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KDDF-201112-03 Evaluation of the Safety, Pharmacokinetics and Efficacy of YN968D1 in Subjects with Solid Tumors(Oncology, Chemical) [01.04.2013]

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Development and Market Objectives

• YN968D1, a small molecule anti-cancer drug candidate, inhibits the growth and metastasis of tumors by selectively binding to VEGFR-2, thereby inhibiting the angiogenesis necessary for the growth of cancer cells. Its biggest advantage is its significantly fewer side-effects and superior anti-cancer efficacy in comparison to existing chemotherapy. Preclinical trials in animal models, as well as clinical trials in humans have proven superior efficacy and lower toxicity. Based on this evidence, we aim to develop YN968D1 as an anti-cancer drug with superior efficacy and lower toxicity compared to other angiogenesis inhibitors.   

• In the US and Korea, clinical Phase 1 assessments in patients with solid tumors are underway.

Unmet Medical Need & Target Patients

• In the US, the cases of patients with solid tumors are approximately 1.3 million per year. Worldwide, approximately 6 million patients are diagnosed with solid tumors on an annual basis (Source, American Cancer Society; Center for Disease Control).

• The market for targeted anti-cancer drugs is continuously growing and is expected to exceed $24,821 million in 2020 (Source, Datamonitor 2011)

• Current chemotherapy drugs are often associated with serious side effect such as nausea, vomiting, alopecia, hepatotoxicity, renal toxicity, leukopenia and thrombocytopenia.

• In recent years, the development of targeted anti-cancer drugs that are different from conventional chemotherapy has been a focus of renewed attention. Targeted therapy using monoclonal antibodies have a high unit cost for production and low stability and patients are required to visit hospitals for intravenous administration.

• In order to solve these problems, low molecular weight targeted anti-cancer drugs with low production costs, excellent stability and oral administration are being developed, however, various side-effects are still observed due to multi-kinase receptor targeting.

• Therefore, the development of small molecule angiogenesis inhibitors with less side-effects and higher specificity is urgently needed.

Status

• In China, clinical Phases 2/3 for YN968D1 have been completed with advanced or metastatic gastric cancer patients and clinical Phase 3 on advanced or metastatic gastric cancers is underway. Currently, YN968D1 is at the stage of product licensing and it is expected to receive SFDA approval for gastric cancer and enter the market in the middle of 2013.

• In order to increase the number of diseases for which the drug is efficacious, a total of six clinical trials, including two trials of non-small-cell lung cancer and triple-negative breast cancer, and one trial of liver cancer and colorectal cancer, are underway in China.

• Additionally, in order to enter the global market, clinical Phases 1/2a for solid tumors are underway in the US and Korea.

Intellectual Property

•   Developer:  Advenchen Laboratories (US)

•   License:  Hengrui (China), LSK BioPartners (US), Bukwang Pharmaceutical Co., Ltd (Europe, Korea, Japan)
 
•   Information on Patents 
 
Country Patent No. Patent title
US US 7,129,252 B2 Six Membered Amino-Amide Derivatives
as Angiogenesis Inhibitors
WO WO2005/000232 A2
Europe EP 1633712 A0
Japan JP 5046643
Canada CA 2568608
Korea KR 10-1159034

Competitive Advantages

• High potent and specific VEGFR-2 inhibitor (IC50, 1 nM)

• Low production cost, as synthetic small molecule

• Broad spectrum and potent anti-cancer activities (CRC, NSCLC, HCC, Gastric, Breast)

• Product licensing is underway in China

Indication

Anticancer drug
 

Research Period

Apr. 1, 2012 ~Jun. 30, 2013
 

Company

Bukwang Pharmaceutical Co.,Ltd.
 

Developmental Stage

Phase 1 clinical trial
 

Additional Information

Contact Information

Contact
Address Company Name: Bukwang Pharmaceutical Co.,Ltd.
WebSite Homepage: http://www.bukwang.co.kr Contact Person: Jong Moon Kim, Ph.D.
E-mail: jmkim@bukwang.co.kr Contact: +82 2 828 8510

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