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- 2026-04-28 14:33:05
- Policy
- 'BIO KOREA 2024' begins
- by Lee, Hye-Kyung May 10, 2024 05:47am
- 'BIO KOREA 2024' will be held on May 8-May10 for three days at Coex, Seoul. The conference is co-organized by the Korea Health Industry Development Institute (President Soon-do Cha, referred to as KHIDI) and Chungcheongbuk-do Province (Mayor Young Hwan Kim, referred to as Chungbuk), and sponsored by the Ministry of Health and Welfare (MOHW). Celebrating its 19th convention this year, BIO KOREA started back in 2006 with the participation of 300 companies from 20 countries. The number of participants has more than doubled, and by 2024, it reached 600 companies from 50 countries. BIO KOREA became the international bio-health convention representing South Korea. The theme for BIO KOREA 2024 is "The Future of Biotechnology Innovation and Global Collaboration." The convention aims to share the latest trends and prospects of innovative technologies in the bio-health industry and provide opportunities for business collaboration among global companies, institutions, researchers, and investors. Various programs will be organized for three days, including Business Partnering, Invest Fair, Exhibition, and Conference. This year, 640 companies from 55 countries are participating. At Business Partnering, Korean and foreign companies, including global pharmaceutical companies, participate in one-on-one business meetings to discover new partners with promising technologies, discuss technology collaboration and joint research, technology transfer, and investment. Of note, Global companies, including Eli Lilly, Takeda, Merck, MSD (Sharp & Dohme), Sanofi, Roche, Boehringer Ingelheim, and Johnson & Johnson, and companies representing the biopharma industry in South Korea, such as SK Bioscience, ST Pharm, GC Corp, Yuhan, Hanmi Pharmaceutical, Handok, and Dong Wha Pharm, are participating. At Invest Fair, equity firms utilizing K-BIO mega funds and global investors will share the prospects of the bio-health industry in South Korea and present the industry’s potential for growth. Experts from various companies will participate in presentations and panel sessions. The participants include Johnson & Johnson Development Corporation’s Melinda Richter, ARCH Venture Partners’s Ari Nowacek, Teralys Capital’s Cedric Bisson, Kurma Partners’ Daniel Parera, Yuanta Asia Investment’s ChiaYen Lo Sam. A session focusing on the successful attraction of foreign investment cases by domestic bio-innovation startups is also planned. This session aims to enhance understanding of investment value and global collaboration in the Korean biotech industry and explore strategies for commercializing innovative technologies. This year, participation from national delegations has expanded compared to the previous year, with 81 companies from 10 countries, including Australia, Sweden, Denmark, the United Kingdom, the United States, and Germany, set to showcase their promising technologies and engage in exchanges with interested companies in South Korea. Thirty-eight companies from fields such as CDMO, CRO, and microbiome are participating at the Australian Embassy in Seoul booth. Additionally, at the Nordic booth jointly operated by the Swedish Trade and Invest Council and the Danish Embassy in Korea, 13 companies specializing in CRO, vaccines, and drug development are participating. In addition, local companies will participate at the booths of the British Embassy in Seoul, BioCom California in the United States, and the state of Bavaria in Germany to promote their outstanding technologies and engage in business exchanges with domestic companies. At the conference, 71 speakers from 9 countries who are experts in the bio-health industry in South Korea and foreign countries. Speakers will participate in 11 sessions discussing 10 topics, including Drug Discovery Platform, Diabetes-Obesity Treatment, Cancer Vaccine, and Global Open Innovation. On May 9th, a special session called 'New Drug Modality Development Strategies' will be held. In this session, speakers will share the latest strategies for the development of new modality drugs, such as Antibody-Drug Conjugate (ADC), Targeted Protein Degradation (TPD), and Cell and Gene Therapy (CGT). They will also discuss cases of global cooperation. The speakers for the session include Zheru Zhang of WuXiBiologics, Mikio Kasahara of Roche, and Dr. Ulf bethke of Miltenyi Biotec. Following the session, some Korean companies, such as PINOTBIO and AbTis, will give pitch talks. They will showcase promising technologies developed by these Korean companies and discuss development strategies. KHIDI’s President Soon-do Cha said, "We hope that BIO KOREA will provide the opportunity for the domestic and foreign companies, institutions, and researchers in the bio-health industry to converge and discuss business strategies and collaboration.” He added, “We also hope that outstanding technology developed in South Korea will enter the global market through global partnership.” More convention details are available on the BIO KOREA 2024 website (www.biokorea.org). Additionally, people who have not pre-registered but wish to attend the convention can still register at the registration booth set up at Coex during the convention.
- Policy
- Celltrion Pharm completes localizing 3 Edarbi products
- by Lee, Hye-Kyung May 09, 2024 05:52am
- Celltrion Pharm has completed the localization of Edarbi Tab (azilsartan medoxomil potassium), a treatment for essential hypertension. On the 8th, the Ministry of Food and Drug Safety (MFDS) simultaneously withdrew and approved the authorization of Celltrion Pharm's Edarbi Tab 20mg. In December 2020, Celltrion Pharm acquired the entire rights, including sales and patents, of Takeda Pharmaceuticals' 12 ETC and 6 OTC drugs in 9 countries in the Asia-Pacific region for USD 278.3 million (approximately KRW 307.4 billion). The Edarbi license that was withdrawn this time is the item Takeda Pharmaceuticals received approval for in May 2017 and then sold to Celltrion Pharm. Celltrion Pharm had previously received approval for its Edarbi 40 mg and 80 mg in December 2023 and then withdrew the licenses for the Edarbi Tab 40 and 80 mg that the company acquired from Takeda Pharmaceuticals in March 2024. With the simultaneous approval and withdrawal of Edarbi 20mg, the company completed preparations to localize the production of the hypertension treatment. Celltrion Pharm acquired all rights to Edarbi and has been preparing to self-produce and sell the drug to ensure stable product distribution. Edarbi is an angiotensin II receptor blocking (ARB) class drug used for the management and treatment of hypertension. The drug lowers blood pressure by blocking angiotensin II receptors and suppressing angiotensin II, a hormone that increases blood pressure. Adults may take 40 mg of Edarbi once daily, with or without food, and may increase the dose to a maximum of 80 mg per day if the patient’s blood pressure is not adequately controlled. Edarbi 20 mg is indicated as an initial dose for the very elderly (75 years or above) who are at risk for hypotension, patients with mild-to-moderate hepatic impairment, and patients with possible intravascular volume depletion. Following the launch of its alogliptin+metformin combination therapy for diabetes the past year, Celltrion Pharm has received approval for its Edarbi as ‘Celltrion Azilsartan Medoxomil Tablets’ for export and as ‘Edarbi Tab’ for domestic use.
- Policy
- Name of transferred and aquired drugs can be changed in KOR
- by Lee, Hye-Kyung May 09, 2024 05:52am
- Korea’s regulations now stipulate that brand names of a drug transferred to a different company can be changed. According to industry sources on the 7th, the Ministry of Food and Drug Safety recently announced the revision of the 'Casebook for Drug Product Naming Practices (Citizen's Guide)' and announced the allowance of brand name changes. The MFDS changed the regulation that only allowed the company name of a product to be changed upon transfer of a drug that was specified in 2016 to allow the product name to be changed as well. However, in response to inquiries from the pharmaceutical industry regarding the transferred drug’s product name, the MFDS has been responding that "the product name is determined after comprehensive consideration on its domestic use (including similar product names) at the time of completion of the marketing authorization (report).” The pharmaceutical industry had also inquired whether a pharmaceutical company that voluntarily withdraws its marketing authorization for the product and acquires a product with the same ingredient from a third party can apply for the grant to change the product name of the new item to the name previously held by the company. In general, in order to change the product name upon receiving approval for the change in manufactured and imported items (report) due to transfer or assignment, Article 10 (9) of ‘Regulation on Pharmaceuticals Approval, Notification, and Review’ allows for change of a product’s name if it meets the criteria of Article 10 (8) of the same regulation. If a company wishes to use the same product name as the withdrawn item, the company may change the product name to the other name if it is clear that the withdrawn item was not distributed in the market and lacks production and import performance within the period of use granted for the withdrawn item before the transfer. However, the authorities added that the situation at the time of marketing authorization would need to be considered. However, during the revision of the citizen’s guide, the MFDS has given a clear answer that "it is possible to use” the previous product’s name in the event of a product transfer (merger or acquisition, etc.). The MFDS may grant permission to a company to change the name of a product in accordance with Article 11, paragraph 2 of the 'Rules on the Safety of Medicines, etc.' if the product name the company seeks to use is in accordance with Article 11, paragraph 2 of the 'Rules on the Safety of Medicines, etc.’ Meanwhile, the MFDS also reviews the conformity of the product name change as part of the drug's labelling during marketing authorization reviews.
- Policy
- AZ renews orphan drug Strensiq’s risk-sharing agreement
- by Lee, Tak-Sun May 09, 2024 05:52am
- The risk-sharing agreement (RSA) for Strensiq Inj (asfotase alfa, AZ), a treatment for hypophosphatasia, has been successfully renewed in Korea. The drug was last covered under the RSA scheme in June 2020, when it was listed for reimbursement in Korea under the Expenditure Cap Type and Refund Type RSA. According to the National Health Insurance Service on the 8th, AstraZeneca and NHIS recently completed negotiations to renew the risk-sharing arrangement for 5 Strensiq Inj items. Both sides reportedly settled on appropriate terms for the agreement. The 4-year RSA term for Strensiq Inj was set to expire on May 31, but with the renewal, the drug will continue to be reimbursed for 5 years thereafter. The drug’s prior authorization requirement was also removed recently. Previously, if a patient with perinatal/infantile- and juvenile-onset hypophosphatasia wished to use Strensiq as a long-term enzyme replacement therapy to treat bone symptoms, he or she had to be reviewed on an individual basis by the Heath Insurance Review and Assessment Service’s review panel. After 4 years of prior authorizations, Strensiq’s reimbursement status has been converted to post-approvals due to its high prior authorization rate and lack of fluctuation in the number of patients. When it was first introduced, Strensiq was distributed domestically by Handok but has been supplied by AstraZeneca Korea since last year. The exclusion of the prior authorization requirement and RSA renewal are expected to improve patient access to Strensiq in Korea.
- Policy
- MSD’s Cancidas will retain premium pricing for up to 5 yrs
- by Lee, Tak-Sun May 08, 2024 05:48am
- MSD's antifungal injection Cancidas’s premium pricing will be maintained for 5 years after generic entry. Originally, the price should have been adjusted to 53.55% of the highest price, but for various reasons, its price has remained at the level of 70% of the highest price. According to the industry sources on the 6th, Cancidas’s drug pricing premium was supposed to end on the 1st of this month, but the pricing premium was extended for another year according to the opinion of the Drug Reimbursement Evaluation Committee. As a result, the price of Cancidas 50mg will remain at KRW 215,977 and Cancidas 70mg at KRW 275,989. Sam Chung Dang Pharm’s Casfun Inj, the only generic version of Cancidas, also maintained its markup, and its price ceiling will remain at KRW 188,198 for Casfun Inj 50mg and at KRW 238,253 for Casfun Inj 70mg for another year. In principle, after the entry of generics, the price of the original drug drops to 70% of the highest price through ex officio adjustment, and after 1 year, it becomes the same price as its generic, set at 53.55% of the highest price. However, the price of Cancidas remains at the 70% level for 5 years. In the meantime, the principle of equal pricing for generic drugs has been broken. In June 2020, the price of Cancidas was adjusted to its current price following generic entry. The adjustment was temporary and set to last until May 2021. However, a year later, the number of generic companies remained below three, so the markup was maintained for 2 more years. Then, in April of last year, the 3-year premium pricing period passed, but the company wanted to extend the period for reasons such as ensuring a stable supply of the product, and DREC accepted the request and decided to maintain the premium pricing for one more year. This year, despite the expiration of the premium pricing period (3+1year), the premium pricing period was extended another year until May 2025 on the basis that if a drug manufacturer, contract manufacturer, distributor, or importer wants to extend the premium pricing period for reasons such as ensuring a stable supply of products, the period can be extended following DREC opinion. In January 2021, the Ministry of Health and Welfare reorganized the premium pricing system to allow up to 5 years of premium pricing through 1+2+2, including 1 year of markup upon initial registration, up to 2 years of premium pricing maintenance for drugs with 3 or fewer manufacturers, and 2 years of additional premium pricing granted after DREC deliberation when the pharmaceutical company wishes to extend the premium pricing. Cancidas’s premium pricing is being maintained for up to 5 years through the new system. Cancidas’s sales in Korea had been KRW 8 billion in 2022 (IQVIA). The drug is used for ▲ Empirical therapy for presumed fungal infections in febrile, neutropenic patients; ▲treatment of Candidemia and Other Candida Infections; ▲ treatment of esophageal candidiasis; and ▲ treatment of invasive aspergillosis. Sam Chung Dang Pharm was the only Korean pharmaceutical company to launch a generic version of Cancidas in May 2020. Since then, Sam Chung Dang Pharm ‘Casfun Inj ‘ has been the only generic version that entered the market.
- Policy
- Will oral anemia drugs for dialysis patients be reimbursed?
- by Lee, Tak-Sun May 07, 2024 05:50am
- AstraZeneca recently withdrew Evrenzo, an oral treatment for anemia in chronic kidney disease, from the Korean market Industry interest in rising on whether oral treatments used to treat anemia in dialysis patients will be covered by health insurance in Korea. The drugs have long been approved in Korea since 2020, but one of the products recently withdrew its license. The other two have yet to be reviewed for reimbursement, raising interest. According to industry sources on the 3rd, AstraZeneca dropped the license for its Evrenzo Tab (Roxadustat, AstraZeneca), which is used to treat symptomatic anemia in patients with chronic kidney disease, on April 30. The market withdrawal comes more than 3 years after its approval in July 2021. The drug was praised for improving the convenience of anemia treatment for patients with kidney disease who previously had to depend on injections by switching to oral medication. Historically, patients with chronic kidney disease have been given injections to stimulate red blood cell production called erythropoietin (EPO) or erythropoiesis-stimulating agents (ESA) to treat anemia, a common complication of chronic kidney disease. However, Evrenzo was developed as an oral formulation that works by activating hypoxia-inducible factor (HIF), a gene involved in erythropoiesis that regulates gene expression and raised expectations on improving the convenience of treatment for the patients. After Evrenzo, JW Pharmaceuticals received approval for Enaroy in November 2022, and Mitsubishi Tanabe Pharma Korea received approval for Vadanem in March last year. Both are reportedly working to list their respective drugs for reimbursement. Under these circumstances, Evrenzo's market withdrawal has raised concerns that the authorities may have a negative stance toward the reimbursement of oral anemia drugs for chronic kidney disease. The reimbursement of these drugs also rose as an issue at the National Assembly audit held in October last year. At the time, Democratic Party lawmaker Sun-woo Kang questioned the denial of reimbursement, to which the HIRA responded that the drugs had not been reviewed for reimbursement in key reference countries and lacked clinical evidence. In a written QA, the HIRA said, "Although the drugs are oral formulations unlike existing ESA preparations that are injectables, additional advantages such as the convenience of dosing in hemodialysis patients, which is the target patient group for approval, are unclear. Although it may be potentially useful in some patient groups such as cancer patients for whom ESA administration increases the risk of tumor progression and recurrence and patients with adverse reactions or poor response to high-dose ESA therapy, it lacks direct clinical evidence of effectiveness and safety in these patient groups.” HIRA added that it would review any additional evidence of their therapeutic benefit in future reapplications or supplemental data submitted, as well as the results of overseas assessments, but was not deliberated by the Drug Reimbursement Evaluation Committee on reimbursement adequacy thereafter. However, as Vadanem received US FDA approval in March and reapplied for reimbursement, it remains of interest whether HIRA will start a reimbursement review for the drug soon.
- Policy
- Handok’s imported PNH drug Empaveli is approved in Korea
- by Lee, Hye-Kyung May 03, 2024 05:53am
- The Ministry of Food and Drug Safety (MFDS) announced on the 29th that it has approved Handok's imported new drug Empaveli Inj (pegcetacoplan). Empaveli binds to complement proteins C3a and C3b and inhibits the complement chain reaction, inhibiting intravascular and extravascular hemolysis. The drug is expected to help expand treatment options for adult patients with paroxysmal nocturnal hemoglobinuria**. The complement system is a part of the body’s innate immune system and helps the body fight off pathogens such as bacteria and viruses. It comprises a large number of different proteins (comprised of C1 through C9) that work together to promote immunity and inflammatory responses. PNH is caused by a somatic mutation in the X-chromosome that makes red blood cells sensitive to the complement response, leading to intravascular and extravascular hemolysis extravasation. Clinically, it manifests as aplastic anemia with decreased hematopoietic stem cells. Symptoms include fatigue, jaundice due to chronic hemolysis, hepatosplenomegaly, hemolytic anemia, hematopoietic deficiency, and venous thrombosis. The MFDS said, "We will continue to make our best efforts to ensure that treatments with sufficiently verified safety and efficacy are promptly supplied based on regulatory science so that patients can gain access to expanded treatment opportunities.”
- Policy
- AZ wins nod for new breast cancer drug 'Tiroo Cap Tab'
- by Lee, Hye-Kyung May 03, 2024 05:53am
- The Ministry of Food and Drug Safety. The Ministry of Food and Drug Safety (MFDS; Minister, Yu-Kyoung Oh) stated that it has granted AstraZeneca Korea’s new breast cancer drug 'Tiroo Cap Tab (capivasertib)' on April 29th. Capivasertib inhibits the activation of AKT protein, a serine·threonine kinase. Thus, it blocks the intracellular signaling pathway, preventing the survival and proliferation of tumor cells. This drug can be used in combination with fulvestrant in adult patients with hormone receptor (HR)-positive, HER2-negative, locally advanced, or metastatic breast cancer who have one or more mutations in PIK3CA/AKT1/PTEN genes during an endocrine therapy or when the disease progresses after completion, or when relapse occurs within 12 months after adjuvant therapy. The MFDS anticipates that this drug will provide a new treatment opportunity for patients with HR-positive, HER2-negative, advanced breast cancer who cannot be treated with existing treatments. The MFDS stated that with their specialty in regulatory science, they are committed to ensuring that treatments with proven safety and effectiveness are promptly distributed to expand patients’ treatment opportunities.
- Policy
- 1488 drugs approved last year…30% diabetes drugs
- by Lee, Hye-Kyung May 02, 2024 05:52am
- A total of 1488 drugs were found to be approved by the Ministry of Food and Drug Safety last year. The MFDS said on the 30th that it published the Drug Approval Report that contains the approval, certification, and report status of drugs, quasi-drugs, and medical devices in 2023. In the case of pharmaceuticals, a total of 1,488 items were approved, including 1,300 finished drugs, 49 APIs, and 139 herbal medicine ingredients. Of the approved finished drugs, 884 (68%) were ETC drugs and 416 were OTC drugs. Also, the number of orphan drug approvals increased continuously, and diabetes drugs accounted for the largest number of approvals among all finished drugs. However, the number of generic drug approvals has steadily decreased after the ‘1+3 system’ was implemented. In terms of the total number of finished drug approvals, diabetes drugs accounted for the largest number of approvals, totaling at 462. This is more than 30% of all finished drugs. This was followed by antipyretic, analgesic, and anti-inflammatory drugs (120 items), other vitamins (87 items), and blood pressure-lowering drugs (77 items). In terms of synthetic drugs approved last year by type, 29 were new drugs, 22 orphan drugs, 390 data submission drugs (including 15 incrementally modified drugs), and 2 APIs. The number of new drug approvals increased by about 50% compared to 2022 to 29 (5 manufactured and 24 imported), and the top efficacy categories by the number of approved items were nervous system drugs (7), diabetes drugs, and antineoplastic agents (6 each), circulatory system drugs and blood and body fluid agents, respiratory system drugs and allergy drugs (3 each). In the case of orphan drugs, a total of 37 products that contain 26 ingredients were approved last year, an increase of 4 ingredients and 7 products from the previous year. This is a threefold increase from 2019 (9 ingredients), which is likely due to increased industry investment and active government support for orphan drug development. Of the 375 new data submission drugs, 50.4% (189) were submitted for new salts or isomers, followed by 24.5% (92) for new compositions, and 13.3% (50) for new dosage forms (with the same route of administration). Looking at the types of incrementally modified drugs developed and approved in recent years, in 2016-2017, the development of combination drugs (drugs containing two or more active ingredients in a single product) with new active ingredient compositions was popular, and in 2018, 6 sustained-release drugs with improved dosing and dosage by reducing the number of required doses were approved. Last year, a total of 15 products were approved, including 14 combination drugs with new active ingredient compositions and 1 product that improved utility by developing a product with different efficacy and effectiveness. Last year, a total of 802 generic drugs were approved and reported. Other drugs accounted for the largest share of generic drugs. Also, 15 of the synthetic drugs among data submission drugs were recognized as incrementally modified new drugs. Since July 2021, the number of applications for generic approvals decreased sharply until 2022 due to the implementation of the '1+3' system, which limits the use of the same clinical trial data to 3 times. The number of applications in 2023 is on par with those in 2022. A total of 929 quasi-drugs were approved and reported. This was mainly due to the eased mandatory requirement and decreased wearing of masks, as well as the active development of quasi-drugs related to daily life, such as sanitary napkins, band-aids, and toothpaste due to the growing interest in health. A total of 7065 medical devices were approved, certified, and reported, with an increase in ▲high-tech medical devices such as artificial intelligence-based medical devices and surgical rehabilitation robots. Also, ▲ medical device software items are on the increase, and ▲digital treatment devices and heavy-ion particle therapy devices were introduced as new means of treatment.
- Policy
- 32 med schools in KOR confirm their admission quota
- by Lee, Jeong-Hwan May 02, 2024 05:52am
- Prime Minister Han Duck-soo. The 32 medical schools that were assigned increased medical admission quota from the government confirmed their final medical admission quota for the 2025 academic year. After withdrawing the initial announcement of increasing the medical school admission quota to 2,000 students, the government allowed universities to adjust their intake autonomously. As a result, the expansion of the 32 medical schools is anticipated to be around 1,550 students. The Korean Council for University Education (KCUE) plans to review changes to next year's college admissions process, including medical school admission quotas submitted by each university. It will notify the universities of the decisions by the end of this month. On May 1st, Prime Minister Han Duck-soo chaired the "Central Disaster and Safety Countermeasures Headquarters Meeting regarding the doctors' collective" at the Government Complex Seoul. During the meeting, he stated, "The 32 medical schools across the country that have increased their quotas have determined the admission quotas for the 2025 academic year and submitted them to the KCUE." The nine regional national universities have decided to reduce 50% of the previously allocated expansion quotas and recruit accordingly. Most private universities have decided to fully utilize the expansion quotas or reduce them slightly by 10 to 20 students. If Soonchunhyang University, Dankook University, Konyang University, and Cha University, which have not disclosed the exact expansion size, decide to recruit 100% of the allocated expansion quotas, the total number of medical school admissions for next year is estimated to be around 1550. According to Han, the KCUE is scheduled to disclose the results of each university’s medical school admission quota on May 2nd. "The President and the main opposition party leader had a long conversation on Monday regarding national affairs. They discussed the medical school expansion and healthcare reform in particular," Han said. "This reflects the support and desire for healthcare reform." "The government will continue communicating effectively with the National Assembly throughout the healthcare reform process," Han added. "We strongly encourage the medical community to engage in dialogue with the government actively." "If the medical community brings forward a scientific and rational single proposal, the discussion on the expansion scale beyond the 2026 academic year is possible," Han said. "However, it is regrettable that another group of hospital professors plans to go on strike this Friday," he added. “While patients feel anxious, some professors say they are to leave their side,” Han said. “I urge medical school professors to continue to stay by the patient's side as they have done so far, and residents and medical students should also return now,” Han emphasized. The Prime Minister also suggested that they plan to discuss allowing doctors to hold additional positions at 119 emergency centers and metropolitan emergency medical situation rooms to respond to emergency patients. Han explained, "We are working to immediately improve regulations in the medical field to allow general practitioners to treat patients in emergency rooms of other medical institutions and permit trauma center specialists to provide emergency room and inpatient care outside their centers." "Today at the Central Disaster and Safety Countermeasures Headquarters meeting, We will discuss ways to facilitate cooperation between universities and hospitals to ensure swift approval for doctors who wish to work in 119 emergency centers and metropolitan emergency medical situation rooms, thereby enhancing emergency patient response capabilities," Han added.
