- LOGIN
- MemberShip
- 2026-04-12 05:55:22
- Policy
- The first COVID-19 vaccine is expected to be approved
- by Lee, Hye-Kyung Jun 28, 2022 06:09am
- Seo Kyung-won, Director General of the National Institute of Food and Drug Safety EvaluationSK Bioscience's "SKY Covione," Korea's No. 1 COVID-19 vaccine, is expected to receive product permission within this month. Seo Kyung-won, Director General of the National Institute of Food and Drug Safety Evaluation, held a briefing at 10 a.m. on the 27th and said, "We will hold a final inspection committee within this month as possible and conclude the final item approval." The MFDS held a meeting of the safety and effectiveness verification advisory group for SKY Covione, which received item permits on April 29, and held the Central Pharmaceutical Affairs Council on the 26th to decide whether to recognize safety and effectiveness. According to the progress of the COVID-19 vaccine permit review, the final item approval will be granted after the 2nd Central Pharmaceutical Affairs Council and the 3rd final inspection committee following the 1st verification advisory meeting. Director Seo said, "SKY Covione is a meaningful vaccine that has been developed in Korea and completed everything from raw materials to commercialization," adding, "It is difficult to say the final approval date, but we are doing our best to take place within this month." The final inspection committee is a process of final inspection to see if the results of the first and second consultations are properly reflected in the permit, which leads to item approval immediately after this step. Meanwhile, the Central Pharmaceutical Affairs Council discussed whether to recognize the safety and effectiveness of SKY Covione and determined that safety, such as abnormal cases in clinical trials, was acceptable. The approval review is currently being conducted with two basic vaccinations, and additional booster shots will be decided after the clinical trial is completed. She added, "Additional vaccination is a clinical trial stage, and it is necessary to discuss with related ministries such as KDCA in the future whether the fourth additional vaccination is possible in preparation for the re-pandemic of COVID-19 in the fall."
- Company
- Kwangdong will sell GSK’s allergic rhinitis treatment
- by Chon, Seung-Hyun Jun 28, 2022 06:09am
- Kwangdong Pharmaceutical announced on the 27th that it has signed a sales partnership agreement with GSK for its allergic rhinitis treatment, ‘Avamys nasal spray.’ Avamys, which was granted marketing authorization in Korea in 2009 is a steroid nasal spray indicated for the treatment of seasonal and perennial (year-round) allergic rhinitis in people 2 years of age and older. It mainly helps reduce the symptoms of allergic rhinitis such as itchy eyes, nasal congestion, runny or itchy nose, etc., and may be prescribed at the doctor’s discretion in various departments including otolaryngology, internal medicine, and pediatrics. Avaymys contains the active substance fluticasone furoate 0.05g that is provided in a spray-type device that is easy to spray into the nasal cavity and may be sprayed up to 120 times. Its 24-hour relief of allergy symptoms is also considered one of its biggest conveniences. An official from Kwangdong Pharmaceutical said, “We have decided to expand our business relations based on the strong trust established between the two companies since 2015 when we began working with GSK for the sale and distribution of their vaccine. We hope to further contribute to improving the allergic rhinitis treatment environment for the suffering patients and HCPs with Avamys.”
- Policy
- Fenofibrate regardless of meals will be listed next month
- by Lee, Tak-Sun Jun 28, 2022 06:09am
- Fenofibrate tablets, which can be taken regardless of meals, will be listed for the first time in Korea. Fenofibrate is a drug used for primary hyperlipidemia. Existing drugs should be administered after meals. Therefore, the newly registered product is expected to improve the convenience of patients. According to the MOHW on the 24th, Yuhan's Fenowell 145mg will be listed at 339 won on the 1st of next month. Fenowell 145 mg is the only Fenofibrate tablet with 145 mg. In addition, it has the advantage of oral administration regardless of meals. It is used for primary hyperlipidemia such as hypercholesterolemia (Type IIa), hypercholesterolemia and hypertriglycerideemia (Type IIb, Type III), and hypertriglycerideemia (Type IV). Adults can take only one tablet (145 mg) a day regardless of meals. Existing Fenofibrate formulations should be administered orally immediately after meals at a dose of 160 mg. It is considered absorption in the stomach. Fenowell 145mg is absorbed by the gastrointestinal tract so it can be taken regardless of food intake. The original is Abbott's Tricor, which was approved by the US FDA in 2004. It is a drug that has not been introduced in Korea. Fenofibrate cholins can also be taken regardless of meal. There is TG Fenon, Daewon Pharmaceutical of Fenocholine by Korea Pharma. Hanmi's Fenocid can be taken regardless of meal. These items are now leading the market with this convenience. Yuhan preoccupied the related domestic market in November 2020 with the approval of Fenowell 145mg. In the same month, GC Pharma was also approved for the same product, Neofeno 145 mg. This product is commissioned by Yuhan. GC Pharma's product is not listed this time, so Yuhan is the only one that sells it with 145mg tablets. The price of 339 won is also cheaper than the existing tablets. Currently, the upper limit of 160mg of Fenofibrate tablets ranges from 316 won to 356 won. Excluding three of these products, the remaining 18 products are listed at the highest price of 356 won. Analysts say that despite the improved convenience of taking drugs, the price is also cheaper, which may serve as a factor for replacing prescriptions. GC Pharma's Lipidil supra, a leading item in the market, recorded 16.5 billion won in outpatient prescriptions last year. The total domestic market is also worth 90 billion won. Attention is being paid to whether the new limited product, which upgraded existing products, will be able to change its competitive structure in the market.
- Company
- Oral SMA drug Evrysdi may be prescribed at general hospitals
- by Eo, Yun-Ho Jun 27, 2022 05:58am
- The oral spinal muscular atrophy (SMA) treatment ‘Evrysdi’ may be prescribed at general hospitals. According to industry sources, Roche Korea’s SMA treatment Evrysdi (risdiplam) passed the drug committee (DC) reviews of several medical institutions including Seoul National University Hospital. Evrysdi was first approved in Korea in November 2020 ‘to treat SMA in adults and children 2 months of age and older.’ In the US, its indication has recently been extended to cover infants less than 2 months of age. As the first oral option introduced in the field of SMA, Evrysdi has the advantage of allowing customization according to age and weight. However, its reimbursement listing process is making little progress. The drug applied for listing in July last year but had made no progress so far. Currently, Biogen’s ‘Spinraza (nusinersen)’ is listed for reimbursement in SMA, and Novartis’ Zolgensma (onasemnogene abeparvovec-xioi) is under drug pricing negotiations with the National Health Insurance Service. As Roche Korea may accept a relatively lower price for Evrysdi than the other high-priced drugs above, this reimbursement competition may also be worth attention in the future. Meanwhile, Evrysdi’s efficacy has been demonstrated through the FIREFISH trial conducted on infants from 2 months to 7 months of age, and the SUNFISH trial conducted on children and adults from 2 years to 25 years of age. In the SUNFISH trial on 180 Type 2 or 3 SMA patients, Evrysdi improved motor function at month 12, as measured by the Motor Function Measure 32 (MFM-32) score from baseline. Also, in the FIREFISH trial that was conducted on infants 2 to 7 months of age with Type 1 SMA, 88% of the patients that were administered Evrysdi for 2 years survived the 2 consecutive years without ventilator support. Based on the Bailey Infant Development Test (BSID-III) that measures infant development and motor activity, 59% of the infants that were administered Evrysdi were able to sit without support for at least 5 seconds. Also, 65% of the infants were able to control their neck for 1 year, 29% were able to turn on their buttocks, and 30% were able to stand with support.
- Policy
- The use of Benzalconium chloride is not interrupted
- by Lee, Hye-Kyung Jun 27, 2022 05:58am
- As a result of reviewing the feasibility of safety management measures for drugs containing Benzalconium chloride used as humidifier disinfectants, it was concluded that there was no basis for restricting the use of drugs. Benzalconium chloride is used as daily necessities such as hand sanitizers, nose sanitizers, eyewash, preservatives, preservatives, antibacterial tissues, floor cleaners, and other medicines such as surgical tool disinfectants and skin disease treatments. According to the minutes of the Central Pharmaceutical Review Committee recently released by the MFDS, the safety of Benzalconium-containing drugs should be considered separately from repeated inhalation toxicity tests of Benzalconium chloride conducted by the Ministry of Environment. In the case of drugs, it is tested at 100% purity, but according to the repeated inhalation toxicity test conducted by the Ministry of Environment, the purity of Benzalconium chloride is 50.5%, which is not suitable for the toxicity test criteria for drugs. Although the nasal spray containing Benzalconium chloride has been used for a long time, there are no data that the product has caused problems in the respiratory system so far, so there were opinions that excessive information could cause fear to users. When comprehensively reviewing related data such as conference data, it is not enough evidence to stop using Benzalconium chloride in medicines based on the Ministry of Environment's report on repeated inhalation toxicity. The prevailing opinion was that the MFDS should end up with strengthening safety use and changing permits for information disclosure rather than suspending the use of Benzalconium-containing drugs. The MFDS said, "As a result of a comprehensive review of safety, efficacy, and adverse reactions, it should be judged in consideration of benefits and risks in medicines. We will collect opinions from external experts and provide accurate information." Rather than reflecting safety information only on precautions for use, it is necessary to ensure that meaningful information is delivered for patients who have no choice but to use drugs containing Benzalconium chloride, such as asthma treatments, according to their doctor's instructions, said a member. The MFDS reviewed various measures such as inquiring opinions on changing usage precautions to provide accurate information to consumers, and expressed its opinion that it would communicate between related ministries.
- Company
- This time it’s acyclovir… impurity issue rises again
- by Chon, Seung-Hyun Jun 27, 2022 05:57am
- The drug impurity risk issue has spread to the antiviral acyclovir. According to the impurity issue that arose abroad, the health authorities have started making safety measures on pharmaceutical companies. According to industry sources on the 23rd, the Ministry of Food and Drug Safety has recently ordered pharmaceutical companies to conduct a review for N-nitrosodimethylamine (NDMA) impurities on finished drugs that contain acyclovir. The MFDS has ordered the companies to submit test results conducted on the companies’ representative batch numbers of the finished acyclovir products available on market. Products that are manufactured in below 3 batch numbers are required to submit test results of all batches This safety measure was made according to the safety information that finished tablet products containing acyclovir were recalled abroad due to excess NDMA impurities. The MFDS ordered companies to immediately report their test results after completion even before the impurity data submission deadline. Acyclovir is an antiviral used for the ‘treatment and prevention of initial and recurrent genital herpes, Herpes Simplex Virus Encephalitis, and Mucocutaneous Herpes Simplex Virus Infection’ as well as for the ‘treatment of herpes zoster (Shingles).’ Its annual outpatient prescriptions amount to 15 billion won a year. This is the first time an impurity issue arose in the area, and around 50 companies sell acyclovir tablets in Korea. With acyclovir, the total number of ingredients with new impurity risks increased to 3. The MFDS had previously requested pharmaceutical companies to investigate their montelukast imported and manufactured APIs and finished products for N-nitrosodipropylamin (NDPA) impurities and submit its results in January. In April, the MFDS had ordered pharmaceutical companies to submit data including the impurity test results and data on the possibility of N-Nitroso-Aryl Piperazine (NNAP) impurities in quetiapine products.
- Company
- Belvarafenib confirmed its safety & effectiveness
- by Chon, Seung-Hyun Jun 27, 2022 05:57am
- Major clinical results of Belvarafenib + Cobimetinib included in Roche corporate briefing dataA study showed that the new anticancer drug Belvarafenib, which Hanmi Pharmaceutical exported technology to Genentech, confirmed its safety and effectiveness overseas. According to Hanmi Pharmaceutical on the 22nd, Roche revealed the progress of clinical research on "Belvarafenib," which is being developed by its subsidiary Genentech, at a corporate briefing held during the recent ASCO event. Belvarafenib, which Hanmi Pharmaceutical exported to Genentech in 2016, is a targeted anticancer drug based on pan-RAF inhibitors. It acts as a mechanism to suppress RAF, a type of MAP kinase that mediates intracellular signaling. Hanmi Pharmaceutical received $80 million in a contract for the export of Belvarafenib technology. Roche introduced data on the efficacy and safety of patients with NRAS mutated melanoma identified as clinical trials (1b) for combined administration of Belvarafenib and Cobimetinib (MEK inhibitor) in 118 patients with different types of solid cancer with RAF or RAS mutations. According to the announcement, 26.3% of NRAS mutated melanoma patients administered belvarafenib and Cobimetinib showed partial response (PR), and 42.1% of patients reached stable lesion (SD). The median value of the total progression-free survival period (PFS) was 7.3 months. No new adverse reactions were observed beyond the safety of individual drugs. All patients who showed partial reactions were NRAS mutant melanoma patients with a history of treatment with Imune checkpoint inhibitor, and this result could show new hope for patients who recurred after Imune checkpoint inhibitor treatment, Hanmi Pharmaceutical explained. "Belvarafenib, developed by Hanmi Pharmaceutical, is a powerful selective RAF mutation inhibitor," said Andrew Chan, managing director of Genentech. "We confirmed its safety and anti-tumor effects when administered in combination with Cobimetinib in patients with NRAS mutated melanoma who previously received Imune checkpoint treatment." An official from Hanmi Pharmaceutical said, "Innovative anticancer drugs developed and exported by Hanmi Pharmaceutical are being developed smoothly based on close consultation with partners," adding, "We will focus more on R&D capabilities for rapid commercialization of various innovative drugs, including Belvarafenib."
- Company
- The flu is going around in the southern hemisphere
- by Whang, byung-woo Jun 27, 2022 05:57am
- Concerns are growing that the influenza epidemic may begin as the COVID-19 pandemic turns into an endemic and social distancing such as lifting outdoor masks is eased. As the flu is showing signs of a full-fledged epidemic in Australia, one of the southern hemisphere countries that uses the flu as an indicator of the flu epidemic in the second half of the year, concerns are also being raised. It is pointed out that it is necessary to prepare countermeasures as the flu vaccination rate has fallen due to the influence of the COVID-19 pandemic over the past two years, and there may be repercussions from the release of masks. In the case of the flu epidemic, the epidemic scenario in the northern hemisphere is often calculated based on the situation in the southern hemisphere in the first half of the year. As winter comes first in the southern hemisphere, it is to guess the trend of infectious diseases. According to the Australian Influenza Surveillance Report (AISR), published biweekly by the Department of Health, the number of patients with flu symptoms in Australia has increased since March this year. In May, Australia's medical institutions confirmed influenza viruses in samples such as patient sputum and runny nose and reported more than 25,000 cases to the Ministry of Health per week, and by early June, 87,989 cases were reported to Australia's NNDSS, of which 47,860 occurred in late May and early June. This is a rapid increase compared to data from the past five years, and the gap is wider considering that the flu epidemic has not occurred due to COVID-19 in the past two years. In the end, it is pointed out that the same phenomenon may occur during the domestic flu epidemic in the second half of the year. Jung, Ki-seok, a professor of respiratory medicine at Hallym University Sungsim Hospital, said, "I don't know how much more exchanges between countries will occur in the second half, but I think the domestic flu will be the same." He said, "It is also difficult to predict the presence or absence of new mutations in COVID-19, but I think it is highly likely to be prevalent once more." Choi Young-joon, general director of the KSPID (Korea University's Department of Pediatrics and Adolescents), also said, "We say that the epidemic will be this year because we haven't caught much flu over the past two years," adding, "There has been no local transmission and there is a high possibility of infection." Companies such as Pfizer and Moderna have started to develop Combo vaccines that inoculate flu vaccines and COVID-19 vaccines at once, but as they have not yet succeeded in developing them, it is also the best countermeasure to plan individual vaccination plans at this stage. During the COVID-19 pandemic, the number of vaccinations increased significantly due to concerns over twin-demic during the 2020 vaccination period, but the site explained that NIP-oriented flu vaccinations were made in 2021. Vice Chairman of the KIES Shin Kwang-chul said, "In 2020, I have been vaccinated the most and I remember securing as many flu vaccines as possible," adding, "But last year, we set the demand for flu vaccines low enough to order only 30% of the quantity in 2020." With the possibility of a flu epidemic, companies that produce flu vaccines are also getting busy. As SK Bioscience has not produced a flu vaccine this year following last year, domestic companies and multinational pharmaceutical companies are filling it up. Sanofi Pasteur has already submitted to supply 2.2 million doses per dose at 10, 433 won per dose in connection with the procurement of the national vaccination (free flu vaccine vaccination project) for influenza vaccines, and has been selected as the top priority. 3 million doses of flu vaccine for Ilyang Pharmaceutical, which previously included NIP, are expected to be vaccinated in the private market. Already on the 18th of last month, U.S. health authorities began discussing ways to vaccinate flu and coronavirus at the same time in preparation for the simultaneous spread of COVID-19 and flu in winter. There are negative opinions due to concerns over the stability of vaccinating two vaccines, but we cannot ignore the situation in which twin-demise will occur. Domestic experts also say that it is necessary to consider temporarily expanding the scope of NIP as well as vaccinating COVID-19 and flu vaccines at the same time. Professor Jeong said, "There will be no big problem because the guidelines have already been set for inoculating two types of vaccines with one arm on each side." "If the flu vaccine epidemic is expected, we think it will be necessary to think about expanding the NIP range as we did before," he said.
- Policy
- Is "Platform of Drug Delivery" starting?
- by Lee, Jeong-Hwan Jun 24, 2022 05:46am
- The Ministry of Science and Technology recently decided on the demonstration exception of OTC teleconference bending machine at the 22nd ICT regulatory sandbox meetingWill the new government's implementation of the OTC teleconference bending machine demonstration special case serve as a signal for full-fledged activation of the "drug delivery platform"? Analysts say that as the government introduced the OTC teleconference bending machine, which is virtually not allowed by the Pharmaceutical Affairs Act, regulations on platform operators such as drug delivery apps are also likely to be eased significantly in the future. In particular, the Ministry of Science and ICT seems to be more proactive in looking at deregulation as the situation develops rather than the MOHW at the forefront of management and regulation of non-face-to-face treatment and drug delivery apps. On the 23rd, the health and medical community is paying keen attention to the direction of the new government's digital platform policy operation. Yoon Seok-yeol's government has decided to foster the digital online platform industry as a national task. In order to revitalize new industries, it is in a position to boldly break down existing regulatory barriers and collect opinions from industries quickly and actively. The OTC teleconference bending machine regulation special case seems to be the result of reflecting this new government policy. The problem is that the OTC teleconference bending machine is a regulatory exception that is relatively local and has little ripple effect. Digital platform technology is not used in that electronic devices are installed inside and outside existing pharmacies to allow the sale of general drugs in some efficacy groups with the pharmacist's OTC teleconference bending machine medication map. In the end, it is evaluated that deregulation of digital platforms in the health care sector will gradually flow in the direction of activating drug delivery platforms. The new government is implementing a one-sided policy of deregulation of digital platforms every day. The Ministry of Science and Technology is planning to lead the promotion of platforms by jointly announcing strategies for developing digital platforms within this year. Minister of Science and Technology Lee Jong-ho recently held a policy forum with digital platform companies such as Naver, Kakao, and Coupang and promised to "establish a private-led self-regulatory organization." The plan is to increase the effectiveness by providing legal grounds for establishing and supporting self-regulatory organizations so that the private sector, not the government, can set up platform regulations on its own. Of course, health and medical platform companies such as drug delivery apps did not attend the forum, but the wider the scope of the government's promotion of the platform industry, the more likely the drug delivery apps will also benefit from deregulation. The opposition Democratic Party of Korea is expressing some concern about the stance of the new government. Even if the digital platform industry is fostered, the Democratic Party of Korea believes that deregulation should be applied conservatively in health care fields such as non-face-to-face treatment and drug delivery apps. It's directly related to national health It takes into account the fact that it can bring considerable shock waves to the health care delivery system such as local clinics and the ecosystem of pharmacies. An official from the Democratic Party's policy committee said, "The OTC teleconference bending machine was applied by the government to the regulatory sandbox track after it was put on hold during the legislative debate in the National Assembly. Although it was allowed, I don't think the actual ripple effect will be significant, he said. "However, there will definitely be an effect of activating platform operators such as drug delivery services." The OTC teleconference bending machine is an agenda limited to pharmacists in a way, but the activation of health care platforms such as non-face-to-face treatment and drug delivery apps will have a great impact on the medical community and the pharmaceutical community, the official said. It will be necessary to respond to platform regulations in the health care sector," he added.
- Company
- Sanofi’s Allegra dominates OTC·ETC drug market
- by Nho, Byung Chul Jun 24, 2022 05:46am
- The market for OTCs and ETCs of the antihistamine ingredient fexofenadine hydrochloride has been showing stagnant performance with its sales making a rectangle pattern for several years now. The market is virtually monopolized by the original drug, Sanofi’s Allegra Tab., with the total market estimated to be in the ₩8 billion range. One aspect to note is that the high-dose 120mg Allegra Tab. is listed for reimbursement as an OTC, and the other 180·60·30mg strengths of Allegra are distributed and prescribed as ETCs in Korea. This is analyzed as a strategic decision made by the company in consideration of the clinical protocol, design, and efficacy of its drug. Allegra is in the undisputed lead among fexofenadine hydrochloride OTCs, showing a vendor performance of ₩2-3 billion. Hanmi Pharmaceutical's Fexonadine, Huon’s Allerdin, and Chong Kun Dang’s Pecsone 120mg had sold ₩350 million, ₩150 million, and 120 million each, respectively. These latecomers were all released around 2005 and 2008, and all three drugs are all listed at ₩226 per tablet. The price of Sanofi’s finished imported pharmaceutical, the OTC Allegra, has been discounted to ₩225/tablet in 2017, ₩224/tablet in 2018, then to ₩222 in 2022, and is currently sold at a lower price than its domestic latecomers. Allegra and other OTC drugs with identical APIs that are effective in alleviating symptoms of allergic rhinitis are recommended to be administered with caution in patients with kidney failure, cardiovascular disease, or old age, and require particular medication guidance on the pharmacist’s part. In addition, its related ingredients are classified as pregnancy risk category C, and are used when there is a clear clinical basis or reason for its inevitable use. In the fexofenadine hydrochloride ETC market, the original, Sanofi’s Allegra and its bioequivalent, Hanmi Pharmaceutical’s Fexonadine are in a two-way battle. Allegra 180mg sold ₩3.1 billion, Fexonadine 180mg ₩870 million last year, and Allegra 30mg ₩240 million, Fexonadine 30mg ₩140 million. The 180mg strength of Allegra that was approved in 2000 is used to treat allergic dermatitis, and its price had been reduced to ₩314/tablet in 2017, ₩313/tablet in 2018, ₩312/tablet in 2020, and then to ₩311/tablet in 2022. The price of Allegra 60mg is currently set at ₩181/tablet and is effective in relieving symptoms of seasonal allergic rhinitis. According to the insert paper, etc. patients with hypertension, diabetic kidney disease, hyperthyroidism, and benign prostatic hyperplasia are requested to consult with their doctor, dentist, or pharmacist before taking the drug. Allegra 30mg, which is priced at ₩91/tablet, is prescribed to relieve symptoms of seasonal allergic rhinitis and allergic dermatitis. Hanmi Pharmaceutical’s Fexonadine 30mg, which was approved as a bioequivalence-assured product in 2007 is listed at ₩91/tablet, at the same price as the original drug. Meanwhile, one point of interest is in their distribution. The distribution of Allegra is dualized so that the OTCs are directly managed by Sanofi while the ETCs are imported and sold by Handok Pharmaceuticals.
