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- 2026-04-09 03:05:55
- Policy
- Abbvie’s Skyrizi is approved for Crohn's disease in Korea
- by Lee, Hye-Kyung Nov 16, 2023 05:46am
- Abbvie’s ‘Skyrizi,’ which was first introduced to Korea as a psoriasis treatment, has received additional marketing authorization for its Crohn's disease indication The Ministry of Drug and Safety approved Abbvie Korea’s ‘Skyrizi Inj (risankizumab)’ and ‘Skyrizi Cartridge Inj (risankizumab)’ on the 15th. The products, which contain 600mg and 360mg doses of risankizumab, are indicated ’ for the treatment of moderately to severely active Crohn's disease in adults who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or biologic therapy. Skyrizi Cartridge Inj is a self-injectable product that contains a prefilled cartridge and an electric drug injection pump (on-body injector) as an administration device, improving the convenience of administration for patients. In Korea, Abbvie had received approval for different doses of its risankizumab ingredient as ‘Skyrizi Prefilled Syringe Inj,’ ‘Skyrizi Prefilled Syringe Inj 150mg/mL,’ and ‘Skyrizi Prefilled Pen Inj 150mg/mL.,’ for plaque psoriasis and psoriatic arthritis. The European Commission approved Skyrizi as a treatment for adult patients with moderately to severely active Crohn's disease in November 2022. Skyrizi is the first interleukin-23 (IL-23) inhibitor approved to treat moderately to severely active Crohn's disease. The European Commission’s approval of Skyrizi in Crohn's disease was supported by results from the 3 global Phase III programs. Interleukin inhibitors are biological agents and are mainly used to treat moderate to severe adult plaque psoriasis, and can largely be divided into IL-17 inhibitors and IL-23 inhibitors. The IL-17 inhibitors approved in Korea include Janssen’s ‘Stelara (ustekinumab),’ Lilly’s ‘Taltz (ixekizumab),’ and Novartis’s ‘Cosentyx (secukinumab).’ In the case of IL-23 inhibitors, they include Janssen’s ‘Tremfya (guselkumab),’ and Abbvie’s ‘Skyrizi.’ According to the market research institution IQVIA, the size interleukin inhibitor market rose 30% YoY to exceed KRW 100 billion last year. In particular, Janssen’s Stelara is the first interleukin inhibitor approved for Crohn's disease. Therefore, if Abbvie releases Skyrizi for Crohn's disease in Korea, it is expected to compete with Stelara.
- Company
- Poteligel can be prescribed at hospitals
- by Eo, Yun-Ho Nov 15, 2023 05:39am
- 'Mycobacterial Breed' and 'Poteligel', a treatment for 'siary syndrome', have entered the prescription of a general hospital. According to the relevant industry, Korea Kyowa Kirin's Poteligio (Mogamulijumab) has passed the Drug Committee (DC) of medical institutions such as Seoul Asan Hospital. Potelio passed the Cancer Disease Review Committee of the Health Insurance Review and Evaluation Agency last month and is waiting for the chairman of the Drug Payment Assessment Committee. If the registration is successful, it is judged that the prescription will be made immediately. This drug is a treatment for mycoid sarcoma and sia syndrome, which targets CCR4 (C-C chemokine receptor 4). It was designated as Breakthrough Therapy by the U.S. Food and Drug Administration (FDA) in August 2017. It has been rated as the first-in-class in the UK SMC and approved in the country in September last year. PORTRIDGEO HAS PROVEN VALIDITY THROUGH MAVORIC STUDIES. The study recruited 372 patients with recurrent, unresponsive fungal sarcoma or syndrome on the largest scale related to skin T-cell lymphoma (CTCL) systemic therapy to assess their effectiveness and safety. The study included patients with mycoccal sarcoma or syndrome who had previously received one or more (median 3 median) systemic therapy. 55% of patients had heterogeneous sarcoma, 45% had syndrome, and 77% had stage 3B or higher. 66% were accompanied by blood disease. As a result of the study, Poteligel showed a superior effect over the control group, Borinostat. Portelliggio has statistically significant improvements in non-progressive survival (PFS) compared to Vorinostat. The PFS median for Potelliggio was 7.7 months, while the control group was only 3.1 months.
- Company
- Korean bio companies intent on developing new AD drugs
- by Son, Hyung-Min Nov 15, 2023 05:39am
- Despite downturns, including the return of the rights for JW Pharmaceutical’s atopic dermatitis drug candidate, clinical trials for new drugs to treat atopic dermatitis are still ongoing in Korea. Last month, JW Pharmaceutical announced that its technology transfer agreement for its atopic dermatitis treatment JW1601 which it signed with the Denmark pharmaceutical company Leo Pharma has been terminated. JW1601 owns a dual-action mechanism that selectively acts on the histamine H4 receptors to suppress inflammation and itching. Histamine is a major mediator of allergic inflammation. However, the candidate was unable to satisfy its primary efficacy endpoint in a global Phase II trial. With no other atopic dermatitis treatment owning the same mechanism of action, the drug had the potential to become a First-in-class drug but was unable to reach the commercialization stage. However, JW Pharmaceutical plans to continue to review its direction of development and potential to acquire new indications. Clinical trials are being actively conducted on various mechanisms that suppress inflammation… stem cell treatment starts later phase trial In addition to the failed candidate that targets histamine H4 receptors, various new drug candidates that target atopic dermatitis are being developed in Korea right now. A Stem cell therapy, as well as new drug candidates targeting Bruton's tyrosine kinase (BTK), interleukin-2-inducible T-cell kinase (ITK), and Janus kinase (JAK) are also being studied for commercialization potential. One of the candidates that is evaluated to be close to commercialization is a stem cell treatment. Kangstem Biotech is a leader in the field of stem cell treatments for atopic dermatitis. The company recently completed patient administration of ‘FURESTEM-AD Injection,’ a new drug candidate being developed in a Phase III trial. FURESTEM-AD Inj is being developed as a treatment for patients with moderate-to-severe atopic dermatitis who have not responded to existing treatments. Kangstem Biotech plans to complete the Phase III trial by the first half of next year and apply for its marketing approval. Interim results of the Phase III long-term follow-up study disclosed by the company showed that in patients who were administered FURESTEM-AD Inj, 58% achieved Eczema Area and Severity Index-50 (EASI-50) in the first year, 66% in the second year, then 75% in the third year. EASI-50 refers to the percentage of patients whose dermatitis symptoms improved by more than 50% compared to the baseline. ‘SCM-AGH,’ a stem cell treatment for atopic dermatitis that is being developed by SCM Lifescience, has also secured positive results in a Phase II trial. In a clinical trial comparing the efficacy and safety of SCM-AGH compared with placebo, SCM-AGH met the primary endpoint. Also, the SCM-AGH arm saw significant results in the secondary endpoint achieving ESAI-90 at 24 weeks. Also, none of the 55 subjects who were administered SCM-AGH showed side effects. Due to safety issues that arose in some inflammation treatments the fact that no side effect occurred is considered positive. SCM Lifescience plans to conduct its Phase III clinical trial in Korea with Handok. In addition, Daewoong Pharmaceutical is conducting 2 clinical trials in the US. Its ‘DWP212525’, which targets JAK3 and TEC family kinase (TFK), is in a preclinical trial, and ‘DWP213388’, a BTK/ITK inhibitor, is in a Phase I clinical trial. Novacell, an affiliate of DongKoo Bio&Pharma, is developing NCP112, which targets G protein-coupled receptors (GPCRs) and formyl peptide receptor 2(FPR2), which are involved in the resolution of inflammation, as a treatment for mild-to-moderate atopic dermatitis. NuGel, a GPCR19-targeted inflammation modulator being developed by Chaperone in the US, has successfully entered Phase II trials.
- Policy
- Chinese immunotherapy tislelizumab to soon arrive in KOR
- by Lee, Hye-Kyung Nov 15, 2023 05:39am
- A PD-1 cancer immunotherapy developed in China is soon expected to receive marketing approval in Korea. According to industry sources on the 14th, the Ministry of Food and Drug Safety has completed the drug safety and efficacy review for BeiGene Korea’s ‘Tevimbra 100mg (tislelizumab).’ If no issues were found during the safety and efficacy review, the authorities can immediately grant marketing authorization for the drug. If approved, the Chinese immunotherapy drug will be competing with MSD’s ‘Keytruda (pembrolizumab),’ and BMS’s ‘Opdivo (nivolumab).’ BeiGene Korea has been conducting Phase II and III trials in Korea since 2020. The company completed a Phase III clinical trial on patients with locally advanced unresectable NSCLC whose disease had not progressed after concomitant chemotherapy who were selected based on the PD-L1 expression status, to compare the ‘ociperlimab ((BGB-A1217)+tislelizumab (BGB-A317)’ combination with durvalumab. BeiGene had previously signed a collaboration and license agreement with Novartis worth USD 2.2 billion (approx. KRW 2.942 trillion) for the drug in June 2021 but mutually agreed to terminate the agreement in September this year. On the same day of the agreement termination, the European Commission (EC) approved tislelizumab as monotherapy for the treatment of adult patients with unresectable, locally advanced, or metastatic esophageal squamous cell carcinoma (ESCC) after prior platinum-based chemotherapy. BeiGene completed over 20 clinical trials for Tevimbra’s approval and secured positive results for 10 Phase III randomized trials and 4 Phase II trials. In China, the drug has 12 indications including non-small cell lung cancer, small cell lung cancer, liver cancer, stomach cancer, nasopharyngeal cancer, and bladder cancer.
- Company
- Will the new ADC breast cancer drug Trodelvy be reimb?
- by Eo, Yun-Ho Nov 15, 2023 05:39am
- ‘Trodelvy,’ another new ADC drug for breast cancer, is seeking reimbursement listing in Korea. According to industry sources, Gilead Science Korea has submitted an application for the reimbursement of its triple-negative breast cancer treatment Trodelvy (sacituzumab govitecan-hziy) on July 31, and the agenda is awaiting to be presented for deliberation by the National Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee on the 22nd. However, the key is in setting its drug price. Various treatment options that target different mechanisms of actions or genes have been introduced to the field of TNBC treatment, however, none has been reimbursed until now in Korea. In fact, another ADC, ‘Enhertu (trastuzumab deruxtecan)’ passed the CDDC review in May, but its reimbursement agenda has not been presented for deliberation to the Drug Reimbursement Evaluation Committee until now. Whether Trodelvy will be able to overcome the difficulties and succeed in being reimbursed in Korea remains to be seen. Trodelvy is an antibody-drug conjugate (ADC) that consists of a monoclonal antibody that binds to the cell surface antigen Trop-2 and ‘SN-38,’ a TOP1 inhibitor payload. The drug received approval from the Ministry of Food and Drug Safety in May to treat adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies, including at least one prior therapy for metastatic disease. Trodelvy is the only non-cytotoxic chemotherapy approved as a second line or higher line of treatment for the entire TNBC patient population in Korea. It can be used regardless of genetic mutations or biomarkers. The National Comprehensive Cancer Network (NCCN) guidelines recommend Trodelvy as a Category 1 preferred treatment option for adult patients with metastatic TNBC who have received prior treatment. Trodelvy’s clinical efficacy was confirmed through the Phase III ASCENT study. In the study, Trodelvy significantly reduced the risk of death by 49% compared with a treatment of physician’s choice (TPC) in patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. Also, the Trodelvy arm showed a 57%
- Policy
- Drug price lawsuit recovery & refund, effective on the 20th
- by Lee, Jeong-Hwan Nov 15, 2023 05:39am
- Pharmaceutical company to reduce drug price, abusing lawsuit to reduce 'term profit' strategy In order to recover or refund the loss of drug costs as a result of the drug price-down lawsuit, the NHIS must notify the pharmaceutical company of the details such as the amount of refund, method, and the deadline for submitting opinions. The Corporation of Public Security shall refund the amount of the amount of loss to the pharmaceutical company within one year from the date of the administrative trial or administrative lawsuit's citation review, or judgment is confirmed. The amount of loss is calculated as 100% of the difference in the drug price in the case of a reduction, 40% of the difference in the drug price in case of suspension or exclusion, or reduction. On the 14th, the Ministry of Health and Welfare issued a partial revision of the Enforcement Rules of the National Health Insurance Act. The revised enforcement rules will take effect on the 20th, when the Drug Refund and Refund Act comes into effect. Specifically, the Ministry of Health and Welfare has established a new provision in the Enforcement Regulations of the Health Care Act, such as 'Collection and payment procedures for equivalent losses when disputes 60-2 drugs'. The relevant provision stipulated the matters that should be notified in advance when the Korea Medical Security Corporation collects or pays the amount of losses caused by the suspension or cancellation of drug price in accordance with paragraphs 1 and 2 of the health and 2 of the health security Act, which stipulates the Drug Expenses Repayment and Refund Act. In addition, the attached details such as the standard for calculating the amount of loss and the standard for calculating the added money corresponding to interest have been specified. The Corporation shall include in the notice the name (name or business name of the corporation), address, etc. of the pharmaceutical manufacturer, from the reduction of the upper limit on the cost of the drug care benefits, that is, the drug price is, but the title of the suspension or adjustment of the application of medical care benefits, and the drug manufacturer's name and address. Details such as the amount of loss caused by the drug price-down lawsuit, the calculation of the increase, the method of loss payment and payment, and the deadline must be notified in advance, and if you do not submit the opinion of the target pharmaceutical company, you must also present the processing law. At this time, the period for pharmaceutical companies subject to drug recovery should be 10 days or more from the date of receipt of notice from the Corporation. After the opinion submission period, the Corporation must send a payment notice when collecting (refunding) the loss, and a document stating the reason for payment, payment amount, payment method, and expected payment date at the time of payment (refund) to the target pharmaceutical company. The Corporation shall pay the loss to the pharmaceutical company within one year from the date the citation decision or judgment of the administrative trial or administrative lawsuit is finalized. The criteria for calculating losses and extra money are in accordance with Schedule 82 of the Enforcement Regulations, and other details related to recovery and refunds can be determined by the chairman of the Corporation after approval of the Minister of Welfare. According to Table 82, which stipulates the criteria for calculating the loss and the added money, 100% of the drug price difference that occurred during the period when the drug price was stopped due to the administrative trial committee or the court's suspension of execution in the case of the dispute over the drug price drop disposition, and 100% of the drug price difference that occurred during the period when the administrative trial or administrative lawsuit decision is finalized from the time of drug price. In the event of a dispute over suspension, exclusion, or reduction, 40% of the approximate price difference is a loss. With the promulgation of the revised enforcement rules of the Ministry of Welfare, all the work on sub-laws related to the drug price recovery and refund system scheduled to be implemented on the 20th has been completed. The Ministry of Health and Welfare expects that the implementation of the drug price reduction and refund system will reduce the number of indiscriminate suspension and cancellation lawsuits of drug price reduction, significantly reducing the amount of health insurance finances.
- Policy
- Enforcement rules for the recovery of drug price
- by Lee, Jeong-Hwan Nov 14, 2023 05:49am
- The amendment to the enforcement rules of the 'Refund and Refund Act', which was legislatively announced by the Ministry of Health and Welfare, was judged to be important in the preliminary review of the Regulatory Reform Commission, leaving only the procedure for confirming the enforcement rules as announced in the near future. According to the Ministry of Health and Welfare on the 10th, the sub-enforcement ordinance of the National Health Insurance Act, which stipulates the drug price recovery and refund law, was amended and promulgated on the 7th, followed by the enforcement rules soon. The main contents of the amendment to the Enforcement Rules of the Health Care Act previously announced by the Ministry of Health and Welfare are as follows. First, when the Health Insurance Corporation wins the drug administration dispute, the pharmaceutical company's refund will be set as the amount of 'the drug cost paid by the Health Insurance Corporation to the drug' minus the 'drug cost that the Corporation will pay if there was no decision to stop the execution of the court'. Conversely, when the pharmaceutical company wins, the Corporation's refund is the amount of 'the drug cost that the Corporation will pay if there is no adjustment such as drug price adjustment' minus 'the drug cost already paid by the Corporation'. Interest on the amount of loss (refund amount) due to drug disputes is subject to the interest rate of the national tax refund addition under the Enforcement Decree of the National Tax Collection Act. In addition to the matters specified in the amendment, the details necessary for collection and payment, such as the collection and payment procedures for losses, calculation criteria and periods, were determined by the Corporation. It decided that the enforcement rules of the Ministry of Welfare were not important enough to receive the main regulatory review, and passed the Ministry of Welfare with only a preliminary examination, and it went through the procedure of the Ministry of Legislation to be confirmed.
- Company
- Market for montelukast revive…overcomes impurity issue
- by Kim, Jin-Gu Nov 14, 2023 05:49am
- The market for asthma treatments containing the ingredient montelukast has succeeded in complete revival. This market shrank significantly in 2020-2021 due to the side effects issue and the COVID-19 outbreak, but made a rebound last year, and is expected to expand to the largest size ever this year. The market which remained stagnant for 2 years...is expected to revive completely after making a market rebound the previous year According to the market industry research institution UBIST on the 13th, the cumulative outpatient prescriptions of asthma treatments containing montelukast in Korea reached KRW 106.5 billion in Q3 this year. This is a 27% increase in 1 year from the KRW 83.6 billion made in the same period in the previous year. Montelukast is one of the most common ingredients used to treat allergic rhinitis and asthma. The original drug is Organon Korea’s ‘Singulair’. In Korea, MSD Korea received approval for the original drug in 2000, and around a hundred domestic pharmaceutical companies are selling generic versions with the same ingredient. The market was analyzed to have made a complete recovery this year. It had continuously grown until 2019 but then had greatly contracted in 2020-2021. In 2020, the prolonged COVID-19 crisis reduced hospital visits by children and adolescents, reducing prescriptions. During a similar period, the US Food and Drug Administration required a ‘Black box warning’ be attached to montelukast products regarding its neuropsychiatric side effects. Black box warnings are the highest level of warnings issued regarding side effects. Due to the overlapping unfavorable events, the market, which was worth KRW 119.9 billion in 2019, contracted to KRW 97.7 billion in 2020 and KRW 97.6 billion in 2021. Quarterly market size of montelukast asthma treatments But the market made a rebound last year. The market size expanded again to KRW 118.9 billion last year, which is a similar level to what it made in 2019. The market then continued to grow further this year. By quarter, it sold KRW 31.2 billion in Q1, KRW 34.7 billion in Q2, KRW 29.4 billion in Q3. The analysis is that the rise in influenza and cold patients by Q3 year has increased prescriptions to alleviate related symptoms. This is similar to how prescriptions for pseudoephedrine or cephalosporin-based antibiotics had increased during the same period. In the case of Singulair, the flagship product, the supply of some doses had even become temporarily suspended due to rising demand. In general, prescriptions for this ingredient used to be concentrated in the Q4 each year. For this reason, the industry predicts that the market for treatments with this ingredient will expand to KRW 140 to 150 billion by the end of this year. Unless there are any special issues, it is expected to expand to the largest scale ever. Sales of Singulair generics soar… Lukio 18%, Montezal 44%↑ Prescriptions for major montelukast products also increased at the same time. In the case of the original Singulair, its cumulative sales increased by 8% from KRW 20.2 billion in Q3 last year to KRW 21.9 billion in Q3 this year. Sales of its generic products had risen more rapidly. Sales of HK Inno.N’s Lukio increased by 18% from KRW 6.9 billion to KRW 8.1 billion during the same period. The price of Hanmi Pharmaceuticals Montezal increased by 18% from KRW 4.5 billion to KRW 6.4 billion. Changes in major montelukast asthma treatment prescriptions Sales of Boryung’s Asluka rose by 44% YoY to KRW 6.4 billion, Hutecs’ Singuldown by 58% to KRW 4.5 billion, Dong Kook’s Singulmon by 23% to KRW 3.7 billion, and Daewoong Bio’s Daewoong Montelukast by 78% to KRW 3.1 billion, respectively. The same goes for montelukast+levocetirizine combination drugs. Hanmi’s Monterizine is the only available combination drug. Monterizine’s cumulative prescriptions in Q3 reached KRW 11.2 billion, up 27% YoY compared with the KRW 8.8 billion raised in Q3 last year. Monterizine is also facing challenges due to the imminent entry of montelukast. 10 companies - Genupharma, Huons, Daehwa Pharmaceutical, DongKoo Bio&Pharma, Binex, Boryung Pharmaceutical, Daewon Pharmaceutical, Daewoong Pharmaceutical, Medica Korea, and Jeil Pharmaceutical – won the patent challenges against Hanmi Pharmaceuticals and owns generic exclusivity for Monterizine generics and waiting to release their generics.
- Policy
- Discussions on external drug price referencing reevals begin
- by Lee, Tak-Sun Nov 14, 2023 05:49am
- The National Health Insurance Review and Assessment Service will start collecting industry opinions for the external pricing reference system reevaluations next year. At the first meeting, the pharmaceutical industry is said to have expressed disapproval, complaining of fatigue accumulated from successive reevaluations. At the meeting on the 10th, the Ministry of Health and Welfare, HIRA, Korea Pharmaceutical and Bio-Pharma Manufacturers Association, Korea Research-based Pharmaceutical Industry Association, and working group members of pharmaceutical companies gathered to share opinions. At the meeting, the government reportedly explained the legitimacy and necessity of conducting reevaluations through external reference pricing. However, the pharmaceutical industry is said to have expressed resistance to the external reference pricing reevaluation itself due to difficulties experienced due to the accumulated burden from successive reassessments conducted this year, including the price ceiling standard requirement reevaluations, drug reimbursement adequacy reevaluations, actual transaction price survey, etc. At the meeting, the government only announced the principle of sequentially re-evaluating drugs for chronic diseases whose patents have expired starting next year was expressed, and did not share specific plans. However, it has been reported that reevaluations will be carried out by calculating the highest price of each country based on the adjusted price calculation standards of the A8 countries (US, UK, Germany, France, Italy, Switzerland, Japan, and Canada) that were newly set by through revised regulations this year and comparing it with the highest price in Korea. However, it has not been decided whether to adjust the average price using the highest prices of the A8 countries, the median price, or the average price excluding the highest and lowest price, and the government is said to be planning to decide this based on industry opinion. Accordingly, the pharmaceutical industry is expected to begin collecting opinions on adjusting the price method starting this week. An industry official explained, “We plan to run a simulation to see which of the four proposed methods, including using the adjusted average price, median price, and adjusted average price excluding the maximum and minimum prices, is more advantageous.” Industry officials said that too many agendas remain in need of review, such as details on subjects for drug price cuts, and that it would be difficult to complete collecting opinions on the remaining agendas in just one or two meetings. However, the government plans to make no change in its plan of finalizing its plan this year and starting reevaluations next year. As a result, is expected that the pharmaceutical industry meeting scheduled for this month will be held, and if necessary, additional meetings will be held to complete opinion collection and report the reevaluation plan at the Health Insurance Policy Deliberative Committee meeting scheduled for next month.
- Company
- Conquest of low survival gallbladder cancer
- by Nov 14, 2023 05:49am
- In the area of bile duct cancer, where survival rates are low and treatment options are scarce, new drug candidates from domestic pharmaceutical companies have been confirmed in clinical practice and are one step closer to commercialization. HDB001A, a new drug candidate for gallbladder cancer that Handok is developing, has recently been approved by a multi-national Phase 2/3 clinical trial plan (IND) in Korea. The company plans to compare and evaluate the effectiveness of Paclitaxel alone through the combination of HDB001A and platinum-based anticancer drug Paclitaxel. Handok emerged as a dark horse in the area as HDB001A entered a late clinical trial, along with the acquisition of domestic permission for the new gallbladder cancer drug , which was introduced from U.S. company Insight. Major bioventures plan to confirm their effectiveness through the combination of new drug candidates and immunocancer drugs under development. Genome & Company GEN-101, G Innovation GI-101, and SMT Bio SMT-NK are each undergoing clinical trials in combination with Keytruda. Handok confirms the validity of Phase 2 clinical trial Handok is collaborating with Compass Therapeutics in the United States to develop a treatment for bile duct cancer. HDB001A, which is being developed, is a new drug candidate for gall cancer developed by ABL Bio, a domestic company, and the domestic copyright is held by Handok and the global copyright is held by Compass. HDB001A is known to simultaneously target DLL4 and VEGFA and play a role in the formation of new blood vessels in tumor-fine environments. The company aims to obtain conditional approval from the Ministry of Food and Drug Safety through clinical results that will end next year. Last month, SMT-NK was recognized by the Ministry of Food and Drug Safety and obtained approval for the use of drugs for clinical trials in patients with bile duct cancer. G-I Innovation is undergoing clinical phase 1 in the United States to confirm the effectiveness of GI-101 and kitluda combination therapy. It aims to secure indications for solid cancer that include bile duct cancer. The company is confirming the possibility of commercialization through combination therapy with various immune anticancer drugs. 5-year survival rate of bile duct cancer 29%, Evaluation of lack of professional treatment options for bile duct cancer Bleduct cancer is one of the cancers that is difficult to diagnose early because there are no self-aware symptoms. The 5-year survival rate for bile duct cancer is 29%, which is lower than lung cancer (34%) and liver cancer (37%). As early diagnosis is difficult, treatment options are limited. In advanced bile duct cancer, platinum-based chemotherapy has been used as a standard treatment for the past 10 years. This is a first-generation anticancer drug, a cytotoxic anticancer drug that is used not only for bile duct cancer but also for lung cancer and colorectal cancer. Side effects are also known to be high. Secondary standard therapy includes FOLFOX, but it is also not a specialized treatment for bile duct cancer. Recently, immunoanticancer agents have secured encouraging data and are attracting expectations. The impinji developed by AZ was approved as the first treatment in the country in November last year. However, targeted treatments for bile duct cancer are still insufficient. It is noteworthy whether new drug candidates from domestic pharmaceutical companies can solve the unfulfilled demand of bile duct cancer patients.
