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- 2026-04-13 01:42:36
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- Second new migraine drug ‘Ajovy’ aims at reimbursement
- by Eo, Yun-Ho Jan 20, 2022 05:55am
- ‘Ajovy’ is also following the steps of ‘Emgality’ and seeks health insurance benefits in Korea. According to industry sources, Teva-Handok Pharma applied for the reimbursement of its calcitonin gene-related peptide (CGRP) targeting migraine drug Ajovy (fremanezumab). The company quickly applied for reimbursement since launching the drug without reimbursement in October last year. With slow progress being made for the reimbursement of Lilly's Emgality (galcanezumab),’ which applied for reimbursement in April last year, whether the addition of Ajovy to the game will create a synergistic effect remains a point of focus. Both drugs are currently prescribed without reimbursement. Although Emgality and Ajovy are same class drugs, they differ in dosage and administration, allowing patients to be prescribed the drugs according to their characteristics. Emgality is administered in a loading dose of 240mg (two consecutive subcutaneous injections of 120 mg each) followed by monthly doses of 120mg injected subcutaneously. Ajovy is administered in a monthly dosage of one 225 mg subcutaneous injection each month or a quarterly dosage of 675mg subcutaneous injection (three consecutive 225mg injections) every 3 months. Meanwhile, Ajovy demonstrated its efficacy at the HALO EM/CM clinical trial that was conducted for 12 weeks on 2,000 episodic migraine (EM) and chronic migraine (CM) patients. In the HALO EM study that was conducted to verify the efficacy and safety of Ajovy in comparison to the placebo, Ajovy met the primary endpoint by significantly reducing the monthly number of migraine days in both of the monthly and quarterly dosed groups. The proportion of patients with a 50% reduction in migraine days was also higher for the Ajovy administered group than the placebo group. The proportion of subjects that showed a 50% or more reduction in migraine days was 44.4% in the monthly Ajovy and 47.7% in the quarterly Ajovy group compared to the 27.9% of the placebo group. In the HALO CM study, the monthly average reduction in migraine days in the monthly dosing Ajovy group was 4.6±0.3 days, and the quarterly dosing Ajovy group was 4.3±03 days, a significant reduction compared to the placebo group’s 2.5±0.3 days. WonGu Lee, Professor of Neurology at Kosin University Hospital, said, “Unlike existing preventive drugs that required daily dosage, patients may manage their migraines with once-a-month injection with CGRP-targeted antibody drugs. The treatment cost remains an issue, however, we neurologists have high expectations for these drugs because the more the patient receives the targeted therapy, the easier it is to treat.”
- Policy
- Dong-A ST enters Phase III trial for its new OAB treatment
- by Lee, Tak-Sun Jan 20, 2022 05:55am
- Dong-A STNews of new drugs being developed by local companies are coming in one after another from early on this year. Dong-A ST, which had developed three new drugs including the erectile dysfunction treatment ‘Zydena (udenafil),’ antibiotic ‘Sivestro (tedizolid phosphate),’ and antidiabetic ‘Suganon (evogliptin),’ is also receiving attention with its new drug candidate entering final stages of commercialization. The Ministry of Food and Drug Safety approved the Phase III study protocol for Dong-A ST’s 'DA-8010,’ a new drug candidate in development for the treatment of overactive bladder syndrome. The Phase III trial will be conducted to test the efficacy and safety of DA-8010 in 595 patients with overactive bladder in Korea. The trial will be conducted at the Sinchon Severance Hospital. DA-8010 is a new antimuscarinic being developed by Dong-A ST. Antimuscarinics inhibit involuntary contraction of the bladder and reduce urinary urgency to increase bladder capacity by primarily acting in the urinary storage phase where parasympathetic nerves are not activated. Astellas ‘VESIcare (solifenacin)’ is a representative antimuscarinic drug, However, antimuscarinic drugs as such are associated with adverse events such as dry mouth and constipation. DA-8010 is expected to improve such side effects and have a more superior effect over existing products. Dong-A ST had started the development of the drug in 2010 last year and is now awaiting commercialization. In addition to Korea, the company has also completed a Phase I trial for the drug in Europe. Dong-A ST, which is famous for its energy drink ‘Bacchus,’ has been leading the R&D of new drugs in the domestic industry, succeeding in developing 3 new drugs. In particular, its ‘Zydena (erectile dysfunction)’ that was approved in 2005 and ‘Suganon (diabetes treatment)’ in 2015 both made great success in the market and were noted for their marketability as well. ‘4 new homegrown drugs’ approved last year… Daewoong and SK Bioscience expected to again receive approval for new drugs this year Yuhan Corp’s new NSCLC treatment that was approved in January last yearLast year, Korea celebrated the highest number of approvals of homegrown new drugs. Starting with Yuhan Corp’s anticancer drug ‘Leclaza’ in January, Celltrion’s COVID-19 treatment ‘Regkirona’ in February, Hanmi Pharmaceutical’s neutropenia treatment ‘Rolontis’ in March, and Daewoong Pharmaceutical's ‘Fexclu’ was approved in December last year. The companies are developing their drugs abroad as well to target the global market. In the case of Rolontis, the industry believes the drug may be approved by the US FDA within the year. Daewoong Pharmaceutical, which received approval for Fexclu tab in the end of last year, is also planning to introduce a new drug this year. The company plans to complete Phase III trials for the SGLT-2 inhibitor it is developing for the treatment of type 2 diabetes, 'DWP16001,' as a monotherapy and combination therapy. The COVID-19 vaccine candidate ‘GBP510’ that is being developed by SK Bioscience also completed patient enrollment for the Phase III trial by registering 4,000 patients and started the efficacy analysis. GBP5010 is expected to be commercialized in the first half of this year.
- Policy
- SK Bioscience has completed recruiting phase 3 participants
- by Kim, Jung-Ju Jan 20, 2022 05:55am
- The COVID-19 vaccine GBP510, which is being developed by Korean companies, is undergoing phase 3 global clinical trials. The recruitment of 4,000 people from six countries has been completed. Today (18th), the government held the 26th meeting of the pan-government TF to support clinical trials of COVID-19 vaccines and treatments to discuss the progress of the development of COVID-19 vaccines in Korea. The meeting was attended by Ryu Geun-hyuk, the second vice minister of the MOHW, related ministries, and private experts, and SK Bioscience President Ahn Jae-yong announced the progress of clinical trials for the COVID-19 vaccine currently under development. In Korea, eight companies are currently conducting clinical trials for the COVID-19 vaccine. Participating companies are SK Bioscience, EuBiologics, Geneone, Genexine, Quratis, HK inno.N, Cellid, Aijin. Among them, SK Bioscience's GBP510 is being developed the fastest with its entry into phase 3 clinical trials as of August 10 last year. Phase 3 clinical trials of GBP510 have recruited clinical participants from five foreign countries, including Korea, Thailand, the Philippines, Vietnam, Ukraine, and New Zealand, with a total of 3,990 subjects in five months since it began administration on August 30 last year. SK Bioscience announced that it plans to complete the development of vaccines in the first half of this year through rapid sample analysis and data acquisition for vaccines under development in the future. When the development of GBP510 is completed with CEPI support, it will be supplied to countries around the world through the COVAX Facility. Meanwhile, the government is also conducting a pre-purchase process for 10 million doses of domestic vaccines under development by SK Bioscience. Until now, the government has supported the recruitment of clinical participants, supported rapid clinical proceedings such as clinical permits through overseas missions in clinical countries, and supported rapid sample analysis led by the government for vaccine efficacy analysis through Korea National Institute of Health and the International Vaccine Institute. As of the 17th, a total of 2,163 cases have been received, and 1,764 cases have been analyzed, and the sample analysis is supported to proceed quickly as soon as the sample is received. In addition, a cross- and additional vaccination clinical trial under the supervision of KDCA is underway for the safe vaccination of the people after the development of domestic vaccines. Second Vice Minister Ryu Geun-hyuk said, "Even when it is difficult to recruit clinical participants due to COVID-19 vaccination, we were able to complete the recruitment of clinical trial participants for domestic vaccine development smoothly thanks to the public's high interest and active cooperation. After that, we will focus on support at the pan-government level so that sample analysis, approval, examination, and commercialization can proceed quickly. We will support the development of various domestic vaccines and treatments, including SK Bioscience, until the end."
- Policy
- Additional Paxlovid for 10,000 people will be introduced
- by Kang, Shin-Kook Jan 20, 2022 05:54am
- Prime Minister Kim Bu-gyeom visited the Residential Treatment CenterPrime Minister Kim Bu-gyeom announced that he would introduce an additional 10,000 servings at the end of this month as patients' condition improved after taking the COVID-19 treatment. Prime Minister Kim posted a message on his SNS on the 17th and said, "The prescription and administration of COVID-19 treatment began last week." He said, "I visited the residential treatment center in Jung-gu, Seoul a while ago and looked at the status of medication for eating treatments. "I met the elderly who were taking the medicine on the screen and asked how they were doing over the phone, and I heard that the elderly were taking the medicine well and are currently improving well without any adverse reactions." He said, "In addition to the elderly I called today, it is very fortunate that patients who were prescribed during home treatment are being treated without any major adverse reactions. There are drugs that patient shouldn't take together, so patient needs to be careful with prescriptions, and speed is important because he/she has to take the medication within five days of symptoms." He said, "Looking at the scene today, if the prescribed person is taking a medicine that should not be taken together, the notification function is immediately activated on the system. "We were well prepared for quick and safe administration through the world-class drug safety use service (DUR)." Prime Minister Kim said, "The introduction of treatments is also proceeding without much difficulty." He said, "Last week, Doses for 21,000 people were introduced, and an additional doses for 10,000 people will be arrived at the end of this month. If active prescriptions begin, the severity rate and mortality rate will be lowered through the treatment taken, which will be a good response to Omicron mutations, he predicted. In addition, he said, "The government will thoroughly manage the monitoring of adverse reactions of treatments to be taken and actively respond to side effects."
- Company
- PCSK9i Praluent can be prescribed after 5 years of approval
- by Eo, Yun-Ho Jan 19, 2022 06:07am
- Praluent can be prescribed at general hospitals. As a result, practical competition for PCSK9 inhibitors began five years after domestic approval. According to related industries, Sanofi-Aventis Korea's Praluent (Alirocumab) passed the Drug Committee of medical institutions such as Seoul National University Bundang Hospital, Gangnam Severance Hospital, Chonnam National University Hospital, and Pusan National University Hospital, including Asan Medical Center. Praluent was approved in Korea in January 2017, but it was not until June 2021 that insurance benefits were listed. Amgen Korea's Repatha(Evolocumab) was approved in April 2017, and the willingness to register was stronger. Repatha was first listed as an indication for homogeneous family hypercholesterolemia (HOFH) in August 2018. There were two PCSK9 inhibitors, but in fact, Repatha was the only option. Since last year's registration, Sanofi has carried out the landing process at a general hospital, and the competition between the two drugs is expected to begin in earnest as they show results this year. Repatha, which has advanced into the benefit right, has already entered the medical institution code and is attracting prescriptions. It can be prescribed at major medical institutions nationwide, including Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, Asan Medical Center, and Sinchon Severance Hospital. PCSK9 inhibitors had a wide range of areas requiring prescriptions other than HoFH, and in January 2020, Repatha succeeded in expanding the benefit criteria to patients with high risk of atherosclerotic cardiovasic disease (ASCVD), Heterozysocial Hypercholesterolemia (HeFH), and statin-insensitive patients. The competitive areas of the two drugs are actually expected to be ASCVD and HeFH. Praluent added HoFH indications in the United States in April last year. Meanwhile, Praluent tended to reduce the risk of all-cause death, and was approved in two doses of 75 mg and 150 mg, and patient-specific dose selection is possible by referring to patient status and LDL-C levels. Listed Repatha has already entered the medical institution code and is attracting prescriptions. Prescriptions are available at major medical institutions nationwide, including Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, Asan Medical Center, and Sinchon Severance Hospital.
- Company
- 3 Korean companies accelerate Stelara biosimilar development
- by Ji Yong Jun Jan 19, 2022 06:06am
- Korean companies are rushing to get a share of Stelara’s autoimmune disease treatment market that brings in ₩9 trillion in annual sales. Samsung Bioepis, which had been late in starting the development of Stelara biosimilars than its competitors like Dong-A ST and Celltrion, completed patient recruitment for its Phase III trial and pulled forward its study completion date. All three companies are expected to complete clinical trials for the commercialization of their Stelara biosimilars within this year. According to ClinicalTrals.gov, the clinical information website operated by the US National Institutes of Health, on the 19th, Samsung Bioepis had recently completed patient enrollment for its global Phase III clinical trial for SB17 (Name of Stelara biosimilar in development). The company completed patient recruitment in only 6 months since the company started Phase III trials in July last year. This Phase III trial that is being conducted in patients with moderate-to-severe plaque psoriasis registered 503 patients, exceeding the company's initial goal of enrolling 464 patients. The expected completion date was also pulled forward from March 2023 to December this year. Such moves are interpreted as Samsung Bioepis’s effort to accelerate the development of SB17. Stelara is an IL-12 and 23 inhibitor developed by the multinational pharmaceutical company Janssen. It is used to treat autoimmune diseases such as psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. In 2020, the drug raised $7,707,000,000 (approximately ₩9,155,900,000,000 based on exchange rates on the 18th) in global sales. However, Stelara will soon face competition with latecomers as its substance patent expires in the US in September 2023 and Europe in July 2024. In other words, the mega-market that brings in ₩9 trillion a year will soon be open for entry by biosimilars from September next year. With Samsung Bioepis pulling forward its clinical trial completion date, Celltrion and Dong-A ST are also planning to complete their clinical trials for their Stelara biosimilar within this year. Celltrion will be completing its trial in the first half of this year, and Dong-A ST in the second half of this year. Celltrion’s Stelara biosimilar, CT-P43, is being developed the fastest. Celltrion started Phase III trials for CT-P43 in January last year and completed patient enrollment with 509 patients in May of the same year. The company is in its final stages of the trial and is expecting trial completion by May this year. Celltrion plans to commercialize CT-P43 in line with Stellara's substance patent expiry in the US and Europe. If the company keeps up its pace of development, the company is expected to be able to easily enter the global core market. Dong-A ST is also speeding up its clinical trial for DMB-3115, its Stelara biosimilar in development. Dong-A ST started global Phase III trials for DMB-3115 in April last year. In November of the same year, the company completed enrolling 605 patients for the trial. Dong-A ST plans to complete the Phase III trial for DMB-3115 in November this year. Dong-A Socio Holdings and Meiji Seika Pharma had been jointly developing DMB-3115 since 2013. In July 2020, the right to develop and commercialize DMB-3115 was transferred from Dong-A Socio Holdings to Dong-A ST. Currently, the drug is being jointly developed by Dong-A ST and Meiji Seika Pharma. The two companies have also completed preparations for the global commercialization of the drug. In July last year, Dong-A ST and Meiji Seika Pharma signed a global license-out agreement for DMB-3115 with Intas Pharmaceuticals, transferring the rights for approval and marketing of DMB-3115 in the global region, excluding Korea, Japan, and some Asian countries. An industry official said, “Biosimilars earn a profit by taking a piece of the original’s market share of the pie. Therefore, earlier entry is beneficial to accumulate prescription data, etc.”
- Policy
- Bill for Rotarix·RotaTeq to be covered by NIP
- by Lee, Jeong-Hwan Jan 19, 2022 06:06am
- A bill to promote the health of infants and young children while reducing consumer burden by including rotavirus vaccines in the National Immunization Program (NIP) is being promoted. If passed, the bill will turn GSK’s Rotarix and MSD’s RotaTeq that are already being used in Korea into free national vaccinations. Since the WHO recommends mandatory vaccination of the rotavirus vaccine and the nature of the virus that is highly infectious among infants and young children, attention is focused on the legislative direction of the bill. On the 18th, NA member Bae Hyun-jin of the People Power Party announced that she had submitted a bill as representative for the partial amendment of the ‘Infectious Disease Control And Prevention Act’ to incorporate such changes. The incidence of rotavirus infection is very high among children aged under 5 to the extent that most of these infants are infected at least once with the virus. NA member Bae Hyun-jin expressed concerns that some parents give up rotavirus vaccinations due to the high cost even though rotavirus vaccinations are recommended for all newborns after 6 weeks of age. According to the KDCA’s Immunization Registry System, 7.9%, 21,728 of the 274,221 newborns eligible for vaccinations did not receive rotavirus vaccines in 2020. Statistics over the past 5 years show that 14.8% of the infants and young children eligible for vaccinations – 222,565 – did not receive rotavirus vaccines. Rotavirus vaccines are relatively high-priced, costing around ₩200,000-₩300,000. The two rotavirus vaccines currently sold in the market are GSK’s Rotarix and MSD’s RotaTeq. Rotarix is given in 2 doses, RotaTeq in 3. The two vaccines cost ₩70,000-₩100,000 and ₩100,000-₩130,000 per shot, respectively. In total, Rotarix costs around ₩200,000-₩260,000 and RotaTeq ₩210,000-₩300,000 to get fully vaccinated. The issue regarding the price of rotavirus vaccines has risen several times intermittently. GSK and MSD had raised the price of Rotarix and RotaTeq by 12% and 17% respectively, increasing the burden borne by consumers. Rotavirus vaccines are considered essential for newborns, and therefore its consumers are highly sensitive to their change in price. As a result, some local governments have implemented policies to provide free rotavirus vaccines for infants. Bae believes that the government should pay for the cost of the rotavirus vaccine inoculations to prevent enteritis in infants and young children, contribute to promoting public health, and reduce the burden borne by the consumers. Therefore, the bill contains a plan to include rotavirus infection as a disease eligible for regular vaccinations. Bae said, “The reality is that the need for rotavirus vaccination has been discussed for a long time but was excluded from support due to its high cost. However, no infants nor young children should be left out, unable to receive essential vaccinations due to financial reasons.”
- Company
- Exporting medicines to North America ↑ 2.6 times in 2 years
- by Kim, Jin-Gu Jan 19, 2022 06:06am
- Exports of domestic drugs hit an all-time high last year, especially exports to the North American market surged, the report showed. Exports to the U.S. and Canada have increased 2.6 times in two years. 2017-2021 Amount of medicines exported to the North American market Germany is still the largest exporter, but it is estimated to have decreased slightly compared to last year. In addition, exports of medicines to Japan, Italy, and Vietnam have increased significantly. ◆Last year's US exports amounted to $1.1 billion, 71% compared to $600 million in 2020 ◆ According to the Korea Customs Service on the 16th, pharmaceutical exports amounted to $8.12144 billion last year, up 18% from $6.8935 billion in 2020. Exports to the North American market have increased significantly. U.S. exports amounted to only $643.04 million in 2020. Last year, it rose 71 percent to $1.097.85 billion. Canadian exports increased 130% from $32.99 million to $75.99 million during the same period. The total exports to the North American market increased 1.7 times from $676.03 million in 2020 to $1.173.83 billion last year. Compared to $44329 million two years ago, it has increased 2.6 times. ◆ Biosimilar, K-new drug and botulinum toxin are in full swing Celltrion and Samsung Biologics account for a large portion of exports to the North American market. Celltrion exports Remicade biosimilar "Remsima," Mabthera biosimilar "Truxima", and Herceptin biosimilar "Herzuma" to the North American market through Celltrion Healthcare. Celltrion Healthcare's cumulative exports to the North American market in the third quarter of last year amounted to 491.4 billion won. Remsima occupies the highest market share among Infliximab biosimilars in the US market. Samsung Biologics entrusts and produces antibody drugs from global pharmaceutical companies. Last year's exports amounted to 377.6 billion won until the third quarter. The annual exports to North America in 2020 exceeded 289.5 billion won early. On top of that, domestic new drugs and domestic botulinum toxin drugs have been adding strength since last year. Sales of SK Biopharm's new epilepsy drug Xcopri (Cenobamate) in the North American market have begun in earnest. SK Biopharm's cumulative exports in the third quarter of last year amounted to 187.9 billion won, up 19 times from the cumulative 9.9 billion won in the third quarter of 2020. Almost all are estimated to be Xcopri sales. SK Biopharm received Xcopri marketing approval from the U.S. FDA in November 2019. It went on sale in May 2020. Since then, sales in the North American market began in earnest last year, and SK Biopharm's exports have also soared. The full-fledged sale of domestic botulinum toxin in the U.S. market after the "Strain Dispute" agreement is also cited as the background of the increase in exports to the region. Last year, domestic botulinum toxin exports amounted to $235.85 million, up 15% from $2528 million in 2020. In particular, exports to the United States increased significantly. Domestic botulinum toxin exports to the U.S. stood at $15.8 million in 2020, but more than doubled to $31.3 million last year. Early last year, Daewoong Pharmaceutical and Medy Tox concluded the dispute over botulinum toxin strains through an agreement. From the second quarter, sales of Daewoong Pharmaceutical's "Nabota (Jeubeau)" in the North American market began in earnest. Sales of Xcopri (left) in North America have begun in earnest North American market. ◆Germany, the largest exporter, fell 5% year-on-year, while exports to Japan and Vietnam surged Although exports to the U.S. have soared, Germany is still the largest exporter of domestic medicines. Last year, exports of medicines to Germany amounted to $1.76922 billion. Compared to 2020, it decreased by 5%. Germany's share of pharmaceutical exports fell from 26.9% to 21.8% during the same period. Exports to Japan, Vietnam, and Italy surged. Last year, exports of medicines to Japan amounted to $48699 million. It increased 42% from $265.17 million in 2020. Exports to Vietnam increased 70% from $144 million to $253.11 million , while exports to Italy rose 187% from $65.28 million to $187.2 million.
- Policy
- The benefit standard for Braftovi & Lorviqua was set
- by Lee, Hye-Kyung Jan 19, 2022 06:06am
- At the first Severe (Cancer) Disease Review Committee held this year, the benefit standards for Braftovi, a direct bowel cancer treatment of Ono Pharmaceutical Korea, and Pfizer's Lorviqua, were set. The HIRA (Director Kim Sun-min) today (12th) released the "Result of Review on benefit Standards for Drugs for Cancer Patients" reviewed by the 1st Cancer Disease Review Committee in 2022. Today's cancer screening was newly participated by members of the 9th committee formed in November last year, and Braftovi and Lorviqua, who applied for medical care benefit decisions, set benefit standards, and Antigene's Xpovio did not set standards. Braftovi, which standard was set, was approved by the MFDS on August 19 last year for the use of combination therapy with Erbitux in adult patients with direct bowel cancer who had previous treatment experience and confirmed BRAF V600E mutation. Since Lorviqua was designated as a rare drug in March 2020, it is approved in Korea in July 2021 for use in cases treated with Xalkori and at least one other ALK inhibitor, or with a primary ALK inhibitor as a monotherapy for the treatment of adult patients with ALK-positive progressive non-small cell lung cancer. Xpovio has not established a benefit standard for both permits, such as recurrent or refractory multiple myeloma and recurrent or refractory giant B cell lymphoma. The standard was set for Lynparza tab's standard. Meanwhile, in accordance with Articles 5 and 5-2 of the National Health Insurance Medical Care Benefit Standards, the HIRA may publicly announce drugs prescribed and administered to severely ill patients after deliberation by the Severe Disease Review Committee. The benefit criteria for the drug may be set differently according to clinical literature, domestic and foreign guidelines, and expert opinions within the scope of the efficacy and effectiveness of the MFDS' permission, and the benefit criteria may change during the follow-up procedure.
- Policy
- Daewoong tx are being developed for skin side effects
- by Lee, Tak-Sun Jan 18, 2022 06:06am
- Daewoong PharmaceuticalDaewoong Pharmaceutical has started to develop a treatment for skin side effects caused by anticancer drugs. This treatment is known as a stem cell-based drug. The MFDS approved the phase 2 clinical trial plan for DWP708 submitted by Daewoong Pharmaceutical on the 17th. This clinical trial is conducted to explore the efficacy of DwP1708 and evaluate safety for the treatment of EGFR inhibitor-related skin side effects. The test methods are multicenter, randomized, double-blinded, placebo-controlled, therapeutic search phase 2. It will be held at Gyeongsang National University Hospital and Dong-A University Hospital for 96 patients in Korea. EGFR inhibitor is mainly used in the treatment of arsenic lung cancer. It has a mechanism to reduce cancer cell proliferation by inhibiting EGFR, and types of anticancer drugs include treatments containing Erlotinib, Cetuximab, and Gefitinib. These anticancer drugs, however, are known to have frequent serious skin side effects. 50-90% of patients administered EGFR anticancer drugs suffer from skin side effects. Mainly, skin rashes, follicles, and dry skin occur in the face and upper body. Treatment of skin side effects is said to be managed with steroids or antibiotics, but the effect is not significant. Accordingly, Daewoong Pharmaceutical has been conducting research on related drugs, believing that EGFR inhibitory anticancer drugs block normal cell proliferation such as keratinocytes, causing skin side effects. According to the list of Daewoong's R&D tasks, DWP708 is indicated as a stem cell treatment. The study started in 2007 and received approval for phase 2 clinical trials this time and will begin full-scale human application research. The new drug candidate is known to be the first anticancer drug to be applied as a skin side effect treatment. Daewoong Pharmaceutical expects that it will contribute to controlling the dose of anticancer drugs and reducing the discontinuation rate due to skin side effects as a mechanism to suppress skin epithelial regeneration and inflammation. It is not possible to determine the exact market size as there are no anticancer drug skin side effects treatments, but if the drug is commercialized, it is expected to significantly improve the quality of life of cancer patients administering EGFR treatments.
