Shin Poong Pharm. Co., Ltd., Attend at BIO USA 2018

– the World’s Largest BIO International Convention.

Announcement of SP-8203, the first-in-class drug for the stroke treatment

Announcement of the clinical trial phase 2a results of SP-8203 involving the safety and efficacy, and the other new drugs in the current pipeline, scheduled on June 6^th

Open to partnering with the global pharmaceutical companies for in/out-licensing and investment as well as co-marketing, co-promotion, and co-R&D

From June 4^th to 7^th, Shin Poong Pharm. Co., Ltd. steps in the BIO International Convention 2018 – the world's largest BIO event – this year in Boston, the US. On June 6^th (local time) Jei-man Ryu, the CEO, opens the curtain with the clinical results of SP-8203, the first-in-class for the stroke treatment during the company presentation.

The company also introduces, as per the others, the overall performance including not only the achievements in the current R&D pipeline but also some commercial products amongst which the new anti-malarial ‘Pyramax^®’, the fixed dose combination drugs, and medical devices are centered around.

From those in the current R&D pipeline, SP-8203 is the front runner recently out of the clinical phase IIa. In order to confirm the safety and efficacy of the SP-8203 in clinical trial phase IIa, 80 patients were recruited and treated by the combination therapy with tPA – the standard of care for the acute ischemic stroke – for 90 days (1st stage: 11 patients for open label, single dose, 2nd stage: 69 patients for double-blind, randomized, parallel, 2 doses placebo-controlled).

Through that study, SP-8203 confirmed the safety via the incidence of cerebral hemorrhage, mortality, and side effects, and showed statistically significant neurological outcomes.

It has proved that SP-8203 has a multiple neuroprotective effects through a variety of stroke animal models. Particularly, because it extends the therapeutic window when combined with tPA, more patients would have the benefit of reducing cerebral infarction and edema as well as hemorrhage and mortality, all of which are caused by the delayed administration of tPA.

SP-8203 won the top 10 future pharmaceutical special projects run by the Ministry of Health and Welfare, because it is highly distinctive from the other stroke treatments for such characteristics above; and it will have the supporting cash-in for the further clinical studies until 2020.

Currently, Boehringer Ingelheim's Actilyse (tPA) is the only FDA approved thrombolytic drug, and every one’s eyes are to have been fixed on this niche market for the past few years. And Shin Poong Pharm. Co., Ltd. believes SP-8203 is a leading candidate in such a niche market and expects, given all the circumstances, the feasibility into the life as with its own know-how earned via the new drug development for cardiovascular disease.

The company plans to secure and bring in a variety patient group as well as diversified races to it as per the clinical trials in many countries; for example, those with the acute ischemic stroke in Korea, USA, Germany, Japan, Australia and so forth such that it backs-up the safety and efficacy of SP-8203 on a strongly basis.

"SP-8203 is going to be in the clinical trial phase 2b as early as possible by the end of the year, based on the clinical trial outcomes, commercial potential, and government-oriented supports." said Jei-man Ryu, the CEO of the company. He went on "As previously did with the development of Pyramax® the new anti-malarial drug, once again, we will deliver such a distinctive technology into the world and this time it is SP-8203. Partnering meetings with global pharmaceutical companies and investors are also scheduled."