C3b inhibitors(complement C3b inhibitors), C4B inhibitors(Complement factor C4-B inhibitors), Complement receptors antagonists(Complement receptors antagonists)

Therapeutic Areas

Congenital DisordersEye DiseasesCardiovascular Diseases+ [1]

Active Indication

Inactive Indication

Choroidal Neovascularization

Originator Organization

Innovent Biologics (Suzhou) Co. Ltd.AP Biosciences, Inc.

Active Organization

Innovent Biologics (Suzhou) Co. Ltd.AP Biosciences, Inc.

Inactive Organization-

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

Gene Sequence

Sequence Code 25108715

Source: *****

Clinical Trials associated with Efdamrofusp alfa

CTR20232229 / RecruitingPhase 3

一项评估在新生血管性年龄相关性黄斑变性受试者中玻璃体腔注射IBI302的疗效和安全性的随机、双盲、活性对照的III期临床研究

[Translation] A randomized, double-blind, active-controlled Phase III clinical study to evaluate the efficacy and safety of intravitreal injection of IBI302 in subjects with neovascular age-related macular degeneration

与2 mg阿柏西普每8周一次治疗相比，8 mg IBI302在新生血管性年龄相关性黄斑变性（nAMD）受试者中的最佳矫正视力（ BCVA）变化是否能达到非劣效性

[Translation]

Whether IBI302 8 mg achieves non-inferiority in change in best corrected visual acuity (BCVA) compared with aflibercept 2 mg every 8 weeks in subjects with neovascular age-related macular degeneration (nAMD)

Start Date21 Sep 2023

Sponsor / Collaborator

Innovent Biologics (Suzhou) Co. Ltd.

NCT05972473 / RecruitingPhase 3

A Phase 3, Randomized, Double-masked, Active-Controlled Study to Evaluate the Efficacy and Safety of Intravitreal IBI302(Efdamrofusp Alfa) in Subjects With Neovascular Age-Related Macular Degeneration

The study is designed for multi-center,randomized,double-masked,active-contralled study to evaluate effective and security of intravitreal injection of IBI302 in subjects with neovascular age-related macular degeneration.

Start Date15 Aug 2023

Sponsor / Collaborator

Innovent Biologics (Suzhou) Co. Ltd.

NCT05403749 / CompletedPhase 2

A Multi-center, Randomized, Double-masked, Active-controlled Study to Evaluate the Longer Interval of Intravitreal (IVT) Injection of IBI302 in Subjects With Neovascular Age-related Macular Degeneration (nAMD)

The study is designed for multi-center, randomized, double-masked, active-controlled study to evaluate the longer interval of intravitreal injection of IBI302 in subjects with neovascular age-related macular degeneration.

Start Date29 Jun 2022

Sponsor / Collaborator

Innovent Biologics (Suzhou) Co. Ltd.

100 Clinical Results associated with Efdamrofusp alfa

100 Translational Medicine associated with Efdamrofusp alfa

100 Patents (Medical) associated with Efdamrofusp alfa

Literatures (Medical) associated with Efdamrofusp alfa

01 Aug 2024·Ophthalmology Retina

Efficacy and Safety of Efdamrofusp Alfa versus Aflibercept in Participants with Neovascular Age-Related Macular Degeneration

Article

Author: Li, Jinying ; Wen, Ying ; Lu, Shujie ; He, Tao ; Yu, Songping ; Li, Haoyu ; Wang, Xian ; Xu, Yihua ; Wei, Wenbin ; Dai, Hong ; Tong, Jianping ; Zhang, Wenfang ; Jia, Huixun ; Wang, Wei ; Wu, Miaoqin ; Zhang, Jinglin ; Zheng, Qinxiang ; Pei, Cheng ; Li, Mingxin ; Liu, Qinghuai ; Deng, Junjie ; Mao, Junfeng ; Cui, Ling ; Ye, Jian ; Gong, Yuanyuan ; Hao, Jilong ; Guan, Huaijin ; Tao, Liming ; Liu, Xiaoling ; Yan, Ming ; Bi, Yanlong ; Shu, Xiangwen ; Qian, Lei ; Ding, Lin ; Sun, Xiaodong ; Peng, Hui ; Fan, Ke ; Li, Chaopeng ; Song, Yanping ; Xu, Xiangzhong ; Sun, Junran ; Wu, Zhifeng ; Zhao, MingWei ; Wang, Hong ; Zhu, Dan ; Lu, Peirong ; Wang, Feng ; Liu, Wei

PURPOSE:

To evaluate efficacy and safety of efdamrofusp alfa compared with aflibercept in neovascular age-related macular degeneration (nAMD).

DESIGN:

Randomized, double-masked, multicenter, active-controlled, non-inferiority phase 2 study PARTICIPANTS: A total of 231 treatment-naïve and previously treated participants with active choroidal neovascularization secondary to nAMD were enrolled.

METHODS:

Eligible participants were randomized (1:1:1) to 2 mg efdamrofusp alfa, 4 mg efdamrofusp alfa or 2 mg aflibercept groups. Participants in all groups received three initial monthly loading doses, followed by treatment every 8 weeks with assessment every 4 weeks up to week 52.

MAIN OUTCOME MEASURES:

The primary endpoint was the mean BCVA change from baseline to week 36. The pre-specified noninferiority margin was set as -5 letters (80% CI).

RESULTS:

Each treatment group included 77 participants. The mean BCVA changes from baseline to week 36 for 2 mg efdamrofusp alfa, 4 mg efdamrofusp alfa and aflibercept groups were +10.6, +11.4, +12.0 letters, respectively; Least Squares (LS) mean difference were -1.4 (80% CI: -3.5 to 0.7) between 2 mg efdamrofusp alfa and aflibercept, and -0.6 (80% CI: -2.7 to 1.6) between 4 mg efdamrofusp alfa and aflibercept. Mean central retinal thickness changes were consistent across groups. Adverse event rate was comparable among the groups.

CONCLUSIONS:

Efdamrofusp alfa demonstrated noninferiority to aflibercept in BCVA improvement, accompanied by a similar safety profile.

01 Apr 2023·American journal of ophthalmology

A Novel Bispecific Fusion Protein Targeting C3b/C4b and VEGF in Patients With nAMD: A Randomized, Open-Label, Phase 1b Study

Article

Author: Li, Tong ; Gong, Yuanyuan ; Lu, Shujie ; Wang, Fenghua ; Jia, Huixun ; Feng, Liqi ; Liu, Haiyun ; Qian, Lei ; Sun, Xiaodong ; Liu, Wenjia ; Wan, Qiuchen ; Chen, Jieqiong ; Wang, Hong ; Sun, Junran ; Liu, Xiaoling

PURPOSE:

To evaluate the safety, tolerability, and efficacy of efdamrofusp alfa in patients with neovascular age-related macular degeneration (nAMD).

DESIGN:

Prospective randomized, open-label, multiple ascending-dose, phase 1b study.

METHODS:

Patients aged 50 years or older with active choroid neovascularization (CNV) secondary to nAMD were screened from 2 hospitals in 2 provinces in China. The first 9 patients were randomized 2:1 to intravitreally receive efdamrofusp alfa 2 mg at weeks 0, 4, and 8 or aflibercept 2 mg at weeks 0, 4, 8, and 16. After the dose-limiting toxicity assessment, 9 additional patients were randomized 2:1 to intravitreally receive efdamrofusp alfa 4 mg at weeks 0, 4, and 8 or aflibercept 2 mg at weeks 0, 4, 8, and 16. All patients were followed until week 20. Primary outcomes were safety and tolerability of efdamrofusp alfa. Secondary outcomes included changes from baseline in best-corrected visual acuity (BCVA), central subfield thickness (CST) as measured by spectral domain optical coherence tomography (SD-OCT), and CNV area as measured by fluorescein angiography (FA).

RESULTS:

A total of 18 patients were enrolled. Six each of them received efdamrofusp alfa 2 mg, efdamrofusp alfa 4 mg, or aflibercept 2 mg, respectively. No dose-limiting toxicity was reported, and all patients completed the study. No ocular serious adverse events were reported. All ocular treatment-emergent adverse events were intravitreal injection related and were mild or moderate in severity. At week 20, mean changes from baseline in BCVA were 5.64 ± 3.56, 8.93 ± 3.59, and 7.92 ± 3.55 letters for patients receiving efdamrofusp alfa 2 mg, efdamrofusp alfa 4 mg and aflibercept 2 mg, respectively. Meanwhile, CST and CNV area reductions indicative of anatomic improvement were observed in the majority of the patients receiving both doses of efdamrofusp alfa and aflibercept.

CONCLUSIONS:

Intravitreal efdamrofusp alfa dosed up to 4 mg every 4 weeks was well tolerated in nAMD patients with similar vision acuity and anatomic improvements.

01 Jun 2022·Science translational medicineQ1 · MEDICINE

Targeting C3b/C4b and VEGF with a bispecific fusion protein optimized for neovascular age-related macular degeneration therapy

Q1 · MEDICINE

Article

Author: Li, Tong ; Song, Yanping ; Jia, Huixun ; Wang, Tao ; Gu, Qing ; Liang, Jian ; Wang, Fenghua ; Zhai, Yuanqi ; Li, Yiming ; Wan, Xiaoling ; Qian, Lei ; Li, Xiaomeng ; Lu, Shujie ; Luo, Xueting ; Li, Min ; Yang, Shiqi ; Liu, Junjian ; Sun, Xiaodong ; Yu, Dechao ; Gao, Min ; Yang, Xiaotong ; Huang, Zhen

Antiangiogenesis therapies targeting vascular endothelial growth factor (VEGF) have revolutionized the treatment of neovascular ocular diseases, including neovascular age-related macular degeneration (nAMD). Compelling evidence has implicated the vital role of complement system dysregulation in AMD pathogenesis, implying it as a potential therapeutic strategy for geographic atrophy in dry AMD and to enhance the efficacy of anti-VEGF monotherapies in nAMD. This study reports the preclinical assessment and phase 1 clinical outcomes of a bispecific fusion protein, efdamrofusp alfa (code: IBI302), which is capable of neutralizing both VEGF isoforms and C3b/C4b. Efdamrofusp alfa showed superior efficacy over anti-VEGF monotherapy in a mouse laser-induced choroidal neovascularization (CNV) model after intravitreal delivery. Dual inhibition of VEGF and the complement activation was found to further inhibit macrophage infiltration and M2 macrophage polarization. Intravitreal efdamrofusp alfa demonstrated favorable safety profiles and exhibited antiangiogenetic efficacy in a nonhuman primate laser-induced CNV model. A phase 1 dose-escalating clinical trial (NCT03814291) was thus conducted on the basis of the preclinical data. Preliminary results showed that efdamrofusp alfa was well tolerated in patients with nAMD. These data suggest that efdamrofusp alfa might be effective for treating nAMD and possibly other complement-related ocular conditions.

News (Medical) associated with Efdamrofusp alfa

06 Nov 2024

·www.echemi.com

Innovent Biologics Faces Three Major Crises: Escalating Losses, Failed PD-1 Overseas, Unclear Path to Internationalization!

The investment in Fortvita, the market is highly concerned about the actions of innovative pharmaceutical companies, which is a supervisory force, which is also increasingly normal for innovative pharmaceutical companies. At the same time, a good company should be able to stand up to and respect multiple opinions. So can a persuadable creature of faith still be trusted? After the emotion, the debate has calmed down, or to return to the main line of investment growth logic. Innovent Biologics is facing three key changes: break-even, the birth of pharmaceutical king, and internationalization, which means value enhancement. After the PD-1 encountered obstacles at sea, Innovent Biologics had a deep sense of crisis, and pursued efficiency and fine management through a low-key bottom-up route, and miraculously supported a huge R&D pipeline with robust R&D expenditure. The product revenue of Innovent Biologics 2024Q3 exceeded 2.3 billion yuan, an increase of 40% year-on-year and 15% quarter-on-quarter. In the last four quarters, product revenue has climbed continuously, which is better than expected, verifying the excellent strength of domestic commercialization capability. Unlike most Biotech companies, Cinda no longer only looks at the situation of a single product, but wins with a diversified product matrix, which is similar to the robustness of traditional pharmaceutical companies Hengrui Pharmaceutical and China Biopharmaceutical. According to IQVIA statistics, in 2024H1, the total patient share of listed PD-(L)1 in China was the first for Xinda Biobasu, with a total share of 56% together with Beigene Beizan, and the market pattern was still relatively concentrated. As a cornerstone drug for cancer treatment, PD-1 market share is crucial, representing the right of pharmaceutical companies to speak in the field of cancer drugs. Innovent Biologics has crossed the death valley of the life cycle of innovative pharmaceutical companies, is sprinting to the break-even line, 2024H1 loss convergence to 393 million yuan, 2025 is expected to achieve adjusted EBITDA breakeven. This is all based on endogenous product revenue, rather than transient external BD licensing revenue. Cinda Bio-Mastal peptide is the world's first GLP-1R/GCGR dual-target agonist in the NDA stage, with NDA applications submitted in January 2024 for weight loss indications and NDA applications submitted in August 2024 for Type II diabetes indications, and both indications are expected to be approved for marketing in the first half of 2025 at the earliest. Compared with competing products (Simeaglutide, Tipotide), Maaldotide has a strong weight loss effect, and the 9mg group achieved a better weight loss benefit of 18.6% at 48 weeks when the average BMI and average body weight were higher at baseline. In addition to weight loss, Masidin is more worthy of expectation in terms of comprehensive metabolic benefits. The improvement of fatty liver was more obvious, activated liver GCGR, promoted fatty acid oxidation and lipopolysis, and the phase III clinical results showed that the liver fat content decreased by 80.2%, which was better than GLP-1R single agonist and other double-target agonists. Cinda has proven its commercialization efficiency, and Masaldopeptide as a super drug is about to explode the market. In the field of cardiovascular metabolism, there are high-potential products such as Symbila (PCSK9), which was approved for market last year, and Tetuzumab for thyroid ophthalmopathy, which is expected to be approved next year. Ophthalmology, free of large products are expected to be approved within 1-2 years. Tetuzumab (IGF-1R) was accepted as the NDA for the treatment of thyroid eye disease in May 2024, which is the first IGF-1R antibody to be declared for market in China, which will be a breakthrough variety exclusive to Cinda in this field; Piconcibezumab (IL-23p19) in the treatment of plaque psoriasis has potential better efficacy and advantages of long interval administration, and has been submitted for application. IBI302 is the world's first VEGF/ complement dual-target molecule in the treatment of stage 3 age-related macular degeneration. In recent years, we have also seen that Innovent Biologics is preparing for internationalization. The first is the layout of a new generation of innovative technology and self-research pipeline, involving ADC, double antibody, multi-antibody, small nucleic acid, in the first half of this year, self-developed varieties IBI343 (CLDN18.2 ADC) and IBI363 (PD-1/IL-2) disclosed preliminary clinical phase I data, showing positive early clinical signals. Secondly, the company invests more resources to simultaneously carry out overseas early clinical research and expand overseas research and development teams. It can be seen that the company attaches great importance and prudence to internationalization. From the appearance of the sea platform Fortvita, the company is still in a very early stage, the risk is extremely high, most of them are pre-clinical research and development projects, there is no pipeline assets to reach overseas POC, the layout is related to antibodies, involving tumor, non-tumor fields, similar to listed companies. It does not yet have production and sales functions. We seem to see that the muscle memory of the last failure is still dull, and Cinda Biology is extremely cautious about the first step of internationalization. Fortvita's current situation and direction are unclear, which precisely shows that internationalization is still in the exploratory stage. It is not ruled out to open other channels or ways to go to sea, License-out, NewCo model, cooperative development are all potential options, everything is full of variables. It is in the midst of uncertainty that management is prepared to demonstrate its commitment to internationalisation with real money, and that the market is too quick to judge the ethics of management. Even if the deal is withdrawn now, Fortvita's independent sea is still a proposition that Xinda and shareholders need to solve jointly. In any case, the internationalization of Innovent Biologics is also like an arrow from the string, there is no turning back, and it will eventually be achieved. China's new drugs are trekking a difficult road, fortunately has run out of a small number of leading companies, the fate is not tied to a clinical trial or business progress. Compared with the broad fundamentals of Xinda, this controversial event is just a small floating cloud, which will not shake the value of Innovent Biologics.

Clinical ResultPhase 1Phase 3Drug ApprovalNDA

28 Aug 2024

·www.prnewswire.com

Innovent Announces 2024 Interim Results and Business Updates

Strong commercial performance and significant pipeline milestones support sustained growth and innovation SAN FRANSISCO and SUZHOU, China, Aug. 28, 2024 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces its 2024 interim results and major business updates. Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated: "For the first half of 2024, our company's strategy of sustainable growth and global innovation continue executing very well: we achieved strong revenue growth, improved operational efficiency in all areas, and reached significant milestones in our late-stage pipeline to support our sustained growth. We also reported promising data readouts from early-stage assets, reinforcing our confidence in achieving global innovation and contributing to new long-term opportunities. The successful first half of 2024 has laid a solid foundation for achieving our full-year's growth. With strong commercial and financial execution, a high-value late-stage pipeline, and disciplined investments in next-generation innovation, we are well-positioned to deliver long-term value for patients, employees, shareholders and society." Enhanced operational efficiency and strong financial performance S trong revenue growth momentum: total revenue was RMB3,952.3 million in the first half of 2024, with a strong year-over-year growth of 46.3%, reflecting robust demand for our innovative portfolio and the advantage of our sustainable business model. Significantly improved financial performance: EBITDA Loss was significantly reduced, driven by strong revenue growth, enhanced operational efficiency and notable financial improvement. The gross profit margin of total revenue was 84.1%, a year-over-year increase of 1.8 percentage points The selling and marketing expenses of product revenue was 48.6%, a year-over-year decrease of 5.9 percentage points The administration and expenses of total revenue was 5.2%, a year-over-year decrease of 4.9 percentage points R&D expenses were RMB1,293.9 million; cash and short-term financial assets were RMB10,112.3 million, or approximately over USD1.4 billion, which enables us to focus on the long-term sustainable development EBITDA loss was RMB160.8 million, a notable year-over-year decrease of 39.9% Strong product revenue growth; preparing for CVM commercialization Product sales revenue reached RMB3 ,811.4 million in the first half of 2024, a strong year-over-year growth of 55.1%. Expansion of commercial portfolio into new approved products, new indications and broader NRDL coverage [1] , [2] and patient access: Eleven approved products: TYVYT®, BYVASDA®, SULINNO®, HALPRYZA®, PEMAZYRE®, Olverembatinib, CYRAMZA®, Retsevmo®, FUCASO® , SINTBILO® and DUPERT® (new product, KRAS G12C inhibitor) . TYVYT® and PEMAZYRE® were newly approved in the Macau market. TYVYT® and BYVASDA® were included in the NRDL for the treatment of EGFR-mutated NSCLC. Solidify oncology leadership; in active preparation for new commercial opportunities in general biomedicine. Oncology: we strengthened our leadership with a robust product portfolio, including TYVYT® (sintilimab injection), and expanded out oncology business with a 10th product, a ROS1 inhibitor, set for approval in the second half of 2024. General biomedicines: Following the approval of the first CVM product SINTBILO® (tafolecimab injection) in 2023, we have successfully submitted three new drug applications (NDA)—two for mazdutide, targeting obesity/overweight population and T2D, and one for IBI311 (IGF-1R) for thyroid eye disease (TED). As a key strategic priority, we are steadily building our commercialization capabilities in the CVM field with systematic approaches, aiming to unlock substantial commercial opportunities and drive sustainable growth. Material innovation delivery supports strategic goals 7 new assets are in NDA review or pivotal registrational clinical trials, and 18 assets are in early-phase clinical studies Substantial milestones delivered for key late-stage assets Encouraging progress in the next wave innovation of "IO+ADC" TYVYT® (sintilimab): submitted an NDA for its eighth indication, 2L endometrial cancer (EMC). New registrational clinical trials for neoadjuvant therapy in colon cancer and perioperative therapy in NSCLC have been initiated. Additionally, we are exploring the potential of combination therapies through multiple collaborations with novel modalities. IBI310 (CTLA-4 )：initiated a Phase 3 clinical trial for IBI310 in combination with sintilimab as neoadjuvant therapy in treating colon cancer. IBI343 (CLDN18.2 ADC)：Phase 1b positive data readout in GC and a Phase 3 trial is in preparation. Accelerating new launch momentum in general biomedicine to unlock significant opportunities Mazdutide (GLP-1R/GCGR) : first NDA for weight management in obese or overweight populations and second NDA for T2D treatment, both under NMPA review. We plan to develop new indications, including adolescent obesity, metabolic dysfunction-associated steatohepatitis (MASH), obstructive sleep apnea (OSA), and heart failure with preserved ejection fraction (HFpEF). Teprotumumab (IGF-1R) : the NDA for TED is under NMPA review. With a longstanding lack of innovative TED treatments in China, Teprotumumab is set to be a transformative therapy for this significant unmet need once approved. Picankibart (IL-23p19) : the only IL-23p19 that reported over 80% subjects achieving ≥90% improvement in Psoriasis and Severity Index (PASI90) in 16 weeks of treatment, along with strong long-term skin clearance maintenance and quarterly dosing interval advantage. We plan to submit an NDA in the second half of 2024. IBI128 (XOI) : potential best-in-class XOI for the treatment of hyperuricemia in gout patients. It is currently undergoing overseas Phase 3 clinical trials overseas with our partner LG Chem, and we have completed patient enrollment for a Phase 2 clinical trial in China. IBI302 (VEGF/C) : Phase 3 study initiated for the treatment of nAMD, following stable and robust visual benefit observed with an extended dosing interval and potential macular atrophy inhibition in two Phase 2 studies. Abundant early-stage pipeline to support long-term growth and global ambition Encouraging data readouts from multiple oncology assets in Phase 1 studies, eyeing most difficult-to-treat cancers IBI363 (PD-1/IL-2 α -bias ) : preliminary positive signals in multiple IO-failed/cold tumor types; further investigations across different rumor types are ongoing; a Phase 2 clinical trial in the U.S. has been initiated. IBI343 (CLDN18.2 ADC) : encouraging positive signal in pancreatic cancer, with FDA fast track designation granted. Plans are underway for a clinical trial in the U.S. IBI389 (CLDN18.2/CD3) : encouraging and differentiated signals in GC and PDAC in Phase 1 studies; Phase 1b study is continuing. Multiple programs ongoing including IBI3003 (GPRC5D/BCMA/CD3), IBI115 (DLL3/CD3); IBI3004 (DR5/CEA); IBI3001 (EGFR/B7H3 ADC), IBI130 (TROP2 ADC), IBI133 (HER3 ADC) Develop next-generation general biomedicine programs to improve chronic disease treatment IBI3016 （ AGT siRNA ） : a new-generation siRNA drug candidate, entered into a Phase 1 clinical trial for hypertension. IBI355 (CD40L), IBI356 (OX40L) and IBI3002 (IL-4R α / TSLP) : innovative autoimmune molecules entered into first-in-human studies to explore other unmet medical needs in various types of autoimmune diseases. IBI324 (VEGF-A/ANG-2) and IBI333 (VEGF-C/VEGF-A) : both are in the Phase 1 stage to explore the potential differentiation clinical values versus existing therapy. Research innovation published in high-impact scientific journals and medical conferences, such as: AACR, ASCO, ESMO GI and ESMO plenary for oncology pipeline innovation, including 10+ oral presentations ADA, APAO, ICE, CSE for general biomedicine pipeline material progress, such as mazdutide and teprotumumab Facilitates and Manufacturing capacity adhering to high-standard quality: Shanghai R&D center (medical) is newly operational in August 2024 First manufacturing site: 60,000L antibody production capacity and ADC production lines in operation Second manufacturing site: first phase of 80,000L completed construction to secure CDMO business Devoted to responsible business practices and enhancing ESG management practices We remain committed to sustainable development, corporate responsibility and ethical business practices. We newly launched our ESG website to enhance our efforts in sustainability, corporate responsibility and ethical business conduct. The new platform highlights our initiatives, policies and performance in key ESG areas, including "Excellent Governance", "Enjoying Good Health", "Ensuring High-Quality Products", "Empowering Employees", and "Embracing Ecology". Innovent is graded 'A' level in MSCI ESG rating, ranking at the forefront of the biotechnology industry. About Innovent 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 treat some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has 11 products in the market, 3 new drug applications under the NMPA review, 4 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare leaders, including Eli Lilly, Roche, Sanofi, Adimab, Incyte 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). Forward-looking statement 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 Biologics ("Innovent"), are intended to identify certain of such forward-looking statements. The Company 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 the Company 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 the Company'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, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company 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 is otherwise inaccurate. SOURCE Innovent Biologics

Phase 1Phase 3Financial StatementPhase 2Fast Track

20 Mar 2024

·www.biospace.com

Innovent Announces 2023 Annual Results and Business Updates

A transformative year of strong performance and material innovation progress ROCKVILLE, M.D. and SUZHOU, China, March 20, 2024 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces its 2023 annual results and major business updates. Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated:"2023 marked a transformative year for Innovent with material progress. We delivered strong revenue growth, improved operational efficiency and financial performance, and enhanced ESG management practices that underline our sustainable business model. Concurrently, we have achieved material innovation progress in both late- and early-stage R&D development, advanced pipeline portfolio across oncology and general biomedicine, and broadened our global pipeline development scope, reinforcing our global innovation strategy. These achievements underscore the dedication to our strategic goals in the second decade – sustainable growth and global innovation. We will continue our high-quality business growth and advance global innovation progress, and create sustainable value for patients, employees, shareholders and society." Solidified business operations with strong revenue performance and improved financials Strong revenue growth: total revenue RMB6,206.1 million in the year of 2023, an increase of 36.2% compared with the year of 2022; product sales revenue RMB5,728.3 million in the year of 2023, an increase of 38.4% compared with the prior year, reflecting robust demand for our innovative portfolio and the advantage of our sustainable business model. Enhanced operational efficiency and financial performance : EBITDA Loss was significantly narrowed, whose key drivers include strong revenue growth, enhanced operational efficiency and remarkable financial improvement. The selling and marketing expenses of total revenue was 49.3%, a year-over-year decrease of 7.3 percentage points The administration and expenses of total revenue was 8.8%, a year-over-year decrease of 5.3 percentage points R&D expenses was RMB1974.9 million; cash and short-term financial assets was RMB10969.6 million, or approximately USD1.5 billion, which enables us to focus on the long-term sustainable development EBITDA loss was RMB600.1 million, a notable year-over-year decrease of 73.0% Note: The financial numbers mentioned above were based on non-IFRS measure. Detailed disclosure can be found at the Company's 2023 annual results announcement. Solidify oncology leadership; build CVM commercialization capability Expansion of commercial portfolio into new approved products, new indications and broader NRDL coverage[1],[2] and patient access: Ten approved products: TYVYT®, BYVASDA®, SULINNO®, HALPRYZA®, PEMAZYRE®, Olverembatinib, CYRAMZA®, Retsevmo®, FUCASO® (new product, for the treatment of RRMM) and SINTBILO® (new product, for the treatment of hypercholesterolemia and mixed dyslipidemia). All seven approved indications of TYVYT® (sintilimab injection) were included in the NRDL. It is also the only PD-1 inhibitor in the NRDL for the treatment of GC and EGFR-mutated NSCLC. As for market expansion, TVYVT® (sintilimab injection) was newly approved in the Macau market in February 2024. Olverembatinib's first indication was included in the NRDL; and its second indication was newly approved to benefit broader CML patients. All indications of BYVASDA® (bevacizumab injection), HALPRYZA® (rituximab injection) and SULINNO® (adalimumab injection) were also included in the NRDL. Oncology and general biomedicines as key growth pillars of the company: Oncology: we have launched eight products including TYVYT® (sintilimab injection), established a mature commercial presence of nearly 3,000 employees, nationwide patient access and a well-recognized brand image. We will continue to solidify leadership and expand business in oncology. General biomedicine: we have made considerable progress in past years advancing and expanding our pipeline in general biomedicine, including cardiovascular and metabolism (CVM), autoimmune, and ophthalmology, which we believe will result in substantially increased commercial opportunities and diversified long-term growth. Therefore, as part of the strategic plan, we have been steadily establishing our commercialization capability in the CVM field with systematic approaches. We plan to implement a comprehensive structure and form strategies for key factors, such as patient access, distribution channels, and marketing activities, to ensure all capabilities, personnel and strategies are in place to facilitate effective operations of our business, and to foster long-term brand image and competitive advantage in this new area. Material innovation progress in both late- and early-stage clinical development 8 assets are in NDA review or pivotal registrational clinical trials, and 18 assets are in early Phase 1/2 clinical studies Oncology: robust leadership spanning all phases of R&D and novel modalities Deepened synergies of product portfolio with two target therapies for lung cancer under NDA priority review, which are anticipated to launch in 2024: IBI344 (ROS1, taletrectinib): 1L and 2L ROS1 positive NSCLC IBI351 (KRAS G12C, fulzerasib): 2L KRAS G12C mutated NSCLC Encouraging progress in the next wave innovation of "IO+ADC" TYVYT® (sintilimab): multiple clinical trial collaborations to explore potential of combination therapy with various ADCs for solid tumors IBI310 (CTLA-4)：plan to initiate a Phase 3 clinical trial for IBI310 in combination with sintilimab in treating neoadjuvant colon cancer IBI343 (CLDN18.2 ADC)：preparing for a MRCT Phase 3 clinical trial for IBI343 in 3L GC, subject to regulatory communications; a PoC trial in PDAC is ongoing Advancing multiple bi-/tri-specific antibodies and ADCs with global potential in early-stage clinical trials IBI363 (PD-1/IL-2) : preliminary PoC signals in multiple IO resistant/unresponsive cancer types; plan to initiate a Phase 2 clinical trial in the U.S. Multiple programs ongoing including IBI389(CLDN18.2/CD3), IBI334 (EGFR/B7H3), IBI3003 (GPRC5D/BCMA/CD3), IBI3001(EGFR/B7H3 ADC), IBI130 (TROP2 ADC), IBI133 (HER3 ADC) CVM : multiple new-generation product candidates achieved substantial R&D milestones SINTBILO® (tafolecimab injection): the first domestic self-developed anti-PCSK9 monoclonal antibody, approved for the treatment of hypercholesteremia and mixed dyslipidemia Mazdutide (GLP-1R/GCGR): globally the first GLP-1R/GCGR dual agonist in the NDA stage. First NDA of mazdutide was accepted for chronic weight management. Five Phase 3 registrational trials and more clinical trials are underway. IBI128 (XOI): potential best-in-class XOI for the treatment of hyperuricemia in gout patients. It is undergoing overseas Phase 3 clinical trials conducted by our partner LG Chem. We plan to initiate Phase 1 and Phase 2 clinical trials in China in pace with the global registrational progress. IBI3016（AGT siRNA）: a new-generation siRNA drug candidate to address unmet need in hypertension. We will collaborate with SanageneBio and plan to initiate a Phase 1 clinical trial in 2024. Next-generation projects will enter into IND-enabling stage in 2024, underscoring our dedication to expanding our strategic presence in the CVM field Autoimmune: address global unmet needs in various autoimmune diseases IBI112 (IL-23p19) : potential long-lasting efficacy advantage and convenient extended dosing intervals for psoriasis. We anticipate completing the Phase 3 registrational clinical trial in support of an NDA submission in 2024. IBI353 (PDE4): the multi-regional Phase 2b clinical study (led by UNION) of IBI353 in psoriasis attained positive topline results. IBI355 (CD40L) , IBI356 (OX40L) and IBI3002 (IL-4Rα/TSLP): innovative autoimmune molecules entered into first-in-human studies to explore other unmet medical needs in various types of autoimmune diseases, such as primary Sjögren's syndrome (pSS), systemic lupus erythematosus (SLE), atopic dermatitis (AD) and asthma. Ophthalmology: a long-standing commitment to elevate standard-of-care IBI302 (VEGF/C): Phase 3 study initiated for the treatment of nAMD, based on the observed stable and robust visual benefit under extended dosing interval and potential inhibition effect in macular atrophy in two Phase 2 studies. IBI311 (IGF-1R): Phase 3 clinical trial met the primary endpoint, demonstrating favorable safety and excellent efficacy; we plan to submit an NDA in 2024 IBI324 (VEGF-A/ANG-2) and IBI333 (VEGF-C/VEGF-A) : both are in the Phase 1 stage to explore the potential differentiation clinical values versus existing therapy. Global innovation as unwavering long-term strategic priority Innovent Academy as the innovation powerhouse: In 2023, Innovent Academy has successfully delivered eight high quality novel molecules into IND enabling stage. A significant portion of preclinical programs lies in key non-oncology areas, including CVM, ophthalmology and autoimmune diseases, forming another important growth pillar of global innovation as oncology counterparts. Research innovation published in high-impact scientific journals and medical conferences, such as: Preclinical results publication of IBI363 in Nature Cancer Preclinical results of IBI334 (EGFR/B7H3), IBI343 (CLDN18.2 ADC), IBI3001 (EGFR/B7H3 ADC) are accepted as Late-breaking Researches by the American Association for Cancer Research (AACR) 2024 Manufacturing capacity adhering to high-standard quality: Suzhou manufacturing site: 60,000L antibody production capacity and ADC production lines in operation Hangzhou manufacturing site: 170,000L production capacity (first phase of 80,000L completed construction, second phase of 90,000L in plan) to secure global supply Shanghai R&D center will be operational in 2024 Devoted to responsible business practices and enhancing ESG management practices Innovent has been upgraded to 'A' level in MSCI ESG rating, ranking at the forefront of the biotechnology industry. In active support of the United Nations' sustainable development goals (SDGs) and in fulfilling our social responsibilities, we continued to enhance ESG management across several key dimensions, including: "Excellent governance", "Enjoying good health", "High-quality as key", "People first" and "Green ecology". About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to provide high-quality biologics that are affordable to all. The company discovers, develops, manufactures and commercializes innovative medicines that treat some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has 10 products in the market, 3 new drug applications under the NMPA review, 5 assets in Phase 3 or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare leaders, including Eli Lilly, Roche, Sanofi, Adimab, Incyte 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). Forward-looking statement 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 Biologics ("Innovent"), are intended to identify certain of such forward-looking statements. The Company 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 the Company 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 the Company'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, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company 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 is otherwise inaccurate. Company Codes: HongKong:1801, OTC-PINK:IVBIY, HongKong:01801

Phase 3Phase 2Drug ApprovalClinical ResultPhase 1

100 Deals associated with Efdamrofusp alfa

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Wet age-related macular degeneration	Phase 3	CN	Innovent Biologics (Suzhou) Co. Ltd.	15 Aug 2023
Diabetic macular oedema	Phase 2	CN	Innovent Biologics (Suzhou) Co. Ltd.	18 Nov 2021
Choroidal Neovascularization	Phase 1	CN	Innovent Biologics (Suzhou) Co. Ltd.	28 May 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05403749 (NEWS) Manual	Phase 2	Wet age-related macular degeneration	132	IBI302 6.4 mg	fvecebionw(fpoxlqgeov) = mgaifjwwno jfcihrvffd (oyxdtwviby ) Met View more	Positive	19 Mar 2024
				IBI302 8.0 mg	fvecebionw(fpoxlqgeov) = tuhjbehkdv jfcihrvffd (oyxdtwviby ) Met View more
NCT04820452 (PRNewswire) Manual	Phase 2	Wet age-related macular degeneration	231	IBI302 2 mg	elafztqqie(ipcnwzgtcs) = hwwijmtrrc yswvspwtmb (idhqzderpm ) View more	Non-inferior	05 Nov 2023
				IBI302 4 mg	elafztqqie(ipcnwzgtcs) = mwrcqggfsb yswvspwtmb (idhqzderpm ) View more
NCT04370379 (Pubmed) Manual	Phase 1	Wet age-related macular degeneration	18	efdamrofusp alfa 2 mg	arwzrmojjg(rknjfyorrc) = vlzqvadkdv ushjzxnasu (fribiefxlo ) View more	Positive	21 Nov 2022
				efdamrofusp alfa 4 mg	arwzrmojjg(rknjfyorrc) = ptutlmafjg ushjzxnasu (fribiefxlo ) View more
NCT04370379 (PRNewswire) Manual	Phase 1	Wet age-related macular degeneration First line	18	IBI302	lcipworgov(hrgulduruh) = improved by a mean of 6.4 letters from baseline banbbogjen (vkstiatseg ) View more	Positive	14 Nov 2021
				Aflibercept
AAO2021	Phase 1	Wet age-related macular degeneration	-	2-mg IBI302	zapjtpwhtp(ygkzmiwvqt) = ugogviprvs vejsyvphlc (eftqqklyjg )	-	13 Nov 2021
				4-mg IBI302	zapjtpwhtp(ygkzmiwvqt) = rvoavdczfg vejsyvphlc (eftqqklyjg )
NCT03814291 (PRNewswire) Manual	Phase 1	Wet age-related macular degeneration	31	IBI302	ukxutcctsn(emosgvfoaw) = no serious adverse event uujirrqgsl (fzeokbnhoc ) View more	Positive	15 Nov 2020

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