On March 20, 2024 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, reported its 2023 annual results and major business updates (Press release, Innovent Biologics, MAR 20, 2024, View Source [SID1234641302]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
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) (Free AACR Whitepaper) 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".