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- 2026-04-13 04:34:39
- Policy
- President Moon "will make all efforts to return to normalcy"
- by Lee, Jeong-Hwan Jan 04, 2022 05:56am
- During his 2022 New Year’s address, President Moon Jae-in expressed his gratitude and respect to the medical professionals and personnel working to contain and prevent COVID-19 and restressed the excellence of Korea’s disease control and prevention system. The president also expressed his ambition to achieve complete recovery of the peoples’ lives by strengthening epidemic prevention and control in the new year. While delivering his New Year’s address at Cheong Wa Dae on the 3rd, President Moon Jae-In said,” Korea’s response to the virus has risen to prominence on its merit amid the global fight against COVID-19." “During the past two years of the COVID-19 pandemic, the Government and the people have come together as one to surmount crises. We have turned those crises into opportunities while demonstrating once again the potential of the crisis-resilient Republic of Korea. This achievement has been made possible by combining the efforts of the Government, the dedication of medical professionals, and our people’s strong sense of solidarity.” President Moon said, "We stand again on the starting line of a New Year. I wish everyone a happy New Year and a year to make yet another leap forward, inspired by the tiger’s vigorous energy. Even at this moment, our anti-epidemic workers and medical professionals are struggling in freezing temperatures. Once more, I extend my profound respect and gratitude to them.” President Moon emphasized that moving toward normal daily routines while strengthening epidemic prevention and control is the starting point for a full recovery and that the country's anti-epidemic measures have begun to take effect. He expected that as the number of confirmed cases will continue to decrease, the number of severely or critically ill patients will also decline soon. However still, the president expressed concerns over the rise of COVID-19 cases due to the spread of the Omicron variant. The president is determined to make all-out efforts to overcome the COVID-19 crisis that arose from the variant and achieve complete recovery in the people's lives. President Moon said, “The administering of booster shots and the inoculation of adolescents are also picking up speed, and a great number of hospital beds and medical professionals are being secured. Starting this month, pills for oral COVID-19 treatment will be dispensed. However, it is too early to let our guard down as the number of newly confirmed cases is breaking records around the world due to the Omicron variant." “We will work intensively to overcome this crisis. With a long-term perspective, the government will nourish hope for a return to normal life by riding out the difficulties along with the people in a steady manner. It is truly regrettable that our people are facing growing hardships in their livelihoods with tightened anti-epidemic measures being extended and a return to normalcy being delayed. I’d like to give special words of comfort to the microbusiness owners.” While mentioning the upcoming presidential election in March, the president expressed wishes for the election to become an election of unity that embodies the hope of the people, instead of hostility, hatred, and division. President Moon said, “With the presidential election up ahead, I hope that the election will become a celebration of democracy in which a candidate is chosen by the people through fierce competition, for the sake of people’s lives and the country’s future. Our people are the master of politics, and their participation is what advances democracy and raises the level of politics.” He added, “As an administration devoted to overcoming the crises and pioneering the future, my administration will work at full capacity for the remaining four months.”
- 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.
- Policy
- Minister Kwon said he would develop vaccines and txs
- by Kim, Jung-Ju Jan 04, 2022 05:55am
- Minister of Health and Welfare said he will foster the biohealth industry by investing in building a global bio-human resource training hub, developing vaccines and treatments, creating a "K-Global" vaccine fund and revitalizing the use of domestic medical devices in 2022. Minister Kwon issued a New Year's address today (31st) and explained tasks and directions such as responding to the current COVID-19 crisis, developing and fostering the health industry, establishing a medical system, and strengthening health insurance coverage. First of all, the government's budget for next year has been confirmed to be 607.7 trillion won, of which the budget is set at 97.4767 trillion won. It accounts for the largest portion of the government's budget at 16%. Minister Kwon said, "Next year, we will do our best to overcome the COVID-19 crisis by actively investing our budget in preemptive securing of COVID-19 vaccines and treatments, securing treatment beds for severely ill patients, and supporting COVID-19 depression." Regarding the pharmaceutical bio-industry, he also explained that he plans to foster the bio-health industry by investing in building a global bio-human resource training hub, developing vaccines and treatments, creating a K-global vaccine fund, and activating the use of domestic medical devices. Minister Kwon said, "The MOHW will always think about whether even a single policy can change the lives of the people and contribute to the happiness of the people, and work while finding answers and communicating on the spot." He said, "As it is Year of the Black Tiger, I look forward to starting the year vigorously with the spirit of Black Tiger and overcoming the COVID-19 crisis."
- Policy
- Additional contracts for COVID-19 PO tx are under discussion
- by Kim, Jung-Ju Jan 04, 2022 05:55am
- The government is pushing for additional purchases of oral COVID-19 treatments separately from existing contracts.The KDCA announced its 2022 work plan today (30th) under the theme of "COVID-19 Disease Control and Prevention Response and National Health Support." Authorities plan to strengthen severe prevention by introducing oral treatments next year. It plans to expand the target institutions for domestic antibody treatment and operate a rapid supply system to reduce the transition of mild patients to severe diseases. It will also actively introduce oral treatments to supply them to home treatment patients and hospitalized patients dedicated to infectious diseases, reduce hospitalization or death of patients, and maintain a medical and quarantine system. Currently, authorities are pushing for a pre-purchase contract for 1 million and have signed a contract for 604,000 people so far. Authorities said they are discussing additional purchase contracts separately from the existing contract volume for the spread of Omicron and a soft landing of daily recovery, and will sign the contract in early January next year and disclose it to the public. ◆ By strengthening daily disease prevention and management= the KDCA operates a visiting tuberculosis screening and regular screening center, and strengthens support for tuberculosis patients in vulnerable groups through integrated health and welfare services. In addition, genital infections caused by HPV, the main cause of cervical cancer, can be prevented by vaccinating more than 90%, but it will be actively supported by expanding the free support for HPV vaccinations due to expensive vaccination costs. The target, which was limited to 12-year-old girls this year, will be expanded from next year to girls aged 13 to 17, basic livelihood recipients aged 18 to 26 from 2018 to 2026, and women in the second-highest class.The government will continue to promote the prevention and management of non-infectious diseases by expanding the scope of registration management of hypertension and diabetes and medical expenses to rare diseases. The results of the first climate health impact assessment will be announced in the first half of next year after evaluating the impact of climate change on people's health, and based on this, a disease management policy will be established to prepare for climate change. In preparation for future public health threats, the government will provide all-out support to advance the national quarantine system = commercialization of COVID-19 vaccine in Korea, and strengthen its full-cycle investment in R&D to secure various technologies such as new technology platform vaccines (mRNA). The KDCA expands core technology development, non-clinical research, and establishes a regular cooperative system for clinical research to strengthen its capability to develop new strain virus treatments such as COVID-19. International cooperation will be strengthened through cooperation in sharing information and substances on infectious diseases through participation in WHO new hubs and expansion of ASEAN infectious diseases and technological cooperation. In order to respond quickly and effectively to new infectious diseases such as COVID-19, related systems such as infectious disease systems and quarantine systems will be efficiently integrated to establish an integrated quarantine information system. It plans to systematically collect and manage information related to COVID-19 (confirmed patients, vaccinations, adverse reactions, etc.) and promote policies to respond to infectious diseases based on scientific evidence.
- 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.
- Company
- 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.
- Product
- Is the price of Paxlovid reasonable?
- by Jan 03, 2022 05:55am
- On the 27th, Paxlovid, an oral treatment for COVID-19, was approved for EUA by the MFDS, and the Pharmaceutical Association for Health Society asked questions about the insolvency and effectiveness of the screening process on the 30th. The Health Pharmaceutical Association said, "Paxlovid is expected to be used in patients with high risk among mild and moderate coronavirus patients, and is known to have side effects such as taste abnormalities, diarrhea, and elevated blood pressure, and to be careful of various drugs such as anti-antibodymetic drugs." The Pharmaceutical Association said it would inquire about ▲ the inadequacy of the Ministry of Food and Drug Safety's examination process, ▲ possibility of effectiveness in the field, ▲ whether there is a treatment benefit for the use of mild patients, ▲ lack of efforts to solve the supply shortage problem,▲ in the absence of fair price negotiations, and▲ the lack of review of the supply of North Korean treatments. ▲How did Paxlovid finish its evaluation in 6 days?= Other new drugs also undergo a preliminary review process and have an average approval review process of 10 months. In addition, the data on the approval of new drugs are so vast that it is impossible to review all of them in six days. Therefore, there is a concern about insolvency screening, or it is doubtful whether it is a permit review relying on foreign regulators. ◆Is the restriction on clinical subjects actually effective?= Subjects of EPIC-HR, an important clinical trial of Paxlovid, were mainly mild and moderate patients who were not hospitalized, those with a high risk of COVID-19, those with one or more symptoms within 5 days, those who were not vaccinated, and those who participated as soon as possible after diagnosis.However, in actual clinical trials, those who have been vaccinated, those who are not at high risk, those who have passed five days of onset of symptoms, those who have been delayed from diagnosis to treatment, and patients with moderate or higher can also take medicine. Further research is needed on the effect of this. ◆Is it an appropriate treatment to administer to mild patients= So far, the proven effect of Paxlovid is the effect of lowering the risk of hospitalization and death. And the actual price is unknown, but the U.S. transaction price is said to be approximately 630,000 won. It is necessary to examine whether it is an appropriate price to administer 630,000 won to treatments to lower the risk of hospitalization and death of COVID-19 patients. The Institute for Clinical and Economic Review analyzed Remdesivir in a traditional cost-effectiveness method, and assessed that it had a therapeutic benefit of $2470 when used for secondary and severe patients, but only $70 when used for mild patients. The current COVID-19 is a global public health crisis. The Dominican government is considering generic for Paxlovid to respond to COVID-19. And it is known that this drug can be produced without any special technology. The government should prioritize public protection, not Pfizer's interests, to cope with infectious diseases. ◆Is the price of Paxlovid at the disposal of the seller? = Originally, drug pricing needs sufficient negotiation efforts between the government and pharmaceutical companies. Excessively high prices can undermine the patient's right to treatment and too low prices can undermine pharmaceutical companies' motivation for development. In order to simultaneously achieve patient accessibility and promotion of R&D in the pharmaceutical industry, fair drug prices should be considered. Drug price information should be disclosed as transparently as possible, but Pfizer continues to undermine price transparency with a public health crisis as a weapon in the COVID-19 situation. ◆Why don't we discuss the supply of Paxlovid to North Korea= North Korea is one of the few countries that have yet to start getting vaccinated against COVID-19. There are many reasons why vaccines are not supplied to North Korea, but it is known that there is a heavy burden on the storage conditions below the freezer and the exemption of side effects that occur in healthy people. Since Paxlovid is used in patients with COVID-19 symptoms, side effects can be avoided and storage can be done at room temperature for a long time, thereby overcoming these limitations. Since Pfizer doesn't apply Paxlovid patents in 95 low-income countries, including North Korea, the South Korean government will be able to consider producing and supplying generic for Paxlovid to North Korea using domestic pharmaceutical facilities for humanitarian purposes.
- 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.
- Company
- 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.
