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- 2026-05-18 20:59:54
- Policy
- MSD's Sinemet products have been withdrawn
- by Lee, Tak-Sun Jul 29, 2021 05:52am
- All three items of MSD's Sinemet (Carvidopa-Levodopa) were withdrawn as of Monday. Accordingly, the same active ingredient containing product in Korea is Perkin by Myungin. It is analyzed that Sinemet has lost its competitiveness since the launch of Stalevo (Carvidopa, Entacapone, Levodopa). The MFDS dropped Sinemet CR, Sinemet 25/100 and Sinemet as of Thursday. Sinemet is a best-selling Parkinson's disease treatment approved in 1995. Since the launch of Stalevo, Sinemet's copyright has been changed and discontinued. In 2013, Sandoz Korea brought domestic copyright, and in 2019, it reported to the MFDS that it had been out of stock for a long time. As a result, sales of outpatient prescriptions based on UBIST last year remained at ₩10 million, combining Sinemet and Sinemet CR. Perkin by Myungin, unlike Sinemet, recorded ₩3.6 billion in outpatient prescription last year. Perkin's sales are expected to continue in the future as Sinemet withdrew completely from the domestic market with the cancellation. The market for Parkinson's disease treatment in Korea is about ₩50 billion. However, it is expected that new drugs such as Ongentis (Opicapone) and Equifina (Safinamide Mesilate) have recently been released in the domestic market.
- Company
- Daewoong's COVID drug PO is effective for patients over 50
- by Lee, Seok-Jun Jul 29, 2021 05:52am
- Daewoong's COVID drug PO has cut the time to improve respiratory symptoms of patients aged 50 or older by half compared to placebo. Daewoong announced the results of Topline in clinical 2b of Coviblock (Camostat), which is being developed as a treatment for COVID-19. Clinical trials were conducted in 24 institutions from February to July this year for 342 patients with mild COVID. The main evaluation variable is the "time it took for clinical symptoms to improve. Other key evaluation variables are 'safety' and 'worsened proportions of patients'. Clinical symptoms include fever, cough, difficulty breathing, chills, muscle aches, headaches, and sore throat, and the degree of symptoms (0-3) has improved to "None" or "Weakness (1)" and remained for 24 hours. The analysis confirmed safety in all patients given Camostat. The time it took for clinical symptoms to improve was 7 days for Camostat compared to 8 days for placebo. A Daewoong Pharmaceutical official said, "Because of the characteristics of mild patients, it was difficult to identify the difference in time taken to improve symptoms due to patients with good symptom management, high natural healing rate, and low drug use conformity." "There is also a limitation in clinical symptom determination standards that are subjective to patients." However, significant results were obtained in patients with high drug conformity. During the test period, the company observed patients taking more than 70% of Camostat or placebo. As a result, the improvement time for 175 patients (86 patients in Camostat group and 89 in placebo group) who are representative symptoms of coughing or having difficulty breathing was reduced by about 40% compared to the placebo group (8 days), indicating statistically significant results. The time to improve respiratory symptoms has been reduced by less than half in patients in their 50s and older, who are more likely to spread to severe diseases. According to an analysis of the symptom improvement time of 98 patients (48 Camostat groups and 50 placebo groups) who had at least one cough or difficulty breathing, Camostat improved more than twice as fast as 9 days in placebo groups on the 4th. Daewoong Pharmaceutical is developing a cure for chronic pancreatitis called "Foistar" as a treatment for COVID-19. Daewoong applied for Coviblock in December last year and completed registration in May this year.
- Company
- Nitrosamines test plan must also be submitted
- by Chon, Seung-Hyun Jul 28, 2021 05:56am
- The government is further strengthening pharmaceutical companies' self-inspection of impurities. Plans should be submitted by the end of this month to test for possible Nitrosamine impurities.. The submission of test results is due in May next year. According to the industry on the 27th, the MFDS recently asked pharmaceutical companies to submit a test plan for drugs that are feared to develop Nitrosamine impurities by the 29th. Pharmaceutical companies should submit to the MFDS a list of products that are feared to cause impurities, a plan to proceed with the test inspection, and a scheduled date of submission of test results. If there is a possibility of impurities among the drugs currently being produced and sold, it should be informed in advance when the test inspection will be carried out and the results will be submitted. In November 2019, the MFDS ordered pharmaceutical companies to submit a report on the possibility of Nitrosamine-related impurities of all raw materials and finished medicines, and the data was submitted in a year and six months. Initially, the MFDS requested submission of data by May last year, but postponed it to May this year. Pharmaceutical companies submitted data indicating the possibility of impurity generation for all licensed raw and finished medicines. The data included the results of checking whether the drug's properties or manufacturing environment could produce Nitrosamine impurities such as N-Nitrosodimethylamine (NDMA). It only shows the list of raw materials and finished drugs in possession and the possibility of impurity generation. For example, if Sodium Nitrite or other Nitrite is used, it is classified as a product that is likely to produce Nitrosamine impurities. The MFDS ordered products that are considered to have a possibility of developing Nitrosamine impurities to report the results of the impurity test by May 31, 2022. It did not mention submission of the test inspection plan. An official from the MFDS explained, "The deadline for submitting the test is about 10 months, but the intention is to quickly conduct the test inspection on products that are at risk of impurities." As the risk of impurities has recently been raised in Sartan series of hypertension treatments and Varenicline, it is interpreted as an intention to check with strict standards by pharmaceutical companies. If Nitrosamine impurities are detected in the future in products that pharmaceutical companies have pointed out as unlikely to produce impurities, they may be held responsible. An official from a pharmaceutical company said, "We are once again looking at the possibility of generating impurities for products being produced and sold according to the MFDS' instructions to submit a test inspection plan."
- Company
- Samsung Biologics record-high earnings of ₩166.8 in Q2
- by An, Kyung-Jin Jul 28, 2021 05:55am
- Samsung Biologics Samsung Biologics posted positive records despite the prolonged COVID-19 crisis. The increased utilization rate of the company’s third plant and new product orders drove the company to record the highest-ever sales and operating profit this quarter. On the 27th, Samsung Biologics announced that its operating profit in Q2 this year was 166.8 billion won, which was a 105.6% year-on-year increase. Its sales revenue also rose 34.0% year-on-year to record 412.2 billion won. Both are the largest-ever quarterly records to be made by the company. The company’s cumulative sales revenue in the first half of this year was 673 billion won, a 30.7% increase from the previous year. Its operating profit also increased 67.8% to record 241.1 billion won. The company believes that the sales increase was possible due to increased new product orders in addition to COVID-19 related products, and the increased utilization rate of its third plant. Also, along with the increase in sales, profitability improved as the increased utilization rate of the third plant began to generate profit in full-scale. In May, Samsung Biologics had signed a CMO deal with Moderna to provide fill-finish manufacturing of Moderna’s COVID-19 vaccine and started production. The company plans to finish establishing a manufacturing facility that can produce the active ingredient of the mRNA vaccine in the first half of next year, and expects it will be able to provide an end-to-end service that covers the full process from manufacturing the active ingredient to the finished product. In addition, the company plans to focus on managing effective operation of its manufacturing facilities and winning early orders for its fourth plant. As a response to the surge in demand for biopharmaceutical products, the company has started building its fourth plant with a capacity of 256,000ℓ in August last year. The plant, when completed, will have the world’s largest production capacity for a single plant. The company plans to commence partial operations by the end of next year and start full operations in 2023. An official from Samsung Biologics said, “We are actively taking orders to complete early orders for our fourth plant, even though a considerable amount of time is left until its completion. We plan to contribute to bringing an early end to the COVID-19 pandemic by stably and promptly supplying COVID-19 vaccines and treatments to those in need around the globe.”
- Company
- Domestic DDP-4 inhibitors fare better amid sales decline
- by Kim, Jin-Gu Jul 28, 2021 05:55am
- Prescription of DPP-4 inhibitors, which used to drive the diabetes treatment market, are on the decline. In just a single year, the market size of DPP-4 inhibitors decreased 4%, and this is the third consecutive quarter the market saw a decline since Q4 last year. Also, multinational companies and domestic companies have seen opposite results in the sales performance of their products. While prescriptions of all DPP-4 inhibitors from multinational companies fell, most products from domestic companies continued to make growth. ◆Is the party over for DPP-4 inhibitors?... market decreased 4% in one year According to the pharmaceutical market research institution UBIST on the 27th, the diabetes drug market size for DPP-4 inhibitors was 141.6 billion won in Q2 this year. This was a 4% decline compared to the 148.2 billion won recorded in Q2 last year. Quarterly records show that the market has seen a steady decline since the Q3 last year. After first being formed in 2008 with the introduction of MSD’s ‘Januvia (sitagliptin),’ the market saw repeated growth with the release of latecomer drugs and became 'the most frequently prescribed diabetes drug.’ In Q1 2016, the market made the first quarterly sales that exceed 100 billion won. The market peaked in Q3 last year and made 156 billion won. However, since then, the market saw 3 consecutive quarters of decline, from 156 billion won. (4Q 2020) to 146.4 billion won (Q1 2021), to 141.6 billion won (Q2 2021). If this trend persists, the overall market size of antidiabetics is expected to fall below 600 billion won by the end of this year. ◆Market No.1 and 2 – ‘Januvia’ and ‘Trajenta’ both decline 8% Multinational pharmaceutical companies and domestic companies have seen opposite results in the prescriptions of their products. While prescriptions of products from multinational companies all declined, most products developed or introduced by domestic companies saw a growth in sales. The market’s leading product, MSD’s Januvia series saw an overall decline of 8% from the 43.4 billion won in Q2 last year to 40.1 billion won in Q2 this year. The sales drop was more vivid in its single-agent product. Januvia’s sales fell 11%, while sales of the combination drugs Janumet and Janumet XR decreased 8% and 3%, respectively. The same went for the market’s runner-up product ‘Trajenta (linagliptin).’ Its sales dropped 8% from 31.9 billion won to 29.3 billion won in the same period. Both the single-agent and combination drugs Trajenta and Trajenta Duo saw an 8% drop in sales. Sales of Novartis’ ‘Galvus (vildagliptin)’ series dropped 7% from 10.9 billion won to mark 10.7 billion won. Sales of Takeda Pharmaceutical's ‘Nesina (alogliptin)’ series fell 11% from 7.9 billion won to 7.1 billion won. Also, sales of AstraZeneca’s Onglyza (saxagliptin) series also fell 7% from 6.8 billion won to 6.3 billion won. ◆'Zemiglo' fares better…The latest latecomer DPP-4 inhibitor ‘Suganon’ shows rapid growth On the other hand, domestic DPP-4 inhibitor products performed well despite the overall market downtrend. Sales of LG Chem's 'Zemiglo (ingredient name: gemigliptin)' series, which had ranked third in the market, increased by 2% from 28.4 billion won to 29.1 billion won in a single year. Despite the 3% sales decline of the single-agent Zemiglo (8.8 billion won → 8.6 billion won), the overall prescriptions performance of the series increased with the 5% increase (19.4 billion won → 20.4 billion won) in sales of the combination drug Zemimet. However, it is evaluated that the overall growth drive has somewhat weakened compared to the past. LG Chem’s Zemiglo, Handok’s Tenelia, Dong-A ST’s Suganon, JW Pharm’s Guardlet (clockwise from the left upper corner). Zemiglo and Suganon and self-developed new durgs, Tenelia and Guardlet were introduced to Korea Sales of Handok’s ‘Tenelia (teneligliptin)’ increased 4% from 10.3 billion won to 10.7 billion won in the same period. Sales of the single-agent drug Tenelia grew 4%, and the combination drug Tenelia M grew 5%, respectively. Tenelia is a diabetes drug from Japan’s Mitsubishi Tanabe that Handok introduced to Korea. Using Tenlia, Handok had self-developed the combination drug Tenlia M by adding metformin. Currently, the combination drug is prescribed more than the single-agent drug. Dong-A ST’s self-developed new drug ‘Suganon (evogliptin)’ series has been showing the most rapid growth among all drugs recently. Its prescriptions only amounted to 5.7 billion won in Q2 last year, however, this increased 31% to mark 7.4 billion won in just one year. The Suganon series, which was introduced in Q2 2016, was the last to enter the DPP-4 inhibitor market. At that time, its prescriptions amounted to only 0.6 billion won. However, this had increased over tenfold in just 5 years. The ‘Guardlet (anagliptin)’ series that JW Pharmaceutical introduced from Sanwa Kagaku Kenkyusho, was the only product to see a decline in prescriptions among all domestic products. Its prescriptions, which amounted to 2.9 billion won in Q2 last year, decreased to 1.5 billion won. This decline was influenced by impurities detected in some of the metformin products. JW Pharmaceutical's Guardmet’s sales were suspended due to the detection of impurities. Without Gaurdmet, which accounted for over half of the sales in the Guardlet series, prescriptions of the whole family also decreased to around half of what it was before. However, prescription for the single-agent drug Guardlet itself had increased 7% from 1.4 billion won to 1.5 billion won in one year.
- Policy
- Regulations are required on GMP violations
- by Lee, Jeong-Hwan Jul 28, 2021 05:54am
- The National Assembly is discussing legislation with health authorities on health insurance finances for the recovery of drug benefits from pharmaceutical companies, which filed a lawsuit to cancel the disposal of drug price cuts for fraudulent purposes. It is also discussing ways to enhance stability of quality of domestic manufactured medicines by supporting and strengthening GMP regulations. The National Assembly, the MOHW, and the MFDS are discussing the proposed revision of the Health Insurance Act and the Pharmaceutical Affairs Act. As the National Assembly recently completed the review of the supplementary budget bill and agreed to form a legislative body including the chairman of the Legislation and Judiciary Committee, it is expected that the bill will begin in earnest next month. The two bills are expected to have a significant impact on drug benefits and drug manufacturing and production sectors in the domestic pharmaceutical industry. Kwon Deok-chul, Minister of Health and Welfare, also acknowledged the need for a bill to recover reimbursed drug benefits from pharmaceutical companies that filed administrative lawsuits to delay or disable the government's drug price reduction and suspension. When a pharmaceutical company deliberately filed an administrative lawsuit to avoid the government's legitimate drug reduction, it will impose the right to plan for the recovery of drug benefits and penalties. There is a possibility that the government will compensate for the damage caused by pharmaceutical companies when they finally won the government's drug price lawsuit and the drug price reduction has been proven unfair. Choline alfoscerate, which was confirmed to reduce the benefit due to some of its indications last year, is still showing a large amount of prescription in 2020, with a prescription amount of ₩42,574,1.53 million. Choline alfoscerate recorded more than ₩200 billion in prescriptions in the first half of this year. Nam In-soon, a memver of the Democratic Party of Korea, criticizes, "Even though the benefit reduction by adaptation has been confirmed, pharmaceutical companies are wasting hundreds of billions of won a year in health insurance finances." The bill is expected to have the effect of preventing a recurrence of such controversy through legislation. The purpose of legislation for GMP support and regulation of domestic pharmaceutical manufacturers is to prevent GMP serial violations. It plans to significantly increase the level of punishment for pharmaceutical companies that violate GMP and cancel GMP certification or item permission for pharmaceutical companies that violate GMP regulations even once by introducing the so-called "one strike out" system. In addition to the GMP legislation, which focuses solely on strengthening punishment of pharmaceutical companies, the government is also preparing legislation to prevent violations of GMP by strengthening the authority of the chief manufacturer. The current law neglects the situation of violating GMP even though it is aware of the illegal fact because the authority of drug manufacturers such as director of Pharmaceutical Manufacturing is relatively unclear or weak. Attention is focusing on what kind of legislation the National Assembly and regulatory authorities will finally come up with to support and regulate domestic pharmaceutical GMPs An official of the National Assembly's Health and Welfare Committee said, "The bill to prevent drug cuts has formed a consensus between the welfare committee members and the MOHW." "The two bills will be discussed in earnest when pending issues such as the second supplementary review are dealt with," he added.
- Company
- 3 generics for Champix have been withdrawn in just one year
- by Lee, Tak-Sun Jul 28, 2021 05:54am
- Anti-smoking treatment Varenicline, a smoking cessation drug, is being withdrawn. It is believed that the impurity incident, which occurred last month, affected the cancer. According to the MFDS on the 26th, eight items of Varenicline have been withdrawn since June. On the 22nd of last month, the MFDS also began a safety survey after recovering Pfizer's Champix due to concerns over cancer-causing substances in countries such as Canada. As a result, pharmaceutical companies with Varenicline will have to conduct tests on impurities by August 31. The MFDS recommended that Varenicline are needed to use only the minimum amount for treatment and consider other treatments if possible until the results of the impurity test were published. It released a product developed in November 2018 with different salt from Champix, but later in December 2019 all sales were suspended due to the loss of patent litigation. It was released again after seven months. However, it has already lost trust due to the suspension of sales, and the sales performance of generics has fallen short of expectations. Currently, there are 62 generics for Champix. Only CTC Bio and Jeil are producing Varenicline. The rest of the pharmaceutical companies are supplied by two pharmaceutical companies. An official from related companies said, "We were originally going to clean up because it does not produce generic directly, and we have decided not to delay further because of the impurity incident." Other companies are similar. It is known that two additional items have been submitted to the MFDS. Including this, 30% of all licensed products will be canceled or dropped within a year of release. Eight of them were revoked on charges of selling them during the patent period.
- Policy
- The weighted average price may vary when charging Xarelto
- by Lee, Hye-Kyung Jul 28, 2021 05:54am
- When pharmacies claim Bayer Korea's Xarelto, they need to reconfirm the purchase price. This is because the weighted average price may change due to changes in drug prices due to lawsuits such as suspension of the execution of notification on drug price cuts. In particular, if a pharmacy claims a drug price change without checking it, it needs to be careful because it can be disposed of as a claim mismatch through "regular confirmation of the purchase price" in the future. The HIRA conducted a "Guidance on Xarelto's Suspension Claims" on Sunday. Following the Seoul High Court's decision to suspend the execution of the revised Xarelto (2.5/10/15/20 mg), the MOHW suspended the notice as of July 2. The existing upper limit price was reduced by 30% from June 8 to July 1, but returned on July 2, causing a change in the price of medicine. Since it is a period that is reflected in the calculation of the purchase price of medical treatment in August and October of this year, the medical institutions should check once more when they claim it. The purchase price will be calculated based on the "quarterly weighted average price" divided by the total purchase amount of the drug purchased quarterly. It will be the purchase price for the treatment that lasted from the beginning of the second month of next quarter to the third month. If Xarelto is charged from August 1 to October 31, the weighted average price will be the average of the purchase price in the second quarter of this year. It is accurate if checking the medical expenses claim → medication management → pre-weighted average price → weighted average price by medication on the website of the medical institution's task portal. The history of the purchase can be managed by registering the purchase details of the drug in → claim for medical treatment → medication management → purchase medicine calculation management in the pharmacy's task portal screen.
- Policy
- Moderna vaccine by Samsung Biologics is supplied worldwide
- by Kim, Jung-Ju Jul 27, 2021 05:36am
- Prime Minister Kim Bu-gyeom briefly mentioned in a radio media interview today (the 26th) when Samsung Biologics' moderna COVID vaccine will be released, and quarantine authorities said that hundreds of millions of doses of Samsung Biologics products will be supplied to the world except the U.S. next year. The KDCA made the announcement in a regular "COVID-19 briefing" this afternoon. Earlier, Prime Minister Kim Bu-gyeom appeared on radio media and said, "I know that Samsung BioLogics' Moderna vaccine will be released in late August or early September." Regarding the production schedule, the KDCA said, "We understand that Samsung Biologics is doing its best to produce this year, and will supply hundreds of millions of Doses to the world except for the U.S. by next year."
- Policy
- When will Phase 3 trials of K-COVID-19 vaccines begin?
- by Lee, Tak-Sun Jul 27, 2021 05:35am
- Development of domestic COVID-19 vaccines has come to a standstill before entering the final stages - the phase 3 trials. Cellid, which had shown the fastest progress in development, is planning to reenter phase 1 trials with an improved version of its vaccine. Due to such changes, the industry has a negative outlook on the commercialization of domestic vaccines by the first half of next year. According to the Ministry of Food and Drug Safety on the 26th, there are currently 10 candidate COVID-19 vaccines in clinical trials in Korea. The Phase 1 clinical trial for HK Inno.N’s recombinant vaccine, ‘IN-B009,’ was approved on the 22nd to increase the count to ten. 5 are recombinant vaccines, 3 are DNA vaccines, 1 is a viral vector-based vaccine, and 1 is an RNA vaccine. 자료제공 : 식약처The only viral vector-based vaccine, Cellid’s 'AdCLD-CoV19,’ was approved for a new Phase 1 clinical trial on the 23rd. The trial will evaluate the candidate vaccine’s safety and immunogenicity on 40 healthy adults. Cellid’s candidate vaccine is no different from the vaccine that was approved for a clinical trial in December last year. However, the vaccine’s production yield was improved to allow mass production. Cellid plans to proceed with Phase 3 trials for its improved vaccine candidate immediately after completing the Phase 1 trial, as a Phase 2 trial for its previous vaccine candidate is already in progress. Clinical trials can be divided into 3 parts: Phase 1 trial that assesses the safety of a drug, Phase 2 that determines the dosage, and Phase 3 trial to confirm the drug’s effectiveness in a large number of patients. However, no domestic COVID-19 vaccines have been verified for their efficacy yet. Many trials have been approved since SK Bioscience received approval for the first clinical in November last year, but all are still in their early stages. However, SK Bioscience had submitted a Phase 3 clinical trial protocol for its recombinant vaccine ‘GBP510’ last month and is awaiting MFDS approval. The vaccine received support from the Bill and Melinda Gates Foundation and CEPI. SK Bioscience plans to start its Phase 3 trial for its candidate vaccine as early as August. The MFDS has approved companies to conduct Phare 3 trials in comparison with previously authorized vaccines to reduce the burden of the large-scale Phase 3 trials. As a result, the trial is expected to assess the candidate vaccine’s efficacy and immunogenicity using currently marketed vaccines as comparators such as Pfizer, Moderna, AZ, and Janssen vaccines in around 3,000 healthy adults. However still, as a Phase 3 trial takes a long time from participant recruitment to analysis, there are growing concerns about whether Korea will be able to produce a domestic vaccine soon. Even if the candidate vaccines enter Phase 3 trials in the second half of this year and completes it successfully, experts believe that it will be difficult to commercialize the vaccine in the first half of next year.
