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- 2026-07-01 12:03:08
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- OAD drug Betmiga’s price halved with the entry of generics
- by Kim, Jin-Gu Jul 29, 2022 05:51am
- Prescription sales of Astella’s overactive bladder (OAD) treatment ‘Betmiga (mirabegron)’ halved in just one year. The analysis is that Betmiga’s sales took a direct blow from the launch of generics and the drug price cut that followed. Its generics, which had been released after Q2 in 2020, have been gradually increasing their influence in the market. In particular, with 17 more generic companies awaiting to join in the competition starting next month, sales of the original drug in the market are expected to continue to decrease. ◆ Betmiga’s price cut 47% …prescriptions performance also fell by half According to the market research institution UBIST on the 29th, the OAD treatment market size for mirabegron fell 34% in one year from ₩39.1 billion in 1H last year to ₩26 billion in 1H this year. The reduced prescriptions of the original drug Betmiga have played a key role in the market reduction. Betmiga’s prescription sales in 1H this year were ₩16.3 billion, a 50% YoY decrease from the ₩32.8 billion that was made in 1H last year. Until Q3 last year, Betmiga had made over ₩15 billion in quarterly sales every quarter. However, sales dropped to ₩12.8 billion in Q4 last year, then to ₩8.3 billion in Q1 and ₩8 billion in Q2 this year. Pic of the mirabegron original Betmiga (left) and generic Mirabek·Selebeta Analysts believe Betmiga’s price cut has directly affected the reduced prescription sales. Betmiga’s drug price had jumped up and down since the release of its generics in Q2 2020. Astellas had defended the 30% drug price cut disposition on Betmiga due to the release of its generics by filing administrative suits and suspension of disposition execution requests. During the first and second trials, the drug price was lowered and increased, and the execution was suspended and lifted repeatedly. In November last year, the government lowered the drug price through an ex officio adjustment following the lifted suspension of execution. In addition, Betmiga’s drug price had incurred more twists and turns with the PVA (Price-Volume Agreement) negotiation results being applied and lifted, a pricing premium being applied as a drug produced by less than 3 companies then again lifted with the entry of additional generics companies. As a result, Betmiga 50mg, which was priced at ₩673 until October last year, was discounted 47% to become ₩360 since January. The 25mg strength also fell 47% from ₩449 to ₩240. ◆17 more generic companies to enter in 2H…competition will intensify The industry prospect is that Betmiga’s prescription sales will continue to fall in 2H this year as many more generics will be entering the market following the expiry of the first generic exclusivity period. The first generic exclusivity period for Hanmi Pharmaceuticals’ Mirabek and Chong Kun Dang’s Selebeta expired in February this year. Hanmi and Chong Kun Dang successfully challenged Betmiga’s patent and consecutively released mirabegron generics in June and July of 2020. At the same time, the companies also achieved generic exclusivity and sold their generics exclusively on the market until February this year. Quarterly prescription sales of mirabegron original Betmiga and generic Mirabek·Selebeta (Unit ₩100 million, Data: UBIST) After the generic exclusivity period expired in February, 4 generic companies -Medica Korea, DongKoo Bio&Pharma, QL Pharma, and Genuone Science- joined in the competition 17 more companies will be joining the competition from next month. Il-Yang Pharmaceutical, Kyung Dong Pharm, Aju Pharm, The U Pharmaceuticals, Dongkwang Pharm, Ahngook Pharmaceutical, Boryung Pharmaceutical, Huons, Pharmbio Korea, Hutecs Korea Pharmaceutical, JW Pharmaceutical, JW Shinyak, Mother’s Pharmaceutical, Daewon Pharm, Samjin Pharmaceutical, Whan In Pharm Daewoong Bio, Dongkook Pharmaceutical among others announced they will be releasing 50mg mirabegron generics with reimbursement. In addition, Chong Kun Dang announced the plan to release a generic version of the 25mg strength that was exclusively sold by Astellas until now. Due to this, it is predicted that products that had been bringing in more than ₩60 billion a year until last year could sink to earn ₩30 billion a year. Among various Betmiga generics, Hanmi Pharmaceuticals’ Mirabek recorded the highest sales of ₩6.3billion in 1H this year. Chong Kun Dang’s Selebeta has made ₩2.6 billion in 1H this year.
- Policy
- MFDS announces a series of tasks for innovation
- by Lee, Hye-Kyung Jul 29, 2022 05:51am
- “If the 3 strategies set for the direction of the food and drug administration are the three mountains to conquest for the Ministry of Food and Drug Safety, the 100 National Tasks Roadmap that will be announced soon is like the 100 trees that we will be planting on the 3 mountains." Yu-Kyoung Oh, Minister of Food and Drug Safety, announced so at the ‘Briefing on the Standards for Globally Leading Innovative Food and Drug Administrative Measures ’ that was held at 1:30 p.m. on the 28th. After holding a public debate on regulatory innovation for the pharmaceutical sector on the 21st and the food sector on the 25th, the MFDS finally announced the measures for food and drug administrative innovation at the briefing. The 100 regulatory innovation tasks that will form the detailed tasks under the innovative measures, will be established and announced in line with the 100th day of President Suk-Yeol Yoon’s inauguration. The MFDS’ administrative measures for innovation will be to innovate its regulatory capabilities to a global level, support the global entry of new technologies with guaranteed safety, and enable the public to quickly enjoy the benefits of new technologies. Minister Oh said, “Global entry of drugs in the past had been difficult because the private companies had to seek their own paths of entry after the MFDS completes the approval process. As it is a regulated industry, each country has its own and diverse regulatory barriers." Therefore, the MFDS plans to analyze the global food and drug regulatory policies and operate a strategy task force to allow the industry to enter the global market after penetrating the regulatory barriers set for each country. Yoon-Joo Park, Director-General of the MFDS’s Drug Evaluation Department, said, “New product development has been increasing in the biohealth industry with scientific innovations like AIs as well as environmental changes. We will raise our regulatory capabilities so that passing the regulatory scientific standards set by the MFDS would mean that it could pass those set by global regulatory institutions.” Also, the operation of the three-tier system for regulatory relief that includes outside experts had been further explained at the briefing. (From the left) Yu-Kyoung Oh, Minister of Food and Drug Safety; Sang-Bae Han, Director General for Planning & Coordination; Oh-Sang Kwon, Director-General of the Food Safety Policy Bureau; Yoon-Joo Park, Director General of the Drug Evaluation Department; Sang-Bong Kim, Director General of Biopharmaceuticals and Herbal Medicine Bureau; Nam-Hee Lee, Director-General of the Medical Device Safety Bureau; Suk-Yeon Kang, Director-General of the Pharmaceutical Safety Bureau Sang-Bae Han, Director General for Planning & Coordination, said, “When a company requests regulation relief, the relevant departments first respond and make evaluations at the first tier. If the request is not accepted at in first tier, the company’s request goes on to the second tier and is applied the regulatory verification responsibility system.” The second tier mainly consists of civilian experts who will be determining whether the deregulation request should be accepted. Han said, “If the request is again not accepted at the second tier, we apply the last and final third tier, where the Minister of Food and Drug Safety directly checks the facts and seek for alternatives.” Regarding the ‘WHO Listed Authorities (WLA)’ that is being promoted, Minister Oh said, “The WHO has high regards for Korea’s regulatory capabilities and is reviewing Korea as the first candidate for WLA listing. We will be listed on the WLA at the end of this year at the earliest, and by next year at the latest. Suk-Yeon Kang, Director-General of the Pharmaceutical Safety Bureau, said, “We have started receiving the WLA review from March this year, and 56 countries are currently on the tentative list. Korea is also on the tentative list, but we are being reviewed as the first candidate as the WHO recommended that we receive evaluations as the most qualified country for listing.”
- Company
- Ildong Pharmaceutical operates about 20 R&D pipelines
- by Chon, Seung-Hyun Jul 29, 2022 05:51am
- Ildong Pharmaceutical is using an aggressive new drug development strategy, risking a deficit for seven consecutive quarters. Ildong Pharmaceutical is operating about 20 new drug pipelines, and five of them have entered the clinical stage. It is focusing on enhancing the performance and possibility of new drugs by establishing a cooperation system with R&D subsidiaries. According to IR data from Ildong Pharmaceutical on the 28th, the company has a total of 20 new drug pipelines at the group level. New drugs are being developed in areas such as metabolic diseases, NASH, COVID-19, ophthalmic diseases, neurological diseases, cardiovascular diseases, and cancer. Among them, five cases, including diabetes treatments, COVID-19 treatments, acute migraine treatments, and anticancer drugs, have entered the clinical stage. In the case of IDG16177, a new drug candidate for type 2 diabetes treatment, it entered phase 1 clinical trial in July last year after obtaining approval from a German pharmaceutical and medical device management institution. IDG16177 is a new drug candidate in the family of GPR40 agents with a mechanism to regulate blood sugar by activating GPR40 (G protein-binding receptor 40) in pancreatic beta cells, minimizing the risk of hypoglycemia due to drug administration Idience, a subsidiary of Ildong Holdings, is conducting a phase 2 clinical trial of the new anticancer drug candidate IDX-1197 that was handed over from Ildong Pharmaceutical. IDX-1197 is a target anticancer drug candidate that selectively acts on a deep poly ADP-ribose polymerase (PARP) enzyme related to cancer production to suppress cancer cells. It was developed by Ildong Pharmaceutical on its own and handed over the rights to . is a bio-venture founded by Ildong Holdings in May 2019. It advocates NRDO bioventures that are dedicated to development without discovering new drugs directly. In November last year, Ildong Pharmaceutical started clinical trials in Korea on Shionogi's oral COVID-19 treatment candidate "S-217622" and is currently undergoing phase 3 clinical trials. Reyvow, a migraine treatment that Ildong Pharmaceutical secured in Korea, was approved by the Ministry of Food and Drug Safety in May after a phase 3 clinical trial in Korea. Reyvow is the first migraine treatment to act as a serotonin (5-HT) 1F receptor. Ildong Pharmaceutical signed a development partnership with CoLucid in the U.S. in 2013 to secure domestic copyright. The new drug candidate for NASH treatment ID119031166 is being developed globally. ID119031166 is a NASH treatment with the FXRagonist mechanism that activates the receptor by combining it with farnesoid X receptor (FXR) and aims to enter phase 1 clinical trials overseas by the end of this year. Ildong Pharmaceutical predicted that the gastroesophageal reflux disease treatment ID120040002 and the dry eye disease treatment ID110410395 will enter clinical trials within this year. Ildong Pharmaceutical invested 34.1 billion won, the largest amount ever, in R&D expenses in the second quarter. 21.0% of sales were spent on R&D investment. It has tripled in two years from 11.6 billion won in the second quarter of 2020. During this period, Ildong Pharmaceutical invested 176 billion won in R&D. Ildong Pharmaceutical is also using a strategy to increase the efficiency and speed of new drug development by establishing a cooperative system with three unlisted bio-ventures such as Idience, AIMS BioScience, and iLeadBMS. iLeadBMS succeeded in attracting 40 billion won in investment last year. Last month, it received a total of 65 billion won since its launch, including investments from Ildong Holdings. The investment secured by iLeadBMS is expected to be used as a resource for developing new drugs. Ildong Holdings acquired AIMS BioScience, a new drug development strategy consulting firm, in December 2019. AIMS BioScience is responsible for providing advice on the development of new drugs to Ildong Pharmaceutical, Idience, and iLeadBMS. It is a method of providing consulting when new drug development companies request AIMS BioScience for strategic advice on providing development data. iLeadBMS, acquired by Ildong Pharmaceutical last year, plays another role in the development of new drugs in the group. Founded in December 2020, iLeadBMS is a bio-venture that develops new drugs in the field of low molecular compounds. It started as an in-house venture centered on Ildong Pharmaceutical researchers and launched an independent corporation in 2020. In July last year, Ildong Pharmaceutical invested 13 billion won in cash to secure a 40.0% stake in iLeadBMS by participating in a paid-in capital increase. iLeadBMS is developing new drugs using low molecular compound pharmaceutical chemistry in various fields such as glaucoma, liver cancer, non-alcoholic fatty liver, biliary disease, Parkinson's disease, glaucoma, breast cancer, Alzheimer's disease, Parkinson's disease, and metastatic breast cancer. Ildong Holdings is also planning a scenario to increase the success rate of new drug development by handing over the new drug candidate materials derived by iLeadBMS to Idience.
- Company
- Tax credit when acquiring an overseas vaccine company
- by Kim, Jin-Gu Jul 29, 2022 05:50am
- Starting next year, domestic companies that buy overseas vaccine technology companies are expected to be able to expect corporate tax deductions of up to 10% of the acquisition price. According to the pharmaceutical industry on the 27th, the Ministry of Strategy and Finance recently finalized and announced the "2022 Tax Reform Plan." The government plans to revise the Restriction of Special Taxation Act after collecting opinions based on the tax reform plan. The tax reform plan includes expanding the scope of tax exemptions following the acquisition of foreign corporations with high-tech technologies to national strategic technologies. Under the current Restriction on Special Taxation Act, tax deductions are granted only when domestic corporations acquire stocks and stakes of so-called small managers related foreign corporations such as materials, parts, and equipment or take over businesses and assets. The deduction rate is 5% for large companies, 7% for medium-sized companies, and 10% for small and medium-sized companies. The acquisition price for each acquisition is recognized up to 500 billion won. For example, if a domestic pharmaceutical company A acquired overseas vaccine technology bio-venture B for 500 billion won, large companies will deduct 25 billion won in corporate tax and 50 billion won in small and medium-sized companies. The government plans to expand the special taxation regulations from small department heads to 34 national strategic technology companies. Last year, the government designated 34 technologies in three major areas, including semiconductors, batteries, and vaccines, as national strategic technologies. Among them, vaccines include ▲ vaccines, raw materials, and raw material equipment development and manufacturing technologies, ▲ vaccine manufacturing technology with protective substances such as antigen, nucleic acid, and virus vector, ▲non-clinical testing technology that evaluates vaccine candidate substances with cell and animal models, ▲ phase 1, 2, and 3 clinical trials of vaccine candidate materials, and ▲development and manufacturing technology of raw materials, raw materials, and immunosupplement necessary for vaccine development and manufacture,
- Company
- 13 companies overcome key patents for Entresto
- by Kim, Jin-Gu Jul 29, 2022 05:50am
- Domestic pharmaceutical companies won the first trial of the patent dispute over Novartis' Entresto (Valsartan + Sacubitril). it is predicted that domestic pharmaceutical companies will soon launch generics for Entresto as they succeeded in targeting use patents that were considered key patents among Entresto patents. ◆ 13 domestic pharmaceutical companies succeeded in overcoming use patents that are key to Entresto According to the pharmaceutical industry on the 27th, the Korean Intellectual Property Tribunal recently ruled on the invalidation of Entresto filed by 13 pharmaceutical companies, including Hanmi Pharmaceutical, against Novartis. It is significant in that Korean companies succeeded in targeting usage patents, which were classified as key patents among Entresto's five patents (including one unregistered). Entresto is protected by a total of five layers of patents. ▲ a pharmaceutical patent that expires in November 2028, ▲ a pharmaceutical patent that expires in January 2029, ▲Salt and hydrate patents that expire in November 2026 (not registered), ▲Patents for use that expire in July 2027 and ▲Decisive patent expiring in September 2027. Entresto is a combination of Valsartan and Sacubitril, and there is no separate substance patent. Instead, the use patent actually serves as a material patent. ◆ Hanmi Pharmaceutical leads Entresto patent targeting Among many domestic pharmaceutical companies, Hanmi Pharmaceutical is the fastest target of Entresto patents. Except for one unregistered product, it overcame all four patents. In the case of pharmaceutical patents that expire in 2028, only Hanmi Pharmaceutical has been avoided. In the case of another pharmaceutical patent that expires in 2029, Hanmi Pharmaceutical and Daewoong Pharmaceutical succeeded in targeting it. In addition, Crystalline patents for Entresto were overcome by Hanmi Pharmaceutical, Elyson, Yoo Young, Hana, Hanlim, Ann-gook, Chong Kun Dang, Daewoong Pharmaceutical, Genuonescience, Samjin, Genupharma, CTC bio, and Yuyu. Hanmi Pharmaceutical succeeded in targeting all four patents registered with Entresto for the first time in Korean history, crossing all hurdles for the release of generics. Hanmi Pharmaceutical, which meets the requirements for generic for exclusivity, plans to release generic as soon as it obtains the license.
- Company
- Sanofi to increase supply volume of its flu vaccines in KOR
- by Jul 28, 2022 05:54am
- The competition in the flu (influenza) vaccine market is expected to intensify this year. With Sanofi succeeding in making the government bid at a cheaper price and expected to bring more supply into the private market, larger-than-expected quantities of the flu vaccine are expected to be released into the private market. According to industry sources on the 28th, the influenza vaccine amount for vaccinations will be lot released starting at the end of August. Compared to the previous year, when the vaccine return rate was high due to COVID-19, the demand for vaccinations is expected to increase this year. Influenza vaccine manufacturers are fiercely planning their strategies for the private market this year. This is because although SK Bioscience decided not to manufacture a flu vaccine this year as it did last year, Sanofi may enter as an unexpected contender. Sanofi, which had introduced a smaller amount of its flu vaccine than other Korean companies in Korea, started increasing its supply amount last year. This year, the company is known to have introduced more than it had done last year. Its participation in the influenza vaccine bid for senior flu vaccines under the National Immunization Program (NIP) in addition to the one made for the children’s NIP flu vaccine supply is one indicator of its increased supply in Korea. Sanofi had bid the lowest price of ₩10,433 for 2.2 million doses in the NIP bid for influence vaccines by the Korea Disease Control and Prevention Agency that was held in June. Sanofi, which was chosen No.1 for its lowest price, will be able to supply all of the 2.2 million doses it had written out. The second in line, Korea Vaccine, will supply 1.7 million doses at ₩10,670, followed by Boryung Biopharma supplying 1.8 million doses at ₩10,687. GC BioPharma and Il-Yang Pharmaceutical, which had written out the highest price, were tied at fourth place, among which GC BioPharma was selected first due to its larger amount supply. GC BioPharma, which had bid 6 million doses, will be supplying 4.96 million doses. Sanofi was able to increase its vaccine supply this year because of the influenza strains that were chosen for the northern and southern hemispheres this year. Every year, the World Health Organization announces the anticipated circulating strains in both the northern and southern hemispheres, and an unusual coincidence where the anticipated circulating strains in the southern hemisphere in 2021-2022 and those of the northern hemisphere in 2022-2023 were identical occurred this time. Therefore, Sanofi will be able to sell the amount that it was unable to sell in the southern hemisphere in the northern hemisphere this year. Therefore, the industry believes that more than the 2.2 million doses that were bid for NIP by Sanofi may be released into the private market this year. Also, the addition of Il-Yang Pharmaceutical’s 1.9 million doses that were not procured for the NIP will also be released into the private market. A vaccine industry official said, “The competition is expected to intensify further due to Sanofi’s success in making the NIP bid and the projection of its faster supply to the market this year. Also, the standard price for the vaccine bid next year will also be lowered due to Sanofi’s lowest price this year, deepening concerns of the vaccine companies.
- Company
- Samsung Biologics's 1H sales exceed ₩1 trillion...
- by Kim, Jin-Gu Jul 28, 2022 05:54am
- Samsung Biologics 1H sales exceeded ₩1 trillion for the first time since its establishment. The company attributed its improved results to the rapid growth of its CMO business, the increased capacity utilization rate of its 3rd plant, and the increased exchange rate. ◆"Lands 7 contracts in 1H… the company’s 1st, 2nd, and 3rd plant is operating at full capacity" On the 27th, Samsung Biologics publicly announced that it had recorded consolidated sales of ₩1.1627 trillion and an operating profit of ₩346.1 billion in the 1st half of this year. Excluding the performance of its subsidiary Samsung Bioepis, the non-consolidated, separate sales by Samsung Biologics itself exceeded ₩1 trillion to record 1.015 trillion. This is the first time the company exceeded ₩1 trillion in 1H sales since its establishment. In terms of 1H sales, the company has grown an average of 78.8% per year since 2019. Samsung Biologics explained that the increase in factory utilization rate and the exchange rate led to the expanded results. Samsung Biologics signed CMO deals for 7 products from 5 global pharmaceutical companies including Janssen, Merck, GSK, Lilly, and Novartis in 1H this year. As such, the cumulative number of CMO deals made by the company reached 73, amounting to $7.9 billion. With the added deals, all of Samsung Biologics’ plants(1st,2nd,3rd) are operating at full capacity. If the 4th plant, which has 256,000 liters of total manufacturing capacity, becomes complete, Samsung Biologics will account for 30% of the global biopharmaceutical CMO production capacity. An official from Samsung Biologics said, “On July 18th, Samsung Biologics signed a purchase agreement with the Incheon Free Economic Zone (IFEZ) to purchase an additional 350,000 square meters of land in Songdo, Incheon for the establishment of its 2nd Bio Campus. We are now ready to further solidify our status as a world-class global No.1 CDMO. ◆"Samsung Biologics fully acquires Samsung Bioepis …powered by robust global sales of biosimilars The incorporation of Samsung Bioepis into the company had also contributed to Samsung Biologics’ sales growth. In April, Samsung Biologics fully acquired the shares of Samsung Bioepis from Biogen for US $2.3 billion. With the acquisition, Samsung Bioepis has become a consolidated wholly owned subsidiary of Samsung Biologics. Samsung Bioepis’ results have been reflected through consolidated accounting in Samsung Biologics’ financial results from May. Samsung Bioepis’ 1H sales were ₩431.9 billion with an operating profit of ₩93.2 billion. In Q2, sales had increased 24.2% YoY to record ₩232.8 billion, and operating profit increased 95.7% YoY to record ₩58.5 billion. The company explained that its Q2 results improved due to an increase in the sale of its biosimilar products in the global market, including in the US and Europe. Samsung Bioepis has a total of 6 biosimilars commercially available in the market, and its revenue has steadily grown driven by increases in global product sales and milestone payments. SB4 (Enbrel biosimilar), its autoimmune disorder treatment that had been released in Europe in 2016, has surpassed its originator’s sales in Europe and overtook the majority of the market share. The company also released SB11, (Lucentis biosimilar) in June this year in the US. In addition to the 6 already commercialized products on market, 4 additional biosimilar candidates are currently in late-stage development in the company, most of which are nearing commercialization. The rare disease treatment SB12 (Soliris biosimilar) is under marketing authorization review, and the Phase III trial for the ophthalmologic disease treatment SB15 (Eylea biosimilar) is complete. Also, Phase III trials for SB16 (Prolia biosimilar) and SB17 (Stelara biosimilar) are currently underway.
- Policy
- 500 billion won fund by the end of this year
- by Lee, Jeong-Hwan Jul 28, 2022 05:54am
- Public-private partnerships to develop blockbuster vaccines and treatments. The government will focus on supporting vaccines and treatments for infectious diseases under development by domestic bio-health companies. It plans to fully support vaccine candidate materials for diseases such as COVID-19 and core technologies for responding to infectious diseases, and strengthen licensing, location, and foundation support, tax deduction and financial support to revitalize private investment in biohealth. It will also expand public-private investments such as K-bio and vaccine funds, and will create a joint public-private fund worth 500 billion won within this year and pay a total of 2.2 trillion won in R&D expenses for new drug pipelines. The MOHW discussed the "BioHealth Industry Innovation Plan" at the 4th Emergency Economic People's Assembly presided over by President Yoon Seok-yeol on the morning of the 27th. The MOHW diagnosed that Korea's investment in vaccine and treatment development support is limited compared to other developed countries. Compared to AstraZeneca's development of COVID-19 vaccines and treatments with 2 trillion won, 1.9 trillion won for Novavax, and 550 billion won for Janssen, Korea spent only 257.5 billion won for vaccines and 155.2 billion won for treatments. The MOHW decided to continue to support the development of COVID-19 vaccines and treatments from 17 companies under clinical trials in six domestic companies. It helps Korea's No. 1 vaccine to enter the global market by passing the pre-qualification examination by the WHO and confirming the efficacy of additional vaccinations. After securing core technologies by researching and developing vaccine candidate materials for COVID-19 as well as candidates for infectious diseases such as MERS and Zika virus, it supports rapid development of vaccines in case of crisis. In order to revitalize private investment worth 13 trillion won by 2026, including Samsung Biologics, Lotte Biologics, SK Bioscience, and EuBiologics, it will also provide support at the level of ministries. It will closely support licensing, location, and foundation creation, and quickly strengthen tax deductions, financial and policy funding support for each major related institution, and expansion of support limits. In a recently announced tax reform plan to promote investment in vaccines, the deduction rate for investment in national strategic technology facilities of large companies was raised from 6% to 8%. In order to develop innovative new drugs and secure vaccine autonomy, it will create a private joint "K-Bio and Vaccine Fund" worth 500 billion won that invests in pharmaceutical and bio companies within this year, and expand it to 1 trillion won in the future. It has also decided to provide 2.2 trillion won in research and development expenses, including 1.5 trillion won in state funds, to new drug pipelines that have entered the second phase of clinical trials in discovering effective substances. Regulatory innovation will also be carried out. Innovative medical devices such as AI and digital will be improved so that they can be used as non-reimbursement or Medical Benefits after licensing. In the case of innovative medical devices, the evaluation period required for them to be put into the medical field after minimum administrative measures after licensing will be drastically reduced from 390 days to 80 days. It will fully redesign regulatory systems suitable for high-tech product characteristics such as digital and high-tech bio to closely support entry into the global market, and establish a biohealth-specific regulatory sandbox that reflects the specificity of innovative technologies and services. Lee Ki-il, the second vice minister of the MOHW, said, "We will present a roadmap for bio-health regulatory innovation and actively resolve difficulties through continuous communication with the industry."
- Product
- Nearly 100,000 COVID-19 confirmed cases
- by Kim JiEun Jul 28, 2022 05:54am
- Society has no guidelines despite the spread of the disease. As COVID-19 spreads again, face-to-face administration at pharmacies is also increasing significantly. Individual pharmacies are trying to quarantine, but confusion is also detected as it goes against social sentiment. On the 26th, the Central Disease Control Headquarters of the Korea Centers for Disease Control and Prevention announced that as of midnight, there were 99,327 new confirmed cases (98,974 domestic cases and 353 overseas inflows). It is the largest in 97 days since April 20, when it was around 110,000 people. As the number of new COVID-19 confirmed patients approached 100, the ratio of face-to-face administration at pharmacies has also increased significantly since last week. Pharmacists say that there are many cases in which so-called "Shy Corona" patients, who have symptoms but are reluctant to visit or test medical institutions, visit pharmacies to purchase OTC drugs. As the number of direct administration and medication guidance of confirmed patients increases and pharmacists and employees continue to be confirmed, front-line pharmacies are reinforcing their own quarantine, which has been loosened. A pharmacist in Busan said, "Until a few weeks ago, the average daily face-to-face administration of confirmed patients fell to about one, but since last week, the number has increased to an average of 20 per day. This week, as one pharmacist was confirmed, all pharmacy employees were tested, he said. "We stopped self-disinfection as the number of confirmed patients decreased and the number of face-to-face administrations of confirmed patients decreased, but we are disinfecting them every day again." A pharmacist in Seoul also said, "The number of face-to-face administrations of confirmed patients has increased recently, but the number of patients with suspected symptoms has definitely increased." He said, "I'm worried that it can increase even more after the holiday season." This is because the lifting of social distancing has loosened public sentiment on quarantine than before, and the government is actually pursuing autonomous quarantine, saying it is scientific quarantine. There is also a conflict between pharmacists and patients over whether to wear masks or take medicines at pharmacies. The Pharmaceutical Affairs Association also said that considering current government policies and social sentiment, there is an ambiguous aspect in notifying member pharmacies of quarantine-related guidelines or guidance text messages. An official from the Korea Pharmaceutical Association said, "Currently, the crisis warning is clearly in the 'serious' stage. The Pharmaceutical Affairs Association is also guiding member pharmacists in line with the crisis alert stage, but it added that there are ambiguous aspects as it seems to be different from the national quarantine policy and social atmosphere.
- Policy
- Outpatient tx 14.7 times a year per person in Korea
- by Kim, Jung-Ju Jul 28, 2022 05:54am
- In 2020, the number of outpatient treatments per capita in Korea was 14.7 times a year, the highest among OECD countries. This is 2.5 times the average 5.9 times of member states. As a result of evaluating drug sales per capita with Purchasing Power Parity (PPP) reflecting the price level of each country, $ 760.9 PPP was 1.4 times higher than the OECD average of $547.2 PPP. The MOHW analyzed and announced the level and status of Korea and each country by major indicators of "OECD Health Statistics 2022" announced by the OECD on the 4th. Among them, we looked at health care use and health care resources. ◆ Outpatient treatment, average number of days of hospitalization, examination, and current medical expenses = In 2020, the number of outpatient treatments per capita in Korea was 14.7 times a year, the highest among OECD countries, 2.5 times higher than the average of member countries (5.9). Japan (12.4) has the second highest number of outpatient treatments per person after Korea, while Costa Rica (1.9), Mexico (2.1), Chile and Sweden (2.2), Colombia (2.6) and Greece (2.7) have less than three. In 2020, the average number of hospitalization days per inpatients in Korea was 19.1, the second longest among OECD countries after Japan (28.3 days). The OECD average is 8.3 days. The average number of hospitalization days per inpatients for acute treatment was 7.8 days, longer than the OECD average (6.6 days). Over the past 10 years, the average number of hospitalization days per inpatients in Korea has been on the rise, but the number of patients treated in acute phase has been on the decline. The total number of hospitalizations increased by 1.9% annually, and acute treatment decreased by 2.5% annually. In 2020, Korea's MRI usage was 71.7 cases per 1,000 people, which was lower than the OECD average, and CT was 250.0 cases per 1,000 people, which was higher than the OECD average. Over the past 10 years, CT and MRI usage in Korea has continued to increase. CT usage increased by 8.3% annually, and MRI usage increased by 14.6% annually. Current medical expenses, which mean the total annual expenditure of the entire people spent on services and goods in the health care sector, were 8.4% of GDP in 2020, lower than the OECD average (9.7%). The per capita current medical expenses were $3,582.3, an annual average increase of 6.9% over the past 10 years, higher than that of the OECD (3.3%). The proportion of medical expenses (direct household burden) borne by households gradually decreased to 34.0% in 2010, 33.7% in 2015, and 27.8% in 2020. ◆ Number of beds and medical equipment = In 2020, the number of hospital beds was 12.7 per 1,000 people, the largest among OECD countries, and about 2.9 times the OECD average (4.3). Among them, 7.2 beds per 1,000 people were treated in acute phase, more than twice the OECD average (3.5). In 2020, Korea's number of MRIs was 34.2 per 1 million people and CT was 40.6 per 1 million people, which was higher than the OECD average (29.1 units). "OECD Health Statistics is important to use as basic data for policies to provide the quality of health care services that people can feel directly by analyzing and evaluating the level of health care in Korea in the international community," said Yang Kyung-jin, a policy statistics officer.
