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- 2026-07-01 12:03:09
- Company
- SK Bioscience has applied for CMA of SKY Covione
- by Kim, Jin-Gu Aug 02, 2022 06:02am
- SK Bioscience announced on the 29th that it has applied for Conditional Marketing Authorization (CMA) of the COVID-19 vaccine to MHRA, a British pharmaceutical regulator. The product name in the UK and Europe is SKY Covione. SK Bioscience explained that it has been conducting a Rolling Review since March to receive prompt approval from MHRA. Rolling Review is a system that quickly evaluates promising vaccines and treatments by submitting efficacy, safety, and quality data sequentially before applying for final permission. SK Bioscience submitted additional phase 3 clinical data recently secured to MHRA. MHRA will begin a full-fledged review for SKY Covione's CMA. Starting with the UK, SK Bioscience plans to apply for CMA to the European Medicines Agency (EMA) in the future and apply for registration on the World Health Organization's Emergency Use List (EUL). Ahn Jae-yong, president of SK Bioscience, said, "This application for permission will take the first step to introduce a domestic COVID-19 vaccine with excellent safety and immunity to the global big Pharma-centered COVID-19 vaccine market." Starting with the application for CMA in the UK, we will introduce Korea's technology to the global vaccine market through Europe and WHO EUL listing, he said. "In addition, it will contribute to restoring safe daily life through COVAX Facility." In June, SK Bioscience was approved for "SKY Covione multi injection" as the first domestic COVID-19 vaccine. SKY Covione is a COVID-19 vaccine developed by SK Bioscience based on its global network. It was jointly developed by IPD and SK Bioscience at the University of Washington, USA, and GSK's Adjuvant AS03 was applied to strengthen the immune response. It received development cost support from BMGF and CEPI from the early stage of development, and plans to be supplied to the global market through COVAX Facility after acquiring WHO EUL. SKY Covione demonstrated excellent immunogenicity and safety during basic vaccination through phase 3 clinical trials of 4,037 adults in five countries at home and abroad. Additional studies in phase 1/2 of the SKY Covione clinical trial showed a high immune response to the omicron mutation (BA.1). SK Bioscience is conducting clinical trials for ▲ heterogeneous booster shots and ▲ of the same kind of booster shot , and it plans to conduct ▲ an additional study to confirm the response effect of omicron mutations.
- Opinion
- [Reporter’s View] New guideline refrains off-label NOAC use
- by Eo, Yun-Ho Aug 02, 2022 06:02am
- Off-label refers to the use of drugs for an indication other than those approved by the Ministry of Food and Drug Safety. Although people may question the need for off-label use when the appropriate use for a drug has already been set by the health authorities, these off-label prescriptions are made at the doctor’s discretion. Often, off-label use of a drug is encouraged or shunned according the situation of each disease or drug. Voices on their necessity or non-necessity are also raised accordingly. The latter goes for new oral anticoagulants (NOACs). Relevant societies and specialists have continuously raised concerns over the prescription of low-dose NOACs, but still, this low-dose off-label prescription trend persists in Korea. Recently, the Korean Heart Rhythm Society (KHRA) published the revised “Guidelines for NOAC use in atrial fibrillation patients," which presented specific standards for NOAC use according to each situation. After collecting and discussing all data on the use of various doses, the KHRA guideline decided to recommend the use of on-label doses according to each indication. The first NOAC was approved in 2011 and listed for reimbursement in 2013. Currently, 4 NOACs have landed in the field in Korea. Quite a time has passed since NOACs landed in Korea, but still, off-label prescriptions of NOACs have not lessened much. According to the National Institute of Health, over half - 64.4% - of the patients that use NOACs in Korea are being prescribed low-dose NOACs. The leading cause of this off-label use is bleeding concerns. Asians have a smaller physique and different genetic characteristics than Westerners, therefore, worries that the bleeding risk may increase with the use of standard-dose NOACs is why doctors have been prescribing the low-dose NOACs against indications. Of course, off-label use of drugs is allowed at the doctor’s discretion according to his/her medical judgment. However, the indication of a drug is approved based on clinical research on a large number of patients that is conducted to identify the appropriate dose. The ultimate purpose of using NOACs is to prevent strokes. If prescribing low-dose NOACs in fear of bleeding rather increases the number of stroke patients, this in itself would be a huge loss. Off-label use of drugs is like a double-edged sword. It is this reporter's wish that the new guidelines will guide patients who are tired of using warfarin and practitioners that were reluctant to use anticoagulants due to lack of high-priced monitoring equipment and difficult prescription management to fully enjoy the benefits provided by NOACs.
- Policy
- Mandatory notification for correctional facilities
- by Kim, Jung-Ju Aug 02, 2022 06:02am
- A bill that stipulates that the MFDS should also notify the MFDS of narcotics prescriptions conducted at correctional facilities and military units will be promoted. Representative Choi Yeon-sook of the People's Power represented the partial revision bill of the Drug Management Act. With the increase in the handling of medical narcotics, the MFDS is reporting related matters from drug handlers through the integrated drug management system to manage the handling of narcotics. It is pointed out that the integrated drug management system cannot confirm the prescription of drugs in the correctional facility, and that it is difficult to confirm the prescription of drugs in the Ministry of National Defense under the current law. The main purpose of this amendment is to prevent misuse of narcotics and to resolve blind spots by stipulating to the MFDS about the prescription of narcotics and prescription of narcotics in the Ministry of National Defense. This bill is based on the premise of the resolution of the "Partial Amendment of the Act on the Execution of Sentences and the Treatment of Detainees" proposed by Choi. Therefore, if this bill is not resolved or revised, it must be adjusted accordingly. This initiative will be joined by Rep. Choi, Kang Min-guk, Kwon Eun-hee, Seo Byung-soo, and Chung Chang-min, Kim Min-seok of the Democratic Party of Korea, Rep. Ryu Ho-jung, and Rep. Lee Eun-joo of the Justice Party , Independent Party Yang Jung-sook and Yang Hyang-ja.
- Company
- Dong-A ST, applies for permission to Sugadapa
- by Kim, Jin-Gu Aug 02, 2022 06:01am
- Dong-A ST announced on the 29th that it has applied to the MFDS for the item license of type 2 diabetes complex Sugadapa. Sugadapa is a complex that combines Evogliptin 5mg, the main ingredient of the DPP-4 inhibitor-based diabetes drug Suganon, developed by Dong-A ST, and Dapagliflozin 10mg, the SGLT-2 inhibitor-based drug. DPP-4 inhibitors can control blood sugar without weight gain and hypoglycemic side effects. SGLT-2 inhibitors are known to reduce blood sugar while causing little hypoglycemia, reduce weight and blood pressure, and relieve heart failure. An official from Dong-A ST said, Sugadapa is expected to improve blood sugar control in diabetics and improve convenience and medication compliance, so we will lead the diabetes market with Sugadapa, which combines the advantages of Evogliptin and Dapagliflozin. Dong-A ST's Suganon was approved by the MFDS in 2015 as the 26th new drug in Korea. In 2016, it was approved for the approval of Sugamet, a combination of Suganon and Metformin. If Sugadapa is licensed, it will be the third drug in the Suganon series.
- Company
- SK Bioscience applies for CMA of its COVID-19 vaccine to EMA
- by Chon, Seung-Hyun Aug 02, 2022 06:01am
- On the 1st, SK Bioscience announced that it has submitted an application for a Conditional Marketing Authorization (CMA) of its COVID-19 vaccine, ‘SKYCovion,' to the European Medicines Agency (EMA), SKYCovion is a COVID-19 vaccine that induces neutralizing antibody responses by administering an antibody protein made with SK Bioscience’s recombinant protein vaccine technology. SKYCovion was developed with SK Bioscience’s recombinant protein vaccine technology and the ‘self-assembly nanoparticle’ design technology of the Institute for Protein Design (IPD) at the University of Washington School of Medicine. From the initial stages of development, SKYCovion has been supported by funding from the Bill & Melinda Gates Foundation and Coalition for Epidemic Preparedness Innovations (CEPI). SKYCovion will be available through the COVAX Facility, etc. for procurement and equitable allocation worldwide after it is approved for Emergency Use Listing (EUL) by the World Health Organization (WHO). The company had previously applied for a Conditional Marketing Authorization (CMA) of SKYCovion to the UK Medicines and Healthcare Products Regulatory Authority (MHRA). Starting with the U.K. and European countries, the company plans to introduce this competitive domestic vaccine to the rapidly growing global COVID-19 vaccine market. According to Airfinity, a global healthcare market analysis institution, the global COVID-19 vaccine market size is estimated at around $65.6 billion (₩78 billion) last year, which is twofold the market size of all other vaccines (estimated at $33 billion). With the European Centre for Disease Prevention and Control (ECDC) and EMA that oversees the disease control and healthcare policy in the European Union lowering the vaccination age for the fourth dose from 80 to 60, the European market size for COVID-19 vaccines is expected to further increase. Jaeyong Ahn, CEO of SK bioscience, said, “The daily lives of people around the world are being threatened with the repeated emergence of new COVID-19 variants. We aspire to fulfill our role and responsibility as a global vaccine hub by entering overseas markets with our self-developed vaccine and developing new platforms to respond to the endemic."
- Company
- Daewoong Pharmaceutical's biggest quarterly performance ever
- by Kim, Jin-Gu Aug 01, 2022 09:16pm
- Daewoong Pharmaceutical achieved its highest quarterly performance ever. Separately, sales in the second quarter increased 7.6% year-on-year to 293.8 billion won and operating profit increased 25.8% to 33.6 billion won. Both sales and operating profit are all-time highs based on quarterly performance. Earlier, Daewoong Pharmaceutical also set the highest quarterly operating profit in the first quarter. It then broke its quarterly operating profit record once again for the first time in a quarter. Nabota enters the European market in the second half of the year Daewoong Pharmaceutical cited Nabota's propaganda as one of the reasons for achieving its biggest performance. According to the company, Nabota's second-quarter sales amounted to 37.1 billion won, up 60% from 23.2 billion won a year earlier. Nabota's exports grew 105% from 14.2 billion won to 29.2 billion won during the same period. U.S. exports account for the largest share of Navota exports. Exports to U.S. sales partner Evans doubled from the previous year to 21.1 billion won. Daewoong Pharmaceutical explained that exports to Southeast Asia and Central and South America were also strong. The recent rise in the exchange rate also contributed positively to the improvement of export performance. Sales in the specialized medicine sector rose 5.5% to 205.8 billion won from 5.1 billion won in the second quarter of last year. High-yield products such as hyperlipidemia treatment Crezet, diabetes treatment "Diabex" and antithrombotic Anplone increased by 10% compared to the same period last year. Sales of Forxiga, a diabetes treatment drug in charge of domestic distribution by Daewoong Pharmaceutical, also grew by more than 30% in a year, contributing to sales expansion. The OTC sector posted 34.3 billion won in sales, up 19.9% from 28.6 billion won in the second quarter of last year. Due to the spread of COVID-19, the fever reducer EZN6 grew 45% year-on-year. Ursa, a liver improvement functional drug, also grew by more than 30% during the same period. In the case of health functional foods, sales doubled in a year. Daewoong Pharmaceutical said it is expected to continue to increase profitability in the second half of this year. Nabota, which has become Daewoong Pharmaceutical's new cash cow, is set to be released in Europe, Turkey, and Chile after the third quarter. The addition of FexuClue, a new drug for gastroesophageal reflux disease released by Daewoong Pharmaceutical earlier this month, is also expected to increase its performance. Daewoong Pharmaceutical is moving quickly to expand FexuClue's market share. In Korea, the special features of FexuClue are actively informed to medical staff across the country through various channels. In the case of overseas markets, it has signed 1.1 trillion won worth of technology exports with 15 countries around the world, and plans to expand its export range sequentially to foster it as a global blockbuster new drug. An official from Daewoong Pharmaceutical said, "Nabota's expansion of its market share in major global botulinum toxin markets, including the United States, led to the highest quarterly sales and operating profit ever." He said, "We expect the company's growth and return to rise together when sales of FexuClue, a new drug for gastroesophageal reflux disease, are visible in the third quarter and Nabota is released in Europe and elsewhere."
- Policy
- Daewoong sells the original Ebixa
- by Lee, Tak-Sun Aug 01, 2022 09:16pm
- Daewoong Pharmaceutical, which once sought to develop a high-dose dementia treatment Ebixa, sells original drug in Korea instead of giving it up. Ebixa 20mg, a higher dose than the existing product, is expected to greatly improve the convenience of taking it because patients only need to eat one dose a day. According to the industry on the 29th, Daewoong Pharmaceutical, which has signed a joint sales contract with the original company Lundbeck since 2019, will also carry out a copromotion of Ebixa 20mg, which will be listed on August 1. Ebixa 20mg will be listed at 1, 606 won starting August 1. It is twice the price of the existing Ebixa at 803 won. However, it improves the ease of use. Existing Ebixa requires two tablets a day, but Ebixa 20mg, which has increased the dose, requires only one tablet a day. Daewoong Pharmaceutical is conducting domestic sales and marketing of Ebixa in all sectors, including hospitals, hospitals, and clinics, while conducting a copromotion between Lundbeck and Ebixa in 2019. Ebixa is an NMDA receptor antagonist and has a mechanism to alleviate symptoms by inhibiting excessive NMDA receptor stimulation in the brain of Alzheimer's patients. It is the second most commonly used drug after Eisai's Aricept. Based on UBIST last year, Aricept was 86.1 billion won and Ebixa was 16.9 billion won. Lundbeck is counting on this Ebixa 20mg to close the gap with Aricept. It is calculated that as the convenience of taking has improved, the number of Rxs will increase. Daewoong Pharmaceutical also expects Ebixa 20mg to help improve the market share of dementia drugs in Korea. In particular, Daewoong Pharmaceutical attempted to develop 20mg of Memantine directly before Ebixa 20mg was approved in Korea. In April 2020, the MFDS approved a phase 1 clinical trial under the name DWJ1458, which is known as the development of Memantine 20mg.Daewoong Pharmaceutical stopped clinical research after two months of clinical approval. There were various interpretations of this at the time, but the original Ebixa 20mg copromotion solved the curiosity neatly. Aricept had the domestic license right. After that, the license was transferred to Handok, and Daewoong is currently registered as a consignment producer. Daewoong entered the dementia treatment market directly from Ebixa. Ebixa's propaganda is also needed to make up for the reduction in benefit through re-evaluation of its affiliate, Daewoong Bio's brain function improvement drug Gliatamin.
- Company
- Yuhan Corporation records new quarterly sales
- by Chon, Seung-Hyun Aug 01, 2022 09:14pm
- Yuhan set a new quarterly sales record. In the domestic market, both Rx and OTC drugs were strong, and overseas businesses were also doing well. Operating profit fell due to a decrease in technology fee revenue and an increase in R&D investment. Yuhan Corporation announced on the 28th that its operating profit based on separate financial statements in the second quarter fell 61.9% year-on-year to 10.8 billion won. Sales increased 10.4% year-on-year to 468 billion won. The company's second-quarter sales are the largest ever. It broke 439.4 billion won in the fourth quarter of 2020 for the first time in six quarters. Both domestic demand and overseas business showed growth. In the domestic market, sales of the OTC business were 49.1 billion won, up 23.9% from 39.7 billion won a year earlier. In the second quarter of last year, sales of Rx increased 8.9% year-on-year to 283.6 billion won. Sales of cold medicine Cough rose 154.2% to 7.3 billion won from 2.9 billion won in the second quarter of last year. Due to the spread of COVID-19, it has benefited from the increase in demand for cold medicines. Among the new drug products introduced by multinational pharmaceutical companies, sales of the diabetes treatment Jardiance rose 44.5% year-on-year to 20.5 billion won, and the hypertension treatment Twynsta rose 20.3% to 23.8 billion won. Vemlidy, a hepatitis B treatment, sold 11.6 billion won worth, up 38.4% from the previous year. Yuhan's overseas business sales amounted to 56.8 billion won in the second quarter, up 55.1% from 36.6 billion won in the same period last year. Yuhan buys raw materials produced by Yuhan Chemical and exports them to multinational pharmaceutical companies. Yuhan Corporation's technology fee revenue, which has emerged as a cash cow, has decreased. The company's second-quarter technology fee revenue was 5.2 billion won, down 69.0% from 16.7 billion won a year earlier. Starting with Spinebiopharma in 2018, Yuhan Corporation signed contracts to export new drug technologies with five global pharmaceutical companies, including Janssen Biotech, Gilead Bioscience, Beringer Ingelheim, and Processa Pharmaceutical. Except for Processa Pharmaceuticals, which paid the down payment in stocks, the down payment and milestones received from the remaining four companies are recognized in installments. Technology fee revenue is bound to show ups and downs due to the characteristics of new drug technology export contracts or technology transfer new drug development stages. Leclaza, which transferred technology to Janssen, made a total of $100 million in additional technology fee revenue before the development stage, but no large-scale technology fee revenue occurred this year.
- Opinion
- [Reporter’s View] MFDS minister wills regulatory innovation
- by Lee, Hye-Kyung Aug 01, 2022 05:58am
- The Ministry of Food and Drug Safety’s determination to seek regulatory innovation has surfaced with the inauguration of President Suk-Yeol Yoon’s administration. The MFDS had previously conducted 7 internal debates for each of its fields during the past 2 months to come up with a plan for ‘administrative innovation in food and drug at an international level', in line with the national goal of Yoon Suk-Yeol’s administration. In fact, regulatory innovation is the first assignment given to the MFDS by Yoo-Kyung Oh, the Minister of Food and Drug Safety that was appointed on May 27th. After holding internal debates and public forum for food and drug regulatory innovation on July 21st and 25th, respectively, the MFDS reported the administrative innovation measures for advancing into a global food and drug industry to become a core bio-digital healthcare country to the state affairs review and coordination meeting on July 28th. The MFDS plans to establish and present a ‘100 project roadmap’ to support its innovative measures on the 100th day of Yoon’s inauguration. Minister Oh’s determination for regulatory innovation was evident in the public debate. Oh sat through the public forum for food and drug regulatory innovation that had been conducted for 2 hours. Oh, who said she will humbly listen to the voices of the public rather than conduct a unilateral debate, closed the public forum saying that “We will make one step further from being an institution that answers questions asked by the public. We aim to enable a two-way communication where the MFDS also asks questions to the public for answers.” Also, the key Director Generals of bureaus that represent the drug area at MFDS appeared on the podium. An official from MFDS said, “During my over 20 years of service at MFDS, I have never seen a forum where 4 key Director Generals from major bureaus personally give presentations and answer questions.” This is because a comment made by MFDS Director Generals at such an event is like an oath made to the public. It needs to be kept, no matter what. Minister Oh’s determination had largely influenced the decision of MFDS Director Generals’ personal presentation of the regulatory innovative tasks under review. Oh is that much determined to achieve the national tasks set by the new government. Oh is expected to personally make the presentation on the 100 tasks that will be made in August. Industry expectations are also rising with the MFDS Minister’s personal interest in regulatory innovation. Among the various regulatory innovations planned, the Korea Pharmaceutical and Bio-Pharma Manufacturers Association expressed that it was pleased by the MFDS’s plan to provide global support and reinforce the fast track system. However, the ministry would need to pull through with its plan to the end. As much as the MFDS had endeavored to identify tasks for regulatory innovations, the ministry would need to keep its determination to implement regulatory innovation measures that can lead to changes in the actual field in 5 or 10 years.
- Policy
- MFDS Minister promises COVID-19 vaccineˑTx support
- by Lee, Hye-Kyung Aug 01, 2022 05:58am
- The Minister of Food and Drug Safety Yoo-Kyung Oh met with COVID-19 vaccine and treatment developers and relevant associations and promised support in the future. On the 29th, the MFDS held an MFDS-Industry roundtable meeting for the COVID-19 vaccine-treatment development support. The meeting was held to discuss the difficulties experienced by developers in conducting clinical trials and MFDS’s measures of support in situations where the development of a homegrown vaccine or treatment becomes imperative due to an epidemic. At the event, the MFDS introduced its measures for support in commercializing such products, listened to the difficulties that the industry experienced in the process of developing COVID-19 vaccines, and discussed measures of MFDS support for the development of vaccines and treatments. Minister Oh said, “Korea is an established leader in the pharma-bio sector that owns both a vaccine and treatment for COVID-19. The MFDS will continue to innovate regulations in the field to support the rapid commercialization of homegrown COVID-19 vaccines and treatments." Also, Oh mentioned that it has been linking development-non-clinical trials, clinical trials-approval & review processes while providing professional support on clinical trial design through the commercialization strategy support task force that had been established in April. Minister Oh said, “We plan to seek more efficient operation of the approval and review process for COVID-19 vaccines and treatments through rapid review, rolling review, etc. while thoroughly reviewing their efficacy and safety through close review and expert advice." Companies and related associations that participated in the meeting expressed their gratitude to the MFDS for enabling easier export of products upon domestic approval, which has advanced its regulations through safety-based regulatory innovation and commercialization support efforts and asked for the ministry’s continued support for rapid vaccine development against variants and clinical trial subject recruitment. The companies said, “It is imperative that the MFDS recruits more review personnel to enable rapid development of the second, third homegrown vaccines and treatments. We ask the MFDS to increase their review personnel and strengthen its expertise.” The MFDS expects the meeting to help identify various difficulties experienced in development and come up with support measures. The ministry added it will do its best to support the rapid development of domestic vaccines and treatments by operating programs specialized for COVID-19 and commercialization strategy support teams - such as ‘Our Vaccine Project’ and the ‘Development-focused support council’ - for the prompt development of homegrown vaccines and treatments.
