Innovent Announces 2024 Interim Results and Business Updates

Strong commercial performance and significant pipeline milestones

support sustained growth and innovation

SAN FRANSISCO and SUZHOU,China,Aug. 28,2024 -- 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,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

Strong 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

Theselling and marketing expenses of product revenue was 48.6%,a year-over-year decrease of 5.9 percentage points

Theadministration 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%

Note:The financial numbers mentioned above were based on non-IFRS measure. Detailed disclosure can be found at the Company's 2024 interim results announcement.

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 Macaumarket.

TYVYT® and BYVASDA® were included in the NRDLfor 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® (sintilimabinjection),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 CVMproduct SINTBILO® (tafolecimabinjection) 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 inthe CVMfield 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 anNDAfor its eighth indication,2L endometrialcancer (EMC). New registrationalclinical trials for neoadjuvanttherapy in colon cancer and perioperativetherapy in NSCLChave been initiated. Additionally,we are exploring the potential of combination therapies through multiple collaborations with novel modalities.

IBI310 (CTLA-4)：initiated a Phase3 clinical trial for IBI310 in combination with sintilimabas neoadjuvanttherapy in treating colon cancer.

IBI343 (CLDN18.2 ADC)：Phase 1b positive data readout in GCand a Phase 3 trial is in preparation.

Accelerating new launch momentum in general biomedicine to unlock significant opportunities

Mazdutide (GLP-1R/GCGR) : first NDAfor weight managementin obese or overweight populations and second NDAfor T2D treatment,both under NMPAreview. 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 NDAfor TED is under NMPAreview.With a longstanding lack of innovative TED treatments in China,Teprotumumabis set to be a transformative therapy for this significant unmet need once approved.

Picankibart (IL-23p19) : the only IL-23p19 that reportedover 80% subjects achieving ≥90% improvement in Psoriasis and Severity Index (PASI90) in 16 weeks of treatment,along with strong long-term skin clearance maintenance andquarterly dosing interval advantage. We plan to submit an NDAin the second half of 2024.

IBI128 (XOI) :potential best-in-class XOIfor the treatment of hyperuricemiain 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 initiatedfor the treatment of nAMD,following stable and robust visual benefit observed with anextended 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-2α-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 GCand PDACin 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 siRNAdrug candidate,entered into a Phase 1 clinical trial for hypertension.

IBI355 (CD40L),IBI356 (OX40L) and IBI3002 (IL-4Rα/TSLP) :innovative autoimmunemolecules enteredinto first-in-human studies to explore other unmet medical needs in various types of autoimmunediseases.

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,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 www.innoventbio.com,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.

[1]TYVYT® (sintilimab injection) and BYVASDA® (bevacizumab injection) were approved for their seventh and eight indications,respectively,and included into the NRDL (2023 version,effective January 2024) for the treatment of NSCLC post EGFR-TKI therapy.

[2]The updated NRDL reimbursement coverage of TYVYT® (sintilimab injection) include:For the treatment of patients with EGFR-mutated locally advanced or metastatic non-squamous non-small cell lung cancer who progressed after EGFR-TKI therapy;