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HLB submitted Korea & Japan, protocol plan for Apatinib clinical trial phase III
HLB announced on 8th of Dec, that its subsidiary LSK BioPharma has submitted protocol plan for Apatinib’s global clinical trial phase III on gastric cancer, to Korea and Japan.
It was made after the successful pre-meetings with authorizations like US(FDA), EU(EMA), and JAPAN(PMDA), and it indicates that the full scaled global clinical trial phase III procedure has begun. This also expects that the negotiations on technology export currently will be faster.
Clinical trial phase III this time is going to be performed in app. 90 hospitals in 12 countries, including Korea, Japan, Europe and US, for progressive or metastatic gastric cancer patients.
For about 2 years and 450 patients, each region’s clinical trials will be done through consigned global agencies like LSK Global Pharma Service (Korea), Chiltern (US, EU), MPI (Japan), Statplus (Taiwan).
Sungchul Kim, President of LSKB, says “starting from the discussion with US FDA in July, we completed authorities in Europe and Japan, for Apatinib’s clinical trial phase III.” “Yesterday, we submitted the clinical trial plans for phase III to Korea (MFDS) and Japan (PMDA).”
He continued, “Apatinib is a qualified medicine which has been certified in China, expecting around $20 Mil sales revenue this year.” We will try to get global sales approval, completing this global clinical trial phase III in 2 years.”
Kiwoom Securities Co., Ltd., expects higher possibility in the clinical trial phase III, since Apatinib has already qualified with its stability and effectiveness among tens of thousands of patients. And, it is thought to be valued having additional indications for hepatic and lung cancer, due to its positive results from the clinical trial on lung cancer which was reported in the 17th International Lung Cancer Society, this month.
HLB person said, “as we are preparing for lung & colorectal cancer together with the initiation of the global clinical trial phase III in gastric cancer this time, as scheduled, the value of Apatinib is continuously going to get larger as it can have additional indications”, and “it will affect the technology export negotiation, favorably.”