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- 2026-03-17 16:20:01
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- New triple combo ‘Enerzair’ for asthma lands in 'Big 5'
- by Eo, Yun-Ho Jan 06, 2022 06:09am
- ‘Enerzair Breezhaler,’ a three-in-one triple combination therapy for asthma, can now be prescribed at general hospitals in Korea. According to industry sources, Novartis Korea’s triple combination drug ‘Enerzair Breezhaler (mometasone·indacaterol·glycopyrronium)’ that contains ICS (inhaled corticosteroids) · LABA (beta2-agonist) · LAMA (long-acting muscarinic antagonist) has passed the review of drug committees (DC) of ‘Big-5’ general hospitals including Samsung Medical Center (SMC), Seoul National University Hospital (SNUH), Seoul Asan Medical Center, and Severance Hospital. The company had sought rapid entry into the market after it was approved for insurance benefit in September last year. Enerzair was approved for reimbursement as maintenance treatment of asthma in adult patients (aged 18 or older) who are not adequately controlled with a maintenance combination of LABA and a high-dose ICS who experienced one or more asthma exacerbations in the past 12 months. As a first-in-class combination, Enerzair identified significant results in ▲lung function improvement ▲ exacerbation reduction ▲asthma control ▲quality of life improvement compared to existing two-drug therapy (ICS·LABA) and three-drug therapy (ICS·LABA·LAMA). The drug’s lung function improvement effect was identified in the pivotal IRIDIUM study that compared the efficacy and safety of Enerzair with high-dose ICS·LABA. (fluticasone·salmeterol, mometasone·indacaterol) in asthma patients. In the study, high-dose Enerzair improved the primary endpoint of trough FEV1 (volume of air that can be forced out in the first second of expiration approximately 24 hours post-administration of study drug) by 76mL and 65mL compared to high-dose Atectura Breezhaler (ICS·LABA). In the primary and secondary analysis, it showed a significant improvement in trough FEV1 (199mL) compared to high-dose fluticasone·salmeterol (FLU·SAL) that was administered twice-daily. The FEV1 improvement that was identified at week 26 lasted until week 52. Enerzair also significantly reduced asthma exacerbation rates by 36% (moderate or severe) and 42% (severe) versus high-dose FLU/SAL over 52 weeks. In asthma control, high-dose Enerzair also showed a statistically significant improvement in the rate of patients whose scores improved over the clinically significant difference of 0.5 points at week 4, week 12, and week 52 in the Asthma Control Questionnaire score. Meanwhile, Enerzair also demonstrated an improvement in quality of life even compared to a triple combination therapy that combines the ICS·LABA combo with LAMA. In the ARGON study that compared the improvement in quality of life in patients with uncontrolled asthma of twice-daily FLU/SAL to once-daily tiotropium (TIO), both the medium-dose and high-dose Enerzair demonstrated non-inferiority in the change of Asthma Quality of Life Questionnaire (AQLQ) score from baseline. Enerzair also met the primary endpoint, change in AQLQ from baseline at week 24, and demonstrated non-inferiority to its comparator. In the secondary analyses, medium-dose and high-dose Enerzair improved asthma control (ACQ-7 score, -0.124) and lung function (trough FEV1, 96 mL] compared to high-dose FLU·SAL·TIO.
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- Exports of the biohealth industry surpassed 19 trillion won
- by Jan 05, 2022 05:57am
- Exports of the domestic biohealth industry hit a record high last year due to soaring demand for biosimilars, COVID-19 diagnostic kits and medical devices. Exports in related sectors reached $16.2 billion last year, exceeding $15 billion for the first time. It is expected that strong performance will continue this year due to the release of new biosimilars and the export of Omicron diagnostic kits. According to Ministry of Trade, Industry and Energy on the 3rd, domestic biohealth exports amounted to $16.2 billion last year, up 16.9% from $13.9 billion the previous year. It surpassed $10 billion for the first time in 2020, followed by $15 billion last year. In December last year, it showed an upward trend, recording $1.9 billion in monthly exports (2.2619 trillion won) for the first time in history. The biohealth sector has become one of top 15 major export engines as exports have increased for 23 consecutive years. Biohealth exports increased 2.2 times over the past five years from $7.5 billion in 2017. This is due to the fact that domestic biosimilars are on a roll in global markets such as the European Union (EU), and exports of medical devices such as ultrasound imaging devices and dental implants have steadily increased. In particular, biohealth exports amid the epidemic of infectious diseases shone as global demand for domestic COVID-19 diagnostic kits increased. By country, exports to the EU region rose 9% year-on-year to $4.8 billion. Exports to the U.S. rose 22.9% to $2.1 billion, while ASEAN rose 92.8% to $1.9 billion. In addition, Japan's biohealth exports are insignificant, but they have been increasing for the past nine consecutive months due to the demand for medicines and medical devices caused by the spread of COVID-19 mutations. Expectations are high that biohealth exports will continue to be strong this year. Due to the spread of Omicron mutations, the demand for domestic diagnostic kits that can diagnose Omicron infection in a short period of time is increasing. Domestic diagnostic device companies such as Seegene, Bioneer, and Kogen Biotech have released diagnostic kits that can determine Omicron mutations within 3-4 hours, respectively. Last month, Seegene signed an export contract to supply 2.8 million and 1.7 million new kits to five European countries and Israel, respectively. Exports of domestic diagnostic kits are expected to increase once again as the number of COVID-19 confirmed patients around the world is soaring again with Omicron. Domestic biosimilars will be released in the global market with the approval of new products. In August and September last year, Samsung Bioepis received product permits for Lucentis' first biosimilar Byooviz in the EU and the United States, respectively. Celltrion's Yuflyma, Humira's biosimilar, is expected to expand its European market and enter North America.
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- Only 14% of Pharmas plan to increase jobs due to COVID-19
- by Chon, Seung-Hyun Jan 04, 2022 05:56am
- The prolonged COVID-19 pandemic is expected to bring personnel reshuffling changes to the pharmaceutical and biopharmaceutical industry. CEOs in the pharma industry said that they plan to maintain or reduce the size of new employments in their companies. In addition, 7 out of 10 CEOs predicted that while the companies will maintain the number of jobs, they expect reshuffling to occur within. According to a business strategy survey conducted by Dailypharm on 51 CEOs from pharmaceutical and biopharmaceutical companies, only 13.7% (7) of the CEOs who participated in the survey said they plan to expand the number of new employments this year compared to the previous year. 9.8% (5) responded that they will reduce the number of new employments, and 76.5% (39) said they will maintain the size as is. In other words, 86.3% of the companies will not be expanding the number of new employments this year. Such a trend, where only a few companies decided to scale up new employment, is quite unusual in this industry with the pharmaceutical and biopharmaceutical industry making strong growth every year. This reluctance was evident in the industry in general, regardless of company size. Only 4 of the 32 CEOs (12.5%) of companies with more than 300 employees had responded that they will increase new employment this year. Among companies with less than 300 employees, only 3 out of the 19 companies (15.8%) expected to increase new employment this year. 78.1% and 73.7% of the CEOs in companies with 300 or more employees and 300 employees or less said they will be hiring at a similar level as the previous year. The companies had not increased hiring last year as well. 70.6% (21) CEOs said that they had hired at the same level last year as that of the previous year. 13.7% of the respondents said that they reduced the size of the recruitment compared to the previous year. Survey results showed that many CEOs are expecting the COVID-19 pandemic to bring personnel reshuffling within their companies. On the question asking about the changes in jobs due to changes incurred by the current COVID-19 environment, 68.7% (35) of Pharma CEOs said that “there will be no big change in the total amount of jobs, but there may be changes depending on job function, etc." 17.6% of the CEOs answered that ‘there will be no change’ and only 11.8% (6 people) answered that "there will be more jobs" in their respective companies. Only one CEO predicted job loss. On the other hand, 25.5% of the CEOs expected online security or IT jobs to increase. The expansion of non-face-to-face business such as online video conferencing due to the COVID-19 pandemic is expected to increase the attempts to establish and reorganize the system. Also, 25.5% of the CEOs expected jobs in approval and drug pricing to increase, and 15.7% expected jobs in sales and marketing to increase. On the other hand, 82.4% of the respondents said “no specific jobs in a certain area will decrease.”
- Company
- 2/3 of CEOs plan to continue 'contactless' business activity
- by Kim, Jin-Gu Jan 04, 2022 05:56am
- Three years into the COVID-19 pandemic, 3 out of 4 CEOs from pharmaceutical and biopharmaceutical companies expect their company’s non-face-to-face business activities to expand further this year. The CEOs have also announced plans to maintain or reinforce their non-face-to-face business activities that settled as the ‘new normal’ in the industry over the past two years. ◆Non-face-to-face activities as the ‘new normal’… 75% of CEOs say such activities will “expand further this year" According to a business strategy survey conducted by Dailypharm on 51 CEOs from pharmaceutical and biopharmaceutical companies, 75%(38) of the responders predicted that the prolonged COVID-19 crisis will accelerate change in the work of the overall pharmaceutical industry. Due to the prolonged COVID-19 crisis, non-face-to-face activities have become the new normal in the pharmaceutical and biopharmaceutical industry. CEOs of each company had to make face-to-face and non-face-to-face decisions depending on the severity of the situation. Although there had been discord in the earlier phases of the outbreak, telecommuting and videoconferencing settled into the natural landscape in the prolonged pandemic. This is in line with the second-most amount of CEOs (35·71%) responding that ‘restructuring sales and marketing strategies’ would be most affected this year due to the prolonged COVId-19. Analysts say that the non-face-to-face sales and marketing activities have somewhat settled in the industry during the past two years. ◆66% of CEOs "plan to maintain and expand non-face-to-face activity post-COVID-19 pandemic" Also, the CEOs said they will maintain or expand the current non-face-to-face activities after the end of the pandemic. 66% of the respondents (33 of 50, 1 non-respondent) said they will maintain or reinforce the rate of non-face-to-face work. These responses were consistent across all occupations. 11 of 50 CEOs (22%) responded that they will maintain telecommuting and an agile working system after the COVID-19 pandemic for desk jobs. Twenty-two (44%) responded that they will partly maintain the telecommuting and agile working system for desk jobs. The situation was the same for sales and marketing jobs. 40% of the responders (20 CEOs) answered that they will maintain the proportion of non-face-to-face sales and marketing activities at the current level, and 26% (13) answers that they will rather expand the proportion of non-face-to-face sales and marketing activities post-COVID-19 pandemic. Some Korean subsidiaries of global pharmaceutical companies have officially announced that they will maintain their current non-face-to-face business activities even after the end of the COVID-19 pandemic. Pfizer Korea, Viatris Korea, Novartis Korea, Amgen Korea, among others have made the decision according to the policies of their respective global headquarters. Other Korean subsidiaries of global pharmaceutical companies and some Korean pharmaceutical companies have also joined in the act. ◆ Majority of responders see “Non-face-to-face sales and marketing activities negatively influenced performance” However, on how the non-face-to-face work had affected business in general, the CEOs provided mixed reviews on the performance of internal vs. sales/marketing positions. In general, the CEOs positively evaluated the non-face-to-face work performance of internal positions, but more responders negatively evaluate the non-face-to-face work performance of sales and marketing positions. Among the CEOs that participated in the survey, 17 (33%) believed the non-face-to-face business activity of internal employees was positive, and 14 (27%) said there was no significant difference. In other words, over half of the leaders determined that the non-face-to-face work of internal employees was positive or no different than before. Among others, 11 (22%) responded that it had a negative effect, and 9 (18%) said it was difficult to determine its effect on performance. On the other hand, the majority of the CEOs had given negative evaluations to non-face-to-face work of sales and marketing positions. 27 out of 51 (53%) evaluated that non-face-to-face work in sales and marketing had a negative impact. However still, many CEOs have expressed that they plan to maintain or expand the proportion of non-face-to-face sales and marketing activities. It is analyzed that this is because new sales and marketing methods using mobile and online routes have settled as the new normal in the pharmaceutical industry.
- Company
- Strengthening sales is the top priority in competitiveness
- by Chon, Seung-Hyun Jan 03, 2022 05:57am
- Three out of five CEOs of pharmaceutical companies pointed to "strengthening sales and marketing capabilities" as the most important management strategy to expand competitiveness in the post-Corona era. The view is that it is urgent to establish an effective sales strategy due to rapid changes in the market environment. More than half of the respondents said they should focus on expanding R&D capabilities. More than 70% of CEOs of pharmaceutical companies judged that the prolonged COVID-19 crisis had a negative impact on the company's performance. According to Dailypharm's 2022 management strategy survey of 51 CEOs of pharmaceutical companies on the 3rd, 62.7% of respondents cited "strengthening sales and marketing capabilities" as the most important strategy to expand competitiveness in the post-Corona era. According to a 2022 management strategy survey of 51 CEOs of pharmaceutical companies by Dailypharm on the 3rd, 62.7% of respondents said the most important strategy to expand competitiveness in the post-Corona era is "strengthening sales and marketing capabilities." It was found that relatively small companies highly appreciate the importance of strengthening their sales and marketing capabilities. 19 out of 32 CEOs (59.4%) of companies with 300 or more employees pointed to the need to strengthen their sales and marketing capabilities, while 13 out of 19 CEOs (68.4%) of companies with less than 300 employees answered that strengthening their sales and marketing capabilities is the most necessary strategy to expand their competitiveness. More than half (54.9%) of pharmaceutical CEOs answered that "expanding R&D capabilities" is the most important thing to strengthen the company's competitiveness. Relatively large companies cited expanding R&D capabilities as a more important strategy. In the case of companies with 300 or more employees, 54.9% (19 people) of the respondents pointed to the expansion of R&D capabilities, while companies with less than 300 employees (47.4%) accounted for less than half. It is analyzed that the importance of sales and marketing capabilities is evaluated more highly because the prolonged Corona crisis negatively affected performance. Of the 51 CEOs of pharmaceutical companies, or 70.6%, said the prolonged Corona had a negative impact on their performance. 25.5% (13 people) answered that the prolonged Corona did not affect their performance, while only two (3.9%) answered that it had a positive effect on their performance. 75.0% of corporate CEOs with more than 300 employees said Corona negatively affected their performance, while 63.2% of CEOs with less than 300 employees also said they were hit by Corona. In fact, when asked about management difficulties due to the prolonged Corona, "decrease in performance" accounted for the largest portion. Of the 51 CEOs of pharmaceutical companies, 39 people, or 76.5%, answered the biggest difficulty of "concerns over a decrease in performance due to a reduction in the proportion of sales and marketing." Companies with more than 300 employees (71.9%) and companies with less than 300 employees (84.2%) all pointed out poor performance as the biggest difficulties due to prolonged Corona. "Concerns over shutdown of factories and research institutes due to the outbreak of COVID-19 confirmed cases" also reached 29.4%. It was followed by disruptions in overseas export routes of medicines (27.5%), delays in administrative procedures such as permits and benefits (25.5%), and a decrease in overall work efficiency (13.7%). Compared to the early days of the COVID-19 incident, 45.1% of respondents said that the degree of management crisis they felt over the past two years was a shock similar to what they expected. 27.5% of respondents said the shock was greater than expected, slightly more than 23.5% said the shock was smaller than expected.
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- Expectations rise for prescription of tumor-agnostic drugs
- by Eo, Yun-Ho Jan 03, 2022 05:56am
- Preparations to prescribe`tumor-agnostic' anticancer drugs in the field are well underway. According to industry sources, Bayer Korea’s neurotrophic tyrosine receptor kinase (NTRK) inhibitor Vitrakvi (larotrectinib) has passed the drug committee (DCs) of general hospitals in Korea including the Seoul National University Hospital. Thus, Vitrakvi's prescription is expected to start in earnest when Bayer reaches an agreement with the National Health Insurance Service in the ongoing pricing negotiations. Vitrakvi, which was approved in May last year, is going through the reimbursement listing application process through the pharmacoeconomic evaluation exemption system. In November, the agenda passed the NHIS Pharmaceutical Benefit Evaluation Committee. Roche’s ‘Rozlytrek (entrectinib), Vitrakvi’s competitor with the same mechanism of action, is also undergoing pricing negotiations with the NHIS. Vitrakvi is indicated for use in adult and pediatric patients with solid cancer who have progressed after using conventional treatment options or have no suitable treatment options available that have NTRK gene fusions without a known acquired resistance mutation, that are either metastatic or where surgical resection is likely to result in severe morbidity. In other words, it may be used in virtually most cancer types with an identified NTRK gene. Do-youn Oh, Professor of Oncology at Seoul National University Hospital, said, “After prescribing to a 6-year-old patient with thyroid cancer, Vitrakvi showed such good results that the patient’s cancer mass that had metastasized to the lungs became almost invisible from imaging findings. Also, the side effects that I had concerns about almost did not appear.” Meanwhile, Vitrakvi’s approval was based on data from a Phase I trial on adults 18 years and older, Phase II NAVIGATE study on pediatric and adult patients over the age of 12, and the Phase I/II SCOUT study on pediatric patients aged 1 month to 21 years that included those with primary CNS tumor. According to an efficacy review conducted on 55 patients with identified NTRK fusion in the 3 studies prescribe above, Vitrakvi’s overall response rate (ORR) was 75% and partial response 53% in various cancer types (including soft tissue sarcoma, infantile fibrosarcoma, salivary gland tumors, thyroid cancer, lung cancer, melanoma, colon cancer, gastrointestinal stromal tumor, cholangiocarcinoma, appendiceal carcinoma, breast cancer, and pancreatic cancer) Vitrakvi showed an effect not only in adults but also in pediatric patients. Twenty-four patients aged 1 year or less participated in the studies above, to whom the drub showed the same efficacy as in adult patients. As a result, Vitrakvi was approved for use in both pediatric and adult patients.
- Company
- Samsung Biologics denies rumors of Biogen's acquisition
- by Jan 03, 2022 05:55am
- Biogen shares fluctuated on reports that Samsung Group is trying to acquire U.S. pharmaceutical company Biogen for 50 trillion won. Samsung said, "It's not true."Some media recently observed that Samsung Group has begun negotiations after a preliminary review to acquire Biogen. The acquisition is expected to reach 50 trillion won. Shortly after the report, Biogen shares fluctuated. Biogen shares, which started at $235, soared to a maximum of $265.54, and closed at $258.31, up 9.46% from the previous day. However, Samsung Biologics announced its official position on the 30th that it is "not true at all." Biogen, a multinational pharmaceutical company, was established in the United States in 1978 and is developing treatments mainly for neurological diseases such as stroke and Alzheimer's disease. Last year, annual sales reached $1344 billion (about 15.448 trillion won). In Korea, a corporation was established in 2017 with the SMA treatment Spinraza. Biogen drew attention by offering the first Alzheimer's treatment. The U.S. Food and Drug Administration (FDA) approved the beta-amyloid target drug Aduhelm in June. The FDA External Advisory Committee recommended non-approval with unsatisfactory clinical data, but the FDA granted Aduhelm an item license. However, there were also controversies such as suspicions that Biogen continued to meet FDA members to approve Aduhelm and that it applied to post-hoc to produce good results in phase 3. On top of that, too high drug prices were also a problem. Lower-than-expected sales performance also played a negative role. Biogen shares, which soared to $414.71 with Aduhelm's permission, are on a downward trend. Until early this month, it did not recover to the previous level of $250 to $280. Biogen is putting all its energy into phase 4 clinical trials after Aduhelm's marketing. If Phase 4 fails to prove clear validation data, Eduhelm may be revoked based on FDA judgment. Biogen is also related to Samsung. It co-founded Samsung Bioepis with Samsung Biologics in 2012. Currently, biosimilar products developed by Samsung Bioepis are in charge of global sales.
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- Record number of new homegrown drugs released this year
- by Chon, Seung-Hyun Dec 31, 2021 05:51am
- Domestic pharmaceutical and biopharmaceutical companies this year had received approval for four new drugs. This is the most amount of new drugs released in a single year since the first homegrown drug was introduced in 1999. Major companies with an annual sales record of 1 trillion won such as Yuhan Corp, Celltrion, Hanmi Pharamcetucial, and Daewoong Pharmaceutical have made this performance. According to the Ministry of Food and Drug Safety on the 31st, Daewoong Pharmaceutical’s gastroesophageal reflux disease (GERD) treatment ‘Fexclu,’ which contains fexuprazan, was approved as a new drug on the 30th. Daewoong Pharmaceutical made this achievement in 14 years since it first started the development of Fexclu in 2007. Fexclu is a potassium-competitive acid blocker (P-CAB) GERD treatment. It has a faster onset of action than proton pump inhibitors (PPIs) and has the advantage of being able to be taken regardless of meal ingestion and the longer-lasting effect. These types of drugs had quickly settled in the market since HK inno.N introduced its first P-CAB type of new drug ‘K-CAB’ in 2018. With the approval of Fexclu, a total of 4 new homegrown drugs by local pharmaceutical and biopharmaceutical companies this year. First was Yuhan Corp’s anticancer drug ‘Leclaza’ in January, followed by Celltrion’s COVID-19 treatment ‘Regkirona’ in February and March, and Hanmi Pharmaceutical’s neutropenia treatment ‘Rolontis.’ In January, Leclaza received conditional approval for the treatment of patients with advanced non-small-cell lung cancer who have a mutation in a specific gene (EGFR) who have previously received lung cancer treatment. Leclaza is a targeted anticancer therapy that inhibits the signal transduction that is involved in lung cancer cell proliferation and growth. It is an oral tyrosine kinase inhibitor (TKI) that has high selectivity against the EGFR T790M resistant mutation. It showed superior efficacy and tolerability against lung cancer patients with brain metastasis as it can pass through the blood-brain-barrier (BBB). Celltrion’s COVID-19 antibody treatment ‘Regkirona’ received conditional approval in February. Regkirona Inj. is a recombinant neutralizing antibody produced by selecting a neutralizing antibody gene in a COVID-19 convalescent patient's blood and inserting the selected gene into a host cell that is cultured for large-scale production. Regkirona is the first locally developed COVID-19 treatment and the third COVID-19 antibody treatment in the world to be verified by the regulatory authority. It received marketing approval based on its Phase III trial results in August and its indication was extended to the treatment of high-risk adult patients with mild and moderate symptoms who have been confirmed with COVID-19 according to the provisional pathway. In March, Hanmi Pharmaceutical’s Rolontis Pre-filled Syringe inj. was approved as a new locally developed new drug. Rolontis uses recombinant technology to connect a specific protein to a human’s granulocyte-colony stimulating factor (G-CSF) analog to increase the sustainability of its effect. It is used to treat chemotherapy-induced neutropenia. It binds to the G-CSF receptor to stimulate neutrophil production. This year, domestic pharmaceutical and biopharmaceutical companies have broken the record and received approval for the largest number of homegrown new drugs in a single year, and in three years since HK inno.N received approval for K-CAB in 2018. That these new drugs were released after a long period of time by major companies that recorded annual sales exceeding 1 trillion won - Yuhan Corp, Celltrion, Hanmi Pharmaceutical, and Daewoong Pharmaceutical – is also being considered significant. Yuhan Corp released its second novel drug this year in 16 years since ‘Revancex’ in 2005. Regkirona was Celltrion’s first new drug. Celltrion had focused on biosimilars, but with the spread of COVID-19 in earnest, the company had entered into the treatment development business and succeeded in the commercialization of the treatment within a year. Rolontis is the first new biologic and the only new drug Hanmi Pharmaceutical succeeded in commercializing and is in sale. Hanmi Pharmaceutical had received approval for its NSCLC treatment ‘Olita’ in 2016 but announced the discontinuation of its development after three years, based on the strategic judgment that stopping the development is more beneficial than bearing the cost of Phase 3 clinical trial. Daewoong Pharmaceutical succeeded in developing a new drug in 20 years since Easyef in 2011. It is evaluated that the potential of success of Fexclu is high as the same class drug K-CAB’s marketability was recognized in the industry.
- Company
- Daewoong's drug targets ₩100 bil market as 2nd P-CAB
- by Kim, Jin-Gu Dec 31, 2021 05:51am
- Daewoong Pharmaceutical succeeded in receiving approval for its potassium-competitive acid blocker (P-CAB) ‘Fexclu (fexuprazan)’ for the treatment of gastroesophageal reflux disease (GERD). It is being predicted that the new drug introduced will unfold a full-fledged competition with HK inno.N’s ‘K-CAB (tegoprazan), a GERD treatment that grew to record ₩100 billion in annual prescriptions in only 3 years since its release. ◆Received marketing authorization 14 years after starting development … 34th homegrown new drug The Ministry of Food and Drug Safety granted marketing authorization of Daewoong’s Fexclu tablet on the 30th. Fexclu will likely be designated as the 34th locally developed new drug. Daewoong started the development of Fexclu in 2007 and received approval for the drug after 14 years. This is the second new drug developed by Daewoong since the diabetic foot ulcer treatment Easyef(No.2 homegrown new drug) that was approved in 2001. Fexuprazan is a P-CAB GERD treatment. It inhibits gastric acid secretion by competitively binding to the proton pump and potassium ion located in the final stage of acid secretion from the stomach wall. It was received as it had improved the shortcomings of existing proton pump inhibitors (PPIs). It has a faster onset of action than PPIs and has the advantage of being able to be taken regardless of meal ingestion. In a clinical trial conducted by Daewoong Pharmaceutical, the new drug demonstrated superior symptom improvement and showed longer-lasting effects than the representative PPI class esomeprazole. ◆To start a full-fledged competition with the annual ₩100 billion grossing K-CAB The industry expects that a full-fledged competition with K-CAB is inevitable when Daewoong officially releases Fexclu next year. The only P-CAB drug approved as of now in Korea is HK inno.N’s K-CAB. HK inno.N received approval of K-CAB as the 30th homegrown new drug in late 2018. K-CAB quickly settled in the market and is making new history for domestic new drugs since its release in March 2019. This year, 3 years into its release, it is highly likely that the company is expected to record ₩100 billion in prescriptions this year. This is a new and first record made by a single homegrown new drug. According to the market research institution UBIST, the cumulative prescription amount of K-CAB reached ₩88 billion between January and October this year. Daewoong plans to prevent K-CAB’s sole lead in the market based on its solid position in the domestic digestive drug prescription market. Daewoong had been leading the market for the past decade selling with its ranitidine GERD treatment ‘Albis’ and AstraZeneca’s PPI-class treatment ‘Nexium.’ The two drugs had recorded the highest prescription performance in their respective markets. Daewoong decided to terminate the co-promotion agreement it had had since 2008 for AstraZeneca’s Nexium at the end of this year. It is believed that the decision was made by the company to devote itself to the sale and marketing of Fexclu. ◆HK inno.N establishes defense strategy by extending its indication and developing a new formulation HK inno.N seems to be preparing a defense strategy by extending its K-CAB indication and developing new formulations. The drug was applied for insurance benefit as a gastric ulcer treatment in November, an extension from the previous scope of reimbursement of erosive and non-erosive gastroesophageal reflux disease. Although yet to be reimbursed, K-CAB also has an indication Helicobacter pylori eradication. In addition, clinical trials to extend its indication to maintenance therapy post-GERD treatment and NSAIDs-associated PUD are ongoing. Also, HK inno.N is also developing an oral disintegration tablet formulation of its drug. The company has applied for its marketing authorization to the Ministry of Food and Drug Safety, and the company is planning to release the new formulation of K-CAB in the first half of next year.
- Company
- Competition for KRAS targeted anticancer drugs
- by Dec 31, 2021 05:51am
- Mechanism of action of KRAS inhibitor (Data: Amgen)The development of treatments targeting KRAS mutations in solid cancers, including non-small cell lung cancer, is active. This year alone, seven companies were approved for nine related clinical trials. Amgen, which is leading the competition, is undergoing a domestic permit review. According to the pharmaceutical industry on the 30th, there are a total of nine clinical trials related to KRAS that have been approved by the MFDS this year. The nine development stages were 5 cases in phase 1, 2 cases in phase 1/2, and 2 cases in phase 3. KRAS was first discovered in 1982 as a genetic mutation in solid cancers such as non-small cell lung cancer and colon cancer. In lung adenocarcinoma, patients with KRAS mutation are reported to be up to 25% in the West, and about 10-15% in Asians. Development efforts have continued for about 40 years since the discovery of KRAS, but have repeatedly failed in clinical trials. Since then, the KRAS gene signaling system has focused on subdivided targeted treatments tailored to various subtypes such as G12C, G12D, and G12F. Among them, many drugs target G12C. Amgen developed the first targeted treatment targeting KRAS G12C, which was approved by the U.S. Food and Drug Administration (FDA) in May this year under the name Lumakras. Amgen is speeding up its commercialization by applying for permission in Korea immediately. Competition to catch up with Amgen is intensifying. The pharmaceutical company closely chasing Amgen was approved for two phase 3 in June and September by Mirati Therapheutics. One case is for non-small cell lung cancer and the other for colon rectal cancer. Colorectal cancer is used in combination with the existing treatment Erbitux. KRAS development by Mirati and other pharmaceutical companies is still in its infancy. Novartis and China's InventisBio are conducting phase 1/2 each. Novartis tests the KRAS target anticancer drug JDQ443, which is being developed for advanced solid cancer patients in clinical trials approved in March. InventisBio was approved for clinical trials of "D-1553" in March. InventisBio is scheduled to end the test in October 2023 and Novartis in October 2024. Roche, Beringer Ingelheim, and Lilly have also started to develop KRAS-targeted anticancer drugs. Genentech, a Roche subsidiary that was first approved for clinical trials in March this year, plans to evaluate the safety and appropriate capacity of GDC-6036 for solid cancer patients with KRAS G12C mutations by February 2024. In April, Beringer Ingelheim was approved for two first phases of the new drug BI 1701963. One case is a clinical trial in which BI 1701963 monotherapy and another new drug, MEK inhibitor BI3011441 are tested in patients with KRAS mutated solid cancer. The other case evaluates BI 1701963 monotherapy and combination therapy with the existing MEK inhibitor Meqsel in the same patient group. BI 1701963, which is being developed by Beringer Ingelheim, is a general-purpose treatment (pan-KRAS) that targets various types of KRAS mutations, including major G12 genes. Its strategy is to maximize its effectiveness by using it in combination with MEK inhibitors. Most recently, Eli Lilly also jumped into domestic development with the approval of the first award. Lilly stopped KRAS-targeted new drug substance, which was being developed first last year, due to toxicity problems. Lilly did not stop here, but began to try again with another new drug called "LY3537982." Lilly is planning to conduct phase 1 for solid cancer patients with mutations in KRAS G12C. MSD continues to develop an immuno-cancer drug Keytruda in combination with KRAS-targeted anticancer drugs.
