Tafolecimab

The companies sought approval for sintilimab and fruquintinib to treat advanced endometrial cancer. Credit: Fancy Studio / Shutterstock.com. The China National Medical Products Administration (NMPA) has granted priority review for Innovent Biologics and Hutchmed ’s new drug application (NDA) for the combination of sintilimab and fruquintinib for advanced endometrial cancer. The NDA seeks a new therapeutic regimen for people with proficient mismatch repair or non-microsatellite instability-high tumours who have exhausted previous systemic therapies and are not eligible for curative surgical procedures or radiation. Sintilimab is a programmed cell death protein 1 immunoglobulin G4 monoclonal antibody, marketed in China as TYVYT (sintilimab injection). It has been developed through a collaboration between Innovent and Eli Lilly. The application is based on the data from the FRUSICA-1 study, a Phase II multicentre, open-label trial. The primary measure of success was the objective response rate as assessed by an independent review committee. See Also: FDA accepts AstraZeneca-Daiichi Sankyo’s Datopotamab deruxtecan BLA MASH revival with over $2.5bn for innovator drug partnership deals in 2024 Disease control rate, duration of response, progression-free survival, overall survival and pharmacokinetic assessments were the secondary endpoints. In July 2023, the NMPA recognised the potential of the combination therapy, granting it a breakthrough designation. This status is reserved for treatments that offer a significant advancement over existing options for serious ailments lacking effective therapies, and where clinical evidence indicates substantial benefits. Innovent senior vice-president Dr Hui Zhou stated: “TYVYT (sintilimab injection), as a backbone therapy in immuno-oncology, in combination with an anti-angiogenetic drug, may improve the prognosis for endometrial cancer patients in China. “We are excited about the NDA acceptance and priority review designation, which increases our potential to bring a new treatment option to endometrial cancer patients, and concurrently strengthens the leadership position of TYVYTin China.” In August 2023, the company received approval from China NMPA for SINTBILO (tafolecimab injection) for primary hypercholesterolemia and mixed dyslipidemia .

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