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Policy
Monkeypox becomes Class 2 infectious disease in Korea
by
Lee, Jeong-Hwan
Jun 09, 2022 06:24am
The viral zoonosis monkeypox will be designated and managed as a ‘Class 2 infectious disease’ by law starting today (8th). With its level raised, monkeypox will now be managed and considered to have the same level of risk as COVID-19, tuberculosis, and chickenpox. If a person is confirmed with a Class 2 infectious disease, this must be reported to the quarantine authorities within 24 hours, and the infected person is required to undergo mandatory quarantine. The Korea Disease Control and Prevention Agency said, “In consideration of the characteristics of monkeypox including its severity, monkeypox will be designated as a ‘Class 2 infectious disease that is designated through discussion between the KDCA commissioner and MOHW minister.’ Other notices that have been partially revised include the notification on the diagnostic criteria for infectious diseases and the notification of infectious diseases that the KCA commissioner deems in need of emergency quarantine measures. The main content of the revised notice is to classify monkeypox as a second-class infectious disease and give treatment and quarantine obligations to confirmed patients. Under the Infectious Disease Prevention Act, patients confirmed with statutory infectious diseases are obligated to report their infection. 22 diseases including COVID-19, tuberculosis, and chickenpox are designated as Class 2 Infectious Diseases that require isolation in consideration of the possibility of its transmission. The authorities have issued an “interest” alert for monkeypox after holding a risk assessment meeting on monkeypox with the Infectious Disease Risk Management Committee at the end of last month. Also, due to the increase of overseas visitors and infected cases abroad, the authorities had set up a separate task force to preemptively respond to the rising possibility of its influx to Korea. Previously, the KDCA had evaluated that there is an ‘intermediate’ risk of infection in high-risk groups that have contacted confirmed or symptomatic patients without appropriate personal protective equipment (sexual contact, cohabitant), and a ‘low’ risk of infection in the general public. Monkeypox is mainly transmitted through close physical contact and has a lower transmission rate than COVID-19. Monkeypox, originally an endemic that had previously been confined to Central and West African countries, was first reported in the UK early last month, followed by sporadic reports of the disease globally including in the United States, Spain, Germany, France, Morocco, and Israel. According to the WHO, 780 cases of the disease in 27 countries have been confirmed in non-endemic areas as of the 5th of this month. The authorities are also in the process of introducing a ‘third-generation’ vaccine that has proven efficacy against monkeypox. Bavarian Nordic’s ‘Jynneos’ is being considered a likely candidate. The KDCA already owns 35 million courses of a second-generation smallpox vaccine in preparation for a public health crisis but is not considering using the stockpile for public vaccination. The authorities plan to treat confirmed patients in isolation wards as soon as a case of monkeypox occurs in Korea. Whether to impose quarantine on those in close contact is still being discussed. The authorities have asked those who visit countries where monkeypox occurred to practice good personal hygiene and contact the KDCA call center (1339) if suspicious symptoms occur within three weeks after returning to Korea.
Policy
Evusheld is expected to be introduced this month
by
Lee, Jeong-Hwan
Jun 09, 2022 06:24am
The government is expected to introduce Evusheld, a COVID-19 antibody treatment that is administered to patients who do not form antibodies well even with vaccinations, to Korea this month. Lee Ki-il, the first general coordinator of the Central Disaster and Safety Countermeasures Headquarters, presided over a meeting at the Sejong Government Complex on the 8th and said, "We will complete the EUA procedure of the Evusheld within June and guide local governments and the medical community." Lee Ki-il, the first general coordinator, explained, "It is a preventive antibody treatment for those who are difficult to form antibodies through vaccines because they are receiving immunosuppressants such as blood cancer patients and organ transplant patients." He added, "As the additional budget was confirmed last week, we will quickly push for the supply of Evusheld in Korea." From that day on, all overseas immigrants will be exempted from quarantine regardless of whether they have completed vaccination or their nationality. All restrictions on flights at Incheon International Airport will also be lifted. However, pre- and post-entry inspections are maintained to manage the inflow of new mutations. All entrants must submit PCR test results conducted within 48 hours before entering the country or rapid antigen test results conducted within 24 hours, and submit PCR test results within 3 days after entering the country. Recently, the COVID-19 situation has been managed stably. The number of weekly confirmed patients decreased for 11 consecutive weeks, and the number of critically ill patients and deaths last week also decreased by 29.5% and 56.5% compared to the previous week, respectively. As of the 8th, the operation rate of inpatient bed was also reduced to within 10%, including 8.8% for severe beds, 9.4% for semi-critical patients, and 6.8% for moderate beds, stressing that there is enough room for medical response. The infectious reproduction index was 0.74, which has remained less than 1 for 10 consecutive weeks. The first general coordinator said, "Experts continue to warn of the possibility of a COVID-19 pandemic in the summer. There are still many risks of re-pandemic, including local festivals and vacations in summer and the use of indoor air conditioners in an enclosed environment," he said.
Company
Genomictree's colorectal cancer business is booming
by
Lee, Seok-Jun
Jun 09, 2022 06:23am
FS Research highly evaluated Genomictree's growth potential in a report on the 8th. Genomictree is a company that discovers biomarkers, verifies clinical efficacy, and develops and sells early diagnosis products for various cancers (colonial cancer, lung cancer, bladder cancer, etc.). According to the report, sales of Genomictree's colorectal cancer diagnostic kits are soaring in Korea. Sales of colon cancer diagnostic kits, which recorded 300 million won last year, are estimated to be about 900 million won in the first half of this year, with 3 billion won annually. Hwang Se-hwan, a researcher at FS Research, said, "Genomictree's diagnostic kit is much simpler than colonoscopy because it can diagnose colon cancer with just 1 to 2g of feces. The sensitivity and specificity are 90%, which is significantly higher than the fractional occlusion test. This advantage is that the number of hospitals in sales and supply has increased rapidly since this year," he analyzed. Researcher Hwang said, "Assuming that 11.5 million people aged 35 to 49 undergo colonoscopy once every five years, the number of people subject to colonoscopy is estimated to be about 2 million per year. Due to the large size of potential customers, the domestic market alone has very high growth potential," he predicted. He also mentioned the possibility of expanding global businesses. Genomictree began selling in Southeast Asia and Europe this year, and the U.S. and China are undergoing clinical trials. The U.S. is conducting exploratory clinical trials (1st), and plans to conduct confirmatory clinical trials (2nd) next year and release them in 2024. Researcher Hwang said, "Competitor Exact Sciences, which has a market capitalization of 10 trillion won, has grown 30% by achieving 2.21 million inspections in 2021, seven years after its launch. Genomictree has a similar level of sensitivity and specificity to that of Exact Sciences. It is expected that it will expand its market share in the U.S. with advantages such as low inspection costs, short inspection time, and very small amount of stool inspection." The surge in domestic sales of colorectal cancer diagnostic equipment is evidence that the possibility of success in the global market is increasing. We should pay attention to Genomictree as these expectations can be reflected in the stock price, he added.
Company
Impurity data on schizophrenia and asthma drugs submitted
by
Chon, Seung-Hyun
Jun 08, 2022 05:56am
Pharmaceutical companies are submitting results of their impurity inspections on the schizophrenia treatment ‘Quetiapine’ and asthma and allergic rhinitis treatment ‘Montelukast’ one after another. As of now, no product has been recalled due to excessive impurities, and the health authorities plan to take follow-up measures after reviewing the drug companies' impurity inspection data. According to industry sources on the 7th, pharmaceutical companies submitted data on their schizophrenia treatment ‘Quetiapine’ to the Ministry of Food and Safety by May 27th. The data contained the companies’ evaluation of the possibility N-Nitroso-Aryl Piperazine (NNAP) impurities, process safety review data, provisional management standards, and grounds for setting such standards. This is a follow-up measure made after the MFDS requested the companies to submit impurity data on drugs that contain quetiapine in late April. The MFDS ordered companies to submit test results on the companies’ representative batch numbers among finished quetiapine products that can be sold in the market by July 28th. A representative batch number refers to three or more batches that are nearing expiry every year. Products manufactured in 3 batches or less are required to submit test results of all batches. This precautionary measure was made according to the safety information that NNAP impurity was detected in a single-agent quetiapine product. The MFDS had ordered pharmaceutical companies to submit data including those evaluating the possibility of NNAP impurities in quetiapine products by May 27th. NNAP is a new nitrosamine impurity that has been identified in the market. .Since 2018, two types of nitrosamine impurities, - ‘N-nitrosodimethylamine (NDMA)’ and ‘N-nitrosodiethylamine (NDEA)’ were detected in valsartan, ranitidine, and nizatidine .Quetiapine is a generic used to treat schizophrenia .Its original is Alvogen Korea’s ‘Seroquel.’ Around 30 Korean companies are currently selling quetiapine generics, and the domestic market grosses ₩30 billion a year .No quetiapine product in the market has been detected to have excess impurities in Korea yet, but it is impossible to rule out the possibility that some products with excess impurities may be found in the tests of finished quetiapine products .Based on the submitted data, the MFDS plans to closely review the impurity risk of quetiapine products in Korea .An MFDS official said, “We plan to make follow-up measures after the test results are submitted and a comprehensive review of all the results are made.” None of the montelukast products, on which the impurity issue had arisen earlier this year, have been recalled either .The Ministry of Food and Drug Safety had previously ordered pharmaceutical companies to investigate their montelukast ingredient and finished products for impurities and submit the reports by April 25th .This precautionary measure was issued after the ministry received safety information that N- nitrosodipropylamine (NDPA) was detected in the API montelukast .Manufacturers and importers of montelukast were then required to submit test results on representative batch numbers that can be distributed in the market .The MFDS asked the companies to conduct additional follow-up measures if necessary .Manufacturers and importers of finished products are required to conduct evaluations on the possibility of impurities in the manufacturing process .If necessary, the companies are also required to conduct tests and follow-up measures like the API companies .The MFDS ordered companies that produce raw materials and finished products to immediately report NDPA impurities found during inspection even before the submission deadline .Montelukast is used to treat allergic rhinitis and asthma .The original drug is Organon Korea’s ‘Singulair.’ In Korea101 domestic pharmaceutical companies are selling generic versions with the same ingredient .Its domestic market grosses around ₩100 billion a year .The pharmaceutical companies had submitted impurity inspection results on montelukast products by April according to MFDS instructions, and no impurity issue has been identified in the products sold in Korea as of now .In April, Organon Korea had announced that no impurities were detected in ‘montelukast sodium,’ the active ingredient of its allergic rhinitis and asthma treatment ‘Singulair.’ An MFDS official said, “We are currently reviewing impurity review data on montelukast, and will take the necessary safety measures according to the plan we have previously prepared.”
Opinion
[Reporter's view]Will arbitrary manufacturing be eradicated?
by
Kim, Jin-Gu
Jun 08, 2022 05:56am
A revision to the Pharmaceutical Affairs Act, which allows the imposition of "punitive fines" on pharmaceutical companies that violate GMPs, passed the National Assembly. It also included canceling the judgment of suitability for the GMP if a violation is found, and allowing a prison term of up to five years or a fine of up to 50 million won, apart from the fine. It contains the will of the MFDS that there is no longer tolerance for deceiving the authorities of permission by false or fraudulent means. What is noteworthy in the revised Pharmaceutical Affairs Act is that a 'GMP exclusive investigator' was appointed. In order to increase the administrative efficiency of GMP investigation and evaluation work, GMP manufacturing and quality control investigators were appointed and pharmaceutical manufacturers were allowed to enter and investigate. It is interpreted that the GMP Special Planning and Inspection Team, which was temporarily operated after a series of GMP violations were detected last year, will be changed to a regular operating system. There has been a role in managing and supervising pharmaceutical companies' compliance with GMP. Article 36 of the current Pharmaceutical Affairs Act designates a "Manufacturing Manager" and manages and supervises the overall drug manufacturing work. But it's actually a private law. Many manufacturing managers have long acquiesced in the evil practice of the name. There are also many expedient ways to fill out related documents in double and then take a new pharmacist to sign them. Manufacturing managers were unable to make a proper opinion from the standpoint of receiving a salary from the company. Pharmaceutical companies forced them to be loyal, and the Ministry of Food and Drug Safety remained unaware. It means that there is no role in managing and supervising drug manufacturing, so GMP violations have not continued. It's just that the law hasn't been used properly. The MFDS has steadily detected GMP violations through the pharmacist monitoring system. According to data released at last year's parliamentary audit, the MFDS conducted 1,277 pharmacist monitoring (regular monitoring + special monitoring) for 5 years and 9 months from 2016 to September 2021. In the process, 485 violations of 189 companies were detected. It means that four (38%) of the pharmacist monitoring were caught 10 times. The problem is that 118 companies have been caught twice or more. There were 45 companies caught more than four times, and two companies were caught more than 10 times. This means that there was no appropriate follow-up by the MFDS even after detecting GMP violations. The main point of the new system is to strengthen surveillance and punishment. The plan is to strengthen surveillance through GMP investigators and impose strong penalties on companies caught to prevent recurrence. Strengthening surveillance and punishment in the new system require appropriate interaction. The focus should not only be on detecting GMP violations. Without proper follow-up measures to prevent recurrence, it is meaningless even if the number of GMP violations is doubled or tripled.
Policy
Bringing 3rd gen monkeypox vaccine to Korea in discussion
by
Lee, Jeong-Hwan
Jun 08, 2022 05:56am
The government announced on the 7th that it has started discussions on the quantity and schedule for bringing a ‘3rd generation monkeypod vaccine’ to Korea with its manufacturer. The authorities decided to accelerate the introduction of this third-generation vaccine with proven efficacy as the number of confirmed cases of monkeypox continues to increase worldwide and the possibility of its inflow to Korea rises. The Danish company Bavarian Nordic’s ‘Jynneos’ is the only monkeypox vaccine that received marketing authorization in the world. Jynneos is currently available for vaccination in the US and Canada after receiving FDA approval in 2019. Jynneos is an attenuated, live, non-replicating smallpox and monkeypox vaccine used for the prevention of smallpox or monkeypox in adults over 18 years of age that is known to provide 85% protection against monkeypox. Geun-Young Kwon, head of the vaccination management team of the Vaccination Response Promotion Bureau of the Korea Disease Control and Prevention Agency (KDCA), said, “We are currently discussing the introduction of a third-generation smallpox vaccine to Korea with its manufacturer. We will provide information on its quantity and schedule as soon the discussions are complete.”
Company
Avodart leads 6th quarter
by
Kim, Jin-Gu
Jun 08, 2022 05:56am
Dutasteride are strong in the domestic hair loss treatment market. Both original and generic recorded higher sales growth than competitive drug Finasteride. According to IQVIA, a pharmaceutical market research firm, on the 2nd, GSK Avodart's sales in the first quarter were 10.7 billion won, up 9% from 9.9 billion won in the first quarter of last year. During the same period, Sales of Propecia fell 2% from 9.8 billion won to 9.7 billion won. The gap between Avodart and Propecia is 1.05 billion won, the largest since the second quarter of last year. Avodart, which was used as a treatment for prostate hypertrophy, has been in the shadow of Propecia for more than a decade since it began to be prescribed as a treatment for hair loss, adding indications in 2009. However, it has been maintaining its No. 1 position in the market for six consecutive quarters since it surpassed Propecia by a narrow margin in the fourth quarter of 2020. Quarterly sales of Propecia & Avodart ( Unit: 10 million won Data: IQVIA) In the case of generic, it was found that products with Dutasteride grew more than those of Finasteride. Total sales of Avodart's generics in the first quarter was 7.5 billion won, up 22% from 6.1 billion won in the first quarter of last year. During the same period, Propecia's generics increased only 9% from 12.3 billion won to 13.5 billion won. Sales of major generic products also reflected this trend Among generics for Propecia, sales of the u pharmaceutical's Momopecia increased 7% from 1.4 billion won to 1.6 billion won in a year, while JW's Monda and Genuonesciences's Mypecia fell 19% and 18%, respectively. In the case of generics for Avodart, Sales of Hanall Biopharma's Adamo tripled from 200 million won to 600 million won in a year. The pharmaceutical industry points to price competitiveness as one of the reasons for the increase or decrease in sales of major products. Recently, price competition has been fierce in the hair loss treatment market. Looking at the price supplied to the drugstore's online mall, the original product Propecia costs around 1,590 won. When THE U released Momopecia in 2020, it put a price tag of 600 won per tablet, which is less than half of the original. Momopecia has quickly grown into the highest-selling product among Propecia products with price competitiveness. As Momopecia grew rapidly, lower-priced products also appeared. In the second half of last year, DNBIO set a price of 350 won per 1mg dose t when it released Finaon. Other generic companies are said to have lowered prices one after another. As low-priced products grew around Momopecia, sales of existing high-end generic products such as Original Propecia and Monad (1,320 won) and Mypecia (960 won) naturally decreased. It is explained that Sales growth of Avodart is also related to price. Avodart is currently supplying 0.5mg dose at around 700 won. As the patent expired in 2016, Avodart lowered the existing drug price from 1,300 won to 920 won. In 2017, it was further reduced to 700 won, adding half the price tag compared to Propecia.
Company
Sales of Nexavar fell sharply
by
Jun 08, 2022 05:55am
Sales of Nexavar, which has dominated the primary treatment market for liver cancer for 10 years, are falling. This is because prices have fallen due to the release of generic products, and the status of the first treatment for liver cancer as a new drug has been shaken. Compared to two years ago, quarterly sales have halved. ◆Tecentriq with Lenvima 1Q Sales Half According to IQVIA, a pharmaceutical research agency, on the 30th, Lenvima recorded 2 billion won in sales in the first quarter. The figure is down 41.2% from 3.4 billion won a year earlier. Nexavar's sales have been falling for seven consecutive quarters since the second quarter of 2020. Compared to two years ago, quarterly sales fell more than half from 5.1 billion won to 2 billion won. With the advent of competitive drugs, sales of Nexavar began to decline. It is Lenvima, a new drug for liver cancer treatment that appeared in 10 years. Lenvima, which is used as the first treatment for liver cancer along with Nexavar, narrowed the gap with Nexavar and succeeded in reversing the first quarter of 2021. Lenvima posted 4 billion won in sales in the last quarter, up 17.6% from the same period last year. Nexavar is the first targeted treatment to appear in the market for liver cancer treatments that are difficult to develop. It has been firmly established as the only liver cancer treatment for more than a decade. Annual sales amounted to 26 billion won. Nexavar began to falter with the launch of Lenvima. Initially, sales of Nexavar were overwhelming due to the strength of sequential treatment leading to Nexavar-Stivarga. However, Lenvima slowly boosted its influence with improved data. In October 2019, benefits were applied as the first treatment and settled in the 3 billion won in quarterly sales. ◆ Competitive drugs are emerging one after another Recently, the decline in Nexavar sales has become steeper with the emergence of generics. The government cut Nexavar's insurance cap by 30% in February last year. The move comes after Hanmi Pharmaceutical, which overcame Nexavar's patent, launched generics. Accordingly, the upper limit of Nexavar insurance fell from 18,560 won to 12,992 won. Nexavar Immediately after the weak cut was applied, quarterly sales of Nexavar fell 32% from the previous quarter, and were affected by the cut. Since then, Nexavar has continued its quarterly sales of 2 billion won. generic for Nexavar, released by Hanmi Pharmaceutical, posted sales of more than 400 million won in the first quarter, the fifth quarter of its release. Recently, as a new primary benefit option, it is a combination of Tecentriq, an immuno-cancer drug with a completely different mechanism from Nexava, and Avastin, an anti-VEGF treatment. Tecentriq+ Avastin combination therapy predicted a sensation from the first data release. This is because the reaction rate was more than twice that of Nexavar, and the significantly improved OS and PFS were recorded. Tecentriq combined therapy has already begun to exert influence by expanding its indications as the first treatment for hepatocellular carcinoma in July 2020. Starting this month, the impact is expected to increase further as benefits will be applied to the first treatment. Although there are still no drugs that can be used after Tecentriq therapy, it is predicted that the paradigm of primary treatment, which mainly used Nexavar or Lenvima, will change to Tecentriq therapy.
Policy
The price gap between Memantine products is more than 2.5x
by
Lee, Tak-Sun
Jun 07, 2022 06:04am
Original for Memantine HCl The price difference between Memantine producst was more than 2.5 times. This is because if there are more than 20 generics depending on the price calculation formula, new products are listed at 85% of the lowest price. Memantine preparations have originally had a large price gap between products, but the gap is widening according to this price calculation formula. According to the industry on the 6th, Ibixa (Memantine HCl) of I-World Pharmaceutical was listed at 334 won on the 1st, which is 85% of the lowest price of the listed same product, as more than 20 products are listed. Before Ibixa's registration, 64 Memantine HCl 10mg preparations were registered, and the lowest price was 393 won for Dongkook Pharmaceutical's Mmentine 10mg. Accordingly, Ibixa was registered at 334, which is 85% of 393 won. Since there are more than 20 generics, the drug price will fall again to 85% of the lowest price if the next product is listed. With the registration of Ibixa, the gap between the highest and lowest prices of Memantine products is more than 2.5 times. The highest price is 845 won. The original for Memantine, Ebixa, costs 803 won. In particular, the price difference between the same drugs is widening in dementia treatments. Donepezil tablet 5mg has quadrupled the price difference between the same drugs. It is analyzed that this is due to the specificity of the dementia treatment market. This is because the market size is large and competition is fierce, but it is not easy to enter customers. Regardless of the price difference, this market has high confidence in patients and medical staff for the original. In addition, because the prescription rate of nursing hospitals that are difficult to access (CSO) is high, the lowest-priced products targeting this are also emerging. An official from the pharmaceutical industry said, "The price strategy of dementia treatments takes into account the specificity of Rx." He explained, "In the case of low-priced drugs, there are preferred medical staff because they are not burdensome to use with other drugs, and it seems that they were aiming for the demand to purchase high-priced drugs at low prices and receive incentives." Analysts say that the price difference does not have a significant impact on patients because patient copy of dementia patients is small. However, the industry reports that such a price difference occurs because the preferences of doctors are different.
Company
Neutropenia drugs' sales affected by their sales partners
by
Chon, Seung-Hyun
Jun 07, 2022 06:04am
GC Pharma and Kyowa Kirin are fiercely competing for the lead in the neutropenia treatment market in Korea. At the end of last year, GC Pharma’s Neulapeg had risen to the lead for the first time in 7 years, but Kyowa Kirin has again taken over the lead with Neulasta. The addition of Boryung’s sales power to the products is affecting the sales rank of the two drugs in Korea. According to the pharmaceutical market research institution IQVIQ, Neulasta sold the most and raised ₩6.5 billion in sales in the neutropenia treatment market in Q1 this year. Rising 4.9% YoY, Neulasta took back the lead that it had lost to Neulapeg in Q4 last year. Neutropenia treatments prevent cancer patients from developing the side effect of a weakened immune system due to decreased neutrophil levels when they receive anticancer therapies. Neutrophils are a type of white blood cell that fight infections from bacteria, etc. Neulasta, a pegfilgrastim ingredient drug that was approved in 2012 in Korea is a second-generation neutropenia treatment. Neulapeg’s rising sales have been challenging the lead held by Neulasta in the neutropenia treatment market. Neulapeg is a neutropenia treatment made with pegteograstim and is indicated for ‘the reduction of the duration of neutropenia in patients treated to eliminate solid tumor and malignant lymphoma with cytotoxic chemotherapy.’ Neulapeg is the first biologic anticancer therapy that was developed with GC Pharma’s original technology Neulapeg had little commercial success in the early days of its release. Sales in 2017 and 2018 were only ₩3.2 billion and ₩4 billion, respectively. Most of its quarterly sales had been less than ₩1 billion. However, its sales started to rise steeply with the addition of Boryung’s sales power GC Pharma had signed a joint sales agreement with Boryung in October 2018 to expand the share of Neulapeg by using the sales power held by Boryung Pharmaceutical in the field of anticancer drugs. In Q1 2019, immediately after Boryung’s addition, Neulapeg accumulated sales of ₩1.3 billion and made a new quarterly sales record. Since then, the drug has continued on its rise to record ₩6.3 billion in sales in Q4 last year. Sales had increased sevenfold in only 3 years from the ₩0.9 billion in Q3 2018 before Boryung’s addition to take over the lead product in the market. This change in market demographics is analyzed to be greatly influenced by the switching of sales partners of Neulasta and Neulapeg recently. Boryung, which had driven the rapid growth of Neulapeg, has been selling Neulasta from the start of this year. Boryung had contributed to Neulapeg’s rise to the top at the end of last year, and to Neulasta’s takeover of the lead again this year. In place of Boryung, Jeil Pharmaceutical has been selling Neulapeg as GC Cross’s partner. The company has experience selling Neulasta from 2014 to 2017.
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