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Daewoong Pharmaceutical confirms potential as a COVID-19 treatment in Phase 2a clinical trial of’Hoy Star Tablet’
Daewoong Pharmaceutical (President Seung-ho Jeon) released the results of the Phase 2a clinical topline on the treatment effect of Hoy Star Tablet on the 23rd.
According to Daewoong Pharmaceutical, this clinical trial was conducted in a placebo-controlled, randomized, and double-blind method for a total of 89 mild or asymptomatic confirmed patients hospitalized for COVID-19 with the participation of Professor Myung-don Oh of Seoul National University and researchers from 13 institutions, who are the lead researcher Excluding dropouts, a total of 81 patients (41 patients in the Hoystar group, average age 55 years old / 40 patients in the placebo group, average age 43 years) were compared to analyze clinical efficacy and safety.
Daewoong Pharmaceutical said, “The time taken until the virus negative prevalence, which is the main evaluation variable, was not statistically significant, but the rate at which the virus was removed tended to be faster in the Hoista group than in the placebo group.” Hoystar’s mechanism of action directly kills the virus. This is a remarkable result considering that it is not a drug that is prescribed, but a mechanism that prevents the entry of virus into cells (TMPRSS2 inhibitor).
Moreover, as a result of the analysis of the ordinal scale and news score, the time taken to improve the patient’s clinical symptoms showed a tendency to recover faster in the Hoystar group, and the improvement result of the symptom scale was of great clinical significance. As much as that, detailed analysis will be conducted.
Meanwhile, the researchers who participated in the clinical trial said, “As a result of this phase 2a trial, Hoystar tablets are expected to be effective in improving patients’ symptoms and removing viruses, and confirming the possibility of developing a therapeutic agent that meets the purpose of the therapeutic exploration trial. It is significant,” he said, and said, “We plan to conduct a large-scale phase 2b/3 clinical trial in the future to confirm the treatment effect.”
The current results are top-line results, and since all figures have not been analyzed so far, the final results will be officially published in the journal through further analysis and in-depth consideration with clinical participants and experts in infectious medicine.
Seung-ho Jeon, president of Daewoong Pharmaceutical, said, “The belief that self-treatment can be possible by taking Hoystar tablets from the results of this phase 2a test was confirmed in this clinical trial following the retrospective analysis results.” “Already prepare for phase 2b/3 clinical trials. As it is completed, we will quickly draw the same results in large-scale patients and secure the results of phase 3 clinical trials within the first half of 2021 so that Hoystar can establish itself as a global COVID-19 treatment.”
On the other hand, Daewoong Pharmaceutical received approval from the Ministry of Food and Drug Safety on the 17th as a phase 2 clinical trial of Hoy Star Tablet, which is being developed as a treatment for COVID-19, as a phase 2/3 clinical trial. I have started.
Daewoong Pharmaceutical is planning to finish phase 1 clinical trials of niclosamide injections, which are being developed as a treatment for Corona 19 other than Hoystar, in India and other countries, and prepare for multinational phase 2 clinical trials. Previously, Daewoong Pharmaceutical proved its antiviral efficacy through a viral gene amplification test in a hamster effect model recommended by the National Institute of Health (NIH), and its anti-inflammatory efficacy was confirmed in the lung tissue pathology test results. Daewoong Pharmaceutical expects to shorten the treatment period and improve the survival rate of patients with Corona 19 based on the results of both tests.
■Hanmi Pharm, first Korean company to acquire CP grade’AAA’
Hanmi Pharm (CEO Jong-soo Woo and Se-chang Kwon) acquired the highest CP grade’AAA’ given by the Fair Trade Commission (FTC) among 691 domestic companies that introduced CP.
In July 2001, the Fair Trade Commission introduced the’Compliance Program (CP)’, an internal compliance system that companies autonomously introduce and operate to comply with fair trade related laws and regulations. Prepared.
Hanmi Pharm introduced and operated it company-wide in 2007, and has acquired CP grade since 2013. Hanmi Pharmaceutical continued its efforts to advance CP and received the’AA’ grade in a row in 2015, 2017, and 2019, and this year, it is the only Korean company to obtain the’AAA’ grade since the FTC introduced the CP grade.
The CP grade is divided into six grades, from the lowest D to C, B, A, AA, and AAA, and aims to induce faithful CP operation by providing differentiated incentives to excellent companies.
The FTC has 17 evaluations based on a total of 7 evaluation items including ▲ CP introduction and establishment of operation policy ▲ support from top management ▲ voluntary compliance manual ▲ education and training program ▲ pre-monitoring system ▲ sanctions and incentive system ▲ program effectiveness evaluation and improvement The indicators and 54 detailed measurement indicators are carefully reviewed to give CP grades. Hanmi Pharm has continuously improved by applying detailed indicators necessary for CP enhancement to work.
The CEO of Hanmi Pharm continues to affirm his commitment to self-compliance, establishes standards and procedures for CP operation, and discloses and publicizes internal and external CP operations. It also appoints a compliance manager with guaranteed independence and fully supports the budget and manpower. Employees understand the standards and procedures of CP operation through the voluntary compliance manual, apply them to work, and participate in systematic education and training programs.
In particular, CP-related risks are periodically evaluated and internal and external effectiveness assessments are conducted to reduce risks. CP management committee, pre-work consultation system, whistleblowing system (clean management newspaper, etc.), CP monitoring, personnel sanctions and incentives Various CP management programs such as the system are continuously operated.
In addition, in order to prevent illegal activities through third parties, messages are delivered to 3rd parties (CRO, CMO, marketing related companies, personnel related companies, other companies, etc.) External risk factors are also managed from various angles by simultaneously conducting education on the process of sharing, reporting corruption, and pledges to prevent corruption.
In addition, by enacting April 1 every year as the’Day of Self-Compliance’, and by delivering messages from the CEO and pledges to practice fair trade compliance, all executives and employees are pledged to practice self-compliance and trust through ethical management.
In addition to the Fair Trade Commission’s CP rating, Hanmi Pharm is evaluated as contributing to the spread of ethical management in the domestic pharmaceutical industry by receiving the industry’s first anti-corruption management system, ISO 37001, in 2017.
Hanmi Pharm’s move has led to various government awards. In 2016, the Fair Trade Commission received a Presidential Citation for contributing to the spread of the fair trade culture in the’Fair Trade Day’ government award, and in 2019, the’Korea Beloved Company’ government award was recognized for the achievement of spreading ethical management culture through the introduction of CP. Received the Prime Minister Citation. It has also received commendations from the Chairman of the Fair Trade Commission in 2014, 2015, 2017, and 2020.
“We are pleased to be the first and only AAA among all Korean companies that have introduced CP as well as the pharmaceutical bio industry in Korea,” said Jong-soo Woo, CEO of Hanmi Pharmaceutical. “With a great sense of responsibility, I will make an enterprise-wide effort.”
■Solbio’s “Non-destructive, non-amplified gene biosensor technology” listed in the world’s most prestigious journal
Solbio’s core platform technology,’non-destructive non-amplified gene biosensor technology’, will be listed in the world’s most prestigious nanomaterials journal.
In vitro diagnostic bio-venture’Solbio’ (CEO Se-Hwan Baek) is the world’s most authoritative nano-academic journal,’Nucleic Acid Non-Amplified Gene Biosensor Technology’, developed in collaboration with Prof. It was announced on the 23rd that it will be listed on Nano Letters.
‘Nano Letters’ is an academic journal published by the American Chemical Society (ACS) and is the world’s most influential journal in the nano field. As of 2019, the Impact Factor (Impact Factor) of 11.238 and the Annual Total Citations (165,521) covers the entire world of nanotechnology research, and research results of nanotechnology with wide and groundbreaking applicability are dealt with every year.
The new technology jointly developed by Solbio’s research team and Professor Choi Jeong-woo and Choi Jin-ha’s team is’fluorescence-coloring analysis system’ activated with gold nanoparticles without PCR amplification process and’gene editing technology’ to test target genes. With’biosensor technology’, it is a breakthrough diagnostic technology that greatly improves accuracy and shortens the test time to 1/5 by performing genetic molecule diagnosis and protein immunological diagnosis simultaneously on one platform.
Baek Se-hwan, CEO of Solbio said, “This technology enables simultaneous measurement of cancer-specific exosome surface proteins and nucleic acid biomarkers (miRNA, mRNA, cf-DNA, etc.), which can significantly improve diagnosis accuracy compared to existing cancer early detection technologies. He said, “We will develop into a powerful diagnosis technology to identify the cause of cancer and early diagnosis of personalized cancer by incorporating the optimal multi-biomarker diagnosis algorithm.”
Jeong-woo Choi, a professor of chemical and biological engineering at Sogang University, is a world-renowned scholar who developed the’cell non-destructive nanobiosensor technology’ published in the internationally renowned academic journal’ACS Nano’ in the field of chemistry and nanotechnology. He is the editor-in-chief of the Nano Convergence Journal and a professor at the Sogang-Harvard Disease Biophysics Research Center.He was selected as the’Top 10 Nanotechnology of the Year’ in November, and was awarded the’Prime Minister’s Award’ in the Nano Korea 2016 Research Division, and excellent research in health care technology. It has been awarded the Minister of Health and Welfare Award.
Park Kyung-hwa, a professor of hematology and oncology at Korea University Anam Hospital, said, “This study will be very useful for diagnosing subtypes of various types of breast cancer, predicting treatment, and recurrence because immunodiagnostics and molecular diagnosis are possible at the same time.” .
Solbio is planning to accelerate the commercialization of 2-dimensional chromatography-based nanobiosensor automation equipment capable of multiple diagnosis of protein and nucleic acid biomarkers by securing’non-destructive non-amplified gene biosensor technology’ with this research and development achievement. . In addition, it plans to actively develop a companion diagnosis technology that helps early diagnosis and treatment of acute and chronic diseases customized to individuals with the exosome biomarker-based immunodiagnostic-molecular diagnosis platform technology.
Solbio possesses more than 20 core patents at home and abroad with its unrivaled technology in the field of immune isolation, diagnostic kits, and biosensors, and is seeking to attract Series A following the investment of Free Series A with the aim of listing on the KOSDAQ in 2022. It is a bio-venture company. We have developed a diagnostic technology that detects prostate cancer with an accuracy of more than 90% and early stage 1-2 cancer with an accuracy of up to 95%. CEO Se-Hwan Baek (emeritus professor at Korea University) served as the founding president of the Korean Biochip Society, a scholar who has been conducting immunodiagnostic research for 35 years, and is considered one of the world’s top authorities in in vitro diagnostic technology.
■C&Pharm develops injections for severely ill patients with Corona 19
Hyundai Bioscience (CEO Ki Ki Oh) succeeded in developing’Poly-COV01′, an injection for the treatment of severe patients with novel coronavirus infection (Corona 19), by C&Pharm, the major shareholder, for emergency use with’DT&CRO’, a clinical consignment organization (CRO). It was announced on the 23rd that it had signed a clinical agency contract for approval.
Poly-COV01 is an oral drug among corona19 patients like Feramivir, an injection drug that emerged as the last hope for severely ill patients who were unable to take the oral drug Tamiflu, who was injured as a game changer during the’swine flu’ crisis in 2009. It was developed for very few severely ill patients who could not even administer nasal inhalation drugs, C&Pharm said.
C&Pharm is a drug in which Poly-COV01 improves the short half-life of the blood concentration of nikolasamide based on its’pain-free anticancer drug’ platform. By controlling the number of administrations, virus proliferation is prevented throughout the treatment period. It was developed with the aim of maintaining’IC100′, an effective concentration in blood that suppresses 100%, and it is characterized by minimizing side effects due to drug toxicity, he explained.
Niclosamide, the base drug of Poly-COV01, was selected as the No. 1 candidate for COVID-19 treatment among major drugs in the world by Institut Pasteur Korea in April of this year.It is known in the pharmaceutical world that it can be applied to various diseases such as cancer and diabetes in addition to corona virus diseases. have.
C&Pharm expects that Poly-COV01 can be the last’hopeful injection’ for severely ill patients with Corona 19, who are currently at the crossroads of life and death. Under the policy of conducting the clinical procedure of Poly-COV01 as quickly as possible, the effect of the injection was tested with the relevant authorities. We are discussing the schedule.
Hyundai Bio is pursuing a plan to provide priority supply of Poly-COV01 to severely ill patients who are further driven into the blind spot of treatment due to the’third coronavirus pandemic’ after receiving approval for treatment purposes so that they can administer Poly-COV01 before market approval by the authorities. . ‘Therapeutic Use Approval’ is a system that allows new drugs in the clinical stage prior to new drug approval to be administered to patients with incurable diseases or terminal cancer. It is similar to’.
■Korea United Pharm holds a family concert in Ho Chi Minh City, Vietnam
A classical music performance with both Korea and Vietnam was held in Ho Chi Minh City, Vietnam.
Korea United Pharmaceutical (CEO Kang Deok-young) and United Cultural Foundation (Chairman Kang Deok-young) recently successfully held the ‘2020 United Family Concert with Christmas Carol’ at the Ho Chi Minh City Conservatory, Vietnam.
Including Jin-young Yang of the Vietnam subsidiary of Korea United Pharmaceutical, Sook-mi Moon, Deputy Director of the Korea Trade-Investment Promotion Agency (Cotra), Ho Chi Minh Trade Center, Mr. Hoang Ngoc Long, Director of the National Academy of Music of Ho Chi Minh, and Ho Chi Minh Medical School/Pharmaceutical School/Conservatory, Ton Duc-Tang Pharmacy, About 150 people from Bin Duong Elementary/Middle/High School attended the event.
The performance was conducted in strict compliance with the Vietnam Corona 19 Prevention Guidelines. Participants were required to wear masks and checked for fever, and contact was minimized by distancing participants.
This event, which marks its fifth year this year, was decorated only with performances by local Vietnamese musicians, as it was difficult for Korean musicians to attend unlike previous years. The’United Youth Choir’ composed of about 40 local college students and Vietnamese musicians belonging to the National Conservatory of Vietnam gathered to create a beautiful stage. The performance was filled with familiar and enjoyable songs such as’A Million Dream’,’Last Christmas’, and’Arirang’.
On this day, there was also a ceremony for conferring the’Hometamine Scholarship’ which has been continuing since 2013. Homthamine scholarships are for 40 students from Hanoi medical school/pharmaceutical school, 50 students from Ho Chi Minh medical school/pharmacy/music school, 10 students from Ton Duc-Tang medical school, 50 students from Binh Duong elementary/middle/high school in Binh Duong, where Korea United Pharmaceutical’s factory is located. It was paid to over four people. The total size is 490 million VND (about 24 million KRW).
Managing Director Yang Jin-young said, “Even if there are cultural differences between Korea and Vietnam, I think music is a love that we can share in the contemporary space and time.” “Today’s music performance can wisely overcome current difficulties. I hope it will be comfort and strength.”
The Vietnam Family Concert and Hometamine scholarship events were launched by the United Cultural Foundation and Korea United Pharm to continue social contribution activities in Vietnam. It is intended to contribute to the development of Vietnam’s medical/pharmaceutical industry, as well as return the profits from the Vietnamese market to the local community.
Novartis Korea completes’The 3rd Online Health Course’ for chronic urticaria
Novartis Korea (CEO Josh Benugopal) announced on the 23rd that it successfully completed the ‘3rd Chronic Hives Health Lecture’ held online on the 19th.
This ‘3rd Chronic Hives Health Course’ was prepared as part of the’Chronic Hives 6 Principles Campaign’, which Novartis has been running for two years, and was conducted online in a non-face-to-face manner while thoroughly complying with the COVID-19 prevention guidelines. In particular, as the location restrictions disappeared, more than 70 people, including chronic urticaria symptoms, diagnosed patients, and family members from all over the country, showed high participation rates in real time.
In this lecture, Professor Jae-Hyun Lee of the Department of Allergy at Yonsei University Severance Hospital gave a lecture on the subject of’chronic urticaria, knowing correctly and treating correctly.’ After the lecture, the OX quiz was used to make it easier and clearer for participants to understand chronic urticaria.
In the Q&A session that followed, patients asked questions in real time and Professor Jae-Hyun Lee answered them, solving the pain and problems that patients usually suffer from chronic hives, and correcting misunderstandings about the disease.
One chronic urticaria patient who participated in the online course said, “I suffer from recurrent hives symptoms every day, but it was difficult to properly explain and understand my illness even to my family members.” It was meaningful that the family could understand and sympathize with the disease by being able to participate in the online course together, and by knowing accurately and in-depth about chronic urticaria that they did not know in detail even though they suffered every day, there was also hope that it would be healed if properly managed.” Said.
Professor Jae-Hyun Lee, who taught the lecture, said, “Chronic hives have symptoms lasting for more than 6 weeks, and the progress of repeated deterioration and improvement is unpredictable. “It is a situation in which patients suffer a lot without knowing about the disease.” He said. “Through this online course, it seems to have given patients an opportunity to avoid exacerbating factors to improve symptoms and to inform them of the importance of appropriate medications.” . In addition, he explained, “Chronic hives are still often mistaken for acute hives or other skin diseases. If hives symptoms persist for more than 6 weeks, it is better to actively seek consultation with a specialist early.”
On the other hand, chronic urticaria is a disease that is accompanied by a burning sensation or itching along with the symptoms of urticaria in which the skin swells anywhere in the body, and continues to worsen and improve for more than 6 weeks. The number of chronic urticaria patients in Korea is steadily increasing, and it is estimated to be about 2,310 per 100,000 population (as of 2014).
Since 2019, Novartis Korea has been running the ‘6 Principles’ campaign to raise awareness of chronic urticaria, which is not well known in Korea, and to encourage early diagnosis and correct treatment management. Chronic urticaria ‘6 Principles Campaign’ is an abbreviation of’Principles’ that you need to know in order to break up quickly even with chronic urticaria that lasts more than ‘6’ weeks. From the characteristics of chronic urticaria to treatment,’who takes it, when Whether it is diagnosed, where it appears, what to watch out for, how to treat it, and why is it serious?
■NGChem Life Sciences holds the first individual shareholder meeting
The new drug development company, NG Chem Life Sciences (CEO Son Ki-young) announced that it held the first individual shareholder meeting on the 18th.
The meeting was held non-face-to-face for a total of 1 hour, and all participants were individual shareholders who owned NG Chem Life Science shares for more than 1 year. Through this shareholder meeting, NG Chem Life Sciences presented the realization of shareholder value as the management goal of 2021.
Yang Seok-mo, head of the Investment Strategy Office of NG Chem Life Sciences, said, “Since listing on the KOSDAQ in February 2018, the company has actively and continuously held IR or NDR for domestic and foreign institutional investors and bio analysts. In particular, the individual shareholder meeting started as a new IR platform to share with shareholders the realization of shareholder value, one of the company’s management goals in 2021.”
In addition, “Although it was a non-face-to-face IR due to the rapid increase in the number of patients with Corona 19 in Korea, it is very meaningful to convey how robust and reliable our company’s global new drug development is through this IR, and what achievements and fruits are expected in 2021.” He added.
The reason for the establishment of the Investment Strategy Planning Office in 2020 is to manage shareholder value together with shareholders by strengthening communication with shareholders. Shareholders who attended the meeting said, “Through this individual shareholder meeting, He said, “I am grateful to the company for providing me with this opportunity.” He said, “The reason shareholders hold stock in the company for a long time is due to the belief that the company will continue to grow.” I was very excited about the facts,” he said.
NG Chem Life Science said, “In 2021, we will further strengthen IR communication with domestic and foreign institutional investors, bioanalysts, and individual shareholders, and strive to become Korea’s national representative global biopharmaceutical company by transparently publicizing and promoting the company’s management performance. I will sell out.”
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