Innovent and LG Chem Announce Strategic Collaboration for Tigulixostat, a Novel Non-Purine Xanthine Oxidase Inhibitor for the Treatment of Gout Disease

ROCKVILLE, Md. and SUZHOU, China, Dec. 14, 2022 /PRNewswire/ -- Innovent Biologics ("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, and LG Chem Life Sciences ("LG Chem"), a division of LG Chem, today announced that the two parties have entered into a strategic collaboration and license agreement regarding LG Chem's Tigulixostat (LG R&D code: LC350189, Innovent R&D code: IBI350), a late-stage novel non-purine xanthine oxidase inhibitor ("XOI") for the chronic management of hyperuricemia in patients with gout disease.

In Phase 2 study conducted in the United States (CLUE Study), Tigulixostat showed serum uric acid (sUA)-lowering effects across all dose levels, and achieved a treatment target of sUA<5mg/dL as the primary endpoint at month 3 with all dose groups when compared with placebo as well as with Febuxostat^[1],[2]. LG Chem has initiated multi-regional global Phase 3 clinical trials for Tigulixostat in Q4 2022.

Under the terms of the agreement, Innovent will obtain an exclusive right to develop and commercialize Tigulixostat in China. LG Chem will receive totaling up to $95.5 million for the China rights including $10 million upfront payment, milestones, plus tiered royalties on net sales of product in China.

Hyperuricemia is one of the most prevailing chronic disease globally with a huge patient population. Prevalence rate of hyperuricemia is as high as 13.3% in China^[3]. Moreover, hyperuricemia is the predisposing condition for gout, and the number of hyperuricemia patients with gout symptoms is up to 15.5 million in China. Febuxostat and Allopurinol as XOI inhibitors, are current therapies recommended for the treatment of hyperuricemia including gout, but contain clear limitations: Febuxostat has potential cardiovascular risk and Allopurinol could cause high incidence of hypersensitivity in Asian population. Under these circumstances, there exists a huge unmet medical need for the treatment of hyperuricemia.

Dr. Yong Jun Liu, President of Innovent, stated: "We are delighted to enter this strategic collaboration with LG Chem on Tigulixostat. As hyperuricemia and gout is both a rheumatic disease and a metabolic disease, the collaboration fits into Innovent's strategic portfolio planning in rheumatic and metabolic areas, as well as creates great synergy with our current pipeline, development resources and commercial network. As one of the few next generation XOI drugs in development, Tigulixostat has demonstrated higher efficacy compared to Febuxostat in exploratory analysis and favorable safety profile in the phase 2 study, showing the great best-in-class potential in the treatment of gout. We will work closely with LG Chem to facilitate the development of Tigulixostat, and we hope to bring the novel product to the market as quickly as possible."

Dr. Jeewoong Son, President of LG Chem Life Sciences Company, stated: "Tigulixostat will provide a better treatment option for gout patients in near future, and our collaboration with Innovent will accelerate the global development of Tigulixostat with the goal of bringing a potentially impactful treatment option to the patient with high unmet medical needs. We are very excited to enter into this strategic collaboration which is a major milestone for LG Chem as we are building global biotechnology and R&D capabilities, and hope to maximize the potential of Tigulixostat through this collaboration. We look forward to collaborating with Innovent to expedite the development of Tigulixostat and to commercialize the new XOI drug, based on the strong and broad experience and expertise of both companies."

About Tigulixostat (LC350189, IBI350)

Tigulixostat is a novel xanthine oxidase inhibitor targeting the reduction of uric acid in purine metabolism, by inhibiting the activity of xanthine oxidase. It has a different structure from other xanthine oxidase inhibitors such as the purine analog xanthine oxidase inhibitor, allopurinol. Tigulixostat is under development as a 1st line treatment in the U.S. and has demonstrated sufficient efficacy for sUA lowering and a good safety profile in a Phase 2 study.

About CLUE study

LG Chem had received FDA clearance to commence a Phase 2 trial of Tigulixostat in June 2019 and conducted the Phase 2 study (CLUE study, NCT03934099) with 156 gout patients at 42 clinical sites in the US.

Participants with chronic gout, defined as hyperuricemia and a history or presence of gout according to ACR criteria and baseline sUA levels ≥ 8 mg/dL, ≤12 mg/dL were administered Tigulixostat (50, 100, and 200 mg) or placebo orally, once daily for 3 months, with a subset of 13 out of 156 participants enrolled in a febuxostat, 40mg – 80 mg QD, active control group.

During the study period, colchicine 0.6 mg (QD) was prescribed for prophylaxis of gout flares. The primary endpoint was the response rate achieving sUA < 5 mg/dL at month 3.

Topline results from the CLUE study are as follows:

• The proportion of gout patients reaching sUA < 5 mg/dL at month 3 by study arms was 47% (16/34) at 50 mg, 45% (17/38) at 100 mg, 62% (23/37) at 200 mg Tigulixostat, respectively, 23% (3/13) with Febuxostat and 3% (1/34) with placebo.
• The proportion of patients achieving sUA < 6 mg/dL at month 3 as the secondary endpoint was 59%, 63%, 78% at 50, 100, and 200 mg of Tigulixostat, respectively, 54% in the Febuxostat group, and 3% in the placebo group.
• Tigulixostat showed good dose-dependent reduction in sUA levels lowering rapidly within 2 weeks, and sUA levels were well maintained throughout the study period.
• Tigulixostat was well tolerated in gout patients at all dose levels compared to the placebo group. There was no notable difference in the overall incidence of TEAE (treatment-emergent adverse events) between Tigulixostat and placebo groups.

About LG Chem
LG Chem is a leading global chemical company with a diversified business portfolio in the key areas of petrochemicals, advanced materials, and life sciences. The company manufactures a wide range of products from high-value added petrochemicals to renewable plastics, specializing in cutting-edge electronic and battery materials, as well as drugs and vaccines to deliver differentiated solutions for its customers. LG Chem Life Sciences, engaged in development, manufacturing and global commercialization of pharmaceutical products, seeks to expand and make global presence by focusing on key core therapeutic areas of Immunology, Oncology, and Metabolic Diseases (specifically, diabetes and related metabolic diseases). For more information, please visit www.lgchem.com.

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, metabolic, ophthalmology 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, autoimmune, ophthalmology and other major therapeutic areas, with 8 products approved for marketing in China – TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection), Pemazyre® (pemigatinib oral inhibitor), NAILIKE (olverembatinib) Cyramza® (ramucirumab) and selpercatinib, 2 assets under NMPA NDA review, 5 assets in Phase 3 or pivotal clinical trials, and an additional 20 molecules 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, 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 and developed by 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.

Innovent Biologics, Inc. Forward-Looking Statements

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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.

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