Innovent and LG Chem announce a strategic collaboration for Tigulixostat, a novel non-purine xanthine oxidase inhibitor for the treatment of gout. | Jobs Vox


ROCKVILLE, Md. and SUZHOU, China, December 14, 2022 /PRNewswire/ — Innovent Biologics (“Innovent”, HKEX: 01801) is a world-class biopharmaceutical company that develops, manufactures and markets high-quality medicines for the treatment of cancer, metabolic, autoimmune, ophthalmic and other major diseases. LG Chem Life Sciences (“LG Chem”), a division of LG Chem, today announced that both parties have entered into a strategic collaboration and license agreement for LG Chem’s Tigulixostat (LG R&D Code: LC350189, Innovent R&D Code: IBI350). A novel non-purine xanthine oxidase inhibitor (“XOI”) for the chronic treatment of hyperuricemia in patients with gout.

Phase 2 study United States (CLUE study) Tigulixostat had a serum uric acid (sUA)-lowering effect at all dose levels, achieving the primary endpoint of sUA<5 mg/dL in March compared with placebo and other dose groups. with Febuxostat[1],[2]. LG Chem has initiated a multi-region global Phase 3 clinical trial of Tigulixostat in Q4 2022.

Under the terms of the agreement, Innovent will acquire the exclusive rights to develop and commercialize Tigulixostat. China. LG Chem will accept the total amount 95.5 million dollars for China including rights 10 million dollars upfront payments, milestones, and royalties on net product sales China.

Hyperuricemia is one of the most common chronic diseases worldwide with a huge number of patients. The prevalence of hyperuricemia is as high as 13.3% China[3]. In addition, hyperuricemia is a prerequisite for gout, and the number of hyperuricemic patients with gout symptoms is up to 15.5 million. China. The XOI inhibitors, febuxostat and allopurinol, are currently recommended treatments for hyperuricemia such as gout, but have certain limitations: febuxostat carries a cardiovascular risk, and allopurinol is known to cause hypersensitivity in the Asian population. In this situation, there is a great medical need for the treatment of hyperuricemia.

Dr. Yong Jun LiuPresident of Innovent, “We are excited about this strategic collaboration with LG Chem on tigulixostat. As hyperuricemia and gout are both rheumatic and metabolic diseases, the collaboration is in line with Innovent’s strategic portfolio planning in rheumatic and metabolic areas, which is very promising. In collaboration with our current pipeline, development resources and commercialization network, tigulixostat, one of the few next-generation XOIs in development, is more effective than febuxostat in exploratory studies and has a favorable safety profile in phase 2 studies. demonstrated. A potential treatment for gout. We will work closely with LG Chem to support the development of Tigulixostat and look forward to bringing the new product to market as soon as possible.”

Dr. Jeewoong SonPresident of LG Chem Life Sciences, “Tigulixostat will provide better treatment options for gout patients in the near future, and our collaboration with Innovent aims to accelerate the global development of tigulixostat and bring an effective treatment option to patients with unmet medical needs. We are building global biotechnology and R&D capabilities at LG Chem.” We are very pleased to enter into this strategic partnership, which is an important milestone for us, and we hope to maximize the potential of Tigulixostat through this partnership. We look forward to working with Innovent. Tigulixostat and the strong and extensive experience of both companies , commercialization of new XOI drugs based on experience.”

About Tigulixostat (LC350189, IBI350)

Tigulixostat is a novel xanthine oxidase inhibitor designed to reduce uric acid in purine metabolism by inhibiting xanthine oxidase activity. It is structurally different from other xanthine oxidase inhibitors such as purine analog xanthine oxidase inhibitors and allopurinol. Tigulixostat is being developed as a first-line treatment in the United States, and a phase 2 study showed adequate efficacy and good safety profile in reducing sUA.

About the CLUE study

LG Chem Receives FDA Approval to Initiate Phase 2 Trials of Tigulixostat. June 2019 A phase 2 study (CLUE study, NCT03934099) was conducted in 156 patients with gout at 42 clinical sites in the United States.

Patients with chronic gout defined as hyperuricemia and with or without gout according to the ACR criteria received oral tigulixostat (50, 100, 200 mg) or placebo at baseline sUA levels ≥ 8 mg/dL and ≤12 mg/dL. Thirteen of 156 participants received febuxostat, 40 mg – 80 mg QD, once daily for 3 months, in the active control group.

Colchicine 0.6 mg (QD) was administered to prevent gout flares during the study period. The primary endpoint was response to sUA < 5 mg/dL in March.

The main results of the CLUE study are as follows.

  • The proportion of patients with gout who achieved sUA<5 mg/dL at 3 months was 47% (16/34) with 50 mg, 45% (17/38) with 100 mg, and 62% (23/37) with 200 mg. . mg Tigulixostat 23% (3/13) Febuxostat, 3% (1/34) placebo.
  • The proportion of patients achieving a secondary endpoint of sUA<6 mg/dL at 3 months was 59%, 63%, and 78% in the tigulixostat 50, 100, and 200 mg group, respectively, and 54% and 3% in the febuxostat group. in the placebo group.
  • Tigulixostat showed a good dose-dependent reduction in sUA levels rapidly within 2 weeks, and sUA levels were well maintained throughout the study period.
  • Tigulixostat was well tolerated in patients with gout compared to placebo at all dose levels. There was no significant difference in the overall incidence of TEAEs (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 petrochemicals to renewable plastics, and specializes in delivering the latest electronic and battery materials, pharmaceuticals and vaccines to its customers in diversified solutions. LG Chem Life Sciences, which engages in the development, manufacturing and global commercialization of pharmaceutical products, seeks to expand and focus on key therapeutic areas such as immunology, oncology and metabolic diseases (especially diabetes and related metabolic diseases). For more information, please visit

About Innovent

Inspired by the spirit of “Start with integrity, succeed with action”, Innovent’s mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are accessible to the common man. Founded in 2011, Innovent aims to develop, manufacture and commercialize high-quality innovative medicines for the treatment of cancer, autoimmune, metabolic, ophthalmic and other key diseases. On October 31, 2018Innovent was listed on the Main Board of the Hong Kong Stock Exchange under the stock code 01801.HK.

Since its inception, Innovent has developed a fully integrated multi-functional platform that includes research and development, CMC (chemistry, manufacturing and control), clinical development and commercialization capabilities. Using this platform, the company has built a solid pipeline of 35 valuable assets and approved 8 products to market in cancer, metabolic, autoimmune, ophthalmology and other therapeutic areas. China – TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection), Pemazyre® (pemigatinib oral inhibitor), NAILIKE® rumbat® (Cailikerumbat) (Civasimab ) selpercatinib, 2 assets under NMPA NDA review, 5 assets in Phase 3 or pivotal clinical trials, and 20 additional molecules in clinical studies.

Innovent has built a highly capable international team in the development and commercialization of high-quality biologics, including many global experts. The company also has strategic partnerships with international partners such as Eli Lilly and Company, Sanofi, Incyte, MD Anderson Cancer Center and others. Innovent is committed to working with many colleagues to make progress China improve biopharmaceutical production, drug availability, and improve patients’ quality of life. For more information, please visit: and


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

BYVASDA® (bevacizumab biosimilar injection), SULINNO®, and HALPRYZA® (rituximab biosimilar injection) are unapproved products. United States.

TYVYT® (sintilimab injection, Innovent)

BYVASDA® (biosimilar bevacizumab 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.


1. Indications that have not been approved in the year are still undergoing clinical research China.

2. Innovent is not recommended for off-label use.

Innovent Biologics, Inc. Forward-Looking Statements

This news may contain certain forward-looking statements that are inherently subject to significant risks and uncertainties. Words such as “anticipate,” “believe,” “estimate,” “expect,” “intend” and similar expressions related to Innovent are intended to identify certain forward-looking statements. Innovent does not intend to regularly update these forward-looking statements.

These forward-looking statements are based on the current beliefs, assumptions, expectations, estimates, projections and understandings of Innovent’s management regarding future events at the time these statements are made. These statements are not guarantees of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent’s control and difficult to predict. Accordingly, actual results may differ materially from the information contained in the forward-looking statements as a result of future changes and developments in our business, Innovent’s competitive environment, and political, economic, legal and social conditions.

Innovent, Innovent’s directors and officers undertake no obligation to (a) correct or update any forward-looking statements contained on this site; and (b) assumes no responsibility if any of the forward-looking statements prove to be untrue or incorrect.

SOURCE Innovent Biologics


Source link

Implement tags. Simulate a mobile device using Chrome Dev Tools Device Mode. Scroll page to activate.