Tamgiblimab

Remarkable achievements with accelerated growth and improved efficiency to underpin sustainable growth ROCKVILLE, M.D. and SUZHOU, China, Aug. 23, 2023 /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, metabolic, autoimmune, ophthalmology and other major diseases, announces its 2023 interim results and major company business updates. Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated: "Today is our 12th anniversary since we incorporated Innovent in 2011. Since last year, we have clearly outlined two strategic goals for the second decade of our business operation, which are to achieve sustainable growth and global innovation. During the first half of 2023, we have made remarkable achievements that solidify our ability to establish a sustainable business foundation as Innovent is growing stronger and healthier. We achieved strong revenue performance and improved operational efficiency that underline our sustainable business model; we continued to develop a more diversified pipeline portfolio and enhanced R&D strategy that ensures sustainable growth; and we improved financial margins and maintained high resilience that help us manage risks and enjoy sustainability in the long run. These significant progresses reinforce our confidence and commitment to our strategic goals, through further expansion of commercial portfolio, improvement of operational efficiency, and innovation through advanced R&D platform for the global market. We will uphold the vision of 'to become a global premier biopharmaceutical company' and create sustainable value for patients, employees, shareholders and the society." Solidified business operations with strong revenue performance and improved financials S trong revenue growth: Total revenue RMB2 , 701 .5 million in the first half of 2023, an increase of 20.6% compared with the first half of 2022; product sales revenue RMB2,457.5 million in the first half of 2023, an increase of 20 .4% compared with the same period of prior year, with particularly stronger growth since Q2, mainly driven by fast ramp-up of product sales volume as we fully leveraged the clinical value of our novel medicines with broad NRDL coverage and a diversified oncology portfolio. Enhanced operational efficiency under a sustainable business model: We further improved the productivity and efficiency of our commercial operations. The agile organization benefits from a scientific and systematic resource allocation system that enables more mature and fast responses to the changing environment. The selling and marketing expenses was 54.5% of total product revenue in the first half of 2023, representing a decrease of 12.2% compared to 66.7% in the first half of 2022. Core financial margins improvements: Loss Before Interest, Taxes, Depreciation and Amortization ("LBITDA") decreased remarkably by 74.2% to RMB267.4 million from RMB1,035.7 million in the same period of 2022, brought by our strong revenue growth and core financials improvement attributable to the enhanced operational efficiency under a sustainable business model. Expansion of commercial portfolio into ten approved products, including: 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). NRDL coverage further expanded, benefiting broader patient groups: two additional indications (1L GC and 1L ESCC) of TYVYT® (sintilimab injection), olverembatinib for the first listing, and multiple additional indications of BYVASDA® (bevacizumab injection), HALPRYZA® (rituximab injection), and SULINNO® (adalimumab injection) were included in the updated NRDL. The updated NRDL has taken effect on March 1st, 2023. Broad coverage in commercial channels and networks with an experienced and professional sales and marketing team: expansive coverage of over 5,000 hospitals and a well-structured commercial team of nearly 3,000 talents. The Company is also strategically establishing commercial presence in certain non-oncology therapeutic areas in light of the first approved drug SINTBILO® in cardiovascular area and accelerated development for multiple high value late-stage candidates, aimed for a more diversified and long-term growth. Broad pipeline across therapeutic areas to deliver differentiated innovation and growth potential We have built a strong pipeline with over 30 innovative drug candidates, among which 10 products are approved, 8 assets are in NDA review or pivotal registrational clinical trials, and approximately 20 assets in early Phase 1/2 clinical studies. Oncology: leverage extensive portfolio and navigate novel modalities and therapies to strengthen our foundation Pioneered the development of three drug candidates for treatment of lung cancer: IBI344 (ROS1): Ongoing pivotal Phase 2 for ROS1 positive NSCLC IBI351 (KRASG12C): Ongoing pivotal Phase 2 for KRASG12C mutated NSCLC IBI126 (CEACAM5 ADC): Ongoing Phase 3 for CEACAM5 highly expressed NSCLC Received preliminary positive data for multiple innovative molecules with global potential ： Bispecific antibodies with global innovation: IBI363 (PD-1/IL-2) and IBI389 (CLDN18.2/CD3) with preliminary positive clinical signals observed, IBI334 (EGFR/B7H3) is planned to enter first-in-human study shortly Monoclonal antibodies in PoC exploration: IBI110 (LAG3) , IBI939(TIGIT), IBI310 (CTLA-4) Deeply invested in ADC proprietary platform as a new wave of global innovation: IBI343 (CLDN18.2 ADC) : Phase 1 multi-regional clinical trial ongoing in Australia and China. IBI343 has potential best-in-class profiles with differentiated design for potential wide therapeutic window and high potency. More than 10 differentiated ADC projects in IND-enabling stage. Cardiovascular and metabolism (CVM) : first product approved and prioritized clinical development of multiple best-in-class assets based on robust data readout 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): potential best-in-class GLP-1 dual agonist. Phase 3 registrational studies of mazdutide 6mg in obesity and type 2 diabetes are ongoing. The Phase 2 clinical study of mazdutide higher-dose 9mg met the 24-week primary endpoint, showing bariatric surgery-equivalent 15.4% weight loss efficacy for moderate to severe obesity and a consistently favorable safety profile. IBI128 (XOI): potential best-in-class XOI for the treatment of hyperuricemia in gout patients, with overall superior efficacy and good safety profile. Autoimmune: select novel targets to treat unmet needs in various autoimmune diseases IBI112 (IL-23p19) : potential long-lasting efficacy advantage and convenient extended dosing intervals for psoriasis. The Phase 3 registrational clinical study is ongoing. IBI353 (PDE4): the multi-regional Phase 2b clinical study (led by UNION) of IBI353 in psoriasis reached positive topline results. IBI355 (CD40L) and IBI356 (OX40L): innovative autoimmune molecules will enter first-in-human studies to explore other unmet medical needs in various types of autoimmune diseases. Ophthalmology: accelerate two Phase III trials for two important assets IBI302 (VEGF/C) : Phase 3 study ready to start in the second half of 2023 for the treatment of nAMD, based on the observed longer durability and potential effect in anti-macular atrophy in Phase 2 studies. IBI311 (IGF-1R): quickly advanced into Phase 3 registrational study, eyeing on urgent unmet need in the treatment of TED in China. IBI324 (VEGF-A/ANG-2) and IBI333 (VEGF-C/VEGF-A) are in the Phase 1 stage. The potential differentiation versus existing therapy brought by their innovative mechanisms and molecule designs as bispecific antibodies will be explored. Global innovation continues as core long-term strategy Innovent Academy as the innovation powerhouse continues to advance science to deliver differentiated molecules in oncology and non-oncology areas: In the first half of 2023, Innovent Academy has successfully delivered four high quality novel molecules into IND enabling stage. Further investment in our ADC platform and antibody platform, as preliminary differentiated efficacy and safety signals are observed for the FIC and BIC molecules generated from the platforms. A significant portion of preclinical programs lies in key non-oncology areas, including CVM, ophthalmology and autoimmune diseases, as another important growth pillar of global innovation as oncology counterparts. P roduct development platform utilizes scientific and efficient approaches to scout opportunities for innovative pipeline in early-stage MRCT clinical development Exploring the early-to-mid stage pipeline with global potential in ongoing PoC studies, with several molecules in the oncology and ophthalmology fields. Further explore the early clinical development of novel molecules with global potential, such as PD-1/IL-2, CLDN18.2 ADC in Phase 1 multi-regional clinical trials with preliminary differentiated clinical data observed 140,000L GMP certified production capacity which is currently one of the largest stainless steel bioreactor production capacity in China, adhering to high-standard quality compliance to GMP and providing cost advantage further strengthen our market competitiveness. Compliance and governance continued strengthening in active support to social responsibilities In active support to the sustainable development goals (SDGs) of the United Nations, we continued to adhere to the people-oriented principle, operate with integrity, take high quality as the cornerstone, follow green ecological guidance, drive development with innovation, effectively protect the rights and interests of all stakeholders, and proactively fulfill our social responsibilities. We also paid more attention to governance upgrade compliance operation, operational efficiency improvement, high-quality innovation, diversification and empowerment of employees and low-carbon development, and strived to promote inclusive healthcare, enabling more patients to have equal access to affordable, high-quality and innovative medicines. Financial Highlights for the First Half of Year 2023 Total revenue was RMB2,701.5 million, an increase of 20.6% compared to the same period of prior year. LBITDA for the reporting period was RMB267.4 million, a notably decrease of 74.2% or RMB 768.3 million from RMB1,035.7 million for the same period of prior year. Loss for the reporting period was RMB190.4 million, a notably decrease of 82.5% or RMB 894.9 million from RMB 1,085.3 million for the same period of prior year. *The remarkably decrease was mainly due to our strong revenue growth and core financials improvement attributable to the enhanced operational efficiency under a sustainable business model. *The Loss for the reporting period was mainly due to continuous investment in R&D to support our long-term strategic goal of global innovation. R&D expenses was RMB826.3 million; cash and short-term financial assets was RMB8,526.5 million, or approximately USD1.2 billion, which enables us to focus on the long-term sustainable development. About Innovent "Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune disease, metabolic disorder and other major diseases. Innovent has 10 products in the market. These include: TYVYT® (Sintilimab Injection), BYVASDA® (Bevacizumab Injection), SULINNO® (Adalimumab Injection), HALPRYZA® (Rituximab Injection), Pemazyre® (Pemigatinib Oral Inhibitor), olverembatinib, Cyramza® (Ramucirumab Injection), Retsevmo® (Selpercatinib Capsules), FUCASO® (Equecabtagene Autoleucel Injection) and SINTBILO® (Tafolecimab Injection). In addition, one assets are under NMPA NDA review, seven assets are in Phase III or pivotal clinical trials, and 17 more molecules are in clinical studies. Innovent has also entered into 30 strategic collaborations with Eli Lilly, Roche, Sanofi, Adimab, Incyte, MD Anderson Cancer Center and other international partners. Innovent strives to work with many collaborators to help advance China's biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives. Disclaimer: Innovent does not recommend any off-label usage. Note: TYVYT®, BYVASDA®, SULINNO®, HALPRYZA®, olverembatinib, FUCASO® and SINTBILO® are not approved products in the United States. TYVYT® (sintilimab injection, Innovent) BYVASDA® (bevacizumab injection, Innovent) HALPRYZA® (rituximab injection, Innovent) SULINNO® (adalimumab injection, Innovent) Pemazyre® (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre® was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan. CYRAMZA® (ramucirumab injection, Eli Lilly). Cyramza® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China. Retsevmo® (selpercatinib capsules, Eli Lilly). Retsevmo® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China. 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