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- 2026-04-15 18:24:23
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- SK Bioscience and GSK signed a joint sale of 5 vaccines
- by Kim, Jin-Gu Jan 08, 2021 06:19am
- Product photos of 5 vaccines that SK Bioscience and GSK signed a joint sales contract. Cervarix, Menveo, Boostrix, Havrix, and Priorix clockwise from top left SK Bioscience has signed a joint sales contract with GSK for five vaccines. SK Bioscience announced on the 6th that it has signed a co-promotion contract for major vaccines with GSK to expand the domestic vaccine market. This is the content that SK Biosciences jointly sells and distributes vaccines developed by GSK in Korea. These products are ▲Tdap (tetanus, diphtheria, pertussis) vaccine Boostrix ▲ meningococcal vaccine Menveo ▲ hepatitis A vaccine Havrix1440 ▲ (measles, parotitis, rubella) vaccine Priorix ▲ cervical cancer vaccine Cervarix. Based on its domestic sales network, SK Bioscience is in charge of sales of Boostrix, Menveo, Havrix1440, and Priorix in the adult market, and sales of Cervarix in the entire market including infants and children. The domestic market size of the five vaccines that SK Bioscience and GSK signed a joint sales contract was about ₩128 billion last year. Boostrix is vaccinated in adolescents and adults over the age of 10 and is the only vaccine in Korea that can be vaccinated to seniors over 65 years of age. Menveo is the only meningococcal vaccine available to the widest range of age groups and can be administered from 2 months of age. Havrix, the world's first hepatitis A vaccine, is sold in more than 100 countries. Cervarix can prevent cervical cancer as well as anal cancer and is sold in more than 130 countries. An-joon Choi, head of the marketing division of SK Bioscience, said, "Through this agreement, we have secured a new growth engine in the vaccine market. In the future, we will expand the market and strengthen our position as a leading company by securing a variety of self-developed vaccines and co-sale vaccines."
- Policy
- Boehringer's new obesity drug is conducting clinical trial
- by Lee, Tak-Sun Jan 08, 2021 06:19am
- Boehringer Ingelheim is conducting a clinical trial of a new obesity treatment in Korea. It is noteworthy whether it will exceed the sales of Saxenda (Liraglutide·NovoNordisk), which is currently leading in the Korean market. The MFDS approved the Phase II clinical trial protocol of BI 456906, a candidate for the new obesity drug of Boehringer Ingelheim on the 4th. This clinical trial is a 46-week trial that is administered subcutaneously once a week compared to placebo in obese or overweight patients. As a multinational clinical trial, 16 patients participate in Korea. The total number of subjects is 350. This drug is known as a candidate for a new drug obtained by Boehringer Ingelheim in partnership with the Danish pharmaceutical company Zealand Pharma A/S. It has a mechanism of dual action on glucagon-like peptide-1 (GLP-1) and glucagon receptors. GLP-1 and glucagon receptors play a role in regulating metabolic function. These substances reduce glucose synthesis in the liver and reduce blood sugar by increasing glucose absorption in the muscles. Saxenda Saxenda is also a GLP-1 analog, which induces weight loss by prolonging the action time of GLP-1. Saxenda ranks first in the domestic obesity treatment market. Cumulative sales in the third quarter of last year (based on IQVIA) were ₩28 billion, far ahead of Qsymia (Phentermine and Topiramate, Alvogen Korea), which recorded ₩16.7 billion. Saxenda is sold as a once-a-day formulation, but NovoNordisk is planning to market it as a once-a-week formulation with improved method. Boehringer's drug, which has been approved for clinical trials this time, is also a subcutaneous injection once a week. If commercialization is successful, it is expected to be a strong candidate against Saxenda.
- Policy
- We'll respond more aggressively through vaccines & tx
- by Kim, Jung-Ju Jan 08, 2021 06:19am
- President Moon Jae-in predicted that it will be able to respond more aggressively to COVID-19 as the commercialization and supply of vaccines and treatments will become reality next month. In particular, President Moon predicted that it would become a model country equipped with quarantine, vaccines, and treatments if commercialized, such as applying for conditional marketing authorization (CMA), for the development of domestic treatments. According to Cheongwadae, President Moon presided over the New Year's first cabinet meeting today (5th) and spoke about the early overcoming of Corona 19 and the stability of people's lives. President Moon said, "The Republic of Korea’s top priority this year is to get past the long tunnel of COVID-19 as quickly as possible." President Moon stressed, "Although the spread of COVID-19, after reaching a peak, has recently been contained little by little as evidenced by the fact that the basic reproduction number has been gradually dropping, overconfidence can be very dangerous. The government will respond more thoroughly to prevent COVID-19 so that the daily count of confirmed cases continues descent." President Moon said, "If we pass this hurdle well, we will be able to respond more aggressively through vaccines and treatments from next month. Development of domestic treatments is also becoming a reality, such as applying for CMA." President Moon said, "If treatments are commercialized, the Republic of Korea can become a model country for overcoming COVID-19 with all quarantine, vaccines, and treatments. President Moon said the government will do its best to speed up the daily recovery to make the greatest gift of the new year. Along with this, President Moon said, “Exports to the three new industries such as Bio Health have grown by double-digit, which is brightening the future, and by maximizing the positive changes in our economy, which became stronger amid the crisis, we will strive to foster companies to further increase the competitiveness and dynamics of our economy.”
- Product
- What are the latest COVID-19 drug guidelines?
- by Choi, sun Jan 08, 2021 06:19am
- As COVID-19 pandemic has passed a year, the guidelines for drug use are being updated a lot. As the evidence was accumulated, the differences in the guidelines for use by each country decreased, and detailed recommendations for practical use were derived with recommendations for use and refraining from various cases even with the same drug. Based on the latest academic research, the KSID (The Korean Society of Infectious Diseases) also presented a guideline for drug treatment for COVID-19 infection on the 31st. Based on this, guidelines for drug use and changes in each case were summarized. Remdesivir, approved in Korea in July, has detailed use cases for each patient's condition. The example applied when oxygen therapy is required in patients hospitalized with COVID-19 is different. First of all, Remdesivir can be used (level of evidence: moderate, grade of recommendation: B) for patients with COVID-19 who require oxygen therapy but do not need a ventilator or ECMO treatment, the KSID judged. If this is not the case, the recommendation for administration of Remdesivir was withheld (level of evidence: moderate, grade of recommendation: I). Efficacy and safety of Steroid were also summarized in the latest research. In the early days of COVID-19 epidemic, controversy about the suppression of the immune system and the growth of the virus was raised by steroid administration, but recently, it is being placed on the effectiveness in severe patients. The KSID recommended the administration of Steroids to patients with severe or severe COVID-19 by severity (level of evidence: moderate, grade of recommendation: A). As a clinical consideration for Steroids, Dexamethasone 6mg per day is administered for 7-10 days, and other steroids such as Hydrocortisone 150-200mg, Prednisone 40mg, Methylprednisolone 32mg can be substituted. Steroid administration was not recommended for non-severe corona19 patients (level of evidence: moderate, grade of recommendation: C). Interleukin inhibitors that control inflammation-inducing factors are also classified according to their components and patient severity. Interleukin-6 (IL-6) inhibitors include Tocilizumab and Sarilumab. Interleukin-6 inhibitors can be used within the scope of clinical trials in patients with severe COVID-19 (level of evidence: moderate, grade of recommendation: B), but not recommended for patients with mild COVID-19 (level of evidence: moderate, grade of recommendation: C). Recommendations for the administration of Interleukin-1 (IL-1) inhibitors to COVID-19 patients have been withheld (level of evidence: low, grade of recommendation: I). Plasma treatment, which caused controversy over the effectiveness of treatment, was also put on hold. Plasma therapy is a method of using the immunity of a person who is cured after viral infection. It is a method of collecting COVID-19 antibodies present in the plasma of a cure and administering them to other infected people to fight against the virus, but the effectiveness is still controversial worldwide. As the study that presented the effect and the study that showed no effect were sharply mixed, the lack of clinical participants and the poor clinical design of the study were pointed out as the cause. As a result of combining several studies, the KSID decided to withhold the recommendation for recovery plasma treatment for patients with COVID-19 in the blood system fee (level of evidence: low, recommendation grade: I). General intravenous immunoglobulin (IVIG) administration was also not recommended for patients with COVID-19. However, it suggested that the use of immunoglobulins should not be excluded in the treatment of complications (level of evidence: low, grade of recommendation: C). Chloroquine was actually scheduled to be withheld as a COVID-19 treatment. Chloroquine suppresses the maximum effective concentration of the virus by half in laboratory studies, but in actual studies involving SARS and MERS, there has been no high-quality evidence of efficacy. The KSID also concluded that based on the latest studies, it does not recommend either the administration of Hydroxychloroquine alone or in combination with Azithromycin for COVID-19 patients (level of evidence: high, recommendation grade: C). The KSID concluded that it does not recommend AbbVie's antiviral drug Kaletra (Lopinavir/Ritonavir) for COVID-19 patients. The level of evidence is high. In fact, it means that even the use of the drug is ineffective or that statistically significant differences cannot be identified. Administration of other drugs known to have antiviral effects such as Favipiravir, Ribavirin, Umifenovir and Baloxavir marboxil is not recommended except for clinical trials (level of evidence: low, grade of recommendation: C).
- Company
- Cyramza·Tarceva therapy is expected to be proposed
- by Eo, Yun-Ho Jan 08, 2021 06:19am
- It is noteworthy whether the first combination option of targeted anticancer drugs to enter insurance coverage in the first-line lung cancer therapy will be possible. According to related industries, first-line therapy for non-small cell lung cancer (NSCLC) VEGF receptor 2 antagonist Cyramza (Ramucirumab) and epithelial cell growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Tarceva (Erlotinib), It is expected that the combination therapy of Tarceva (Erlotinib) will be presented to the Review Committee for Cancer Diseases of the HIRA this year, which will be held next week. The combination therapy of the two drugs was approved by the EMA in January and the FDA in June. The new combination targeting VEGF and EGFR is attracting attention because it has shown efficacy in mutant patients such as EGFR exon 19 deletion and exon 21 (L858R), which have been relatively weak so far. Cyramza-Tarceva combination therapy confirmed the possibility of a through phase 3 RELAY trial. In the study, the combined use of Cyramza and Tarceva reduced the risk of mortality by 40% compared to Tarceva alone, and progression free survival (PFS) was also 19.4 months, which was more than 7 months different from the control group. Overall Survival (OS) has not yet been derived. The median follow-up was 20.7 months, and the objective response rate was similar to Cyramza (76.3% in the combination group and 74.7% in the Erlotinib alone group, but the median duration of response was 18 months and 11.1 months.) It is also encouraging that about 70% of them included East Asians. Lee Ki-hyung, professor of hematology and oncology at Chungbuk National University, said, "The EGFR-TKI target therapy, which was used for the treatment of non-small cell lung cancer of existing EGFR mutations, had a relatively low clinical effect in the exon 21 substitution group compared to the exon 19 defect group, so improvement was needed. He added, "The dual inhibition mechanism of Cyramza-Tarceva combination therapy is expected to more effectively inhibit the growth of cancer cells compared to inhibiting one mechanism. It is a remarkable treatment option in terms of overall treatment." Meanwhile, Cyramza was listed as refund type of risk sharing agreement (RSA) in second-line gastric cancer therapy in May 2018. It is domestically approved to ▲second line therapy for advanced/metastatic gastric cancer or ▲metastatic colorectal cancer patients with advanced disease during or after treatment including Bevacizumab, Oxaliplatin, and Fluoropyrimidine, and combination therapy with FOLFIRI (Irinotecan, Folinic acid, 5-FU) ▲patients with metastatic non-small cell lung cancer whose disease progresses during or after chemotherapy including platinum as a combination therapy with Docetaxel. Lilly (a developer of Cyramza ) is also in the process of insurance benefits about Cyramza monotherapy for patients with advanced or unresectable hepatocellular carcinoma that has a serum alpha fetal protein (AFP) of 400 ng/mL or more and patients not tolerated after Nexavar (Sorafenib) administration previously.
- Company
- Mitsubishi Tanabe licensed to market narcolepsy drug Wakix
- by Jan 08, 2021 06:18am
- On Jan. 4, Mitsubishi Tanabe Pharma Korea (CEO : Yomogida Osamu) announced the Ministry of Food and Drug Safety (MFDS) has green lit a narcolepsy treatment Wakix Film Coated Tablet (pitolisant hydrochloride) on Dec. 30, 2020, for marketing in the South Korean market. Wakix is indicated to treat cataplexy in adult patients with narcolepsy. The marketing approval would allow Wakix to be the only treatment option for cataplexy in narcolepsy. A rare chronic disease narcolepsy has limited treatment option in South Korea. In the U.S. and EU, modafinil, sodium oxybate, solriamfetol and pitolisant are used as a narcolepsy treatment, but only modafinil and an isomer armodafinil are approved in South Korea. Narcolepsy is a sleep disorder causing difficulty in regulating sleep-wake cycles due to loss of the neurons creating hypocretin in brain. Major symptoms include excessive daytime sleepiness (EDS) and catalepsy that can enter REM sleep directly from a waking state. Catalepsy is known to be expressed in 70 percent of narcolepsy patients. Wakix is the first treatment approved in South Korea with confirmed clinical efficacy and safety in treating catalepsy. Wakix, a first-in-class medication, is a selective histamine 3 (H₃) receptor antagonist/inverse agonist. Its efficacy could be mediated through its activity at H₃ receptors, thereby increasing the synthesis and release of histamine, a wake promoting neurotransmitter. CEO Yomogida Osamu of Mitsubishi Tanabe Pharma Korea stated, “We are exhilarated to provide an innovative treatment option to South Korean patients with narcolepsy through the health authority’s approval. Wakix is the only narcolepsy treatment in South Korea that has proved safety and efficacy in treating both EDS and catalepsy, the most common symptoms of narcolepsy. The company would do its best to bring practical medical benefit to South Korean patients and healthcare providers.” Wakix was designed and developed by a French-based pharmaceutical company Bioprojet. After the drug was first approved as an orphan drug by the European Medicines Agency (EMA) in March 2016, Wakix has been prescribed to patients with narcolepsy in the U.K., France, Germany and other European countries. In August 2019, the drug also earned the U.S. Food and Drug Administration’s (FDA) approval as well.
- Company
- SK Chemical's Ongentys can be prescribed at BIG 5
- by Eo, Yun-Ho Jan 06, 2021 06:20am
- SK Chemicals' Ongentys can be prescribed in general hospitals. According to related industries, the 3rd generation COMT inhibitor Ongentys (Opicapone) has passed the drug commitee (DC) of Big 5 hospitals such as SNUH, AMC, and Shinchon Severance Hospital. Ongentys, which was listed at a drug price of ₩2,515 last October after domestic approval in November 2019, was introduced by SK from the Portuguese pharmaceutical company BIAL, and was launched with the convenience of taking once a day. Unlike the second-generation COMT inhibitor, there were no side effects associated with severe diarrhea and urine discoloration, and no special safety issues appeared even when long-term administration for more than 1 year. Parkinson's disease, which has the second highest prevalence along with dementia among degenerative neurological diseases, has not yet been developed, so symptomatic management with drug therapy is the only general treatment. Levodopa, a basic drug for Parkinson's disease treatment, has been pointed out as a problem with motor fluctuation, which changes the duration of the drug when administered for a long time. In order to solve this problem, COMT inhibitors are being administered in combination. However, Entacapone, a second-generation COMT inhibitor, had a short duration of drug effect, so it was necessary to take the drug more than 5 to 8 times a day. In addition, side effects such as diarrhea and urine discoloration were also a problem. Meanwhile, it obtained US FDA approval in April of last year after EMA approval in 2016. In Asia, it was released for the second time in Korea after Japan.
- Company
- SK Bioscience loses MSD vaccines but nabs GSK vaccines?
- by Kim, Jin-Gu Jan 06, 2021 06:19am
- SK Bioscience is reportedly sealing the deal on commercializing four types of GSK vaccines in South Korea. When the deal is finalized, SK Bioscience would be able to fill the gap of four types of MSD vaccinea taken over by HK inno.N last year. According to a pharmaceutical industry source on Jan. 5, SK Bioscience and GSK Korea are in discussion for co-promotion contracts on a cervical cancer vaccine Cervarix, a hepatitis A virus vaccine Havrix, a meningococcal vaccine Menveo, and a Tdap vaccine Boostrix. SK Bioscience and GSK Korea left no official comments, but the industry seems to be aware that the two companies are close to inking the co-promotion deal. Since late last year, the local sales licenses for the global pharmaceutical companies’ vaccines have been shuffled around. In last November, seven MSD vaccines’ sales licenses, previously owned by GC Pharma and SK Bioscience, have been handed over to HK inno.N. Apparently, the Korean company started taking actions from the break of the new year. The seven MSD vaccines included cervical cancer vaccine Gardasil 4 and 9, a shingles vaccine Zostavax, a rotavirus vaccine RataTeq, a hepatitis A virus vaccine Vaqta, a measles, mumps, and rubella vaccine MMR2, and a pneumococcal vaccine Prodiax. The popular vaccines like Zostavax and Gardasil were handled by GC Pharma, and the rest of the vaccines—RotaTeq, Vaqta, MMR2 and Prodiax—were sold by SK Bioscience. Zostavax and Gardasil raised 120 billion won a year, whereas RotaTeq, Vaqta, MMR2 and Prodiax generated approximately 24 billion won a year. In just two months, SK Bioscience is getting its hands on GSK vaccines. Currently, four GSK vaccines are sold by Yuhan Corporation and Kwangdong Pharmaceutical, each focused on sales in children and adolescents, and in the rest of the target, respectively. The industry experts expect SK Bioscience would nab the vaccines sold by Yuhan. GSK has reportedly suspended the supply of vaccine to Yuhan as of Dec. 31, 2020. If SK Bioscience successfully signs the co-promotion deal on the four vaccines by GSK, the company would be able to compensate the loss from losing MSD’s Cervarix, Havrix, Menveo, and Boostrix, which used to generated 28 billion won annually. A pharmaceutical industry insider commented, “GSK has cut the ties with Yuhan for the new contract. Highly likely that SK Bioscience would take over all the vaccine sales and marketing, except for the pediatric market. However, both SK Bioscience and GSK are reserving any definite answer. SK Bioscience official explained, “We have no comment to make on the domestic sales licenses on GSK vaccines.” GSK official also stated, “There is nothing to confirm except that the talk is in progress.”
- Policy
- The vaccination date of AZ’s vaccine will be advanced
- by Lee, Jeong-Hwan Jan 06, 2021 06:19am
- The MFDS announced that it will accelerate the marketing approval period as much as possible by approval/review process of AstraZeneca's COVID-19 vaccine, which was accepted for approval on the 4th, and the national lot release at same time. The approval/review system takes up to 40 days and lot release takes up to 20 days, but it is technically the intention to work together to shorten the time of inoculation by cooperating between the departments. On that day, Director of the MFDS Kim Sang-bong made this statement at the COVID-19 briefing at Central Disease Control Headquarters. AstraZeneca submitted an application for COVID-19 vaccine approval to the MFDS, and the MFDS were continuing a briefing on approval of the vaccine with the KCDA. Director Kim Sang-bong said some media reported that it took at least 60 days for AstraZeneca's vaccine to actually be marketed, but this was not true. It is true that the approval/review process takes up to 40 days and lot release takes up to 20 days, but this can be shortened as much as the maximum period of the administrative procedure. If the review of approval/review system data is completed within 20 days, it will be processed in 20 days instead of 40 days, and allow lot release as soon as it is confirmed. It is explained that a plan is being devised to advance the time of vaccination for the people by simultaneously conducting review and lot release. "The lot release usually takes 2-3 months, but we have built the infrastructure for the lot release of COVID-19 vaccine from last year. The principle is that approval/review and lot release are not carried out at the same time, but Pfizer, Janssen, Moderna and others are also sharing the application for approval." He said, "Clinical data and review results will be released through the media. However, at the time of completion of the approval, we will explain to the public in detail,and it was a measure to submit some of the experimental data." KDCA Commissioner Jung Eun Kyeong said that it has not been decided whether or not the overseas COVID-19 vaccine will be commissioned in Korea except for Astrazeneca’s vaccine. She said she is doing her best to prepare for safe distribution and vaccination after the vaccine is marketed. She advised not to use a combination of different types of COVID-19 vaccines. This means that the drug should be administered according to the efficacy and safety and vaccination cycle confirmed in clinical trials. She said, "Pfizer mRNA COVID-19 vaccine will be introduced in the third quarter. We are discussing for an early supply. It is difficult to say everything because there is confidential between institutions. We plan to explain it to the people once it is confirmed." She said, "We are preparing to discuss and simulate the distribution plan of COVID-19 vaccine with cold chain that can be distributed at –70°C and –20°C. It takes a lot of time to set up an inoculation center to prepare for vaccination. It is not a rule to mix different types of vaccines, and the relatively identical vaccines should be administered at the same time."
- Policy
- Prostate cancer treatment Erleada by Janssen was approved
- by Lee, Tak-Sun Jan 06, 2021 06:19am
- Janssen Korea has received domestic approval for a new prostate cancer drug. The emergence of new options after Zytiga (Abiraterone acetate) is expected to expand its influence in the prostate cancer treatment market. The MFDS approved Janssen's Erleada (Apalutamide) in Korea on the 30th. It is approved as a combination therapy with androgen blockade (ADT) in the treatment of patients with hormone-responsive metastatic prostate cancer (mHSPC). The recommended dose is Erleada 240mg once a day (4 tablets of 60mg). Erleada proved its effectiveness through a phase III SPARTAN study. In the SPARTAN study, the Erleada-treated group had a 72% reduction in the incidence of distant metastasis (cancer cells traveled to distant sites through blood vessels and lymphatic vessels to proliferate) or death compared to the placebo group. Metastasis-free survival (MFS) was also 40.5 months, which was 2 years longer than that of the control group. Erleada was approved by the US FDA in February 2018. At the time, Janssen emphasized that Erleada would be an alternative option to delay metastasis in the treatment of prostate cancer. Janssen is already expanding its influence in the market with a prostate cancer treatment called Zytiga. As of last year's IQVIA, Zytiga's domestic sales amounted to ₩6.9 billion. Zytiga has been recognized as a first-line treatment for metastatic castration-resistant prostate cancer since last year. The sales have been steadily increasing. Sales of Zytiga/Erleada are growing in the prostate cancer treatment market, and Astellas' Xtandi (Enzalutamide) and Bayer's Nubeqa (Darolutamide) are expected to compete in earnest.
