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- 2026-04-10 05:23:34
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- Ebixa 20mg may be prescribed at general hospitals in Korea
- by Eo, Yun-Ho May 26, 2023 06:47am
- The high-dose formulation of the Alzheimer’s treatment ‘Ebixa’ has landed at general hospitals in Korea. According to industry sources, Lundbeck Korea’s ‘Ebixa (memantine) tablet 20mg’ passed the drug committees of medical institutions in Korea, including Seoul National University Hospital, Seoul Asan Medical Center, Sinchon Severance Hospital, and Seoul National University Bundang Hospital. The drug has stably established a prescription environment in Korea since its launch in August last year. Ebixa is an NMDA receptor antagonist approved for the treatment of moderate-to-severe Alzheimer’s disease. It blocks glutamate, a neurotransmitter involved in learning and memory, to prevent or slow down the progression of the disease. It is used to treat Alzheimer’s disease in patients with an MMSE total score of 20 or lower and CDR2-3 or GDS 4-7 accompanied by cerebrovascular disease. Ebixa 20mg is a new formulation that increased the dose by 2 times from the existing 10mg dose. If the original Ebixate 10mg had to be administered twice a day based on the maintenance dose for healthy adults, the 20mg can be orally administered once a day, improving the patient's medication compliance through simplification of the regimen. However, the 20mg dose should be administered at the same time every day and can be administered up to twice a day if necessary. Pharmacokinetic tests and comparative trials that administered Ebixa 20mg once a day showed that its safety and efficacy were similar to the twice-a-day oral administration of the existing Ebixa 10mg formulation. As a result, Ebixa 20mg reduces the burden of dementia patients having to remember the time and frequency of taking medications and reduces the possibility of them taking incorrect medications. Ebixa 20mg’s safety and efficacy have been confirmed through pharmacokinetic tests and comparative clinical trials. In May 2008, the drug was approved for once-daily use by the EMA and approved for use as once-daily use in 30 European countries, Argentina, Mexico, Turkey, Singapore, Japan, and Australia.
- Company
- Lucentis sales fell 34%
- by Chon, Seung-Hyun May 26, 2023 06:47am
- Humira, Avastin, Herceptin, and Mabthera also saw drug prices cut after entering the market for similar drugs. Domestic sales of Lucentis, an eye disease treatment, fell by more than 30%. As Chong Kun Dang and Samsung Bioepis launched biosimilars, drug prices went down and sales took a direct hit. New drugs from multinational pharmaceutical companies, such as Remicade, Enbrel, Herceptin, Mabthera, Humira, and Avastin, are experiencing repeated sales declines due to drug price cuts after the introduction of domestically developed biosimilars. It is evaluated that a virtuous cycle structure in which domestic companies' R&D achievements generate hundreds of billions of won in health insurance financial savings is being established. According to IQVIA, a drug research agency on the 26th, sales of Lucentis in the first quarter were 5 billion won, down 34.2% from the same period last year. It decreased by 20.1% in one quarter from 6.2 billion won in the fourth quarter of last year. Lucentis, sold by Roche and Novartis, is a drug used to treat eye diseases such as macular degeneration and diabetic macular edema. This drug is used for ▲ the treatment of neovascular (wet) age-related macular degeneration, ▲ treatment of visual impairment due to diabetic macular edema, ▲ treatment of proliferative diabetic retinopathy, ▲ treatment of visual impairment due to retinal vein occlusive macular edema, ▲ It is used for treatment of visual impairment due to the formation of choroidal neovascularization. A direct factor behind the decline in Lucentis' sales was drug price cuts following the entry into biosimilars. Samsung Bioepis and Chong Kun Dang received permission for Lucentis' biosimilar products. Samsung Bioepis obtained approval for Lucentis biosimilar Ameliebou in May last year, and Chong Kun Dang got approval for Lusenbier in October last year. Ameliebou and Lusenbies have been listed on the health insurance benefit list since January. Lucentis has lowered its insurance cap by 30% since February. The insurance price of Lucentis 10mg (3mg/0.3mL) went down from 820,636 won to 574,445 won, and Lucentis 10mg (2.3mg/0.23mL) went down from 828,166 won to 579,716 won. The drug price of Lucentis PFS (826,231 won → 578,362 won) was also cut by 30%. In principle, when a biosimilar appears in the domestic drug price system, the upper price standard for original drugs is lowered by 30% compared to before the patent expiration. 'Items developed by a company that signed a joint contract with an innovative pharmaceutical company, a company equivalent to it, a domestic pharmaceutical company, or a foreign company, or items for which Korea was the first licensed country or items produced in Korea' Guaranteed up to 80% of the original product. With the advent of a biosimilar developed by a domestic company, Lucentis saw a 30 percent drop in drug prices, and a drop in sales equal to the rate of drug price cut became a reality at once. Recently, sales of global blockbuster products Humira and Avastin also plummeted due to drug price cuts following the entry of biosimilars. Autoimmune disease treatment Humira saw its sales drop 24.7% in the first quarter from 27.5 billion won in the first quarter of 2021 to 20.7 billion won in the second quarter. Humira is a TNF-alpha inhibitor that treats autoimmune diseases by suppressing the expression of tumor necrosis factor (TNF-α). As of June 7, 2021, Humira's insurance cap has been reduced by 30%. The price of Humira Pen 40mg/0.4mL, Humira PFS 40mg/0.4mL, and Humira 40mg vial fell 30% from 411,558 won to 288,091 won, and Humira PFS 20mg/0.2mL from 224,002 won to 156,801 won. When Samsung Bioepis registered Humira biosimilar Adalloce for reimbursement in May 2021, Humira's upper limit fell a month later. Humira posted sales of 104 billion won in 2020, but decreased by 12.3% to 91.2 billion won in 2021. Last year, it was 85.8 billion won, down 17.5% from two years ago. In just two years after the introduction of biosimilars, sales decreased by about 30 billion won. Roche’s anti-cancer drug Avastin recorded sales of 19.4 billion won in the first quarter, down 32.4 percent in two years from 28.7 billion won in the first quarter of 2021. Avastin is an anticancer drug used for metastatic colorectal cancer, metastatic breast cancer, non-small cell lung cancer, advanced or metastatic renal cell carcinoma, glioblastoma, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and cervical cancer. Avastin showed a stable growth flow, such as 28.7 billion won, 30.2 billion won, and 30.8 billion won, from the first quarter of 2021 to the third quarter, but in the fourth quarter, it decreased by 28.6% from the previous quarter to 22 billion won. The drop in sales was inevitable due to drug price cuts following the introduction of biosimilars. Samsung Bioepis received permission for Avastin's first biosimilar, Onbevezy, in March 2021, and was listed on the health insurance list in September of the same year. With the listing of Onbevezy, the upper limit of Avastin 0.1g/4mL in October 2021 was reduced by 30% from 33,387 won to 231,271 won. Avastin 0.4g/16mL fell 30% from 1,077,531 won to 752,746 won.
- Company
- Shingles vaccine Shingrix occupies 29% of market in 3 months
- by Jung, Sae-Im May 26, 2023 06:47am
- GSK’s shingles vaccine ‘Shingrix’ occupied 29% of the market in Q1 this year. In only 3 months of its release, it beat MSD’s ‘Zostavax’ and ranked 2nd in the market. The company has made a smooth start by actively conducting marketing activities in partnership with a domestic pharmaceutical company. According to the market research institution IQVIA on the 25th, the shingles vaccine market in Korea in Q1 reached KRW 21.9 billion, a 147% increase from the KRW 8.9 billion in Q1 of the previous year. The shingles vaccine market, which had been on a downward curve due to COVID-19, has started rising again this year. In Korea, three shingles vaccines are currently available in the market - SKYZoster, Zostavax, and Shingrix. In particular, Shingrix made rapid advances after generating full-fledged sales for the first time this year. Shingrix's sales in Q1 were KRW 6.3 billion. Sales of Shingrix were recorded from Q4 last year, but considering that it started sales in mid-December, full-fledged sales occurred for the first time in Q1 this year. Data: IQVIA Shingrix recorded higher sales than MSD's Zostavax in Q1 and rose to 2nd place. Its share in the domestic shingles vaccine market also reached 29%. On the other hand, Zostavax’s only raised KRW 6 billion, similar to Q1 of the previous year. Although Zostavax sold more products, Shingrix quickly surpassed sales with its high-price strategy. SK Bioscience’s ‘SKYZoster’ also posted KRW 9.5 billion in sales in Q1 this year, which is a 152% increase from the same period in the previous year, contributing to the market expansion. Shingrix is a shingles vaccine that GSK ambitiously released in December last year. Last year, GSK selected GC Biopharma and Kwangdong Pharmaceutical as domestic marketing partners and set out to occupy the market. Expectations were high that Shingrix’s release will rebound the shingles vaccine market that had been on a downward trend due to COVID-19. In only six months of its launch, Shingrix has landed in more than 7,000 clinics and 200 general hospitals in Korea and greatly expanded its market. The company’s Q1 sales were KRW 6.3 billion, which exceeded the company’s initial target. The greatest benefit of Shignrix is its strong shingles prevention effect. In a Phase III clinical trial (ZOE-50) that was conducted on adults aged over 50 years of age, Shingrix showed a 97.2% efficacy compared to the non-vaccinated group at 3.2 years of follow-up. In another Phase III clinical trial (ZOE-70) conducted on adults aged 70 years and above, Shingrix showed an 89.8% efficacy at 3.7 years of follow-up. This is superior to the 5% protection in adults aged over 50 years of age and 41% in adults aged 70 years and above demonstrated with the use of Zostavax. The prevention rate of SKYZoster is also known to be similar to Zostavax. Also, Shingrix’s safety profile was confirmed through 5 clinical trials that were conducted on immunocompromised patients aged 18 years and older. Based on such evidence, patients who received autologous hematopoietic stem cell transplantation or those with solid cancer, blood cancer, or solid organ transplant patients who have an increased risk of shingles are also eligible to receive vaccination with Shingrix. Shingrix's rapid growth was analyzed to have been driven by its overwhelmingly high preventive effect and the distinction that it is the only inactivated vaccine that can be vaccinated to immunocompromised people. In the early days of Shingrix's release, there were concerns in the market due to its higher price than existing vaccines. The price of Shingrix, which is administered two times in total, is set at around KRW 500,000 to 600,000. This is more than twice as high as the existing vaccine, which costs KRW 150,000 to 200,000. For this reason, the vaccine is more used in general hospitals than in clinics. Vaccination with Shingrix is expected to become more active in front-line hospitals and clinics as the price burden felt by consumers gradually decreases. A GSK official said, "Shingrix showed superior results in clinical trials. Based on this, Shingrix is maintaining a high market share in the markets where live vaccines have already been released, such as the US, Canada, and Belgium. We will continue to make efforts to reduce the disease burden of shingles for healthcare professionals and those at risk by stably settling in the Korean market.”
- Policy
- "Nurturing biopharmaceuticals as the second semiconductor"
- by Kang, Shin-Kook May 25, 2023 11:05pm
- Deputy Prime Minister and Minister of Strategy and Finance Choo Kyung-ho announced that he would soon announce a plan to foster the bio-industry, saying he would foster the second semiconductor for biopharmaceuticals. On the 24th, Deputy Prime Minister Choo visited the Aprogen plant in Osong to inspect the biopharmaceutical production site and said this in a meeting with industry officials. Deputy Prime Minister Choo explained in his remarks at the meeting that followed the on-site inspection of the production facilities that "the bio-industry is emerging as a high-tech industry that promotes the creation of new technologies and industries as it is converged with digital." He said, "It is becoming more important from the perspective of supply chain and economic security. We plan to foster the bio-industry as the second semiconductor." He explained, "The growth of the bio industry, such as the development of innovative new drugs based on AI, depends on how to utilize the vast amount of health and medical data accumulated in NHIS and private hospitals." “We will push for drastic regulatory improvements to nurture data-based digital healthcare startups,” he said. Deputy Prime Minister Chu emphasized, "To leap forward as a global biopharmaceutical production hub, the government plans to actively support private companies' bio investment, such as bio-manufacturing innovation R&D." The participants of the meeting highly appreciated the government's will to foster the bio-industry and requested the government's continued interest and support for the technology-intensive bio-industry, which requires enormous funds and time from product development to commercialization. In response, Deputy Prime Minister Chu said that he plans to announce a plan to foster the bio-industry in the near future, referring to the discussions at today's meeting.
- Policy
- Welireg·Camzyos are approved in Korea
- by Lee, Hye-Kyung May 25, 2023 05:46am
- Welireg, a treatment for von Hippel-Lindau and VHL disease characterized by multiple tumors, and Camzyos, which is used to improve motor function and symptoms in patients with NYHA class II-III obstructive hypertrophic cardiomyopathy, received domestic product approval. It announced on the 24th that it had approved Welireg of MSD Korea and Camzyos of BMS Korea. First of all, Welireg is a drug that inhibits HIF-2α related to cell proliferation, angiogenesis, and tumor growth. It can reduce the risk of surgical excision of the tumor. Hippel-Lindau disease is a rare disease in which incurable multiple tumors occur in the kidney, central nervous system, and pancreas due to mutations in tumor suppressor genes. This drug is used for the treatment of renal cell carcinoma, central nervous system hemangioblastoma, and pancreatic neuroendocrine tumor that does not require immediate surgery in adult patients with von Hippel-Lindau disease, providing new treatment opportunities for patients with these rare diseases. Camzyos is the first treatment for symptomatic obstructive hypertrophic cardiomyopathy in Korea and is expected to provide a new treatment opportunity for patients who have previously used only symptomatic therapy to relieve symptoms. Camzyos has been approved for 4 doses (2.5mg, 5mg, 10mg, 15mg) and relieves excessive contraction of the heart muscle by inhibiting cardiac myosin, and is effective in improving the motor function and symptoms of the patient. The Ministry of Food and Drug Safety said, "We will continue to do our best to expand treatment opportunities for patients with rare and intractable diseases by promptly supplying treatments whose safety and effectiveness have been sufficiently confirmed based on regulatory scientific expertise."
- Company
- BMS’s oHCM drug Camzyos approved in Korea
- by Jung, Sae-Im May 25, 2023 05:46am
- BMS Korea (Country Manager: Hye Young Lee) announced on the 24th that the Ministry of Food and Drug Safety has approved the company’s obstructive hypertrophic cardiomyopathy (oHCM) treatment ‘Camzyos (mavacamten)’ to treat adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (oHCM) to improve exercise capacity and symptoms. Camzyos is the first and only FDA-approved cardiac myosin inhibitor that specifically targets excess myosin actin cross-bridge formation, which is the main cause of oHCM. Camzyos can improve left ventricular hypertrophy and left ventricular outflow tract obstruction by separating myosin from actin and relaxing the over-contracted heart muscle. oHCM is a rare disease that occurs when the left ventricular muscle of the heart becomes abnormally thick, obstructing blood flow through the aorta to the rest of the body. Its main symptoms are shortness of breath, dizziness, chest pain, fainting, etc., which appear in various ways and can increase the risk of various cardiovascular complications such as heart failure and atrial fibrillation. It can cause sudden cardiac death during exercise, especially in young adults and children aged 10 to 35 years. There had remained a high unmet need for the treatment oHCM as its treatment focused more on symptom relief than fundamental cure. Treatment options such as beta-blockers and non-dihydropyridine calcium channel blockers can reduce the heart rate and myocardial contractility, but it is difficult to expect long-term improvement with these existing drug treatment options alone. In addition to this, other available options involve surgically removing the enlarged myocardium or injecting alcohol to cause necrosis of the muscle area, but such procedures are performed to a limited extent due to high risk. Sang-Chol Lee, Professor of Cardiology at Samsung Medical Center, said, “oHCM is a serious and rare condition that can even cause sudden cardiac death without warning. We had much difficulty with its treatment as no effective method of treatment had been available for the non-invasive treatment of the enlarged heart structure, which led to patients experiencing worsening symptoms. Camzyos is the first cardiac myosin inhibitor that specifically targets the source of oHCM. The drug, which only needs to be administered orally once a day, showed excellent symptom improvement effect from the beginning of treatment, and is expected to help restore the quality of life for our patients.” The Phase III EXPLORER-HCM trial, which served as the basis for approval, Camzyos demonstrated statistically significant improvements in heart function and exercise capacity compared to placebo. In the trial, the composite primary endpoint was set as the proportion of patients who achieved either an improvement of mixed venous oxygen tension (pVO2) plus maintenance or improvement in NYHA class. Trial results showed twice more patients receiving Camzyos achieved the primary endpoint compared to the placebo. In particular, 20% of the patients that received treatment with Camzyos achieved both primary endpoints, pVO2 improvement, and the NYHA class requirement, and the heart function of half of those patients treated with Camzyos had improved to Class I, the mildest stage. The treatment effects of Camzyos remained consistent throughout the study for 30 weeks. Also, the left ventricular outflow tract (LVOT) gradient improved to the extent that 70% of the patients would not consider surgery. The proportion of patients who improved below the LVOT pressure difference of 50mmHg, which is the standard considered for surgery, showed a large difference of more than 50%, with 74% in the Camzyos arm and 21% in the placebo arm. The proportion of patients who improved to less than 30 mmHg, which is even lower, was also 57% in the Camzyos group, which was higher than the 7% in the placebo group. BMS Korea’s Country Manager Hye Young Lee, said “We are pleased to be able to provide a fundamental treatment benefit with Camzyos for Korean patients with oHCM who have been experiencing worsening symptoms, to the extent that patients had difficulty continuing on their daily life and were at risk of sudden death. We hope that the approval of Camzyos will be able to contribute not only to the treatment of domestic oHCM patients but also to restore their normal daily life," he said.
- Company
- Latecomer new CML drug Bosulif attempts reimb in Korea
- by Eo, Yun-Ho May 25, 2023 05:46am
- The latecomer leukemia treatment ‘Bosulif’ is attempting to receive reimbursement in Korea. According to industry sources, Pfizer Korea submitted an application for its Chronic Myelogenous Leukemia (CML) treatment Bosulif (bosutinib), and is receiving a review for its reimbursement. The drug, which was approved in January in Korea, was rather late in entering Korea after it was approved by the U.S. FDA in 2012. Bosulif is a 2nd generation targeted anticancer therapy like Novartis Kroea’s ’ ‘Tasigna (nilotinib),’ BMS Korea’s ‘Sprycel (dasatinib),’ Il-Yang Pharamceutical’s ‘Supect (radotinib)’. With so many drugs already on the market, no major difficulties are expected in Bosulif’s reimbursement process. Bosulif’s safety and efficacy were verified through a Phase III trial (NCT02130557) that was conducted on patients with newly-diagnosed Ph+ CML. The major efficacy outcome measure was the major molecular response (MMR) at 12 months. Results showed that MMR at 12 months was 47% in the Bosulif arm. The MMR in the comparator arm, which administered the 1st generation drug Glivec (imatinib), was 36%. MMR at 60 months was 74% in the Bosulif arm and 66% in the Glivec arm. The median time to MMR in respondents after 60 weeks of follow-up was 9.0 months in the Bosulif arm and 11.9 months in the Glivec arm In the market, next-generation CML-targeted anticancer drugs are already entering the market. Otsuka Pharmaceutical Korea’s Iclusig (ponatinib)’ is a 3rd generation treatment, and Novartis Korea’s Scemblix (asciminib) is available as a 4th generation treatment. Iclusig was listed for reimbursement in Korea in 2018, and Scemblix passed the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee in April and the company is conducting drug pricing negotiations with the National Health Insurance Service.
- Company
- Seven times stricter standards
- by Chon, Seung-Hyun May 25, 2023 05:46am
- Panoramic view of the Ministry of Food and Drug Safety Health authorities have prepared new standards for managing impurities in Januvia, a diabetes treatment. Prior to the release of Januvia generics, pharmaceutical companies were requested to only ship products within the newly set standard. Pharmaceutical companies are busy with quality control by presenting a standard that is seven times stricter than the temporary acceptance standard applied at the time of the recall of Januvia impurity products. According to the industry on the 25th, the Ministry of Food and Drug Safety recently sent an official letter to pharmaceutical companies with instructions on safety measures and information on nitrosamine impurities in drugs containing ‘sitagliptin’. The MFDS determined that the nitrating agent among the additives of Sitagliptin generated the impurity NTTP during the manufacturing or storage process of the finished drug. It means that it has a chemical structure in which impurities are generated during the manufacturing process of sitagliptin. It suggested the permissible daily intake of Sitagliptin NTTP as 37ng and instructed pharmaceutical companies to implement safety measures. The MFDS ordered, “We will conduct an NTTP test and inspection for impurities and only ship products within the permissible daily intake (37ng/day), and if impurities are detected as a result of the test, we will take step-by-step measures according to the level of detection.” The MFDS ordered pharmaceutical companies to conduct stability tests so that the NTTP can be managed at 30% or less of the acceptable standard during the period of use of the finished product of sitagliptin. In case the standard is exceeded or there is a concern, it is instructed to immediately report it to the Ministry of Food and Drug Safety. Sitagliptin is a DPP-4 inhibitory diabetes treatment, and MSD's Januvia is the original drug. Recently, Chong Kun Dang acquired the domestic sales rights of Januvia. After Januvia's patent expires in September, domestic pharmaceutical companies are preparing to release generics. In other words, the Ministry of Food and Drug Safety presented the impurity control standard before the release of Januvia generics and started a preliminary inspection. The danger of impurities in Januvia was raised last year. In August of last year, the European Medicines Agency (EMA) instructed Januvia to investigate the possibility of detecting a new NTTP impurity. As a result of MSD's impurity analysis at the time, NTTP was found, but it was not detected above the standard level, so it did not lead to a recall action. In Korea, in March, MSD Korea voluntarily recalled two lot numbers (U010253, U012914) of ‘Januvia 50mg’. At the time, MSD Korea said, "The NTTP level detected in Januvia slightly exceeds the temporary release standard (maximum 246.7ng/day)." The Ministry of Food and Drug Safety suggested 246.7ng/day as the standard for the temporary release of Januvia, and Januvia exceeded this standard and voluntarily recalled it. The limit for sitagliptin impurities set by the Ministry of Food and Drug Safety this time is 37 ng/day, which is one-seventh of the temporary release standard applied at the time of Januvia recovery. This means that the standard was set seven times stricter than the temporary release standard. If Januvia's recalled product was detected with NTTP at the temporary release standard level, it means that it exceeded the standard set by the Ministry of Food and Drug Safety by about 7 times. An official from the Ministry of Food and Drug Safety said, “The temporary acceptance standard is a standard that is applied when there is a concern about the supply disruption of the drug.” Explained. This means that the NTTP standard for sitagliptin has been set based on the same standard as other medicines because there is no problem with drug supply and demand even if impurities problems arise in some products when Januvia generics are poured out. It is known that many pharmaceutical companies conducted sitagliptin NTTP quality control based on temporary release standards. However, as the standard proposed by the Ministry of Food and Drug Safety is seven times stronger than the temporary acceptance standard, pharmaceutical companies are forced to conduct NTTP inspections according to more stringent standards. Since impurities in Sitagliptin preparations must be controlled within 30% of the allowable limit during the period of use, pharmaceutical companies complain that the quality control standards have become too strict. Some companies have begun adjusting their impurity quality control plans as the Ministry of Food and Drug Safety presents stricter standards than those set by itself. According to the Ministry of Food and Drug Safety, 100 domestic pharmaceutical companies have approved 715 products containing Sitagliptin and are waiting for the release date. According to UBIST, a pharmaceutical research institute, a total of 109.4 billion won in outpatient prescriptions for sitagliptin-containing drugs was jointly made last year. Januvia and Janumet raised 40.5 billion won and 68.9 billion won, respectively. As Januvia is forming a large market, domestic pharmaceutical companies are preparing to enter the generic market indiscriminately.
- Company
- Leading companies in developing new PO microbiome drugs
- by Nho, Byung Chul May 24, 2023 08:28pm
- The next-generation microbiome, Akkermansia muciniphila, was observed under an electron microscope (photo by Enterobiome) Recently, the world's first oral microbiome treatment obtained approval from the US Food and Drug Administration (FDA). VOWST from Seres Therapeutics in the U.S. is a drug that prevents re-infection after antibacterial treatment for CDI bacteria for people over 18 years of age. As a new microbiome drug, it is the second after Rebyota of Ferring Pharmaceuticals of Switzerland, but if the treatment was an anal-administered drug, VOWST is significant in that it is the first oral formulation treatment of a related drug. As microbiome new drugs are approved one after another, domestic microbiome companies are also accelerating the development of new drugs for various indications based on each company's microbial strain pipeline. The microbiome is a combination of microbe and biome and refers to various microorganisms living in the human body and their genes. Microbiome treatment is one of the fields that many biopharmaceutical companies are challenging because it is based on microorganisms and has the advantage of higher safety than other treatments. Genome & Company's GEN-001 is a microbiome-based immuno-anticancer drug made in an oral formulation by improving a single strain of Lactococcus lactis isolated from the intestine of a healthy person and has currently obtained a domestic patent. GEN-001 acts as a mechanism to activate the body's immunity and is currently conducting phase 2 clinical trials for gastric cancer in combination with Bavencio, an immuno-oncology drug from Merck and Pfizer. In the case of MSD's phase 2 clinical trial of Keytruda, an anticancer drug for biliary tract cancer, it is currently applying for approval to change its IND (clinical trial plan) to the Ministry of Food and Drug Safety, and patients are scheduled to be administered in the second half of this year. KoBioLabs' KBL697 is a Lactobacillus gasseri monostrain substance with an anti-inflammatory immunomodulatory mechanism and is currently patented in the US. The strain is undergoing global phase 2 clinical trials in the US and Australia, targeting psoriasis (KBLP-001) and ulcerative colitis (KBLP-007) caused by an excessive immune response. KBLP-007 recently received IND approval from the Ministry of Food and Drug Safety, which includes Korea for phase 2 clinical trials and is about to proceed with domestic clinical trials. Some companies are developing microbiome treatments using new strains that have not been registered with the Ministry of Food and Drug Safety in Korea. Enterobiome's EB-AMDK19 is Akkermansia muciniphila, a non-notified strain of Akkermansia muciniphila that is non-cultivable and extremely anaerobic that lives in the intestinal mucosa of the body and shows efficacy in diseases such as metabolic and immune diseases. Akkermansia muciniphila, also known as next-generation probiotics, is an extremely anaerobic bacterium that is extremely sensitive to oxygen and requires advanced culture technology because it is difficult to isolate, identify, and culture. Enterobiome has completed the registration of a 'patent for high-yield cultivation technology of anaerobic bacteria' in the United States, Australia, India, and Canada, starting with Korea, and holds six patents related to the EB-AMDK19 strain. The strain has completed the GLP non-clinical toxicity test and is currently scheduled to apply for an IND targeting atopic skin disease in the first half of next year.
- Policy
- Domestic medical device market share ↑50%
- by Lee, Hye-Kyung May 24, 2023 08:26pm
- The share of domestically produced medical devices exceeded 50%. It is believed that the reason is that the production of medical devices such as in vitro diagnostic devices increased as public health medical products were approved for emergency use after Corona 19. Chae Gyu-han, head of the Medical Device Safety Bureau of the Ministry of Food and Drug Safety, said at a press briefing on the 23rd, “We are analyzing the production status of the medical device industry last year, and the market share of domestic manufactured products exceeded 50%.” It means that we can concentrate on producing essential medical devices for public health when an outbreak occurs and create a system that can stably supply them.” Therefore, the Ministry of Food and Drug Safety has expressed its will to improve the system so that companies with competence do not enter the market due to a lack of licensing experience. Manager Chae said, “The core of Regulatory Reform 2.0, which will be announced soon, is to ensure that the medical device industry develops in line with changes in the policy environment.” " said. Although the domestic medical device industry has developed due to the specificity of COVID-19, it is said that the content of Regulatory Innovation 2.0 will be to prepare an evaluation system to create international-level medical products with prepared technology and experience and to lead the medical device market. While Aimmed's 'Soames' and Welt's 'PillowRx' were recently approved as the 1st and 2nd digital treatment devices (DTx), it also indicated that it would prepare for the development of AI big data-based digital medical products in the future. Manager Chae said, "Deputy Director Oh Yoo-gyeong is also very interested in AI-based medical product development. The Power of the People Rep. Jong-heon Baek and Young-seok Seo of the Democratic Party each proposed the 'Digital Medical Products Act as part of this concern. The bill defines digital medical devices, digital convergence medicines, and digital medical and health support devices as digital medical products prepares an evaluation system and evaluates actual use, introduces an excellent management system certification system, and provides preferential treatment for health insurance benefits. there is. Manager Chae said, "It is expected that the bill will be discussed in the legislative subcommittee, and the management system has been established in line with the era of digital transformation so that digital technology can be applied to medical devices and medicines and used for health care." We will make it legislative,” he said. In line with the enactment of the bill, the Ministry of Food and Drug Safety is also preparing guidelines for the development of digital treatment devices. Manager Chae said, "Even before the legislation, we will prepare guidelines necessary for clinical trials and the development of digital treatment devices." In the field of innovative medical devices and innovative diagnostic devices, he emphasized investment support for selection and concentration. Manager Chae said, “There were concerns about the growth of overall medical devices and the growth of specialized fields, and as a result of conversations with the industry, there were many opinions that selection and concentration were needed.” “I think innovative medical devices and diagnostic devices have competitiveness. We plan to develop areas that can be developed and promote measures such as intensive support.” "Regulatory Innovation 2.0 and the promotion of the Digital Medical Products Act are one of the important projects this year," said Joo Seon-tae, head of the Medical Device Policy Department, who was present at the briefing of the Director of the Medical Device Safety Bureau. did. Seong Hong-mo, head of medical device management, said that she is promoting a project to prepare braille and sign language videos for medical devices to improve information access for the disabled. He said, "The recently revised bill contains information related to information accessibility for the disabled, and it will be a recommendation, not an obligation." He added, "If the sub-law is enacted, it will be conducted by meeting with disabled groups, investigating products that require braille or sign language videos, and recommending them to companies."
