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2026-03-16 17:38:25
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Company
The unfinished aftershocks of COVID-19
by
Chon, Seung-Hyun
Oct 26, 2022 05:50am
The market for outpatient prescription drugs was the largest ever. This year, the prescription market has grown significantly due to the expansion of prescriptions such as cold medicine due to the rapid increase in the number of COVID-19 confirmed patients. The size of Expectant prescriptions used to relieve COVID-19 symptoms has more than doubled in a year. According to UBIST, a pharmaceutical research institute, on the 25th, the total amount of outpatient prescriptions in the third quarter was 4.3011 trillion won, up 5.4% from the same period last year. The third-quarter prescription amount is the largest ever. It easily surpassed the previous new record of 4.22 trillion won recorded in the fourth quarter of last year. The domestic prescription drug market has regained its previous year's upward trend this year after the spread of COVID-19. Prescriptions in the first quarter were 4.1248 trillion won, up 6.5% from the previous year, and 5.7% from the previous year in the second quarter. The prescription amount in the first and third quarters was 12.58 trillion won, up 5.9% from the same period last year. In 2020, when COVID-19 began to spread, the size of outpatient prescriptions was 15.6365 trillion won, up 2.7% from the previous year. Last year, the outpatient prescription performance was 16.1126 trillion won, up only 3.0% from the previous year. In 2018 and 2019, the amount of prescriptions increased by 8.1% and 8.2%, respectively, compared to the previous year. The growth rate has fallen to one-third for the second consecutive year since the spread of COVID-19, which means that the growth rate of the prescription drug market is about twice as high this year compared to the past two years. The expansion of the prescription drug market this year is analyzed to be due to the rapid increase in the number of COVID-19 confirmed patients. Since the beginning of this year, there have been many COVID-19 confirmed cases, and prescriptions of antipyretic painkillers, cold medicines, and antibiotics used to relieve COVID-19 symptoms have increased significantly. The supply of cold medicine and other medicines continues to be in short supply. Recently, as tens of thousands of COVID-19 confirmed cases have occurred every day, the demand for COVID-19 symptom relief treatments is increasing. The prescription of Expectant, which is widely used for treating cough and phlegm, a representative symptom of COVID-19, has increased significantly. In the third quarter of last year, the amount of outpatient prescriptions was 70.5 billion won, up 112.5% from the same period last year. In general, Jinhae Gosamje shows a pattern of increasing use in winter and then decreasing in summer when the number of cold patients increases.The amount of expectant prescriptions in the third quarter is 35.2% higher than 52.2 billion won in the fourth quarter of last year. Recently, even though it is summer, there were more spectacular prescriptions than last winter. The amount of expert prescriptions recorded KRW 91.6 billion in the fourth quarter of 2019, but it began to decrease significantly in the second quarter of 2020, when COVID-19 began to spread in earnest. In the second quarter of 2020, it fell 47.6% year-on-year to 40.8 billion won, and in the third and fourth quarters, it shrank 29.8% and 50.0% from the previous year, respectively. The expectant prescription market fell to 32.2 billion won in the third quarter of last year, but then began to rebound in the fourth quarter of last year and continued to grow this year. According to Expectant's prescription performance, it was 44.1 billion won in the third quarter, up 95.0% from the previous year. The amount of expectant prescriptions recorded 54.5 billion won in the fourth quarter of 2019 but remained in the 20 billion won range from the first quarter of 2020 to the third quarter of last year. It rose to around 30 billion won in the fourth quarter of last year and recovered to the level before the COVID-19 pandemic this year. Antitussive compound drugs received 14.4 billion won in prescriptions in the third quarter, up 122.1% from the same period last year. Antitussive complex drugs decreased from 20.3 billion won in prescriptions in the fourth quarter of 2019 to 9 billion won in the second quarter of 2020, when COVID-19 began to spread in earnest. It exceeded 10 billion won in the fourth quarter of last year for the first time in seven quarters and has been on a steep rise this year. The antitussive single system recorded 16.8 billion won in the fourth quarter of 2019 but plunged to 4.1 billion won in the third quarter of last year. The prescription amount more than doubled to 14.6 billion won in the first quarter of last year and continued to grow in the second and third quarters. In the third quarter of last year, the prescription amount was KRW 12.1 billion, up 192.7% from the previous year.
Company
First TYK2 inhibitor Sotyktu will enter Korean market
by
Eo, Yun-Ho
Oct 26, 2022 05:50am
The oral TYK2 inhibitor for psoriasis will soon be introduced to Korea. According to industry sources, BMS Korea applied for domestic marketing authorization for its tyrosine kinase 2 (TYK2) inhibitor ‘Sotyktu (deucravacitinib) in Korea. The drug was approved for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy by the US FDA. Sotyktu is the first TYK2 inhibitor to ever be approved in the world (first-in-class), and the first oral drug introduced in 10 years to treat moderate-to-severe plaque psoriasis. The approval is based on results from the Phase III POETYK PSO-1 and POETYK PSO-2 clinical trials, which compared the efficacy of once-daily Sotyktu compared to placebo and twice-daily Otezla in 1,684 adult patients aged 18 years and older with plaque psoriasis. The study demonstrated superior efficacy of Sotyktu compared to placebo at both 16 and 24 weeks, and responses with Sotyktu persisted through 52 weeks. In the POETYK PSO study, the most common adverse reactions shown in patients at 16 weeks were upper respiratory infections (19.2%), increase in blood creatine phosphokinase (2.7%), mouth ulcers (2.9%), folliculitis (1.7%), and acne (1.4%). Also, 2.4% of the patients who were administered Sotyktu and 5.2 % of the patients who were administered Otezla discontinued their treatment due to adverse reactions. When BMS acquired Celgene, the company had given up Otezla and sold it to Amgen. Ever since then, the company had focused on developing Sotyktu. Sotyktu is being studied for various autoimmune diseases including lupus, Crohn's disease, and ulcerative colitis. Priovant, which was jointly established by Pfizer and Roivant is jointly established, is also developing a TYK2 inhibitor.
Company
Xarelto sales fall 30% due to generics and price cuts
by
Oct 26, 2022 05:50am
The quarterly prescription of new oral anticoagulants (NOAC) containing rivaroxaban, which had reached KRW 15 billion, has shrunk to KRW 13 billion. This decrease is interpreted to be reflected by the price cut of Bayer’s original ‘Xarelto.’ Its generics that entered the market 1 year ago have been starting to slowly increase their share in the market, making KRW 2.4 billion in total. ◆Xarelto takes a direct blow from drug price cuts...Quarterly sales record KRW 11.3 billion According to the market research institution UBIST on the 25th, the domestic outpatient prescriptions of rivaroxaban recorded KRW 13.7 billion in Q3 this year, falling fell 16% compared to the KRW 16.4 billion it recorded in the same period last year. Sales of the original, Xarelto, fell 29% from KRW 15.9 billion to KRW 11.3 billion. Quarterly outpatient prescriptions of Xarelto fell from KRW 15.9 billion in Q3 last year, to KRW 15 billion in Q4, then to KRW 14.2 billion this year, to KRW 13.9 billion in Q1, then sunk to KRW 11.3 billion in Q3. This reduced sale is analyzed to have been greatly influenced by the drug price cut that had been made in August. The Seoul High Court ruled in favor of the Ministry of Health and Welfare in the lawsuit Bayer filed against MOHW to cancel the disposition on lowering Xarelto’s price. With the ruling, the drug price of all strengths(2.5·10·15·20mg) of Xarelto was reduced by 30% from August 22nd. Xarelto’s price had first been set to be reduced in May last year when the generics were first listed for reimbursement, but Bayer filed a suit on the unjustness of the price cut, claiming that the generics were released before Xarelto’s patent expiry, thus the execution of disposition should be suspended. As a result, the price cut had been suspended until the judgment on the merits. After about a year and two months, the final ruling had been made and the drug price was reduced. Considering the 30% price cut, there was no significant change in prescription volume compared to the same period last year. With this, the prescription amount of Xarelto is expected to be in the lower KRW 50 billion range. Its annual prescriptions last year were nearly KRW 60 billion. ◆Generics account for 18%...Sole lead held by Chong Kun Dang Xarelto’s generics have been increasing their influence in the market. In Q3, Xarelto generics made KRW 2.4 billion in total. In Q2 last year, the amount was KRW 0.3 billion, which rose to KRW 0.5 billion in Q3, to KRW 0.9 billion in Q4, then to the KRW 2 billion range this year. In Q1 2022, prescriptions rose to KRW 1.6 billion in Q1 and then KRW 2.1 billion in Q2. In Q3, generics have also been increasing steadily, accounting for an 18% share of the rivaroxaban market. With the sales of the generic increasing slightly and the original dropping significantly, the share of generics in the market rose 5%p from the previous quarter. Even though there was no change in the prescription amount of the original drug, the prescription amount of generics increased with the generic companies’ pioneering of new markets. Generic companies focused their marketing capabilities on local clinics as the original drug is mostly prescribed in hospitals or higher institutions. Instead of competing directly with the original, the companies focused on pioneering new markets. Although more than 60 companies have received approval for Xarelto generics, only Chong Kun Dang and Hanmi Pharmaceutical have made meaningful sales. Chong Kun Dang’s ‘Riroxia’ made KRW 0.8 billion in outpatient prescriptions in Q3, and accounted for 1/3 of the generic market. Chong Kun Dang released Riroxia in May last year, 5 months before patent expiry, and worked to preoccupy the market. Although other generic companies started to enter in October of the same year, unlike Chong Kun Dang which continuously made prescriptions after preoccupying the market, sales of the other generics remain in the KRW 0.1 billion range. Among generics, Hanmi Pharmaceutical’s ‘Riroxvan’ made KRW 0.5 billion in Q3 and is the only generic chasing Chong Kun Dang’s Riroxia’s sales in the market. Hanmi Pharmaceutical succeeded in avoiding Xarelto’s patent with SK Chemical and entered the market with generic exclusivity. Riroxvan, which sold KRW 0.2 billion in Q1, rose to KRW 0.4 billion in Q2, then KRW 0.5 billion in Q3. More than half of the approved generics have not yet released their versions in the market. With the lower dose of Xarelto (2.5mg) being listed for reimbursement from Q3, how this will affect the market is also gaining attention. 16 low-dose versions of Xarelto generics were listed for reimbursement in July. Rivaroxaban 2.5mg is mainly used in combination with aspirin to reduce the risk of cardiovascular events in patients with coronary artery disease and peripheral arterial disease.
Company
Genuone challenges Trajenta’s non-listed patent...Why?
by
Kim, Jin-Gu
Oct 25, 2022 05:46am
Genuone Sciences has challenged the unlisted patents of Trajenta (linagliptin). Industry interpretations are that the move is the company’s strategy to remove uncertainties in releasing generic versions of Trajenta and to additionally attract CMO deals” According to industry sources on the 24th, Genuone Sciences filed a trial to confirm the passive scope of patent rights and invalidation trials for the 5 Trajenta patents, 3 of which are use patents set to expire in May 2027, and one substance and one process patent set to expire in April 2027. One interesting thing to note is that all these patents are not listed on Korea’s patent register. As the patents are not listed on the register, the companies will have no problem obtaining approval for their generic versions even if they do not overcome the patents. However, the situation is different in terms of releasing the products into the market. Administratively, generic drugs can be released when the listed patents expire, but this carries the burden of being involved in a patent infringement lawsuit with the original company. If the original company files an application for an injunction to block the release of the product at the same time it files the patent infringement lawsuit, the release date of generics can be delayed for companies. Also, if generic companies lose the patent infringement lawsuits, this may lead to lawsuits for damages. This is why many generic companies have been challenging unlisted patents to remove uncertainties. Genuone Sciences’ challenge of Trajenta’s unlisted patents is also interpreted to be along this line. There is also the interpretation that Genuone Sciences challenged the unlisted patents of Trajenta to attract additional CMO deals. Genuone Sciences succeeded in avoiding and invalidating the existing Trajenta patent but was unable to receive generic exclusivity (first generic marketing exclusivity) for the drug because it wasn’t able to satisfy the ‘initial request for trial’ condition. 19 companies including Alvogen Korea own generic exclusivity for Trajenta generics. In this context, other companies will be interested in the CMO manufacture of Trajenta generics if Genuone Sciences succeed in removing uncertainties by avoiding and invalidating the unlisted patents. Genuone Sciences CMO Trajenta generics for White Life Science and Pharmgen Science. The company made agreements to manufacture the 2.5mg/1000mg dose only for White Life Science, and manufactures the 5mg/500mg and 2.5mg/850mg dose for White Life Science and Pharmgen Science. By formulation, this means that the company may take on 1-2 more companies for manufacture. Trajeta is Boehringer Ingelheim’s DPP-4 inhibitor antidiabetic. Its outpatient prescription sales had been KRW 130.7 billion for the single agent (Trajenta) and combination agent (Trajenta Duo) last year. Trajenta raised KRW 94.2 billion in sales until Q3 this year. The patent for the product is set to expire in June 2024. 65 companies have overcome Trajenta's patent and received approval to manufacture its generics. The companies are expected to release their products at the time of Trajenta’s patent expiry.
Company
Cibinqo lands in general hospitals in Korea
by
Eo, Yun-Ho
Oct 25, 2022 05:46am
Pfizer’s second Janus kinases (JAK) inhibitor ‘Cibinqo (abrocitinib) has landed and may be prescribed at general hospitals in Korea. According to industry sources, Pfizer Korea’s new JAK1 inhibitor drug (abrocitinib) has passed the drug committee (DC) reviews of the ‘Big 5 tertiary hospitals’ of Korea including the Seoul National University Hospital, Seoul Asan Medical Center, Seoul St. Mary’s Hospital, Asan Medical Center, and Sinchon Severance Hospital, as well as 24 medical institutions including Gangnam Severance Hospital, Korea University Guro Hospital, and Seoul National University Bundang Hospital. The company applied for its reimbursement listing in April, and as the agenda passed Drug Reimbursement Standard Subcommittee deliberations in August, prescriptions will be made quickly once reimbursement is applied. However, Lilly Korea’s ‘Olumiant (baricitinib),’ and ‘Abbvie’s ‘Rinvoq (upadacitinib)’ has already been receiving reimbursement for the atopic dermatitis indication since May, and when considering how the company made the strategic move to accept the weighted average price of its alternatives, its reimbursement progress is not on the faster side. The drug, which was approved for atopic dermatitis, is Pfizer’s follow-up of ‘Xeljanz (tofacitinib)’ that is set to compete with ‘’ Lilly Korea’s ‘Olumiant (baricitinib),’ ‘Abbvie's ‘Rinvoq (upadacitinib)’ in the same indication. Olumiant and Rinvoq were approved for reimbursement in May this year, and the reimbursement listing process for Cibinqo is also in progress. Cibinqo was approved in November of last year when the reimbursement listing for Olumiant and Rinvoq was being reviewed. As a JAK1 inhibitor, the drug modulates multiple cytokines involved in the pathophysiology of atopic dermatitis, including interleukin IL-4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin (TSLP). It is indicated for the treatment of adults and adolescents over the age of 12 with moderate-to-severe atopic dermatitis. Cibinqo demonstrated its efficacy through the Phase III trials JADE MONO-1, MONO-2, COMPARE, etc. The drug reduced the Eczema Area and Severity Index (EASI) by over 70% at week 12 and demonstrated improvement in itch relief in 2 weeks after initiating treatment. Its pivotal study, JADE Mono-1, was designed to evaluate the efficacy and safety of two doses (100 mg and 200 mg once daily) of Cibinqo monotherapy in patients 12 years of age and older with moderate-to-severe AD for 12 weeks. Results showed that 63% of the Cibinqo 200 mg administered group had achieved EASI-75 (improvement of at least 75% in lesion extent and severity) at week 12, which was a significant improvement compared to the 12% in the placebo group. Also, the rate of patients that achieved EASI-90 at week 12 had been 39% in the Cibinqo group, 5% higher than the placebo group.
Company
GSK has signed a sales contract with GC Pharma & Kwang Dong
by
Eo, Yun-Ho
Oct 25, 2022 05:46am
GSK has signed a joint sales contract with two domestic companies, GC Pharma and Kwang Dong, to sell the shingles vaccine Shingrix. GSK Korea announced on the 24th that it signed a Co-Promotion and Distribution Partnership for Shingrix's domestic sales and marketing on the 21st. Through this partnership, GC Pharma and Kwang Dong will jointly promote GSK's new shingles vaccine Shingrix on all distribution channels, including hospitals. GSK subsidiary is expected to strengthen its expertise in the distribution of shingles vaccines by selecting GC Pharma and Kwang Dong, which have domestic sales networks and marketing know-how accumulated in the shingles vaccine sector. "We are pleased to introduce a shingles prevention vaccine for adults over 50 and those over 18 years of age through a strategic partnership with GC Pharma and Kwang Dong, which have expertise in vaccine distribution," GSK President Rob Kempton said. Heo Eun-cheol, CEO of GC Pharma, said, "We are very happy to partner with GSK, a leading global healthcare company. Based on GC Pharma's accumulated vaccine know-how and understanding of distribution, we will work closely with GSK to provide better shingles prevention options to more people, he said. Choi Sung-won, CEO of Kwang Dong, said, "Kwang Dong has achieved various achievements for a wide range of patients and medical staff through partnerships with various domestic and foreign companies." "We will contribute to the health of the people by focusing on Shingrix the professional capabilities that GSK has developed as a vaccine distribution and marketing partner since 2015," he stressed. Meanwhile, Shingrix is scheduled to be released in Korea in December.
Company
Lyumjev can be prescribed in general hospitals
by
Eo, Yun-Ho
Oct 24, 2022 06:08am
The new fast-acting insulin ‘Lyumjev’ can now be prescribed at general hospitals in Korea. According to industry sources, Lilly Korea’s ‘Lyumjev (insulin lispro)’ has passed the drug committee (DC) reviews of various medical institutions including the Samsung Medical Center. Lyumjev, which was approved in Korea in December last year, has been approved for reimbursement since September this year. Its prescriptions are expected to begin in earnest after landing in more general hospitals. As mealtime insulin, Lyumjev contains the active ingredient ‘insulin lispro-aabt,’ and is used to help reduce blood sugar levels in adults with type 1 or type 2 diabetes who have difficulty managing target blood glucose levels or whose blood glucose level increases after meals. The domestic approval was made based on results from the PRONTO clinical trial program that was conducted on adult patients with Type 1 and Type 2 diabetes. PRONTO-T1D and PRONTO-T2D are treat-to-target, multicenter, parallel studies Phase III clinical trials in which patients in each treatment arm were first treated to reach the same blood sugar level, and then compared for their main therapeutic effects, including the rate of hypoglycemia, postprandial glucose (PPG) control, and period of proper blood sugar maintenance. Study results showed that Lyumjev demonstrated non-inferiority to Humalog (lispro 100U)’ in the primary endpoint, which was the change in glycated hemoglobin (HbA1c) from baseline to 26 weeks. Also, Lyumjev demonstrated superiority over Humalog in reducing 1-hour and 2-hour postprandial glucose excursions. Meanwhile, Phase I trial results on Type 1 diabetes patients have also shown that Lyumjev’s absorption of insulin into the bloodstream was faster than that of ‘Humalog,’ ‘Insulin Aspart,’ and ‘fast-acting Insulin Aspart.’ The blood glucose results of patients up to 3 hours following injection of Lyumjev were similar to those of participants without diabetes.
Company
Will Onureg, an acute leukemia maintenance drug be listed?
by
Eo, Yun-Ho
Oct 24, 2022 06:08am
Attention is focusing on whether Onureg will be able to be listed on the insurance benefit list. According to related industries, Onureg of BMS Pharmaceutical Korea is expected to be submitted to the HIRA Cancer Disease Review Committee on the 2nd of next month. Onureg is the only oral maintenance of acute myeloid leukemia. It was approved in Korea in March as a treatment for adult patients with acute myeloid leukemia who achieved CRi or incomplete hematological recovery after induction therapy and were not suitable for hematopoietic stem cell transplantation (HSCT). Acute myeloid leukemia is also fatal among leukemia. Without treatment, 90% of people die within a year. Even if it becomes CR, the risk of recurrence is also high because up to 100 million residual leukemia cells may remain. If proper treatment is not accompanied after CR, the recurrence rate reaches up to 50% within a year, and the median OS value is only 8 months in case of recurrence. Maintenance therapy that can prevent recurrence and maintain CR condition as stable as possible is drawing attention. Onureg proved its validity through a phase 3 study of QUAZAR AML-001 in 472 patients with acute myeloid leukemia. As a result of the study, the mOS of the patient group who took Onureg was 24.7 months, extending the survival period by 10 months from 14.8 months in the placebo group and lowering the risk of death by 31%. At the time of 1 and 2 years of treatment, the proportion of patients who survived in the Onureg group was 73% (56% in the placebo group) and 51% (37% in the placebo group), respectively, which were higher than in the placebo group. RFS also confirmed the effect of reducing the risk of recurrence as Onureg reached 10.2 months, which is 5.3 months longer than the placebo group. The proportion of patients who did not recur after 6 months of treatment was 67% in the Onureg group, higher than 45% in the placebo group, and even at one year, the proportion of patients who did not recur was higher in the Onureg group.
Company
Lucentis biosimilar of Chong Kun Dang gets domestic approval
by
Chon, Seung-Hyun
Oct 24, 2022 06:08am
Chong Kun Dang succeeded in commercializing its second biosimilar. Chong Kun Dang announced on the 20th that it has received approval from the Ministry of Food and Drug Safety for domestic items of the "Lucentis" biosimilar. The indication for "treatment of neovascular (habitual) age-related macular degeneration" has been approved. Lucentis, sold by Roche and Novartis, is a drug used to treat eye diseases such as macular degeneration diabetes, and macular edema. Lucentis is a large product with global sales of 4.4 trillion won last year. Chong Kun Dang proved that the therapeutic effects of CKD-701 and Lucentis were equal through phase 3 clinical trials of 312 neovascular age-related macular degeneration patients at 25 hospitals, including Seoul National University Hospital, from September 2018 to March last year. According to IQVIA, a pharmaceutical research institute, Lucentis recorded 35.1 billion won in sales in Korea last year. Chong Kun Dang is the second Korean company to succeed in commercializing Lucentis biosimilars after Samsung Bioepis. Samsung Bioepis received an item license from Lucentis biosimilar Amelivu in May. Chong Kun Dang said, "We expect CKD-701 to provide patients with various treatment drug choices and expand treatment opportunities." Chong Kun Dang said, "It will be released after going through the health insurance registration process." As a result, Chong Kun Dang produced its own second biosimilar. Chong Kun Dang received domestic permission from biosimilar Nesbell for the anemia treatment NESP in November 2018. After securing differentiated raw material manufacturing technology in 2008, Chong Kun Dang established a biopharmaceutical production infrastructure in 2012 and developed Nesbell.
Company
Tumor-agnostic Vitrakvi lands in Big 5 tertiary hospitals
by
Eo, Yun-Ho
Oct 21, 2022 05:47am
The tumor-agnostic drug ‘Vitrakvi’ has landed in the Big 5 tertiary hospitals in Korea. According to industry sources, Bayer Korea’s neurotrophic tyrosine receptor kinase targeted anticancer drug Vitrakvi (larotrectinib) has passed the drug committees of major hospitals in Korea, including general hospitals like the Samsung Medical Center, Seoul National University Hospital, Seoul St.Mary’s Hospital, Asan Medical Center, and Sinchon Severance Hospital and major medical institutions such as Gangnam Severance Hospital, National Cancer Center, and Seoul National University Bundang Hospital. The drug is seemingly settling quickly in the prescription market after it was listed for reimbursement in April. Vitrakvi, which received marketing approval in Korea in May last year, underwent the reimbursement listing process through the pharmacoeconomic evaluation exemption track and passed HIRA’s Drug Reimbursement Evaluation Committee review in November. Its competitor which has the same mechanism of action, Roche’s ‘Rozyltrek’ 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. Vitrakvi’s approval was based on data from a Phase I trial on adults 18 years and older, the 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 includes those with primary CNS tumor. According to an efficacy review that was conducted on 55 patients with identified NTRK fusion in the 3 studies 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, and the drug showed the same efficacy in these patients as in adult patients. As a result, Vitrakvi was approved for use in both pediatric and adult patients.
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