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- 2025-12-23 07:59:18
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- 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%
- 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.
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- 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.
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- Novartis loses 2nd trial for its Entresto patent
- by Kim, Jin-Gu Nov 13, 2023 05:23am
- The second trial over Novartis’s heart failure treatment ‘Entresto (valsartan+ sacubitril) again ended with the victory of the Korean generic companies. If the companies succeed in winning the remaining 2 suits, the companies will be one step closer to the early release of their generics. Generic companies win first and second trials on Entresto’s composition and use patent According to industry sources on the 10th, the Patent Court of Korea ruled against the plaintiff (Novartis) in the second patent invalidation trial that Novartis filed against 10 generic companies, including Hanmi Pharmaceutical, on the 9th. The patent was a composition/use patent that was set to expire in July 2027. In April 2021, 10 companies including Hanmi Pharmaceutical filed an invalidation trial on the patent. In July of the following year, the Property Trial and Appeal Board (1st trial) ruled the claims valid. After losing the 1st trial, Novartis filed an appeal to the Patent Court of Korea to cancel the trial decision. However, the 2nd trial court also ruled in favor of the generic companies. As a result, the generic companies are now one step closer to the early release of their Entresto generics. If companies win the remaining 2 disputes awaiting 2nd trial rulings, they will be eligible for early release of their generics. However, if Novartis again appeals to the second trial decision and decides to take the matters to the Supreme Court, the dispute can be prolonged with the lingering burden of early release of generics. Generic companies can become one step closer to the early release of Entresto generics if they win the other 2 remaining trials A total of 3, including the ruling made on the 9th, are being tried in the 2nd trial. One is over a crystalline patent that expires in September 2027 and the other is over a salt/hydrate patent that expires in November 2026. In the case of the crystalline patent, Elyson Pharm and other companies filed trials to confirm the passive scope of rights on the patent in January 2021, starting the dispute. The generic companies triumphed in the 1st trial. The Intellectual Property Trial and Appeal Board ruled in favor of generic companies in December 2021, and Novartis, which appealed, filed a lawsuit with the Patent Court of Korea to cancel the decision. Currently, the generic companies and Novartis are awaiting the 2nd trial ruling. The Patent Court of Korea has designated the 21st of next month as the hearing date. The generic companies also won the 1st trial for Entresto’s salt/hydrate patent, and the companies are awaiting its 2nd trial ruling. Daewoong Pharmaceuticals had first filed a suit to invalidate the patent in April 2021. In March this year, the Intellectual Property Trial and Appeal Board ruled in favor of the generic companies, issuing a decision of partial valid and partial dismissal ruling. Novartis appealed the ruling and dragged the case to the second trial. The companies had also challenged Entresto’s 2 composition patents and 1 use patent. The generic companies also won those disputes, however, Novartis did not file an appeal after losing the 1st trials, finalizing the trial decisions. Quarterly prescriptions of Entresto Faced with the imminent entry of its generics, Entresto has been rapidly increasing its prescription performance. According to the market research institution UBIST, Entresto generated KRW 14.8 billion in outpatient prescriptions in Q3. This is a 36% YoY increase compared to KRW 10.9 billion in Q3 last year. Although 6 years have passed since its release in Q4 2017, the drug is still showing high growth. Its performance rose by over 30% every quarter YoY. Its sales exceeded KRW 5 billion in Q1 2020 and expanded to more than KRW 10 billion in Q2 2022. If the current trend continues, its quarterly sales are expected to exceed KRW 15 billion in Q4 this year.
- Company
- Amvuttra receives orphan drug designation
- by Eo, Yun-Ho Nov 13, 2023 05:23am
- ‘Amvuttra,’ the first new drug for amyloidosis with polyneuropathy to be introduced since ‘Vyndaqel,’ has been designated an orphan drug in Korea. The Ministry of Food and Drug Safety announced so through a recent notice of orphan drug designation. siRNA therapy Amvuttra (Vutrisiran) is administered subcutaneously at once every three-month intervals. It inhibits the production of wild-type and mutant-type transthyretin (TTR) by targeting and silencing specific messenger RNA. Its efficacy was demonstrated through the Phase III HELIOS-A study that evaluated the efficacy and safety of Amvuttra in 164 patients with hATTR amyloidosis in 22 countries. The patients were randomized 3:1 to receive either 25 mg of vutrisiran via subcutaneous injection once every three months (vutrisiran arm, 122 patients) or 0.3 mg/kg of patisiran via intravenous infusion once every three weeks (patisiran arm, 42 patients). The efficacy of the vutrisiran arm was assessed by comparing the data with the landmark APOLLO Phase III study of patisiran that evaluated patisiran’s efficacy and safety in a comparable patient population. During the 9-month treatment period, the vutrisiran arm experienced fewer severe neurological damage than the placebo group and improved quality of life. Also, results of the timed 10-meter walk test that evaluates the patient’s walking speed and exercise ability, the vutrisiran arm showed little change compared to the placebo. Also, the arm showed an improvement in NT-proBNP, a biomarker that evaluates heart function. hATTR-PN, which occurs in 1 in 100,000, is caused by a genetic mutation in the transthyretin gene and causes systemic polyautonomic neuropathy, including symptoms related to the heart and digestive system, and eye disease. Generally, symptoms such as pain, abnormal sensations, and paralysis begin in the nerves of the lower extremities, where abnormal proteins tend to accumulate, and then affect the upper body, gradually spreading to the heart, kidneys, and eyes and causing complications. Its life expectancy is on average 7 to 12 years from symptom onset.
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- NMOSD drug Enspryng likely to be reimbursed in December
- by Eo, Yun-Ho Nov 13, 2023 05:23am
- ‘Enspryng’ a new drug for neuromyelitis optica spectrum disorder (NMOSD), is expected to be listed for reimbursement in Korea within the year. According to industry sources, Roche Korea completed drug pricing negotiations with the National Health Insurance Service for the reimbursement of its NMOSD treatment Ensprying (satralizumab). Therefore, reimbursement may be applied from December at the earliest. The company had applied for the reimbursement of its Ensprying in H2 2022 after receiving approval in H1 2021. However, due to its high price, the company and authorities have found it quite difficult to set a reimbursement standard and financial sharing plan. The company had first adopted the strategy of accepting the weighted average price (WAP) of its alternative, Soliris, but due to a delay in Soliris’s reimbursement listing process for NMOSD, the company turned to the pharmacoeconomic evaluation exemption system for its reimbursement. In particular, even after passing a review by the Drug Reimbursement Evaluation Committee of the Health Insurance Review and Assessment Service in August, the company encountered difficulties in accepting the deliberation results and entering drug pricing negotiations due to the tightly set reimbursement standards. In other words, the negotiation was only possible because Roche accepted the ‘fourth or later lines of therapy’ reimbursement standard set by DREC. This therefore also conversely suggests significant restrictions on actual prescriptions after its reimbursement listing. Currently, the immunosuppressant azathioprine is used as first-line maintenance therapy for NMOSD. If a patient fails treatment with azathioprine, mycophenolate or rituximab is prescribed with reimbursement as second-line therapy. Both mycophenolate and rituximab are off-label drugs that do not have NMOSD indications. In other words, Enspryng can only be used as a third or later-line therapy in patients who fail treatment with rituximab. Therefore, it remains to be seen whether the company will seek to extend reimbursement for Enspryng after listing. Meanwhile, Enspryng’s efficacy was demonstrated through SAkuraStar and SAkuraSky clinical trials that were conducted on adult patients with anti-aquaporin(AQP4) antibody-positive NMOSD. In the SAkuraStar monotherapy study’s AQP4 antibody-positive subgroup, 76.5% of ENSPRYNG-treated patients were relapse-free at 96 weeks, compared to 41.1% with placebo. In the SAkuraSky study, which evaluated Enspryng when used concurrently with standard immunotherapy, 91.1% of Enspryng-treated AQP4 antibody-positive subgroup patients were relapse-free at 96 weeks, compared to 56.8% with placebo.
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- Korea Pharma applies for approval of its 24hr ADHD drug
- by Lee, Seok-Jun Nov 10, 2023 05:19am
- Korea Pharma announced on the 9th that it had applied for marketing authorization for its 24-hour long-acting ADHD treatment ‘Methydur SR Cap.’ Methydur is a treatment for attention deficit hyperactivity disorder (ADHD) in children and adolescents developed by Orient Pharmaceuticals in Taiwan. The main substance contained in Methydur is methylphenidate hydrochloride, and it is available in three dosages - 22mg, 33mg, and 44mg - depending on symptoms. In Taiwan, the drug underwent 5 Phase I trials and completed a Phase I trial on 113 children and adolescent patients, demonstrating its safety and effectiveness. The drug obtained marketing approval in Taiwan in 2018. Methydur reduced the side effects that commonly accompany CNS drugs and improved the risk of drug abuse by applying the 'ORADUR®' technology. Using the ORADUR technology, the drug’s drug release rate can be controlled while retaining the characteristics of a sustained-release formulation by filling the capsule with a highly viscous gel form liquid. It can reduce discomfort caused by intranasal or intravenous treatments and prevent misuse or abuse. The number of ADHD patients in Korea have been rapidly increasing every year. However, it is an over-monopoly situation, with certain products taking up more than 60% of the market share. Korea Pharma plans to provide a stable environment for drug supply to patients by introducing Methydur, which can be prescribed in various doses and has a proven safety and effectiveness. Eun Hee Park, CEO of Korea Pharma, said, “If we obtain a marketing authorization for Methydur in Korea, we will be able to provide a clinically improved treatment effect to domestic pediatric and adolescent ADHD patients that are increasing every year.”
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- Development active for microbiome-based therapies in Korea
- by Nho, Byung Chul Nov 10, 2023 05:19am
- Microbiome-based therapies have been expanding their therapeutic areas from simple digestives to immunology and oncology, receiving industry attention. Based on research results that showed that imbalances in the human microbiome are highly correlated with various incurable diseases, such as cancer and obesity, and can cause immune and metabolic diseases, research is being conducted in various fields to develop treatments using microorganisms. In particular, Swiss Ferring Pharmaceuticals' Rebyota (prevention of recurrence of Clostridioides difficile (C. difficile) infection) received FDA approval last year, and Seres Therapeutics' Vowst (prevention of recurrence of Clostridioides difficile (C. difficile) infection) was also approved this year. With drugs continuing to be approved one after another, the companies are also speeding up the commercialization of their respective drugs. In line with this global trend, domestic biotech companies are also entering related fields one after another and exploring their possibilities. First, MD Healthcare is developing a new drug with a focus on extracellular vesicle (EV) secreted by microbiome. EV is a lipid bilayer membrane secreted externally by cells that serve as vital mediators of intercellular communication. The company explained that as these particles are much smaller than cells, they have high absorption capacity and thus can provide radical treatment through a mechanism that works from within the cells. MD Healthcare's representative pipeline drug, 'MDH-014', targets central nervous system diseases (CNS) such as autism spectrum disorder, Alzheimer's disease, and Parkinson's disease. The company had submitted an IND for the drug for the autism spectrum disorder indication and is planning to start Phase I trials next year.. Enterobiome is developing treatments for incurable diseases using extreme anaerobic, non-culturable, next-generation probiotic strains. The company has been developing next-generation probiotics akkermansia muciniphila and faecalibacterium prausnitzii strains that show a negative correlation with various immune and metabolic diseases in the body as pharmabiotics. According to domestic and international studies, akkermansia and faecalibacterium significantly reduced the gut microbiota composition of patients with immune diseases such as atopic dermatitis and cancer as well as metabolic diseases such as obesity and non-alcoholic steatohepatitis (NASH) compared to normal people. Also, patients who were administered the two strains saw a treatment effect. Enterobiome has currently completed non-clinical toxicity testing for its akkermansia muciniphila strain EB-AMDK19 for atopic dermatitis and is preparing to apply for an IND as a new atopic dermatitis drug early next year. Akkermansia muciniphila, observed with an electron microscope. Among companies that are developing next-generation microbiomes, the only two companies leading at the akkermansia R&D and commercialization stage are The Akkermansia Company in Belgium and Enterobiome in Korea. Enterobiome owns a source technology for a high-concentration culture that is 1,000 times more concentrated than its competitors. Liveome has been developing a microbiome therapy based on its gene recombination technology. Libiome’s microbiome-based new drug has both the characteristics of a probiotic therapy and a gene therapy and is referred to as a ‘genetically engineered microbiota therapy.’ These treatments have the advantage of being able to increase effectiveness and drug efficacy by designing and manufacturing microorganisms according to the desired mechanism. Libiome is currently conducting Phase I clinical trials in Australia for its LIV001, a candidate in its inflammatory bowel disease pipeline, that was developed using the genetic recombinant eLBP platform. The candidate was selected as a new project by the Korea Drug Development Fund in July of this year and is receiving KDDF support for related R&D costs. In addition, various companies such as KoBioLab, Genome & Company, and CJ Bioscience are developing treatments for incurable diseases using microbiome, therefore whether a next-generation microbiome drug following Vowst’s footsteps will be born in Korea is gaining industry attention.
- Company
- Will Lixiana hit the 100 billion won mark for the NOAC RX?
- by Kim, Jin-Gu Nov 10, 2023 05:19am
- Attention is focused on whether Daiichi Sanko Lixiana will become the first NOAC drug to exceed 100 billion won in annual prescription sales. As of the third quarter, the cumulative prescription amount was 78.2 billion won, and if this trend continues, it is expected that prescriptions will easily exceed 100 billion won by the end of the year. Lixiana's annual prescription volume exceeded KRW 100 billion, making it the only original company to grow According to UBIST, a pharmaceutical market research firm, on the 9th, Lixiana's outpatient prescription volume in the third quarter was 26.8 billion won. Compared to 24.9 billion won in the third quarter of last year, it increased by 8% in one year. Lixiana's cumulative prescription amount in the third quarter was 78.2 billion won. The pharmaceutical industry predicts that if this trend continues, the number of prescriptions will increase to more than 100 billion won by the end of the year. Lixiana recorded prescriptions worth 96.7 billion won last year. In Korea, products that recorded over 100 billion won in prescriptions last year include Viatris 'Lipitor', Hanmi Pharmaceutical 'Rosuzet', HK inno. N 'K-CAB', Daewoong Bio Gliatamin, Handok 'Plavix', Chongkundang Gliatirin, LG Chemical Zemimet, etc. There are only 7. Even though the domestic NOAC market has reached a plateau, Lixiana is the only original drug that continues to see an upward trend in prescription performance. The NOAC market continued to grow rapidly until last year. The NOAC market, which was 147.2 billion won in 2018, reached 225.9 billion won in 2021, reaching the 200 billion won mark. Last year, the market size further expanded to 242.5 billion won. However, on a quarterly basis, it appears to have slowed down since peaking in the second quarter of last year. The NOAC market, which was 61.8 billion won in the second quarter of last year, decreased to 58.3 billion won in the 4th quarter. This year, it stagnated at 59.3 billion won in the first quarter, 60.2 billion won in the second quarter, and 60.9 billion won in the third quarter. BMS Eliquis, the second-largest product in the market, recorded prescription sales of 19.2 billion won in the third quarter. It remained at a similar level to the third quarter of last year. Eliquis has been recording prescription sales of around 19 billion won every quarter since the third quarter of last year. Xarelto's prescription performance decreased significantly due to the release of generics and the subsequent price reduction. Xarelto prescriptions in the third quarter amounted to 7.6 billion won, a 36% decrease from 11.8 billion won in the same period last year. Xarelto had issued quarterly prescriptions worth more than 15 billion won until the third quarter of 2021, but prescriptions have plummeted since the launch of generics. In the fourth quarter of last year, the quarterly prescription amount fell below 10 billion won and has been steadily decreasing since then. Boehringer Ingelheim Pradaxa's slump is prolonged. Pradaxa's prescription volume in the third quarter was 2.5 billion won, a 19% decrease compared to the same period last year. Generics for Xarelto are rapidly expanding their influence. The combined prescription amount for generics for Xarelto in the third quarter was 4.7 billion won. It increased by 72% compared to 2.7 billion won in the third quarter of last year. Its share in the rivaroxaban treatment market increased to 38%. Compared to 18% in the third quarter of last year, the market share has more than doubled in one year. Xarelto generics were released in large numbers in the third quarter of that year following the release of Chong Kun Dang's Riroxia in the second quarter of 2021. Chong Kun Dang's Riroxia, Hanmi Pharmaceutical's Riroxban, and Samjin Pharmaceutical's Rivoxaban are competing. As of the third quarter of this year, Riroxia's cumulative prescriptions were the highest at 3.3 billion won. Riroxban follows this at 2.4 billion won and Rivoxaban at 2.1 billion won. The remaining 30 companies had cumulative prescriptions of less than 1 billion won in the third quarter.
- Company
- Will Trodelbi become a second-line standard tx
- by Nov 09, 2023 05:43am
- Gilead Sciences Korea held a press conference at the Plaza Hotel in Seoul on the 7th to commemorate the domestic launch of Trodelbi, a treatment for metastatic triple-negative breast cancer Antibody Drug Conjugate (ADC) anticancer drugs first appeared in the domestic triple-negative breast cancer treatment market. To date, there have been no treatment options targeting triple-negative breast cancer treatment other than immunotherapy drugs and PARP inhibitors. Gilead is aiming to make Trodelbi the standard treatment option in this area. Gilead Sciences Korea held a press conference at the Plaza Hotel in Seoul on the 7th to commemorate the domestic launch of Trodelbi, a treatment for metastatic triple-negative breast cancer. Trodelbi is an ADC that targets Trop-2 protein, which is frequently observed on the surface of breast cancer cells and is used as a treatment for advanced or metastatic triple-negative breast cancer. Last May, Trodelbi was approved in Korea for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer that has previously received two or more systemic treatments, at least one of which was for metastatic disease, and was launched in Korea last month. The phase 3 ASCENT study served as the basis for approval. The study was conducted to compare the effectiveness and safety of Trodelbi and chemotherapy in 529 patients with locally advanced or metastatic triple-negative breast cancer who had previously received chemotherapy twice or more. 12% of all patients had brain metastases. The primary endpoint was PFS in patients without brain metastases compared to baseline. Secondary endpoints included overall patient PFS, OS, and ORR. As for clinical results, the median PFS in patients without brain metastases, which was set as the primary endpoint, was recorded by Trodelbi at 5.6 months. This was a higher figure than the 1.7 months recorded for chemotherapy. The OS, measured regardless of the secondary endpoint of brain metastasis, was 11.8 months for Trodelbi and 6.9 months for chemotherapy in the entire patient group. There was a significant difference in ORR, with Trodelbi being 31% and chemotherapy being 4%. In terms of safety, serious adverse reactions such as neutropenia (7%), diarrhea (4%), and pneumonia (3%) occurred during Trodelbi administration. Treatment discontinuation due to adverse reactions was calculated to be 5% for Trodelbi and chemotherapy. Professor Son Joo-hyuk of the Department of Oncology at Yonsei Cancer Hospital said, “Trodelbi is considered a docile anticancer drug. The basic principle is that cytotoxic anticancer drugs kill cancer cells, and as they bind to antibodies, we confirmed a good safety profile without severe toxicity,” he said. “Trodelbi is an anticancer drug that should be used as a standard treatment for metastatic triple-negative breast cancer.” “I think it should be included not only in ESMO or NCCN but also in our country’s treatment guidelines,” he said. According to the NCCN guidelines, Trodelbi is classified as Category 1 for the second-line or higher treatment of adult patients with metastatic triple-negative breast cancer. Rare cancer, triple-negative breast cancer, need for secondary treatment options after treatment failure. Triple-negative breast cancer is classified as a rare cancer among breast cancers. Triple-negative breast cancer, which is negative for human epidermal growth factor receptor type 2 (HER2), hormone receptor (HR), and estrogen, is experiencing difficulties in developing targeted treatments. In particular, compared to HR- and HER2-positive breast cancer, there is a shortage of treatments and treatment outcomes are not as good. In the case of early triple-negative breast cancer, immunotherapy drugs can be used without biomarker analysis. However, in metastatic triple-negative breast cancer, it can only be used if there is PD-L1 expression. If BRCA mutation is confirmed, PARP inhibitors can be used, but if there is no corresponding biomarker mutation, there is no treatment. Professor Kim Ji-hyung of the Department of Oncology at Gangnam Severance Hospital said, “Triple-negative breast cancer has aggressive clinical manifestations and there are almost no targeted therapies available. “The disease-free survival rate is usually only 2 to 3 months, and there is no standard treatment,” he said. “Immunotherapy drugs also require confirmation of the PD-L1 expression rate, so treatment options are limited. “An effective treatment is needed for patients with metastatic triple-negative breast cancer who have failed primary treatment,” he said.
