Ramucirumab

DUBLIN--( BUSINESS WIRE )--The "Global CD47 Inhibitor Drug Clinical Trials Insight & Market Opportunity Outlook 2028" report has been added to ResearchAndMarkets.com's offering. Inhibition of the cell surface protein CD47 has emerged as a novel cancer immunotherapy approach that has piqued the interest of both academia and industry in the recent years. Cancer cells often overexpress CD47, which triggers the "don't eat me" signal pathway, thereby helping malignant cells to escape immune surveillance. CD47 inhibitors seek to uncover cancer cells by inhibiting this protein, leaving them open to immune system attack, specifically through increased macrophage phagocytosis. Although no CD47 inhibitor is currently approved for therapeutic usage, the availability of candidates in phase 3 trials suggests that one may be approved in the coming years. With multiple candidates at varying stages of development, the field of CD47 inhibitor research and development is rapidly evolving. Developed by Forty Seven, which is now a part of Gilead, magrolimab is among the most advanced CD47 inhibitors. In early stage clinical trials for hematological tumors, it has demonstrated encouraging outcomes, especially when combined with other cancer treatments. Furthermore, late stage clinical trials evaluating Magrolimab in solid cancer alongside conventional cancer treatments such as docetaxel, Nivolumab, Pembrolizumab, Azacitidine, and Venetoclax are now under progress. Another significant candidate is Evorpacept (ALX148) from ALX Oncology, a high affinity SIRP? fusion protein that inhibits CD47. Currently, evorpacept is being assessed as a monotherapy and in combination with widely used anticancer drugs in a number of early phase clinical trials for a variety of solid and hematological tumors. Furthermore, a late-phase trial evaluating Evorpacept in combination with Trastuzumab, Ramucirumab, and Paclitaxel for the treatment of HER2+ gastric cancer is also under progress. A number of other CD47 inhibitors, including as TQB 2928 (Chia Tai Tianqing Pharmaceutical), MP 0621 (Molecular Partners), IMC-002 (ImmuneOncia Therapeutics), and CC 90002 (Celgene), are in the early phases of clinical research. The emphasis on combination therapies is undoubtedly one of the key trends in clinical development. Combining CD47 inhibitors with other immunotherapies, targeted treatments, and chemotherapy is being studied in an effort to overcome resistance mechanisms and provide synergistic benefits. Anticipated growth in the global market for CD47 inhibitors is attributed to the rising cancer incidence and increased use of immunotherapies in the upcoming years. The potential of CD47 inhibitors has been acknowledged by a number of prominent pharmaceutical companies, which has resulted in notable partnerships and acquisitions. The commercial interest in this field is demonstrated by Gilead Science's US$ 4.9 billion acquisition of Forty Seven in 2020 and Pfizer's US$ 2.26 billion acquisition of Trillium Therapeutics in 2021. Although Chinese and American companies presently dominate the market, there is increasing participation from South Korea, Australia, Canada, and Japan. Through clinical research, companies such as Shaperon, InnobationBio, Bitterroot Bio, and ImmuneOncia Therapeutics are making strides with their CD47 inhibitors. The market is becoming increasingly competitive, with several firms striving for market share. Therefore, for commercial success, differentiation based on safety profile, efficacy, and possible combination strategies will be essential. The market for CD47 inhibitors has both opportunities and challenges. Strong commercial interest and encouraging clinical evidence point to substantial development potential. However, there are challenges to address, such managing toxicity profiles, coming up with the best combination plans, and demonstrating distinct therapeutic advantages over current treatments. As the field develops, biomarker development for response prediction and patient selection will probably become more crucial for clinical development as well as marketing tactics. In conclusion, the market for CD47 inhibitors globally is an active rapidly expanding area of cancer immunotherapy. In the years to come, CD47 inhibitors could have a big impact on cancer therapy paradigms because there are several candidates in clinical development and a lot of commercial interest. Global CD47 Inhibitor Drug Clinical Trials Insight & Market Opportunity Outlook 2028 Report Highlights Global & Regional Market Opportunity Outlook Insight On More Than 100 CD47 Inhibitor Drugs In Clinical Trials Global CD47 Inhibitors Clinical Trials Insight By Company, Country, Indication & Phase Orphan, Fast Track, Breakthrough Therapy Designation Insight Key Drugs Initiation & Completion Year CD47 Clinical Application & Development Outlook By Indication CD47 Inhibitor Drugs Clinical Developments & Trends By Country Global CD47 Inhibitor Drug Market Dynamics Key Topics Covered: 1. CD 47 As Novel Cancer Immunotherapy Target 2. Global CD47 Inhibitors Drug Clinical Pipeline Overview 2.1 By Country 2.2 By Company 2.3 By Indication 2.4 By Patient Segment 2.5 By Phase 2.6 By Priority Status 3. CD47 Inhibitors Clinical Trials Insight By Company, Country, Indication & Phase 3.1 Research 3.2 Preclinical 3.3 Phase I 3.4 Phase I/II 3.5 Phase II 3.6 Phase II/III 3.7 Phase III 4. Global CD47 Inhibitor Drug Market Opportunity Outlook 4.1 Current Market Overview 4.2 Future Outlook & Opportunities 5. CD47 Clinical Application & Development Outlook by Indication 5.1 Solid Cancers 5.1.1 Breast Cancer 5.1.2 Colorectal Cancer 5.1.3 Lung Cancer 5.1.4 Urogenital Cancer 5.1.5 Gastrointestinal Cancer 5.2 Hematological Malignancies 5.2.1 Lymphoma 5.2.2 Leukemia 5.2.3 Multiple Myeloma 5.2.4 Myelodysplastic Syndrome 5.3 Microbial Infections 6. CD47 Inhibitor Drugs Clinical Developments & Trends By Country 6.1 China 6.2 US 6.3 South Korea 6.4 Australia 6.5 Canada 7. Global CD47 Inhibitors Market Dynamics 7.1 Favorable Parameters 7.2 Market Restraints 8. Competitive Landscape Adagene ALX Oncology ImmuneOncia Therapeutics ImmuneOnco Biopharma Light Chain Bioscience Phanes Therapeutics Virtuoso Therapeutics For more information about this report visit https://www.researchandmarkets.com/r/qs8ua0 About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

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