[Edaily Reporter KIM SAE-MI ] IlyangPharmaceutical(007570)has withdrawn its application for marketing authorization in China for “Spect” (active ingredient: radotinib), a leukemia treatment it developed in-house. This comes approximately 13 years after the company signed a technology transfer agreement with its Chinese joint venture in 2013.

IlyangPharmaceutical announced on the 5th that its Chinese joint venture, Yangzhou Il Yang Pharmaceutical Co., Ltd., had decided to withdraw the New Drug Application (NDA) for “Spect” in China.

Yangzhou Ilyang Pharmaceutical passed a resolution at its board meeting that day to withdraw the New Drug Application (NDA) for Spect. The company plans to resubmit the application for Chinese marketing authorization after changing its contract research organization (CRO). Specific reasons for the withdrawal and the timeline for resubmission were not disclosed.

Previously, in October 2013, IlyangPharmaceutical signed a technology transfer and exclusive sales agreement for “Spect” in China with Yangzhou Ilyang Pharmaceutical. The technology transfer fee was $3 million (approximately 3.2 billion won), and at the time, the company projected sales of approximately 250 billion won in the Chinese market over five years.

Under the agreement, IlyangPharmaceutical was to supply the raw materials for Spect, while Yangzhou Ilyang Pharmaceutical was to produce the finished product at a local facility compliant with current Good Manufacturing Practice (cGMP) standards and exclusively market it in the Chinese market. The structure of the agreement stipulated that Yangzhou Ilyang Pharmaceutical would bear the full cost of clinical trials in China.

Yangzhou Ilyang Pharmaceutical is a joint venture in which IlyangPharmaceutical holds a 52% stake and China’s Huanhua Enyang Investment Co., Ltd. holds a 48% stake.

Spect is Korea’s 18th domestically developed new drug, developed by IlyangPharmaceutical and granted domestic marketing authorization in 2012. With the withdrawal of this application for marketing authorization in China, further delays in the local commercialization schedule are expected to be inevitable.

An official from IlyangPharmaceutical stated, “Yangzhou Ilyang Co., Ltd. plans to resubmit the application for Chinese marketing authorization after changing its CRO.”