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- 2026-03-18 10:27:55
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- 1st reimb. discussion to start on 2 tumor-agnostic therapies
- by Eo, Yun-Ho May 25, 2021 06:04am
- Two types of tumor-agnostic therapies seek reimbursement listing in Korea. Industry sources say Roche Korea’s Neurotrophic tyrosine receptor kinase(NTRK) Rozlytrek (entrectinib) and Bayer Korea’s ‘Vitrakvi (larotrectinib)’ will be up for deliberation by the National Health Insurance Service's (NHIS) Cancer Drug Review Committee meeting on the 26th. Rozlytrek and Vitrakvi are indicated for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. In other words, the two drugs may be used in virtually all cancer types confirmed with an NTRK gene. Both drugs will seek to receive reimbursement approval through the pharmacoeconomic evaluation (PE) exemption track. As the two drugs are in the same class, the government will be discussing reimbursement listing in coordination with the two companies Rozlytrek and Vitrakvi were approved based on a single-arm study that did not involve a control arm. As it already meets subparagraph 2 of the PE exemption criteria, if the committee deems the other conditions are also met, it is likely that the drug will have not much difficulty in receiving the exemption. Rozlytrek’s approval was based on results from the Phase I/II STARTRK-NG study in pediatric patients, as well as data from the integrated analysis of the pivotal Phase II STARTRK-2, Phase I STARTRK-1 and Phase I ALKA-372-001 trials. In the Phase II STARTRK-2 trial, over half of the patients with NTRK fusion-positive, advanced solid tumors receiving Rozlytrek demonstrated a reduction in tumor size with an objective response rate (ORR) of 56.9%. Objective responses to Rozlytrek were observed across 10 different solid tumor types, and the median duration of response (DoR) was 10.4 months. Vitrakvi’s approval was based on data from the Phase II NAVIGATE trial in adult and pediatric patients 12 years or older and the Phase I/II pediatric SCOUT trial in pediatric patients 1 month or older to 21 years with advanced cancer or with primary CNS tumors. Efficacy results from three clinical trials in 55 patients with confirmed NTRK gene fusion showed that Vitrakvi demonstrated an ORR of 75% and partial response rate of 53% in numerous tumor types (including soft tissue sarcoma, infantile fibrosarcoma, salivary gland tumor, thyroid cancer, melanoma, colorectal cancer, gastrointestinal stromal tumors (GISTs), cholangiocarcinoma, gallbladder cancer, breast cancer, and pancreatic cancer).
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- Keytruda leads domestic market sales … Perjeta·Prolia also
- by Chon, Seung-Hyun May 25, 2021 06:03am
- The cancer immunotherapy ‘Keytruda’ firmly held its lead in the domestic pharmaceutical market. This is the 5th consecutive quarter from the first quarter of last year that the drug has recorded top sales among all pharmaceuticals in Korea. Also, the new biopharmaceuticals introduced by multinational pharmaceutical companies like ‘Perjeta,’ and ‘Prolia’ showed rapid growth. Among locally developed new drugs, K-cab showed the most rapid growth. According to the pharmaceutical research firm IQVIA on the 23rd, MDS’s Keytruda recorded the highest sales of 44.1 billion won in the first quarter this year. This is a 27.0% year-on-year increase from the same quarter of the previous year, and comfortably exceeded sales of 'Lipitor,’ which took second place. Since taking the lead in the first quarter last year with 34.7 billion won in sales, Keytruda has held its top place for 5 consecutive quarters. Keytruda is an immune checkpoint inhibitor that was released in Korea in 2015. The drug inhibits the ‘PD-1’ protein expressed at the cell surface of activated T cells. It has boasted overwhelming performance in over 30 types of cancer starting from melanoma to lung cancer, head and neck cancer, stomach cancer, cervical cancer, etc. Immediately after its release, Keytruda’s quarterly sales remained around 3 billion won. However, its sales rose rapidly after the health authorities granted its reimbursement for second-line NSCLC from August 2017. In the first quarter of 2018, Keytruda’s sales exceeded 10 billion and exceeded 30 billion in the second quarter of 2019. In the first quarter of last year, Keytruda caught up with Lipitor, which had kept the lead since the fourth quarter of 2015 in sales, and rose to the top. Since then, Keytruda has maintained its strong growth, increasing the sales gap to 9 billion won last quarter. Among the top ranks, Perjeta, Prolia, and K-cab showed marked growth. Sales of Roche’s Perjeta rose 29.6% YoY in the first quarter of this year to record 21.4 billion Korean won and gained its place in the top 10. Perjeta indicated for use in combination with trastuzumab and docetaxel in patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their disease. Perjeta was approved reimbursement as first-line treatment for HER2-positive metastatic or locally recurrent unresectable breast cancer who have not received previous anti-HER2 therapy in 2017. In May 2019, the drug was granted selective reimbursement, and its sales surged as the Perjeta and trastuzumab combination became the established standard of care in the neoadjuvant treatment environment. Sales of Amgen’s Prolia increased 38.1% YoY to record 19.9 billion won in the first quarter of this year. Prolia is a biologic therapy that was released in Korea in November 2016 for treating osteoporosis by targeting RANKL, an essential protein for the formation, function, survival of osteoclasts that destroys bone. Prolia’s sales started growing since 2017 after it received reimbursement as second-line treatment. After the reimbursement was extended to cover first-line treatment since April 2019, Prolia’s sales increased exponentially. Its effort to strengthen its sales power through a partnership with Chong Kun Dang was also cited as a factor for Prolia’s sales growth. HK Inno.N’s new anti-ulcer drug K-cab showed strong growth amidst the chart full of drugs from multinational pharmaceutical companies. K-cab recorded 19.7 billion won in sales, a 56.7% YoY increase from the first quarter last year, and was the only locally developed drug to land in the top 10 sales. ‘K-cab (tegoprazan)’ is an anti-ulcer potassium-competitive acid blocker (P-CAB) that was released in March 2019 by HK Inno.N (previously known as CJ Healthcare). Its new mechanism of action competitively binds the proton pump, the final common pathway for acid secretion in gastric parietal cells, with potassium ions to inhibit acid secretion. After first receiving approval for as gastroesophageal reflux disease (GERD) therapy, K-cab’s prescription surged with the indication expansion to the treatment of stomach ulcers. K-cab has recorded the most amount of sales among all drugs developed in Korea.
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- Samsung Biologics, commissioned to produce Moderna vaccine
- by Kim, Jin-Gu May 25, 2021 06:03am
- Samsung BioLogics signed a contract with Moderna on the 22nd (local time) to commission the production of COVID-19 vaccines. After producing undiluted corona vaccine abroad, Samsung BioLogics will charge and pack it in Korea. Samsung BioLogics CEO John Lim and CEO Stéphane Bancel Moderna attended the "Korea-U.S. Vaccine Company Cooperation Event" held in Washington, D.C. on the same day and signed the same day. Samsung BioLogics plans to start aseptic charging, labeling, and packaging of hundreds of millions of vaccines to markets outside the U.S. starting in the third quarter. "The Moderna vaccine is the most important vaccine for people around the world fighting COVID-19," said John Lim, CEO of Samsung BioLogics. "We have set a quick production schedule for commercial procurement early in the second half of this year in response to global demand for vaccines." "We expect this contract to help us continue to expand our production capacity outside of the United States," said Juan Andres, chief technology officer (CTO). This is the fourth contract by a foreign pharmaceutical company to be commissioned to produce in Korea by COVID-19 vaccine. Earlier, AstraZeneca, Novavax, and Sputnik V vaccine of Russia signed a consignment production contract with a domestic company. Among them, AstraZeneca vaccine is currently being supplied to South Korea. At the event, there were three MOUs (Memorandum of Understanding) in addition to a modern contract with Samsung BioLogics. The South Korean Ministry of Trade, Industry and Energy will cooperate with Moderna's investment support and business activities in Korea, while Moderna will make efforts to invest in and recruit mRNA vaccine production facilities. Moderna also signed an MOU with the Korea National Institute of Health to develop an mRNA vaccine. In addition, Novavax, SK Bioscience, and the MOHW signed MOU on research and development including COVID-19 vaccine. A total of four contracts and MOUs, including those of Samsung BioLogics, are interpreted as the outcome of the South Korea-U.S. summit on the previous day. President Moon Jae-in and President Joe Biden is epidemic to empower a coordinated response by 21, a joint statement has promised to 'Global Alliance for Vaccines and build a global partnership'.
- Company
- Organon’s spinoff from MDS to be completed in June
- by Eo, Yun-Ho May 24, 2021 05:51am
- Organon’s spinoff from MSD will soon be complete. Industry sources expect the administrative spin-off at the global headquarters of MSD and Organon to be completed within the next month (June). Following the spinoff, Organon & Co. will launch as a completely independent corporation in Korea as well. Organon’s Korean subsidiary has already moved into the shared office 'WeWork Gwanghwamun’ located in The K Twin Tower in Junghak-dong, Jongno-gu, Seoul last year, and has undergone the necessary processes for its separation. However, the legal procedures of the spinoff may take a while. Organon is currently undergoing procedures to change the license holder for its products, etc. The delay in implementing the re-revised ‘Criteria for Decision or Adjustment on Drugs’ by the health authorities that will withdraw the stepped pricing system applied to the transfer of original products has been affecting the transfer of licenses in spinoffs including Organon. MSD had officially announced the spinoff of Organon last February and initiated the spinoff process. Through the spinoff, Organon was to become a newly established corporation focusing on women's health, off-patent drugs, and biosimilars. By product, ▲ ‘Renflexis,’ ‘Brenzys,’ and ‘Ontruzant,’ biosimilars developed by Samsung Bioepis commercialized by MSD; ▲ ‘Nexplanon,’ an etonogestrel implant; ▲ hyperlipidemia treatments ‘Zetia’ and ‘Vytorin’; ▲the respiratory drug ’Singulair'; as well as around 90 off-patent drugs will be transferred to Organon. Based on its leading contraception and fertility treatment business, the new Organon plans to invest in ‘innovation’ to meet the distinct healthcare needs of women today. Organon will also focus on its important biosimilars business, focusing on oncology and inflammatory diseases, while also maximizing the value of its trusted dermatology, pain, respiratory and cardiovascular portfolio in countries around the world where there is still a great need for these treatments. Meanwhile, Organon’s Korean subsidiary has appointed Kim So-Eun, MSD's ex external affairs Lead, as its first CEO. At the time of her appointment, CEO Kim had said, “In the Korean subsidiary, we plan to build a corporate culture where employees can enjoy various opportunities for growth in a horizontal and flexible environment while pursuing continuous growth and leadership for the company as well."
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- Tagrisso's 1st-line reimb. necessary based on its OS benefit
- by May 24, 2021 05:51am
- With ‘Tagrisso (osimertinib)’ winning recognition as the first-line standard treatment for epidermal growth factor receptor (EGFR)-mutated advanced and metastatic non-small cell lung cancer, the demand for its reimbursement as first-line in Korea has also been increasing. At the Lung Cancer 1 session of the 19th Annual Symposium & General Assembly of the Korean Society of Medical Oncology that was held online on the 21st, Ji-youn Han, Head of the Lung Cancer Center at the National Cancer Center Korea emphasized the need for Tagrisso’s reimbursement based on the clinical data of Tagrisso. As a third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI), Tagrisso is indicated as first-line for EGFR mutated patients, but as its reimbursement is only applied when used as second-line, the drug is virtually used as a second-line treatment in Korea. This is in contrast to the reimbursement approved for first-line in other major countries around the world including the U.S., Germany, Italy, U.K, France, and Japan. Also, the National Comprehensive Cancer Network guidelines recommend Tagrisso as a category 1 preferred regimen in first-line in EGFR-mutated NSCLC. The issue arose due to the sub-analysis results of the Asian subset in the Phase III FLAURA trial. The trial demonstrated an improvement in the overall survival (OS) in all patients, however, the hazard ratio for OS in Asian patients in the sub-analysis was 0.995. This means that there is only a 0.005 reduction in risk, which signifies that there is virtually no difference with the control group. This result had raised the question of whether there was any OS benefit in Asian patients. “The FLAURA study demonstrated a statistically significant OS improvement in the Targrisso arm compared to the control arm despite the crossover (allowing patients to switch treatments) that was ethically allowed for the control group, which could have affected the OS data,” said Han. With the crossover, only 5% of the 277 patients in the control group were able to maintain treatment with their original first-line treatment, 1st generation EGFR TKI (gefitinib or erlotinib). 65% crossed over to a different treatment, and around half of these patients, 47%, crossed over to Tagrisso. On the other hand, 22% of the 279 patients in the Tagrisso arm maintained their Tagrisso treatment, and 48% crossed over to different treatments. 68% of these patients received chemotherapy. The subgroup analysis results showed that HR was near 1 only in Asian patients and L858R-mutated patient groups. However, Han explained that Tagrisso’s benefit is also evident in these subgroups. Han said, “In non-Asians, the OS graph shows that Tagrisso and the control group show similar outcomes until year 1, then shows maintained OS improvement. However, in the Asian group, the graph shows a clear difference from the start. And the graph intersects after 3 years,” he explained. “So looking at the OS curve, you can see that the OS improvement is well maintained for over 3 years.” On the reason why the Asian and non-Asian group shows different graph movements, Han explained: “Considering that patients with L858R mutation showed similar graph movements, one can suspect that the L858R mutation rate may have been higher in Asians.” He added, “EGFR subtype by race shows that L858R mutation, which shows unfavorable prognosis, is half that of those with Exon19-deletion in the non-Asian group, however, in the Asian group, the L855R mutation accounted for two-thirds of those with Exon19-deletion. Han’s conclusion was that the OS graph evidently shows Tagrisso’s effect as a first-line treatment. As the progression-free survival (PFS) of Tagrisso is approximately 20 months, not many patients can afford to use Tagrisso without reimbursement in the first-line setting. This is also why doctors tend to consider a narrower scope for the use of Tagrisso. Han said, “At a time when the world is changing to Tagrisso for EGFR-mutated metastatic NSCLC, we are being faced with this barrier of reality and moving backward against the global trend. Oncologists should first consider Tagirsso as first-line treatment, and (the government) should solve the economic issues associated with its use.”
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- 8th meeting for Keytruda’s 3+ yrs pending reimb. to be held
- by Eo, Yun-Ho May 21, 2021 05:27am
- The cancer immunotherapy drug Keytruda will be up for its 8th deliberation by the Cancer Drug Review Committee. According to industry sources, MSD Korea’s application to expand the reimbursement of ‘Keytruda (pembrolizumab)’ to cover first-line treatment of non-small cell lung cancer (NSCLC) is expected to be put on the agenda for deliberation by the Cancer Drug Review Committee on the 26th. In March, MSD Korea had once again revised and submitted a final cost-sharing proposal to the Health Insurance Review & Assessment Service (HIRA). The reimbursement expansion for Keytruda had been discussed since September 2017, and over 3 years had already passed with no result. The biggest barrier to the reimbursement was the condition that the government set for the reimbursement expansion to companies of immunotherapy drugs, for 'the pharmaceutical companies' to bear the administration cost of the initial 3 cycles.' Roche, which owned ‘Tecentriq(atezolizumab),’ a latecomer to the market, was the only company to accept the government’s condition, and 2 types of PD-1 inhibitors – Keytruda and ‘Opdivo(nivolumab)’ did not accept the condition. Since then, MSD had repeatedly submitted and revised its proposal. The last discussion was held in August last year, during which the decision for the drug was put on hold as the committee believed that MSD Korea’s proposal lacked compromise on the company’s part. In September of the same year, HIRA handed the proposal back to MSD Korea and requested a re-revision. A month later, MSD Korea submitted a re-revised proposal, which was discussed by the reimbursement standard sub-committee meeting but to no avail. The agenda of Keytruda’s reimbursement was not deliberated by the Cancer Drug Review Committee. So, once again, MSD Korea submitted a cost-sharing plan to HIRA. The proposal submitted by MSD this time contains an offer equivalent to the company ‘covering the initial 3 cycles’ worth of administration cost’ by measures including adjusting the reimbursement rate. If this proposal is again deliberated and rejected by the Cancer Drug Review Committee, the possibility of expanding reimbursement of Keytruda may virtually be difficult. An MSD official said, “Although we cannot share details as discussions with the government are still ongoing, we will do our best so that our patients in Korea can promptly receive the global standard-of-care treatment.”
- Company
- ASCO 2021 preview: News drugs from Yuhan, Genexin, and Hanmi
- by An, Kyung-Jin May 21, 2021 05:27am
- ASCO 2019 학회 전경(자료: ASCO) The organizers of the 2021 ASCO Annual Meeting (ASCO 2021) released the accepted abstracts on the 19th (local time), two weeks ahead of the virtual event that will be held next month, from June 4-8. The ASCO meeting is considered one of the most important events for biopharmaceutical companies around the world in introducing the latest clinical data on anticancer drugs. Due to the COVID-19 pandemic, all schedules in the 5-day event, including its keynote lectures, poster sessions, and exhibitions will be held virtually, non-face-to-face, for the second consecutive year. The abstracts of Korean biopharmaceutical companies including Yuhan Corporation, Hanmi Pharmaceutical, MedPacto, and Genexin that have been developing new anticancer drugs have also been unveiled with the pre-release. Whether the long-awaited international event will be able to rekindle investors’ interest in the biopharmaceutical industry is drawing attention. At the event, the multinational pharmaceutical company Janssen will be presenting 2 studies on the combination of its EGFR/cMET dual antibody ‘amivantamab’ and Yuhan Corporation’s new drug ‘Leclaza (lasertinib).’ The abstracts are an update from the Phase 1b CHRYSALIS study that received much attention at the ESMO 2020 Meeting last year. The abstract focuses on the potential of the combination in overcoming the resistance issue of its competitor ‘Tagrisso (osimertinib).’ The study focused on delaying cancer progression through treatment with amivantamab in combination with Leclaza in patients with non-small cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) exon 19 deletion or L858R mutations who have acquired resistance to Tagrisso. The study focused on analyzing the biomarkers while conducting genetic testing through next-generation sequencing (NGS) in circulating tumor DNA (ctDNA) to profile each patient’s tumor. If each patient’s response rate could be predicted in advance, this could maximize the response rate of the amivantamab and Leclaza combination therapy. Results showed that among the 45 patients whose disease had progressed on osimertinib that were administered 240mg of Leclaza and 1050mg or 1400mg of the amivantamab and Leclaza combination, the ORR(objective response rate) was 36% (95% CI, 22–51), with 1 patient showing complete response and 15 showing partial responses. Up to this, the data presented were similar to those presented at the ESMO 2020 last year. However, the investigators additionally presented an analysis of potential biomarkers of response. According to the analysis, 8 out of the 17 patients with EGFR and/or MET-based mutations – which is known to be the cause of resistance to Tagrisso – showed a confirmed tumor response. The median progression-free survival (PFS) of these patients was 6.7 months (3.4months- not reached). However, as some (8 patients) of the 18 patients who had unknown mechanisms of Tagrisso-resistance also showed a partial response to the regimen, grounds for its use as a biomarker was seen to be insufficient. 9 out of 10 Immunohistochemistry (IHC) high patients (90%) showed a high response rate to treatment, but the abstract determined that further investigation is warranted. More progressed data on the study will be shared at the oral abstract session for metastatic non-small cell lung cancer on the 5th, the second day of the meeting. The principal investigator of the Phase III LASER301 trial, Professor Byoung Chul Cho (Director of the Lung cancer center, Yonsei Cancer Center), will be presenting the session. Genexin released an abstract on the interim results of its Phase 2 clinical trial that evaluated the combination of its cervical cancer DNA vaccine 'GX-188E' with Merck(MSD)’s immunotherapy ‘Keytruda(pembrolizumab).’ The abstract contained results of the efficacy group of patients with late-stage recurrent or advanced HPV-positive (HPV-16 or HPV-18) cervical cancer. 5 of the 48 patients had a complete response (CR) where the target lesion completely disappeared, and 10 had a partial response (PR) where the target lesion was reduced by 30% or more. The objective response rate (ORR) was 31.3%. Subanalysis results showed that the ORR of patients with PD-L1 positive, HPV-16, and squamous cell carcinoma was highest, being 48%. The combination therapy showed an improved median PFS of 4.1 months, and OS of 16.7 months compared to Keytruda monotherapy. Most of the patients who experienced adverse events showed grade 1 or 2 adverse events, demonstrating that there were no safety issues concerning to the combination therapy. The details of the GX-188E and Keytruda combination will be introduced at the oral abstract session on the first day of the ASCO meeting, on the 4th (local time). MedPacto released the Phase 1b/2a trial results of ‘vactosertib’ (capecitabine)’ combined with ‘Keytruda’ in microsatellite stable (MSS) metastatic colorectal cancer (mCRC) patients. According to the abstract, 5 of the 33 patients enrolled in the trial reached PR, and the ORR was 15.2%. 7 patients had stable disease where the tumor did not grow further. Industry has seen that the study fully demonstrated the potential of vactosertib as a combination option in MSS mCRC as the response rate of Keytruda monotherapy is near 0% for the disease. Further clinical data on more patients and the OS data and doses will also be released in the final poster that will be released on the 4th (local time). Hanmi Pharmaceutical has released the latest update on ‘belvarafenib,’ which was licensed to Genentech. The results are from a Phase I trial of belvarafenib in combination with cobimetinib in patients with BRAF- and NRAS-mutant melanoma. The abstract shows further progress that had been made since the last presentation at the 2019 ASCO meeting. According to the abstract, 5 of the 13 NRAS-mutant melanoma patients reached PR, giving an ORR of 38.5%. Currently, no approved standard of care exists for NRAS-mutant melanoma. According to clinicaltrials.gov, a clinical trial registration website operated by the U.S. National Institute of Health (NIH), Genentech had recently registered a new global Phase I clinical trial on belvarafenib. The Phase 1b study will evaluate the safety, pharmacokinetics, and activity of belvarafenib as a single agent and in combination with either ‘Cotelic (cobimetinib) or Cotelic plus ‘Tecentriq (atezolizumab)’ in patients with NRAS-mutant advanced melanoma who have previously received anti-PD-1/PD-L1 therapy. As this is the first clinical trial initiated for a belvarfenib combination therapy by Genetech in 5 years since singing the technology transfer deal with Hanmi Pharmaceutical, concerns over the deal cancellation have been said to be resolved. Analysts predict that if the three-dug combo including belvarafenib shows a superior response rate over ‘Zelboraf,’ the new drug’s value may increase additionally.
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- Tylenol is in short supply for a long time
- by Kim, Jin-Gu May 21, 2021 05:26am
- Along with the issue of side effects of COVID-19 vaccines in pharmacies, the shortage of Tylenol is intensifying. Domestic companies with generic products are expecting reflective profits. Several companies are said to have started marketing related to Tylenol shortages so that they can lead to increased sales of other generics of acetaminophen. Tylenol According to the pharmaceutical industry on the 14th, Tylenol has become more scarce in outpatient pharmacies over the past month. In the case of Tylenol and Tylenol 8-hour ER, it is confirmed that they are completely out of stock at online malls exclusively for major pharmacies. Analysts say that the issue of side effects of COVID-19 vaccine and the government's guidance have caused a shortage. As the number of people vaccinated against COVID-19 increased, the side effects of fever and muscle pain increased, and more people wanted to buy Tylenol. In addition, the quarantine authorities guided, "If fever occurs after vaccination, it is recommended to take fever reducer such as Tylenol," and most pharmacies are now unable to find Tylenol. Pharmacists are recommending generic products instead of original Tylenol. A pharmacist who runs a pharmacy in Seoul said, "The number of people looking for Tylenol has more than doubled than usual," adding, "We recommend generics because Tylenol is not available." "If the number of people vaccinated against COVID-19 increases in the future, sales of generic products will increase." Another pharmacist in Daejeon said, "We're barely getting Tylenol. I think it's been about a month. Wholesale stores offer limited supplies to each pharmacy. If generics are recommended, one to two out of 10 people buy the drug." As the shortage of Tylenol intensifies, its effects are gradually expanding to other generics. Sales of Samjin's Geworin, Jong Kun Dang's PENZAL-Q, Dong-A's Panpyrin, and Daewoong's EZN6 Ace, which include the same ingredients as Tylenol, are reportedly increasing little by little. Geworin Cooldown Korean companies are also starting related marketing in line with this trend. Emphasizing that it is the generics for those who have not obtained Tylenol, it is necessary to prepare for the possibility of side effects after vaccination. In the case of Geworin, sales volume is said to have increased slightly last month due to the issue of side effects of vaccines. "We are pushing for Geworin Cooldown as a product to prepare for side effects of the vaccine," said a representative for Samjin. "It is true that sales have increased compared to the past." "In the case of Geworin Cooldown, the number of new businesses is increasing just after its release. "We understand the impact of this, the issue of side effects of vaccines, and the result of marketing." An official from Dong-A said, "Panpyrin's sales have increased a little compared to last year," adding, "However, it is too much to blame only the issue of side effects of vaccines." "It's Acetaminophen, but it's more widely known as a cold medicine than a pain reliever. "In case of PENZAL, there is little change in sales compared to the past," said a representative for Chong Kun Dang. "There is a possibility that sales will increase as the number of people vaccinated against COVID-19 increases."
- Company
- Zopista for insomnia to be prescribed at general hospitals
- by Eo, Yun-Ho May 20, 2021 05:56am
- The insomnia treatment ‘Zopista,’ which can be prescribed long-term, is now cleared for prescription at general hospitals. According to industry officials, Huons’ Zopista(eszopiclone) passed the Drug Committees (DCs) of the Big-5s - Seoul National University Hospital (SNUH), Asan Medical Center (AMC), Seoul St. Mary’s Hospital, Samsung Medical Center (SMC), and Severance Hospital – and many other major medical institutions in the nation. Zopista was first introduced in Korea along with its reimbursement approval in November 2019. However, as the drug has been prescribed in the U.S. since 2004, its generics have also soon entered the Korean market, expanding the competition. With no domestic patent or Post Market Surveillance (PMS) period set for the drug, there was no way for the company to deter or block the entrance of its generics. However, with Huons successfully landing its product in general hospitals, whether Zolpidem can maintain its share in the market as the leading product remains to be seen. Contrary to other existing insomnia treatments like ‘Zolpidem,’ Zopista can be used long-term. In case of Zolpidem, its long-term use is not recommended, and the treatment period is regulated to not exceed 4 weeks. However, according to a survey by the Health Insurance Review and Assessment Service, insomnia is a common condition that 1 out of 3 adults in Korea experience, with its market rapidly growing as the number of insomnia patients rose 48.3% from 2013 to 2017. Considering that a relatively small number of patients currently receive treatment for insomnia due to low recognition of the disease, the potential for growth in the market is high.
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- Piqray has been released in Korea
- by May 20, 2021 05:56am
- The first new drug targeting the PIK3 gene in breast cancer has been released in Korea. The MFDS approved Piqray (Alpelisib/50·150·200 mg' by Novartis on the 13th. Piqray is HR- (+)/HER2 (-) and may be combined with the endocrine treatment Faslodex (Fulvestrant) in postmenopausal women and men with progressive or metastatic breast cancer. PIK3CA positive diagnostic tests are evaluated using in vitro diagnostic medical devices licensed by the MFDS. It is the first domestic PIK3 inhibitor. It also obtained permission from the U.S. and Europe in May 2019 and July 2020, respectively. PIK3CA genetic variation is known to be a common pattern in about 40% of patients with HR+/HER2- breast cancer. Sporadic genetic mutations can mutate independently of family history. If PIK3CA mutations are latent, they can lead to cancer proliferation as well as resistance to endocrine therapy and poor prognosis. In a three-phase SOLAR-1 study conducted by Novartis, Piqray and Fulvestrant combined therapy approximately doubled the primary evaluation variable, Progressive Survival Period (PFS). The median survival period for the combined therapy group was 11.0 months and 5.7 months for the sole therapy group. Overall response rate (ORR), an indicator of the proportion of patients who experience at least a 30% reduction in overall tumor size (in patients with measurable disease), was more than doubled when Piqray was added to Fulvestrant in patients with a PIK3CA mutation, (ORR= 35.7% vs 16.2% for fulvestrant alone, p=0.0002). There was a clinically relevant improvement in OS of eight months for patients with a PIK3CA mutation taking Piqray plus Fulvestrant compared to Fulvestrant alone (median OS 39.3 months vs. 31.4 months). This difference did not reach the prespecified threshold of statistical significance set for the secondary objective of OS in patients with PIK3CA-mutated breast cancer. In terms of safety, most of them were mildly reactive, which can be managed by dose control, and the rate that led to discontinuation of medication was similar to that of the sole therapy group. However, during the administration period, patients may experience severe skin irritation due to drugs, which requires management. The MFDS recommended that Piqray be stopped if the skin is more than 30% toxic to the body surface. As the first PIK3CA-targeted treatment that can meet unmet demand has crossed the licensing threshold, attention is expected to be focused on whether to be reimbursed for combined therapy.
