- Sincere achieved clinical implied approval of URC102 from NMPA in China
- Evaluated as the best-in-class among the drugs of promoting the uric acid excretion
- Discussion of global licensing-out with multinational pharmaceutical companies is being accelerated based on the results of phase 2b clinical trial in Korea
December of 2020
Then anti-gout drug developed by JW Pharmaceutical has entered the development stage for the first time abroad.
JW Pharmaceutical announced on the 2nd that the anti-gout drug, URC102 have obtained clinical implied approval(i.e. approval for a phase 1 IND) by the National Medical Products Administration (NMPA) in China.
URC102 is a substance that was out-licensed by JW Pharmaceutical to Simcere Pharmaceutical Co., Ltd. (先聲藥業有限公司) (formerly known as Nanjing Simcere Dongyuan Pharmaceutical Co., Ltd. (南京先聲東元製藥有限公司), a subsidiary of Simcere Pharmaceutical Group Limited (“Simcere”) in 2019. In August of this year, Simcere submitted a phase 1 clinical IND of URC102 (Simcere project name of SIM1909-13) to NMPA in China.
In accordance with the clinical implied approval, Sincere will evaluate the safety and tolerability in a total of 40 healthy Chinese people at Shanghai Public Health Clinical Center.
JW Pharmaceutical has demonstrated excellent safety and reduction of uric acid level in blood in phase 2a clinical trial of URC102 conducted in a total of 140 Korean gout patients. In the subsequent phase 2b clinical trial, the administration of the investigational products was completed last month and clinical data is currently being collected. A report on the results of phase 2b clinical trial is expected to be released in early 2021.
SY Lee, CEO of JW Pharmaceutical said, “With the IND approval in China, the first overseas clinical trial of URC102 has been started. We will continue to strengthen our partnership with Sincere so that the development of URC102 can be completed quickly and supplied to Chinese patients suffering from gout.” He added, “We are expecting favorable results of phase 2b clinical trial in Korea that have progressed smoothly. We plan to accelerate discussion on global licensing-out with multinational pharmaceutical companies based on the results of phase 2b clinical trial.”
JW Pharmaceutical will sequentially receive milestones up to USD 65 million including USD 5 million, the upfront fee received at the time of license-out agreement and in stages such clinical development, approval, and commercialization. The total size of the agreement is USD 70 million which is equivalent to KRW 84 billion. Royalties based on sales are separate.
Sincere owns the exclusive rights to develop and commercialize URC102 in Chinese (including Hong Kong and Macau) markets. The rights to the rest of the country except China are held by JW Pharmaceutical.
※ About Gout and URC102
In Korean, gout is called Tong-Pung, a word composed of two Chinese characters: Tong(痛) meaning “pain” and Pung(風) meaning “wind”. With its original name meaning that ‘even a breath of wind can cause a great deal of pain’, this disease is nicknamed as a “disease of Kings” or a “disease of nobles” because of the high prevalence rate in the upper-class having fat-rich diets. However, due to the changes of diet into western pattern diet in modern days, it is referred to as ‘disease of common people’. The number of gout patients in Korea has increased from 334,705 in 2015 to 462,279 in 2019, soaring by 38.1% in four years. (Source: Healthcare Bigdata Hub of the Health Insurance Review and Assessment Service (HIRA) in Korea) URC102 is a new drug candidate (best-in-class) effective for low-emission gout which has a mechanism of action to promote uric acid excretion. Gout is classified into two major types: “high-production” in which uric acid is produced in excess in the body and “low-emission” in which uric acid is not properly excreted. About 90% of gout patients are known to suffer from the low-emission type, but the conventional medicines for low-emission gout are limitedly prescribed due to their safety issues (adverse events). Therefore, the unmet need of patients for safe and effective drugs is remaining high.
※ Anti-gout Drug Market and Patients in China (including global)
Among about 35 million gout patients in the world, about 14 million (40%) of them are estimated to be Chinese. However, according to IQVIA’s 2017 data, the China’s anti-gout drugs market (USD 105.14 million) merely accounted for 4% of the global market (USD 2,668.11 million), which suggest that there is vast growth potential. Meanwhile, the global anti-gout drug market currently valued at KRW 3 trillion is projected to grow to KRW 10 trillion (USD 8.3 billion) by 2025 according to the report published by the market research firm Grand View Research.