Innovent Presents Phase Ib Clinical Data Update of IBI110 (Anti-LAG-3 Monoclonal Antibody) at the 2022 European Society For Medical Oncology Immuno-Oncology Congress

ROCKVILLE,Md.and SUZHOU,China,Dec. 9,2022 -- Innovent Biologics,Inc. ("Innovent") (HKEX: 01801),a world-class biopharmaceutical company that develops,manufactures and commercializes high-quality medicines for the treatment of oncology,autoimmune,metabolic,ophthalmology and other major diseases,today announced that updated clinical data of IBI110 (anti-LAG-3 monoclonal antibody) in advanced squamous non-small cell lung cancer (sqNSCLC) is presented at the 2022 European Society for Medical Oncology Immuno-Oncology Congress (ESMO-IO),held Dec 7-9,2022.

Efficacy and safety of IBI110 (anti-LAG-3 mAb) in combination with Sintilimab (anti-PD-1 mAb) in Advanced Squamous Non-small Cell Lung Cancer (sqNSCLC): Updated Results from a Phase Ib Study

Poster #: 86P

IBI110 is an IgG4κ recombinant human anti-LAG-3 monoclonal antibody developed by Innovent Biologics. The Phase Ib study aims to evaluate the efficacy and safety of IBI110 in combination with sintilimab and chemotherapy (paclitaxel plus carboplatin) as first-line therapy for advanced sqNSCLC.

20 treatment naïve sqNSCLC patients received IBI110 (200 mg,Q3W) combined with sintilimab and chemotherapy and received at least 1 post-baseline tumor assessment. As of the data cutoff date of Oct 25,2022,median follow-up time was 12.0 (95% CI,11.9 -13.1) months,16 patients achieved partial response (PR),the objective response rate (ORR) was 80%; the 12-month progression free survival (PFS) rate was 60.0% (95% CI,35.7-77.6),the median PFS was not reached; the 12-month overall survival (OS) rate was 85.0% (95% CI,60.4-94.9) .

For safety results,the most common treatment related adverse events (TRAEs) ≥ grade 3 were decreased neutrophil count (30.0%) and decreased white blood cell count (20.0%). Immune-related AEs (irAEs) occurred in 14 patients,in which only 4 patients experienced irAE ≥ grade 3. No treatment-related deaths occurred.

IBI110 combined with sintilimab and chemotherapy in advanced sqNSCLC continues to show robust anti-tumor activity and favorable safety. The study is ongoing with the clinical data in squamous NSCLC continuing to mature and will be disclosed in the future academic conference/journals.

Professor Caicun Zhou,Shanghai Pulmonary Hospital,stated: "Lung cancer is the most commonly diagnosed cancer and the leading cause of cancer death worldwide,of which non-small cell lung cancer accounts for about 80%1. In recent years,PD-1/PD-L1 inhibitors have shown promising efficacy in non-small cell lung cancer2. However,persistent response to immune checkpoint inhibitor monotherapy remains a challenge in clinical practice. IBI110 plus sintilimab indicate promising antitumor activity and a manageable safety profile in untreated squamous non-small cell lung cancer patients. In the current 20 patients,the ORR reached 80% and the 12-month PFS rate was 60%,which warrants further investigation into the safety and efficacy of IBI110 combination therapy in this indication."

Dr. Hui Zhou,Senior Vice President of Innovent,stated: "We are pleased to present our clinical development updates at the 2022 ESMO-IO Meeting. IBI110 in combination with sintilimab demonstrated encouraging efficacy and safety data in sqNSCLC. We will continue to provide updates on the PoC data for IBI110 and plan to initiate pivotal clinical studies. As immunotherapy moves into the next era,we are actively advancing the development of next-generation immune checkpoint inhibitors,among which IBI110 represents a high-potential LAG-3 asset,which we hope will benefit patients in need soon."

To learn more about Innovent's R&D updates and activities,please visit https://investor.innoventbio.com/cn/investors/webcasts-and-presentations/.

About IBI110

IBI110 is an IgG4κ recombinant human anti-LAG-3 monoclonal antibody independently developed by Innovent Biologics. Based on the mechanism of action and preclinical data of IBI110,it is assumed that IBI110 can inhibit the immune checkpoint signaling to achieve anti-tumor effect,which may further improve the efficacy of immunotherapy,overcome the primary drug resistance,and overcome the drug resistance after anti-PD-1 /PD-L1 monoclonal antibody treatment3. Based on the urgent clinical needs,Innovent has carried out clinical studies to explore PK/PD characteristics of IBI110 single agent and combined with sintilimab in humans as well as its efficacy and safety in various advanced tumors. This clinical trial (NCT04085185) is the first in human clinical study of IBI110.

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. On October 31,2018,Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.

Since its inception,Innovent has developed a fully integrated multi-functional platform which includes R&D,CMC (Chemistry,Manufacturing,and Controls),clinical development and commercialization capabilities. Leveraging the platform,the company has built a robust pipeline of 35 valuable assets in the fields of cancer,metabolic disorder,autoimmune disease and other major therapeutic areas,with 8 approved products on the market. These include: TYVYT®(sintilimab injection),BYVASDA®(bevacizumab biosimilar injection),SULINNO®(adalimumab biosimilar injection),HALPRYZA®(rituximab biosimilar injection),Pemazyre®(pemigatinib oral inhibitor),olverembatinib (BCR ABL TKI),Cyramza®(ramucirumab) and selpercatinib. An additional 2 assets are under NMPA NDA review,5 assets are in Phase 3 or pivotal clinical trials,and 20 more molecules are in clinical studies.

Innovent has built an international team with advanced talent in high-end biological drug development and commercialization,including many global experts. The company has also entered into strategic collaborations with Eli Lilly and Company,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. For more information,please visit: www.innoventbio.com and www.linkedin.com/company/innovent-biologics/.

Note:

TYVYT® (sintilimab injection) is not an approved product in the United States.

BYVASDA® (bevacizumab biosimilar injection),SULINNO®,and HALPRYZA® (rituximab biosimilar injection) are not approved products in the United States.

TYVYT® (sintilimab injection,Innovent)

BYVASDA® (bevacizumab biosimilar injection,Innovent)

HALPRYZA® (rituximab biosimilar injection,Innovent)

SULINNO® (adalimumab biosimilar 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,Eli Lilly). CYRAMZA® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China.

Selpercatinib (Eli Lilly). Selpercatinib was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China.

Disclaimer:

1. The indications are still under clinical study,which haven't been approved in China.

2. Innovent does not recommend any off-label usage.

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.

Reference

1 Sung H,Ferlay J,Siegel R L,et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries[J]. CA: a cancer journal for clinicians,2021,71(3): 209-249.

2 中华医学会肺癌临床诊疗指南（2022版）

3 J Thorac Oncol. 2017 May;12(5):814-823. 2. jco.2022.40.16_suppl.e2114