2023-07-18 08:00:17
[시사저널e=이상구 의약전문기자] Shin Poong Pharmaceutical’s R&D project, ‘Pyramax’ and osteoarthritis treatment, have completed phase 3 clinical trials or are in the final stage. In particular, Shinpoong Pharmaceutical announced that the results of the phase 3 clinical trial of Pyramax, which explored the possibility of developing a treatment for Corona 19, are expected to be announced by next month, drawing attention to the results.
According to related industries on the 18th, Shinpoong Pharmaceutical’s global phase 3 clinical trial to develop the malaria treatment Pyramax as a COVID-19 treatment through drug repositioning has ended. Drug re-creation refers to a method of developing new drugs by identifying new indications for drugs that have already been marketed and used and whose safety has been proven, or drugs that are safe but not approved because their efficacy has not been sufficiently proven in clinical trials. Although there were twists and turns, such as receiving approval from the Ministry of Food and Drug Safety for a change in the phase 3 clinical trial plan for Pyramax in March, the company explained that the phase 3 clinical trial was completed in overseas countries such as Korea, the UK, Hungary and Poland.
The industry as well as Shinpoong Pharmaceutical’s shareholders have been paying attention to the clinical results of Pyramax that have gone through this process. At the regular shareholders’ meeting held earlier in March, Jeman Yu, CEO of Shinpoong Pharmaceutical, drew attention by saying, “I think we will know the results of the top line in regarding June.” However, there was no official announcement in the first half of the year, and rumors of an announcement on July 11 were raised among some shareholders, but it ended in a misfire. It is known that some shareholders of Shinpoong Pharmaceutical are aware of the rumor of an announcement in early August.
Regarding the announcement of the clinical results of Pyramax, which is drawing attention, Shinpoong Pharmaceutical is in a position that the timing mentioned by some shareholders is not clear. An official from Shinpoong Pharmaceutical confirmed that “the phase 3 clinical trial of Pyramax global has completely ended” and explained, “We are currently in the stage of analyzing the clinical results.” The official added, “It is difficult to confirm the schedule, but for now, the company expects to announce the results within August at the latest.”
In response, the pharmaceutical industry announced that it would withhold related comments following the announcement of the phase 3 clinical trial results next month. An official from the pharmaceutical industry said, “Everything will be announced in August, so there is no need to rush into mentioning it.” “We hope for good results in the Pyramax clinical trial at a time when the Ministry of Food and Drug Safety approval for Ildong Pharmaceutical’s ‘Zokoba’ is delayed.” said. Infectious disease experts also reserved their position or outlook on Pyramax. Expert A said, “Professors and experts mostly analyze papers or data, but the case of Pyramax as a corona treatment is not easy to predict because there is no evidence of data.” I am cautious regarding related comments,” he said.
In addition, Shinpoong Pharmaceutical announced that the phase 3 clinical trial of ‘SP5M001 inj.’ is also in the final stage. According to regulations, disclosure must be made when phase 3 clinical trials are completed, but the company’s position is that disclosure has not yet been made. SP5M001, a hyaluronic acid osteoarthritis treatment, is an improved new drug of ‘Synobian’ developed by LG Chem. A feature of Synovian is that the effect lasts for 6 months with a single administration. Shinpoong Pharmaceutical emphasized that it confirmed that the effect of SP5M001 was maintained for more than one year in animal experiments. In 2015, a phase 1 clinical trial was conducted to confirm whether this effect is maintained in humans. The phase 3 clinical trial, which started with 200 patients in 2021, six years later, is in the final stage.
According to Shinpoong Pharmaceutical, the key to the results of the phase 3 clinical trial of SP5M001 week is how long the effect can be maintained. This is because it can prove its superiority over competing products only when it exceeds the same six months as Synovian. An official from the pharmaceutical industry said, “The total domestic osteoarthritis market is worth 1.24 trillion won, and the domestic one-time therapy market share is expected to expand to 81.9% by 2028.” It can be a variable in the market,” he predicted.
In the end, it is analyzed that the announcement of the clinical results of the Pyramax clinical trial developed by Shinpoong Pharmaceutical as a corona treatment and the osteoarthritis treatment SP5M001, which has improved the original, is imminent. The success of the two products is expected to have a significant impact on the management of Shinpoong Pharmaceutical. “The value of a pharmaceutical company lies in the development of new drugs and new products,” said an official in the pharmaceutical industry.
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