IBI-343

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.

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