were followed for an additional 12 weeks off treatment, during which they could be retreated based on protocol-specified criteria for disease recurrence that were the same for all groups. At the final study visit of Week 20, 12 weeks after the last mandatory dose, DME patients treated with OLN324 continued to demonstrate greater retinal drying compared to those treated with faricimab, measured as mean change in central subfield thickness on optical coherence tomography (OCT), along with sustained vision gains that were numerically greater for OLN324 4 mg. These improved efficacy outcomes were achieved with fewer retreatments compared to faricimab. 93% of DME patients randomized to OLN324 4 mg completed 12 weeks of follow-up without retreatment, versus 89% of patients randomized to faricimab. In wAMD, the rapid and comparable improvements in retinal drying (mean change in OCT CST) observed from Day 1 to Week 12 with OLN324 and faricimab were sustained through Week 20. Patients treated with OLN324 experienced numerically greater vision gains than patients treated with faricimab; the best-corrected visual activity (BCVA) improvements continued to separate between groups from Weeks 12 to 20, with a mean +2.2 letter advantage observed over faricimab for OLN324 4 mg at Week 20. 82% of OLN324 4 mg patients completed 12 weeks of follow-up without retreatment, compared with 81% of faricimab patients. OLN324 continued to demonstrate a favorable safety profile, with zero cases of intraocular inflammation observed through the entirety of the study, compared with one case in a faricimab-treated patient. There were no cases of retinal vasculitis or occlusive retinal vasculitis with OLN324. “These new JADE study data further strengthen the differentiated profile of OLN324, highlighting its robust anatomic efficacy and durability across both DME and wAMD. Combined with a favorable safety profile, these results underscore OLN324’s potential to become a first-line treatment option for these vision-threatening diseases,” said Jason Ehrlich, M.D., Ph.D., Co-founder and Chief Executive Officer of Ollin Biosciences. “We look forward to advancing OLN324 into global Phase 3 studies in both DME and wAMD later this year. Subject to regulatory communications, we expect the Phase 3 studies to recruit patients from North America, South America, Europe and Japan, and we are actively planning, in partnership with Innovent Biologics, to include China and South Korea.” “We are pleased to see that the latest 20-week data for OLN324 (IBI324) further highlight its differentiated profile and clinical potential,” said Lei Qian, M.D., Ph.D., Chief R&D Officer of General Biomedicine at Innovent Biologics. “We look forward to continuing our close collaboration with Ollin and, following discussions with regulatory authorities, to accelerate the global Phase 3 clinical development of this best-in-disease therapy for retinal diseases.” New Anatomic Results on Pigment Epithelial Detachment (PED) Flattening Highlight Potential for Smaller-Format, Higher-Potency OLN324 to Improve Treatment of wAMD In newly-available, pre-specified data, wAMD patients in the JADE trial randomized to OLN324 4 mg experienced faster and approximately 50% greater reductions in PED thickness at Week 12 compared to patients randomized to faricimab, measured as mean change in neovascular lesion complex thickness on OCT. Through Week 20, in the off-treatment follow-up period, these improvements were more durable for patients randomized to OLN324 4 mg than faricimab. “As a field, we’ve been looking for meaningful advancements that further improve anatomic outcomes in wAMD,” said David Eichenbaum, M.D., FASRS, Director of Research, Retina Vitreous Associates of Florida. “These data suggest that OLN324’s more potent Ang2 inhibition and smaller molecular format may translate into breaking through the efficacy ceiling experienced with current treatments and offering a clinically-relevant benefit in PED improvement – the most difficult to treat component of wAMD.” Retinal fluid (intraretinal and subretinal) and PEDs are two hallmark anatomic features of wAMD. PEDs are present in approximately 80% of wAMD patients. Persistent PEDs following anti-VEGF treatment are associated with development of subretinal fibrosis, an important cause of late vision loss in wAMD. Full details of the final JADE study data are expected to be presented at upcoming medical and scientific conferences. About the OLN324 JADE Study JADE is a randomized, head-to-head Phase 1b clinical study comparing OLN324, a next-generation VEGF/Ang2 bispecific antibody, to faricimab (Vabysmo®), in patients with diabetic macular edema (DME) or wet (neovascular) age-related macular degeneration (wAMD). More than 160 patients with wAMD or DME were enrolled at sites in the United States. All patients initially received three monthly doses of either OLN324 2 mg, OLN324 4 mg, or faricimab 6 mg. Patients were evaluated at Weeks 1, 4, 8, 12, 16, and 20 and could be retreated at Weeks 12 or 16 based on protocol-specified retreatment criteria that were the same for all groups. The primary objective was to assess safety and tolerability (through Week 12 and Week 20). Prespecified exploratory efficacy objectives included the evaluation of OLN324 vs. faricimab on visual acuity and various retinal anatomic parameters. About OLN324 Building on the clinical success of intravitreal VEGF/Ang2 inhibition, OLN324 is a next-generation VEGF/Ang2 bispecific antibody engineered with substantially higher Ang2 potency relative to faricimab, increased molar dosing relative to both faricimab and aflibercept (including Eylea HD®), and a smaller protein format. VEGF and Ang2 are central drivers of retinal vascular diseases such as diabetic macular edema (DME) and wet (neovascular) age-related macular degeneration (wAMD), with Ang2 playing a key role in vascular instability, leakage, inflammation, and fibrosis. OLN324 was discovered by and is being developed in collaboration with Innovent Biologics (HKEX: 01801; Innovent R&D code: IBI324). About Diabetic Macular Edema (DME) Diabetic macular edema, a vision-threatening complication of diabetic eye disease, is a leading cause of vision loss among working-age adults in the developed world. In diabetic macular edema, progressive microvasculature damage, ischemia and microvascular inflammation result in vascular leakage and retinal swelling that compromise vision. About Wet Age-Related Macular Degeneration (wAMD) Age-Related Macular Degeneration, a chronic and progressive retinal disease, is the leading cause of vision loss among older adults in the developed world. In wet (or neovascular) AMD, abnormal blood vessels growing beneath the retina leak and bleed, resulting in significant vision impairment. About Ollin Biosciences Established in 2023, Ollin BiosciencesTM is a clinical-stage biopharmaceutical company dedicated to acquiring and developing best-in-disease therapies for vision-threatening diseases. With a differentiated pipeline, world-class team, and strong investor syndicate, Ollin is redefining what’s possible in ophthalmology. For more information, please visit us at www.ollin.bio and follow us on LinkedIn and X. Vabysmo® is a registered trademark of Genentech, Inc.; Eylea® and Eylea HD® are registered trademarks of Regeneron Pharmaceuticals, Inc.

From China Leadership to Global Premier: Revenue Surpasses RMB 10 Billion, Entering the Era of Profitability and Globalization SAN FRANCISCO and SUZHOU, China, March 26, 2026 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic, and other major diseases, announces its 2025 annual results and long-term strategic blueprint. Dr. Michael Yu, Founder, Chairman of the Board and CEO of Innovent, stated: "2025 marks the most successful year in Innovent's history. We achieved historic breakthroughs across three areas: business scale, financial strength, and global innovation. We successfully upgraded our strategy from an oncology-focused leader to a 'dual-engine growth model' driven by oncology and general biomedicine portfolio. Encouragingly, we delivered our first full year of net profit, marking a formal entry into an era of sustainable profitability. Our robust cash reserves and positive operating cash flow will provide strong support for strategic growth. On the innovation front, three global high-potential assets advanced into or near global registrational clinical development, targeting a combined addressable market value of over US$60 billion. Meanwhile, we accelerated the global value realization of our pipeline through multiple landmark strategic collaborations, laying a solid foundation for global expansion. Total deal value reached over US$22 billion in the past year, accounting for more than 10% of China's innovative pharmaceutical sector outbound licensing value in 2025[1]. These achievements not only validate the foresight of our strategy but also highlight our uniqueness of strong growth and high certainty within China's biopharma industry. Guided by our Vision 2030 to become a global premier biopharmaceutical company, we will continue to drive progress across four core pillars: revenue, profitability, innovative pipeline and organizational capabilities, creating sustainable value for patients, shareholders and society." Revenue Set New Height, Achieved Full-Year Profitability with Strong Cash Position Total revenue reached RMB 13.0 billion, representing a year-on-year increase of 38.4%. Product revenue amounted to RMB 11.9 billion, up 44.6% year-on-year. From the commercial launch of its first product in 2019 to 18 approved products and surpassing RMB 10 billion revenue milestone, Innovent accomplished this in only 7 years, setting a new growth benchmark for China's innovative biopharmaceutical industry. The Company achieved its first full year of net profit. IFRS net profit reached RMB 814 million, and Non-IFRS net profit rose to RMB 1.72 billion, marking a structural inflection in profitability and entry into a sustainable earnings era. Operating efficiency continued to improve. Gross margin improved 2.3 percentage points to 87.2%. Selling and administrative expense ratio declined 2.9 percentage points to 48.0%. EBITDA surged to RMB 1.99 billion (2024: RMB 412 million). As of December 31, 2025, cash reserves totaled RMB 24.3 billion (~US$3.5 billion). Additionally, the Company also generated positive operating cash flow, providing strong financial support for long-term development. [2] Dual-Engine Strategy Fully Implemented, Commercial Foundation Strengthened China Leading Oncology Brand with Synergistic Value of Innovative Portfolio Innovent has established a leading oncology brand in China. Cornerstone products including TYVYT® (sintilimab injection), BYVASDA® (bevacizumab injection) and HALPRYZA® (rituximab injection) have benefited millions of Chinese cancer patients. In addition, five small-molecule targeted oncology drugs—Limertinib (EGFR TKI), DOVBLERON® (Taletrectinib, ROS1i), Dupert® (fulzerasib, KRAS G12Ci), JAYPIRCA® (Pirtobrutinib, BTKi), and Retsevmo® (selpercatinib, RETi) — were successfully included in the 2025 National Reimbursement Drug List (NRDL), further strengthening the competitiveness and commercial performance of Innovent's oncology portfolio. General Biomedicine Franchise Emerged as a New Growth Engine Benefiting from forward-looking strategic layout, Innovent's general biomedicine portfolio delivered strong momentum in 2025. SYCUME® (Teprotumumab, IGF-1R antibody), China's first innovative therapy for thyroid eye disease in 70 years; Mazdutide, the world's first and only approved GCG/GLP-1 dual-receptor agonist for obesity and type 2 diabetes; and SINTBILO® (tafolecimab injection), the first China-domestic PCSK9 inhibitor included in the NRDL—all exhibited robust performance. PECONDLE® (picankibart injection, IL-23p19 antibody), the anchor asset in autoimmune diseases, was also approved at the end of 2025. Within a single year, the general biomedicine portfolio has become a second core engine driving high-speed growth. Today, Innovent possesses one of the highest-quality commercial portfolio and pipeline in the industry, supported by a fully established commercial network, reinforcing its solid commercial foundation. Year of Globalization: Pipeline Value Unlocked, Growth Potential Expanded 2025 marked a breakthrough year for the Company's globalization strategy, unlocking substantial long-term growth potential. Innovent successfully advanced three core assets into or near global Phase 3 clinical trials. According to its partner estimates, these late-stage assets target a combined total addressable market (TAM) of over US$60 billion, including: IBI363 (PD-1/IL-2α-bias): Next-gen IO cornerstone, potential TAM over US$40 billion for first wave of indications In collaboration with Takeda, IBI363 is being advanced globally. The first global MRCT Phase 3 in IO-resistant squamous NSCLC has been initiated. PoC in IO-resistant non-squamous NSCLC is completed, with a new global Phase 3 planned subject to the PoC results and regulatory communications. A Phase 3 trial in 3L colorectal cancer (CRC) in China is planned for 2026. A Phase 2 trial in IO-naïve mucosal/acral melanoma is underway in China. PoC studies in 1L NSCLC and 1L CRC are ongoing. IBI343 (CLDN18.2 ADC): Cornerstone for gastrointestinal cancers, potential TAM over US$8 billion Interim analysis from the China-Japan Phase 3 clinical trial in 3L gastric cancer is expected in 2026. Phase 3 in 3L pancreatic cancer in China was initiated in 2025. PoC studies in 1L gastric and 1L pancreatic cancer are ongoing. IBI324 (VEGF/ANG2): Potential best-in-class retinaltherapy, potential TAM US$15 billion Our partner Ollin Biosciences reported positive top-line results from the Phase 1b JADE head-to-head study against faricimab in wAMD and DME patients in the US. Innovent is working closely with Ollin to engage global regulators in 2026 and advance IBI324 into global Phase 3 trials. Diversified Partnerships to Accelerate Global Innovation Total deal value from Innovent's global collaborations reached over US$22 billion in 2025, representing over 10% of China's innovative pharma outbound licensing value. These partnerships not only accelerate global pipeline development but also help build core capabilities for Innovent to become a truly world-class biopharma. With Takeda: Landmark "IO + ADC" collaboration under a co-development and co-commercialization ("Co-Co") model for IBI363 to build its global R&D and commercialization capabilities. With Eli Lilly: Seventh partnership with an end-to-end innovation model to jointly develop novel oncology and immunology molecules, enhancing full lifecycle R&D frameworks and decision-making from a multinational perspective. With Roche: Leveraging global oncology resources to advance IBI3009 (DLL3 ADC) worldwide. With Ollin: Utilizing global ophthalmology expertise to accelerate IBI324's clinical development and market positioning. High-Quality Manufacturing Standards Total operational capacity of 140,000 liters, accounting for 20% of China's total biologic manufacturing capacity. Site 1 houses 60,000 liters of antibody capacity and ADC commercial lines; Site 2 has 80,000 liters of antibody capacity, supporting global supply and CDMO services. Sustainable Development and ESG Commitment 8,000 employees worldwide, with global R&D centers in San Francisco Bay Area, Shanghai and Suzhou. Over 3,000 new cancer patients initiate Innovent therapies daily; more than 6 million patients have benefited to date. Maintained MSCI ESG AAA rating, leading China's biopharmaceutical industry. First innovative biopharma constituent of the Hang Seng Index ("blue-chip" status). Launched community health initiatives including the MV 'Weight Management Made Easy' and documentary 'Down in Weight, Up in Life' to promote science-based healthy weight management. Published patient education materials on thyroid eye disease and weight management to enhance public health awareness. Implemented multiple patient assistance programs, benefiting over 200,000 patients with drug donations valued at over RMB 3.6 billion. Received honors including "Healthcare Public Welfare Pioneer" and "China Public Welfare Enterprise". Created over 2,200 jobs for new graduates. Cumulative taxes and contributions exceeding RMB 6 billion. Vision 2030: From China Leader to Global Premier Biopharma Entering 2026, Innovent celebrates its 15th anniversary. Building on its strong foundation, the Company reaffirms Vision 2030: to evolve into a global premier biopharmaceutical company. Revenue: Target RMB 20 billion by 2027 with continued expansion thereafter. International revenue will become a new growth driver in the future. Profitability: Maintain high-quality growth while steadily improving profit margins benchmarking industry-leading levels. Pipeline: Focus on advancing high-value assets including IBI363, IBI343 and IBI324. Push next-generation oncology and general biomedicine molecules into global early-stage and PoC studies. Target at least 5 molecules in global MRCT Phase 3 by 2030. Organization: Established a US R&D and operating team of nearly 100 people. Through deep partnerships with Takeda, Lilly, Ollin, Roche and others, Innovent is rapidly building global R&D, regulatory and commercial capabilities. These growing global competencies will further support independent development, enabling Innovent to leap forward into a fully independent, world-class biopharmaceutical enterprise. About Innovent Biologics Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 18 products in the market. It has 5 assets in Phase 3 or pivotal clinical trials and 14 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Lilly, Sanofi, Incyte, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action" Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (s). Ramucirumab (Cyramza)，Selpercatinib (Retsevmo) and Jaypirca (pirtobrutinib) were developed by Eli Lilly and Company. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. SOURCE Innovent Biologics 21% more press release views with Request a Demo