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- 2026-03-16 21:30:23
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- The anesthetic drug Byfavo is available in general hospitals
- by Eo, Yun-Ho Sep 26, 2022 06:08am
- Byfavo, the first anesthetic drug in 30 years, has settled on a general hospital prescription. According to related industries, Hana Pharmaceutical's Byfavo passed the Drug Commission (DC) of Big 5 General Hospitals, including Seoul National University Hospital, Asan Medical Center, and Sinchon Severance Hospital. Byfavo is a new anesthetic drug released more than 30 years after the approval of the frequency prescription general anesthetic Propofol. Byfavo, which was launched in March, secured manufacturing rights and exclusive sales rights from Germany's Paion in 2013. Since 2018, phase 3 clinical trials have been completed for 198 subjects who perform general anesthesia in Korea. The main indication is inducing and maintaining general anesthesia in adults. Byfavo is a pure anesthetic new drug that has no analgesic effect, and has pharmacological and pharmacological advantages of existing general anesthetics such as Propofol and Midazolam. Hana is under construction with German freeze-drying facilities through its new Hagi plant, which is expected to operate in 2023, and designed to supply Byfavo to advanced markets. In addition, it acquired additional copyrights to Byfavo in six Southeast Asian countries from the original developer Paion in Germany, and completed all internal work to receive permission documents in these countries
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- Half of pts with macular degeneration have ↓ effect
- by Sep 26, 2022 06:07am
- Researchers expect the new VEGF inhibitor Beovu to address unmet demand. Patients with neovascular age-related macular degeneration in Korea had more than half of retinal exudates at the time of one year of treatment, indicating that the vision improvement effect was not significant. It was found in PROOF, which evaluated the retinal exudate regulation effect of the first year of existing VEGF inhibitor treatment in age-related macular degeneration patients. The results of the PROOF study, in which 12 domestic ophthalmic medical staff, including Kim Jae-hwi, a specialist at Kim's eye clinc, participated as the author, were published in the Scientific Reports on August 19. According to the study, more than half of the age-related macular degeneration patients in Korea treated with existing VEGF inhibitors such as Lucentis and Eylea remained retinal exudates until the first year of treatment, and their vision improvement effects were relatively poor. The PROOF study is a retrospective study based on the medical records of 600 age-related macular degeneration patients who visited ophthalmology hospitals in Korea from January 2017 to March 2019. The primary evaluation index is the proportion of patients with retinal exudations such as intra-retinal fluid/retinal subcutaneous fluid in the first year of treatment. In the early stages of treatment, 97.2% of patients had retinal exudate, and the rate after one year was 58.1%. The intra-retinal fluid, sub-retinal fluid, and retinal pigment epithelial fluid remained in 24.7%, 37.6%, and 21.2%, respectively. The proportion of patients with retinal exudate in the second year (24 months) of treatment reached 66.0%. In the first year of treatment, patients who did not have retinal effusions adjusted showed better eyesight improvement compared to those who did not. Patients with continuous retinal exudation control for a long period of time until the first year of treatment also showed better vision improvement effects. Whether retinal exudates remain is a major factor affecting vision improvement. Retinal exudates are frequently observed through optical tomography in age-related macular degeneration patients. Some studies have shown that if a new retinal exudate occurs during treatment, vision is likely to decrease by more than five characters. Retinal exudation is considered a sign of disease activity and requires additional VEGF inhibitor treatment. The researchers explained, "In actual clinical sites, there is a burden of treatment of existing VEGF inhibitors due to problems such as frequent administration and frequent hospital visits, and patients are not seeing the optimal treatment effect from a long-term perspective." Accordingly, it is expected that new anti-VEGF treatment therapy will be expected to help solve the unmet demand by reducing the burden of treatment with a prolonged mechanism of action. The researchers mentioned Beovu as a new anti-VEGF treatment. Brolusizumab is an antibody fragment drug that inhibits all VEGF-A isomorphic proteins. In phase 3 clinical trials, the Blucizumab 6mg dose group showed better disease control effects, including superior retinal exudation control effects compared to the Aflibercept 2mg group. After administration of loading dose, the Aflibercept group was administered every 8 weeks, while more than 50% of the Brolucizumab group was administered every 12 weeks. Kang Se-woong, an ophthalmologist at Samsung Medical Center at Sungkyunkwan University, said, "The emergence of anti-VEGF treatments has lowered the rate of blind or vision-damaged patients, but there is still an unmet demand for retinal exudation." He said, "We welcome the introduction of new and diverse treatment options to clinical sites and hope that this will help address unmet demand and ultimately prevent patients from impaired vision."
- Company
- Nubeqa can be prescribed at general hospitals
- by Eo, Yun-Ho Sep 23, 2022 05:52am
- Nubeqa, a prostate cancer treatment, can be prescribed at general hospitals. According to related industries, Bayer Korea's oral androgen receptor inhibitor (ARi) Nubeqa for nmCRPC treatment passed the DC of medical institutions such as Samsung Medical Center, Seoul National University Hospital, Seoul Asan Hospital, and Sinchon Severance Hospital. Nubeqa has not yet been covered by insurance benefits, so it is expected to take time to lead to actual prescription activation. The drug has not been registered since the HIRA Cancer Disease Review Committee ruled it failed in February 2021. Nubeqa is an androgen receptor inhibitor with a unique chemical structure that binds to androgen receptors to inhibit the growth of prostate pressure cells through strong antagonism. It was approved based on ARAMIS, a phase 3 clinical study that compared and evaluated the efficacy and safety of Nubeqa and placebo controls in combination with ADT. The main evaluation item of the study, MFS, was 40.4 months in the Nubeqa and ADT combinations, demonstrating significant improvement over 18.4 months in the placebo and ADT combinations. It was confirmed that the risk of death decreased by 31%. In addition, the Overall Survival data derived from the final analysis results pre-specified in a recent ARAMIS study was published in the New England of Medicine (NEJM) on the 9th. As a result of the study, the combined survival period of the Nubeqa and ADT groups was statistically significantly improved compared to the combined placebo and ADT groups, and the risk of death decreased by 31%. This result is significant in that as of November 15, 2019, when data for final analysis was confirmed, 55% of patients in combination placebo and ADT received treatment for Nubeqa or other life extension as follow-up treatment.
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- Aricept grows to make ₩70B ... Ebixa nears ₩15B
- by Nho, Byung Chul Sep 22, 2022 06:02am
- Eisai Korea’s Aricept (donepezil hydrochloride) continued on its solid lead in the original Alzheimer’s treatment market, occupying nearly 70% of the KRW 100 billion market. According to drug distribution performance data, Aricept’s made KRW 71 billion, 65.5 billion, 69.2 billion, and 70.3 billion in 2018, 2019, 2020, and 2021, respectively, virtually leading the market ever since its release. Aricept Evess, an orally disintegrating tablet formulation with the same ingredient that was approved in 2008 has been showing sales in the KRW 6 billion to 9 billion range. The runner-up in the market, Lundbeck Korea’s Ebixa (memantine hydrochloride), which had maintained blockbuster-worthy sales in the KRW 10 billion range for 3 consecutive years from 2018 to 2020, had seen halved sales last year, making KRW6.2 billion. However, as the company had recorded KRW 7.7 billion in sales in 1H this year, the company is expected to gross sales around KRW14 billion this year. In 2021, Novartis’s Exelon (rivastigmine tartrate) and Janssen’s Reminyl (galantamine hydrobromide) have made around KRW 6.2 billion each. Exelon’s sales in 2018,2019,2020 were KRW 2.9 billion, 4.5 billion, and 5.3 billion, respectively, and Reminyl PR made KRW 4.3 billion, 5.4 billion, and 5.8 billion, respectively, during the same period. Eisai Korea’s Aricept, which was the second dementia treatment to be approved by the US FDA in 1995, is a donepezil formulation that had improved the convenience of intake by allowing once daily intake before sleep. Unlike acetylcholinesterase inhibitors that have the inconvenience of requiring an initial dose-escalation phase, where patients need to start with a very low dose and then increase the dose until the patients achieve the therapeutic dose, the initial dose for Aricept is 5mg, and can be increased to 10mg for maximum effect. Aricept has the advantage as patients can maintain the treatment dose that it has better tolerability and does not cause liver damage. Due to the specificity of the formulation and its mechanism of action, patients who had suffered from ulcers in the past need to frequently monitor gastrointestinal bleeding. Novartis’s Exelon, which had been the third to be approved in the field in 2000, contains rivastigmine, Like Aricept, it works by blocking the enzyme that breaks down acetylcholine --acetylcholinesterase – which transmits excitement to the neuron synapse, a neuronal junction. By blocking these enzymes, Exelon allows patients to recover cognitive function. Exelon is effective in moderate-to-severe Alzheimer’s patients, but if symptoms such as nausea, vomiting, abdominal pain, weight loss, etc. are observed during the course of administering the dose should be reduced. The fact that this drug also does not show hepatotoxicity is evaluated as its greatest advantage. Janssen’s Reminyl PR is the fourth Alzheimer’s treatment that was approved by the FDA in 2001. Reminyl contains galantamine, a herbal ingredient derived from the bulbs of the daffodil, Narcissus pseudonarcissus. Although it has a similar mechanism of action as Aricept or Exelon, it does not have the ability to stop or repair nerve cell damage that is indicated as the cause of Alzheimer's. Therefore, the drug does not dramatically reverse the course of the disease but enables patients to defer progression in cognitive impairment damage or provide slight recovery. At a memory test conducted in a clinical trial, the control group’s memory had deteriorated by 5 to 11 points, compared with the high-dose Reminyl group that maintained its initial score. Also, patients with vascular dementia and mixed type dementia that took Reminyl were able to relatively preserve their memory, orientation, and language ability. Lundbeck’s Namenda (Ebixa) which was approved in 2003 as a severe Alzheimer’s treatment is an antagonist to the NDMA receptors in the nerve cells. It inhibits the overstimulation of NDMA receptors by excessive glutamate. Unlike acetylcholinesterase inhibitor class treatments that are indicated for moderate-to-severe Alzheimer’s, Namenda showed significant inhibition in the deterioration of cognitive or physical function in severe patients in a clinical trial where patients were administered 20mg of Namenda for 28 weeks. Also, the drug has been positively received for raising the level of treatment for dementia of the Alzheimer's type in a clinical trial in combination with Aricept. In June 2021, despite the overwhelming negative opinions from advisors, Aduhelm (Aducanumab), which was developed by Biogen/Eisa received FDA approval. Its launch in Korea is also in preparation. The FDA said Aduhelm provides significant benefits to patients by reducing the build-up of accumulated amyloid beta plaques. Its once-every-four-week method of administration had opened a new horizon in drug delivery, its cost of KRW 60 million per year remain a large burden for the patients. The first FDA-approved drug for Alzheimer’s is tacrine, which was launched in 1933, but the use of the drug is restricted due to hepatotoxicity. Other acetylcholinesterase inhibitors used for the treatment of Alzheimer's disease include donepezil, rivastigmine, and galantamine. Patients should start with a relatively low dose and gradually increase the dose of Alzheimer’s treatment according to the principle of geriatric pharmacology in principle, and must take the drug while closely monitoring its effect and side effects.
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- Moderna releases first Omicron-specific vaccine, Spikevax-2
- by Sep 22, 2022 06:02am
- On the morning of September 21st, vaccine transport vehicle loaded with Moderna On the 21st, Moderna announced it will be releasing ‘Spikevax-2,’ its Omicron-containing bivalent booster vaccine. When released, the vaccine will be the first Omicron-specific vaccine to be released in Korea. Modern’s mRNA vaccine, Spikevax-2 (elasomeran/imelasomeran) has been approved by the Ministry of Food and Drug Safety on the 8th for use in people aged 18 years or older as a vaccine to prevent COVID-19. The approval was based on Phase II/III clinical trial that evaluated the efficacy of Spikevax-2 that compared Spikevax-2 with Moderna’s previous vaccine (Spikevax) in seronegative participants (participants who have never been infected with COVID-19). Results showed that the new vaccine met all major efficacy endpoints, including neutralizing antibody response to Omicron BA.1. Trial results also showed that additional vaccination with Spikevax-2 increased neutralizing antibodies against Omicron by 8 times in the seronegative group. Also, the new vaccine induced a stronger neutralizing antibody response than the previous vaccine against Omicron subvariants BA.4/5. Changes in the geometric mean functional relationship (GMFR) before/after vaccination showed that Spikevax-2 boosted neutralizing titers against BA.4/5 by 6.3-fold. Such results were shown in all participants regardless of prior COVID-19 infection history. Moderna is in close discussions with the Korea Disease Control and Prevention Agency (KDCA) on using Spikevax-2 as a booster dose from early October.
- Company
- Hanmi Poziotinib has greater patient benefits than risks
- by Nho, Byung Chul Sep 22, 2022 06:02am
- Regarding the opinion that Poziotinib's clinical results are not enough to support prompt approval in a briefing released by the U.S. FDA on the 20th (local time) ahead of the Oncology Drug Advisory Committee (ODAC), Hanmi Pharmaceutical said, "We will fully explain the usefulness of Poziotinib at the ODAC scheduled for the 22nd." Poziotinib is considered an innovative treatment that can play a sufficient role as one of various treatment options for patients with HER2 Exon20 mutated non-small cell lung cancer who do not have a suitable treatment so far. The adverse reactions reported so far are cases that appear in other drugs, and it is not only sufficiently manageable, but it is also observed that the benefit of Poziotinib to patients is clearly greater than the risk. Lung cancer is a disease with a higher fatality rate than other cancers, and it is widely believed in the medical community that various treatment options must be provided to patients. Not only can it be administered as a secondary or tertiary treatment to patients who do not respond to existing treatments, but also the usefulness of Poziotinib is clear in that it provides convenience to cancer patients because it is an oral formulation rather than an intravenous injection. "We will do our best to fully explain the usefulness of Poziotinib with our partner Spectrum so that positive recommendations for patients can be made," Hanmi Pharmaceutical said. "The recommendations made after ODAC discussions are not binding, so the FDA will review all situations including ODAC recommendations and decide whether to approve them by November 24."
- Company
- From Factive to Rolontis, commercial success or failure
- by Chon, Seung-Hyun Sep 22, 2022 06:01am
- Domestic development biosimilar and botulinum toxin drugs expand their influence in the U.S Hanmi Pharmaceutical's neutropenia treatment Rolvedon has succeeded in entering the U.S. market. Starting with LG Chem's Factual in 2003, a total of six new drugs made with domestic technology passed the U.S. licensing gate. However, it is evaluated that new domestic development drugs that have entered the U.S. so far have a long way to go to achieve commercial success. Although it is not a new drug, biosimilars and botulinum toxin drugs developed with domestic technologies are gradually expanding their market impact and writing a success story. ◆Hanmi Pharmaceutical's bio-new drug FDA's first approval, and domestic new drug's 6th commercial success is the key According to industries on the 13th, the U.S. Food and Drug Administration (FDA) finally approved Rolontis (U.S. product name Rolvedon), which Spectrum Pharmaceuticals applied for permission on the 10th (local time). Rolvedon is a new bio drug that Hanmi Pharmaceutical transferred technology to Spectrum Pharmaceuticals in 2012. It is administered to cancer patients subject to bone marrow-suppressing chemotherapy for the treatment or prevention of neutropenia. In Korea, it was approved by the Ministry of Food and Drug Safety as the 33rd domestic new drug in March last year. Rolvedon is produced at Hanmi Pharmaceutical's Pyeongtaek bioplant. It is the first bio-new drug in Korea to be produced at a domestic factory that has passed FDA due diligence and enter the U.S. market. Rolvedon is the sixth new drug developed with the technology of a domestic company to pass the FDA approval gate. In 2003, LG Chem's antibiotic Factive was the first to pass the U.S. FDA among domestic new drugs. In 2014, Factive, which was exported by Dong-A ST, obtained FDA approval. In 2016, SK Chemicals' hemophilia treatment Afstyla passed FDA approval. Afstyla is a genetically modified bio-new drug developed by SK Chemicals with its own technology. In 2019, two products developed by SK Biopharm passed the U.S. FDA. In March 2019, SK Biopharm's new sleep disorder drug Sunosi, which was exported by technology, approved the FDA's final permission. Sunosi is a product that SK Biopharm transferred its technology to Jazz Pharmaceuticals in 2011 after completing a phase 1 clinical trial after discovering candidate materials with its own technology. In November 2019, SK Biopharm received FDA approval for XCOPRI, a new drug for epilepsy. XCOPRI is the first new drug developed by a domestic company and carried out FDA approval directly. The industry is eagerly looking forward to the commercial success of domestic development new drugs in the United States. In Factive, its partner GSK suddenly took issue with clinical data, causing a setback in its overseas expansion. More than 300 billion won has been invested in the development of Factual, but sales in the U.S. are insignificant. Last year, Factive's domestic production performance was only 10.5 billion won. Sivextro, which was approved by the FDA in 2014, and Afstyla, which debuted in the U.S. market in 2016, say that commercial performance fell short of expectations. Sivextro disappeared from the market, withdrawing its permission due to low drug prices in Korea. Two new drugs to develop SK Biopharm, which were recently approved by the U.S., are gradually expanding their influence in the market. Sunosi made 25.3 billion won in profits to SK Biopharm last year, followed by 2.4 billion won in exports in the first half. XCOPRI recorded 300.7 billion won in exports last year and 13.7 billion won in the first half of this year. ◆ Domestic development biosimilar accelerates its entry into the U.S.. Although it is not classified as a new drug, biosimilars and botulinum toxin drugs developed by domestic companies are rapidly penetrating the U.S. market. In the case of biosimilars, Celltrion and Samsung Bioepis have been approved for a total of eight products in the United States. Celltrion was granted Remicade's biosimilar Inflectra in August 2016. Celltrion received U.S. permits from Truxima and Herzuma in 2018, respectively. Truxima is a biosimilar product of the anti-cancer drug Mabthera. Herzuma's original product is Herceptin. The biosimilar developed by Celltrion recorded more than 7 trillion won in cumulative exports. Celltrion Development's biosimilar posted 930.3 billion won in exports in the first half alone, with sales in the North American market accounting for 43% and 47% in the first and second quarters, respectively. Samsung Bioepis, which was launched in 2012, has been approved by Europe and the United States for biosimilars of five products, including Enbrel, Remicade, Humira, Avastin, and Lucentis. Since its launch, it has recorded sales of about 3.7968 trillion won until the first half of this year. Sales of 431.9 billion won were recorded in the first half alone, of which sales in the U.S. market account for 20-30%. Recently, Nabota, a botulinum toxin drug developed by Daewoong Pharmaceutical, is doing well in the U.S. market. According to Daewoong Pharmaceutical, Nabota's sales in the first half were 67.5 billion won, up 74.9% from the previous year. It recorded 52 billion won in export performance alone. If this trend continues, Nabota is expected to record more than 100 billion won in exports alone this year. Nabota has accumulated due to accumulation of experience in using the U.S., and export performance has begun to surge since the end of the Medy Tox and strain theft lawsuits conducted since 2019. In February last year, Medy Tox signed a three-way agreement with Daewoong Pharmaceutical's U.S. partners Evolus and AbbVie regarding the sale of Nabota (Jubo) to the U.S. The key to Medy Tox and AbbVie is to grant Jubo's continuous sales and distribution rights to Evolus in the United States and receive a certain amount of money. Earlier, at the end of 2020, the International Trade Commission (ITC) decided to ban Jubo from importing and selling in the U.S. for 21 months. With this agreement, Navota's hurdles for selling to the U.S. are gone. Of Nabota's overseas sales in the second quarter, exports to Evolus doubled from a year earlier to 21.1 billion won.
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- Enhertu lands in Korea...hopes rise for indication extension
- by Sep 21, 2022 05:47am
- The new breast cancer drug Enhertu (trastuzumab deruxtecan), which 50,000 people had petitioned for expedited approval, has finally landed in Korea. The Ministry of Food and Drug Safety announced on the 19th that it had granted marketing approval for Enhertu, the HER2-directed antibody-drug conjugate (ADC) that was jointly developed by AstraZeneca and Daiichi Sankyo. With the approval, Enhertu can be used in Korea for the treatment of ▲unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens (third-line or higher treatment) ▲locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received two or more prior therapies including an anti-HER2-based regimen (third-line or higher treatment). 엔허투주 모식도(자료: Enhertu is an antibody-drug conjugate that combines ‘trastuzumab,’ a monoclonal antibody that binds to specific target proteins, and ‘deruxtecan,’ a strong cytotoxic agent, by a linker. Its selectivity on antibody targets and apoptosis of target tumor cells allows the drug to work selectively only on the tumor cells, increasing its therapeutic effect and minimizing side effects. In the Phase II DESTINY-Breast01 trial that enrolled 184 female patients with HER2-positive, metastatic breast cancer who had received two or more prior anti-HER2 therapies, patients treated with Entertu achieved a Confirmed Objective Response Rate (primary efficacy endpoint) of 60.9%. Its secondary efficacy endpoints, median Duration of Response (mDOR) and median Progression-Free Survival (mPFS), were 14.8 months and 16.4 months, respectively. In the confirmatory trial that the two companies conducted afterward, Enhertu satisfied all of its key efficacy endpoints including PFS and Overall Survival (OS). In the DESTINY-Gastric01 trial that enrolled HER2-positive gastric or gastroesophageal junction cancer patients, the ORR was 48.4%, mOS 12.5 months, mPFS 8.4 months for patients who received treatment with Entertu, which was a significant improvement compared to the 12.9%, 8.4 months, and 3.5% of the control group (that received chemotherapy). Various targeted therapies for HER2-positive breast cancer are already in use in Korea, such as Herceptin, Perjeta, Kadcyla, and Tykerb. Among the drugs, Kadcyla entered the market as the first ADC for HER2-positive breast cancer, just before Enhertu. However, Enhertu’s potential lies in its future indications to come. In the Phase III trial that was recently announced by the company, Enhertu demonstrated its efficacy as a second-line treatment in HER2-positive breast cancer. It had shown a 72% reduction in risk of disease progression or death and nearly a twice higher ORR compared to the first-generation ADC Kadcyla. Based on these results, the National Comprehensive Cancer Network (NCCN) recently recommended Enhertu as a “Category 1 preferred regimen” in the second-line treatment of HER2-positive breast cancer. Furthermore, the drug was acclaimed at the ASCO 2022 meeting held in June as the first treatment to demonstrate efficacy in HER2-low patients who had no other available treatment options. The study results showed that Enhertu reduced the risk of disease progression or death by nearly 50% compared with conventional chemotherapy, with an mOS of 23.4 months, which was a 6.6-month extension from the 16.8 months in the chemotherapy group. Based on these results, the US FDA had also approved Enhertu as the first targeted therapy for HER2-low breast cancer. Voices for Enhertu’s expedited approval had also been high in Korea. The petition for the expedited approval of the breast cancer treatment Enhertu that was uploaded to the National Assembly's petition for public consent was submitted to the National Assembly's Health and Welfare Committee on the 30th of last month after receiving over 50,000 signatures of consent from the public. In the petition, the petitioner implored for expedited approval of Enhertu, saying “My mother suffered through the difficult chemotherapy, but the existing chemotherapy was unable to get rid of her cancer. There are no more drugs available in Korea. Please speed up the domestic approval process so patients in dire need can use Enhertu in Korea.” Daiichi Sankyo and AstraZeneca said, “The approval of Enhertu will offer a new treatment option to patients with metastatic HER2-positive breast cancer. Also, gastric cancer patients that had a high unmet medical need will benefit from Enhertu’s approval as it will allow them to continue their HER2 targeted therapies, as no other therapies available other than trastuzumab had proven clinical significance in the area.” The two companies will be jointly marketing Enhertu in Korea.
- Company
- RET-targeted anticancer drugs are being released in Korea
- by Whang, byung-woo Sep 21, 2022 05:47am
- By disease in patients, is a small but some hospitals were already prescribing patients ahead of the clinical site in anticipation that there is high. But now excluded from prescription for pay from entering that the burden of costs and likely to be consideration of the prescription side effects. According to the pharmaceutical industry on the 16th, RET (REarranged drug transmission) target treatments currently approved in Korea are Lilly's Retevmo and Roche's Gavreto. Retevmo is applied to adult patients with metastatic RET fusion-positive non-small cell lung cancer, adults with progressive or metastatic RET-mutant thyroid cancer and children over 12 years of age who are not compliant with radiation Iodine, have previous treatment experience with Sorafenib and/or Lenvatinib, and others requiring systemic therapy. Gavreto has been approved in Korea as a treatment for adult patients with RET fusion positive local progressive or metastatic non-small cell lung cancer and adult patients with RET mutation local progressive or metastatic medullary thyroid cancer that requires a strategy. However, since it is licensed around the same time as Retevmo, it is predicted that the release date will not show much difference. Currently, the indication that the two treatments are expected to be prescribed the most is non-small cell lung cancer. It is expected that only 1-2% of all patients have RET mutations, but compared to the thyroid gland, there will be more patients. However, it remains to be seen which of the two drugs will have the upper hand. This is because at the time of approval of the RET gene mutation target anticancer drug, experts also showed that there was no difference enough to choose. Experts say that the emergence of the two treatments is positive, given that chemotherapy is the only treatment option for patients with RET mutations so far. This is because at the time of approval of the RET gene mutation target anticancer drug, experts also showed that there was no difference enough to choose. As a result, experts predict that if the number of prescription options increases to two soon, side effects issues will play a greater role than effects. Hong Min-hee, a professor of oncology at Yonsei Cancer Hospital, said, "There is little difference in efficacy in choosing the two drugs and there is a difference in terms of adverse reactions." Professor Hong explained, "Retevmo seems to have more side effects of gastrointestinal relationships and Gavreto has more side effects of bone marrow suppression, so I think I will choose the patient group accordingly." In addition, Yoon Sung-hoon, a professor of respiratory medicine at Pusan National University in Yangsan, said, "Personally, only Retevmo has prescription experience in that Gavreto is not being used sympathetically due to drug supply and demand." Considering this, there is a possibility that experienced treatments that first appear in the market and enjoy the effect of preoccupying the market due to the characteristics of RET gene mutation target anticancer drugs with small patient groups. Since Gavreto is administered once a day, there is a view that it will be a little more advantageous for the younger patients who are relatively active in society. Retevmo and Gavreto are still not able to enter the benefit range, so cost issues are also expected to be hurdles for prescriptions. Retevmo failed to pass the cancer disease review committee, the first gateway to the standard review in May. Currently, Retevmo is known to cost about 7 million won a month. Professor A of oncology at advanced general hospital in Seoul said, "There are patients waiting for the use of RET gene mutation target anticancer drugs, but cost problems and periods vary from patient to patient." He went on to say, "I don't know if the patient group will be able to submit data necessary for the benefit standard, but I don't think it will be possible to enter the benefit when looking at NTRK mutant treatment." He added, "It may not be possible to enter the benefit right now, but we look forward to positive news in the future."
- Company
- Influenza alert in three years
- by Chon, Seung-Hyun Sep 20, 2022 05:57am
- The influenza (flu) alert, which disappeared after the spread of COVID-19, was issued. September 12 years after 2010, influenza alert has come. The pharmaceutical industry is Corona 19 that virtually died out after the spread of flu drug market to expect a revival of the atmosphere. According to the industry on the 19th, the Korea Centers for Disease Control and Prevention issued a flu epidemic warning nationwide on the 16th. The Korea Centers for Disease Control and Prevention issued a flu pandemic warning nationwide between September 4 and September 10 this year, with 5.1 suspected flu patients per 1,000 outpatients exceeding the epidemic standard (4.9). The number of suspected cases per 1,000 for the past 23 weeks, outpatient clinics, flu, the highest this year. 4.8 members leapt over the last 12 weeks. In previous years, the flu epidemic standard was set at 5.8 per 1,000 outpatients, but this year, COVID-19 and the flu are likely to spread at the same time. It is the first time in two years and six months that the number of suspected flu patients per 1,000 outpatients has exceeded five since the ninth week of 2020. It has never exceeded five since it recorded 6.3 in the ninth week of the first week of March 2020. This means that the flu has never been prevalent for more than two years. This is the aftermath of a significant decrease in the incidence of infectious diseases due to strengthening personal hygiene management such as hand washing and wearing masks after the spread of COVID-19. As social distancing was lifted this year, the number of flu patients gradually increased. In the last 24 weeks, the number of suspected flu patients per 1,000 outpatients was only 1.8 but tripled in three months. The pharmaceutical industry is expecting a rebound in flu treatments that have virtually disappeared since the spread of COVID-19. According to UBIST, a drug research institute, the amount of outpatient prescriptions for flu treatments in 2019 recorded 22.5 billion won. However, it fell to 8.8 billion won in 2020, and only reached 40 million won last year. In the past two years, the size of the flu treatment market has decreased by 99.8%. It was reduced by 99.9% in three years from 44.7 billion won in 2018. The flu treatment market recorded 8.4 billion won in the first quarter of 2020, but plunged 99.8% to around 10 million won in the second quarter when COVID-19 began to spread in earnest. The flu treatment market recorded less than 100 million won for nine consecutive quarters from the second quarter of 2020. In the first half of this year, the prescription for flu treatment was less than 100 million won. After the spread of COVID-19, the flu treatment market virtually disappeared as the number of flu patients decreased sharply due to strengthening personal hygiene management such as washing hands and wearing masks. The Oseltamivir market, which is most commonly used as a flu treatment, has virtually disappeared. Oseltamivir is the active ingredient of Tamiflu. In the first half of this year, Oseltamivir's out patient prescription market was only 92 million won. It was only 60 million won in the first quarter and 32 million won in the second quarter. The size of Oseltamivir prescription in 2019 recorded 22.4 billion won, falling to 8.7 billion won in 2020 and shrinking to 40 million won last year. Pharmaceutical companies expect the flu treatment market to rebound as the number of flu patients increases. An industry official said, "We will consider whether to expand the production and supply of treatments while looking at the trend of expanding flu patients in the future."
