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- 2026-05-11 10:50:45
- Company
- 'Saxenda' continues to dominate weight-loss market
- by Kim, Jin-Gu Jun 07, 2023 05:38am
- Product Photos of Saxenda (LT) and Qsymia (RT) 'Saxenda (Liraglutide)' is further strengthening its dominance in the obesity treatment market. In the first quarter, it recorded sales of KRW 15.9 billion, 53% increase from the previous year, more than doubling the gap with the runner-up product, 'Qsymia (Phentermine+Topiramate).' However, it remains to be seen how much longer Saxenda's dominance will last, as release of promising products such as 'Wegovy (Semaglutide)' and 'Mounjaro (Tirzepatide)' are imminent in the obesity treatment market. The pharmaceutical industry predicts that the two products which have proven their marketability in the global market will be released in Korea as early as this year. Saxenda grows 53% in 1 year... more than doubles the gap with Qsymia According to IQVIA, a pharmaceutical market research institute, on the 5th, Novo Nordisk's Saxenda recorded sales of KRW 15.9 billion in the first quarter. This is a 53% increase in 1 year, compared to KRW 10.4 billion in the first quarter of 2022. Saxenda is the world's first obesity treatment approved as a glucagon-like peptide-1 (GLP-1) analog. It has the same ingredients as the type-2 diabetes treatment 'Victoza,' but with different usage and dosage. Saxenda has grown rapidly since its domestic release in the second quarter of 2018. In 2019, the second year after its release, Saxenda dominated the obesity treatment market with sales of KRW 42.6 billion. Saxenda, unlike existing obesity treatments, is not a psychotropic drug, and therefore gained explosive popularity because it is relatively safe and can be taken over a long period. The sales of Saxenda have somewhat slowed down due to the impact of COVID-19 in 2020 and 2021. However, as outdoor activities have become revitalized again from last year, demand for obesity treatments regained its place, and Saxenda's sales soared up to KRW 58.9 billion. Quarterly Sales of Saxenda and Qsymia (Unit: 100 million won, Data: IQVIA) Qsymia, the runner-up product in the market, marked sales of KRW 7.7 billion in the first quarter. Compared to KRW 6.3 billion in the first quarter of last year, sales has increased by 21%. It is analyzed that Qsymia was also affected by the recovery of the obesity treatment market. Qsymia is a combination drug of 'Phentermine' and 'Topiramate,' which Alvogen Korea secured domestic sales right from the US pharmaceutical company Vivus in 2017. Alvogen Korea started domestic sales with Chong Kun Dang at the end of 2019. In addition to the advantage that the content of psychotropic ingredient is relatively low even though it is an oral drug, Chong Kun Dang's sales power generated synergy and quickly penetrated the market despite being a latecomer. However, the gap with Saxenda has widened. Although Qsymia chased Saxenda's sales up to about 90% with KRW 5.9 billion in the first quarter of 2021, the gap is widening again as the obesity treatment market is recovering. In the first quarter of this year, the gap between to two products widened by 2.4 times. Some in the pharmaceutical industry predicts that the gap between the two products will widen further in the future. This is because obesity treatments containing Phentermine and Phendimetrazine, including Qsymia, were included in the 'list of narcotics and drugs of concern for misuse and abuse' as the non-face-to-face treatment pilot project was implemented. The government urged caution in prescibing psychotropic drugs such as Qsymia through non-face-to-face treatment. Saxenda has not been included in the list. In addition, treatments such as Daewoong Pharmaceutical's Dietamin, Korea Prime Pharm's Phendimen, Huons's Hutermin, etc. recorded sales of more than KRW 1 billion in the first quarter. In case of Phendimen, its sales, which recorded just KRW 300 million in the first quarter of last year, increased about 6 times to KRW 1.8 billion in one year, showing remarkable growth. Wegovy and Mounjaro's impending release... Saxenda's domination coming to an end It remains to be seen how much longer Saxenda's dominance will last. Two mega-sized products that have proven their competitiveness in the global market are waiting to be released. In the pharmaceutical industry, the prevailing view is that Saxenda's dominance will come to an end with the advent of next-generation products such as Wegovy and Mounjaro. Product Photos of Wegovy (LT) and Mounjaro (RT) In April, the Ministry of Food and Drug Safety approved Novo Nordisk's Wegovy. Wegovy is a GLP-1 analog, just like Saxenda. Novo Nordisk improved its Saxenda, which was administered daily, to weekly administration. In the US market, in which Wegovy was released earlier, demand for the product soared, with shortages occurring. In particular, due to its popularity, shortage of Ozempic, a diabetes treatment with the same ingredients and usage, has also occurred. Even now, there is still a lack of supply of Wegovy in the US. Due to the circumstances, the official release of Wegovy is being delayed in Korea even after product approval. The pharmaceutical industry predicts that domestic supply will be possible at the end of this year or early next year. The domestic release of Eli Lilly's Mounjaro, which is considered a strong competitor of Wegovy, is also imminent. The Ministry of Food and Drug Safety recently completed a safety and efficacy review on Mounjaro. Completing the review means that the product approval process will soon begin. Mounjaro is a GLP-1 analog, just like Saxenda and Wegovy. After obtaining approval as a type-2 diabetes treatment, Lilly is trying to expand its indications for obesity. In the case of the Mounjaro, in addition to the mechanism acting on the GLP-1 analog, its mechanism also acts on the glucose-dependent insulinotropic polypeptide (GIP). Due to this, Mounjaro's weight loss effect was better than that of Wegovy in each drugs' clinical trials. Lilly also entered a phase 3 clinical trial comparing the effects of Mounjaro and Wegovy on a one-to-one basis.
- Policy
- Voluntary price reduction of Diacomit/Olpadine up to↓40%
- by Lee, Hye-Kyung Jun 05, 2023 05:37am
- The drug prices of Diacomit, a treatment for Dravet syndrome, and Olpadine, a treatment for hereditary tyrosinemia, which is a rare essential drug, fell by up to 40%. The KOEDC said in a press release on the 1st, “In the case of Diacomit and Olpadine, insurance prices were voluntarily reduced on April 1 and May 1, respectively.” As a result, the price of Diacomit per capsule was reduced by about 23% from 19,160 won to 14,700 won. This is due to the fact that overseas wholesalers can reduce transportation costs by importing directly from the manufacturer, and as export certification by the manufacturer becomes possible, tariff exemption is possible under the Korea-EU FTA. Olpadine cut the price by about 40% from 37,386 won per capsule to 22,420 won to adjust for the difference between the cost of import and insurance drug price. As a drug subject to tariff exemption, the insurance price of Enhertu, a breast cancer treatment, was cut from 5.4 million won to 5 million won, and the Alzheimer's drug, Aduhelm, was cut from 3.44 million won to 3.2 million won. The Korea Customs Service imposes a basic tariff rate of 8% when importing medicines from abroad, but no duty is imposed on immune products. The KOEDC took note of this and reduced drug prices through tariff reductions on Enhertu, a breast cancer treatment, and Aduhelm, an Alzheimer's treatment. Enhertu applied for a preliminary review to the Korea Customs Service in June 2022 and was notified of the result in August 2022, and the drug price per vial was reduced from 5.4 million won to 5 million won through tariff reduction. Aduhelm applied for a preliminary review to the Korea Customs Service on March 7, 2023, and was notified of the result on March 20, 2023. Through tariff reduction, the drug price per vial increased from 2.04 million won to 1.9 million won for 170 mg, and 3.44 million won for 300 mg was reduced to 320 million won. In the case of Quinidine, a rare arrhythmia treatment, an attempt was made to import and supply it as an Epic Pharma drug due to Sandoz’s suspension of supply in June 2022, but the cost of the drug was 75 times higher than the existing drug price (50,000 won/bottle), adding to the patient’s burden. The KODC announced that it has been able to supply Nisco Quinidine, which can be imported directly from the manufacturer, by lowering the price to 35,000 won through continuous efforts.
- Policy
- Evrysdi, a tx for Roche's spinal muscular dystrophy, passed
- by Lee, Hye-Kyung Jun 05, 2023 05:37am
- Roche Korea's oral 5q spinal muscular atrophy treatment Evrysdi Dry Syrup has been recognized for its benefits and has crossed the insurance threshold. The HIRA released the results of the '2023 6th Pharmaceutical Reimbursement Evaluation Committee' deliberation on the 1st. Ace Pharma's Megval 50mg and H.I.Pharm's Melpspal 50mg, both of which are Evrysdi and Melphalan Hydrochloride-component multiple myeloma treatments, were all approved for reimbursement. Evrysdi is a liquid formulation that is taken orally once a day and can be applied to patients who have difficulty in spinal treatment. The effect of improving motor function and the safety profile was confirmed in patients with a wide range of disease types, including patients of a wide age range from 2.2 months to 25 months of age and patients with scoliosis-related surgery experience. Since self-administration is possible at home, it reduces not only the additional direct medical costs related to hospitalization and visitation, which occurred during the existing intrathecal injection treatment, but also the burden of indirect medical costs such as study and work interruption, transportation costs, and nursing care, which are accompanied by this, reducing insurance finance It is evaluated that it can produce the effect of reducing the socio-economic burden. In addition, it is a customized prescription according to age and weight, and the liquid formulation corresponding to the recommended dose can be taken once a day. Megval and Melpspal 50mg, whose main ingredient is Melphalan Hydrochloride, have been approved for multiple myeloma treatment. The dosage is 0.4 mg per kg of body weight (16 mg/m2) intravenously over 15 to 20 minutes for adults, and for patients with renal impairment (BUN > 30 mg/dL), reduce the dose by half.
- Policy
- Non-face-to-face demonstration will be alternative relief ?
- by Lee, Jeong-Hwan Jun 05, 2023 05:37am
- While the non-face-to-face treatment pilot project started on the 1st, it is attracting attention that the government will "seek ways to use substitute drugs" as a way to prevent inconvenience caused by the lack of prescription drugs at the pharmacy near the patient after treatment. There is a lot of interest in whether the alternative treatment simplification method can be implemented within the pilot project period, such as exempting the follow-up notification of alternative treatment limited to non-face-to-face treatment. In particular, the government also announced that it will prepare guidelines such as banning automatic allocation of pharmacies after prescribing for non-face-to-face treatment platform management and regulation measures, and to induce improvement in case of problems after monitoring the platform by operating a pilot project advisory group such as the pharmaceutical society. On the 1st, the Ministry of Health and Welfare answered a question about the non-face-to-face treatment operation plan of Rep. Jeon Hye-sook, a member of the National Assembly Health and Welfare Committee. First, the government said that it would use alternative drugs to prevent cases of inconvenience because the medicines prescribed by medical institutions that have performed non-face-to-face treatment are not in pharmacies located near the patient's area. Starting from the pilot project, the method of receiving prescription drugs after the non-face-to-face treatment will be changed from delivery to the patient's (agent)'s direct visit to the pharmacy. The government's will to minimize the situation where the pilot project has a hard time because there is no medicine in the pharmacy through alternative medicine. In order to improve this inconvenience and lack, pharmacists are demanding that non-face-to-face treatment be allowed to 'simplify post-notification of replacement drugs' and 'prescribe ingredients'. However, the Ministry of Health and Welfare did not take a specific position regarding the exemption of non-face-to-face treatment substitutes, the introduction of simpletion, or ingredient name prescriptions. I answered only with the intention of using the alternative medicine system to solve the problem that occurs when non-face-to-face prescription drugs are not in pharmacies. The Ministry of Health and Welfare announced that it has prepared guidelines such as 'prohibition of automatic allocation of pharmacy' on ways to manage and control expedient, illegal, and deviant behavior of non-face-to-to-face treatment platforms. In particular, he said that he would monitor the platform through the operation of a non-face-to-face treatment pilot project advisory group in which health and medical organizations such as the Korean Pharmaceutical Society participate, and would demand improvement if there were any problems. However, the Ministry of Health and Welfare has made it clear that in order to impose legal obligations on platform laws, or to make effective regulations such as data submission requirements and corrective orders, it is necessary to legislate the institutionalization of non-face-to-face treatment. The Ministry of Health and Welfare said it would "promote amendments to the health care law based on the legislation proposed by the National Assembly" regarding platform regulation. The Ministry of Health and Welfare did not provide a specific position or method on the 'electronic prescription' that electronically transfers a prescription issued by a doctor to a patient-designated pharmacy after a non-face-to-face treatment. "The method of sending and delivering prescriptions from medical institutions to pharmacies is to deliver faxes, e-mails, etc. to pharmacies designated by patients," the Ministry of Health and Welfare explained. In addition, during the pilot project period, we reaffirmed our position that it is in principle to implement non-face-to-face treatment with video treatment rather than telephone consultation. He said that the principle of video treatment is to conduct non-face-to-face treatment as a 'means that can communicate with real-time video communication', not just by phone call or voice. "Elderly people who have difficulty making voice calls or do not have smartphones can have non-face-to-face treatment with voice calls," the Ministry of Health and Welfare said. It is read that even if a non-face-to-face patient lies that it is difficult to make a video call or does not have a smartphone, there is no way to specifically isolate or regulate it. When asked if the government plans to support the cost of building a video care system for medical institutions during the pilot period, the Ministry of Health and Welfare said, "there is no separate cost support plan."
- Company
- Interleukin inhibitors Cosentyx·Tremfya busy extending reim
- by Eo, Yun-Ho Jun 05, 2023 05:37am
- News of reimbursement extensions granted for interleukin inhibitors is continuing in Korea. According to industry sources, the scope of reimbursement for Novartis Korea's IL-17A inhibitor 'Cosentyx UnoReady Pen' 300mg/2mL, and Janssen Korea's IL-23 inhibitor ‘Tremfya (guselkumab)' have been extended since last month, and the 1st of this month, respectively. As with the other doses of Cosentyx, its 300mg dose can also be prescribed to patients with moderate-to-severe plaque psoriasis, active and psoriatic arthritis (PsA), adults with active ankylosing spondylitis (AS), adults with severe ankylosing spondylitis, etc. In Korea, Cosentyx is reimbursed for patients with chronic severe plaque psoriasis that lasts for more than 6 months, and ▲10% of the total skin area has been affected, ▲has a PASI 10 or higher, ▲has shown no response to methotrexate (MTX) or cyclosporine when administered for more than 3 months or cannot continue treatment due to side effects, or ▲has shown no response to PUVA or UVB therapy when treated for more than 3 months or cannot continue treatment due to side effects. The reimbursement approval was made based on the MATURE trial. The trial results showed that 95.1%/75.6%/43.9% of patients that received Cosentyx 30mg reached PASI 75/90/100 each, and demonstrated better efficacy over its placebo. In the case of Tremfya, the drug will be granted reimbursement for palmoplantar pustulosis from this month. Under the new reimbursement standards, the drug may be used with insurance benefits from June 1st in patients aged 18 and older with moderate-to-severe palmoplantar pustulosis, ▲whose PPPASI is 12 or higher and has shown no response to therapeutic doses of acitretin, methotrexate, or cyclosporin when administered for more than 3 months or cannot continue treatment due to side effects, or ▲who has shown no response to phototherapy when treated for more than 3 months or cannot continue treatment due to side effects. Palmoplantar pustulosis is characterized by pustular blisters accompanied by erythema on the skin of the palms and soles that turn into brown scales, and then become dry, thick, and cracked. When the condition persists, the patient’s nails may be deformed and even fall out. The condition interferes with the patient's daily life because the condition causes severe itching and pain. As it is difficult to distinguish palmoplantar pustulosis from other skin diseases such as fungal infections, accurate differential analysis between the two is necessary. Cosentyx 300mg was approved on November 1st, 2022 to treat ▲plaque psoriasis patients and ▲psoriatic arthritis (PsA) patients who have accompanying moderate-to-severe plaque psoriasis or have not adequately responded to an anti-TNAα treatment before. Meanwhile, Tremfya was approved as a treatment for adult patients with plague psoriasis in April 2018 and as a treatment for adult patients with palmoplantar pustulosis in May 2019, and the indications applied for insurance benefit in September 2018 and May 2021 respectively.
- Opinion
- [Reporter’s View]Rise of adjuvant therapies amid concerns
- by Eo, Yun-Ho Jun 05, 2023 05:37am
- Although it may not be the same, the concept of administering a drug for ‘prevention’ has been around for a while. Patients who have chronic diseases have been taking drugs to ‘manage’ their condition rather than treat it. Also, some drugs just exist to prevent a condition, like anticoagulants. The same has just recently been applied to anticancer drugs. Companies have been acquiring or seeking indications as adjuvant or neo-adjuvant therapy for early-stage disease with their various new anticancer drugs through various research. Even at the 'American Society of Clinical Oncology 2023 Annual Meeting’ that is being held in Chicago, USA, adjuvant therapy research data are pouring in for 'Keytruda (pembrolizumab)', 'Kisqali ( ribociclib)', 'Herceptin (trastuzumab)' and others. However, concerns have followed the uprise of adjuvant therapy, with the biggest burden being financial. As everyone knows, even after being cured, cancer can frightfully recur. Depending on the type of cancer, some cancers have a recurrence rate that nears 80%. In the current era of high-priced pharmaceuticals, prescribing anticancer drugs that are leading the high-priced trend as adjuvant therapy and granting insurance reimbursement would naturally pose a burden for the health authorities. Another fact is that the benefits of adjuvant therapy are also receiving attention from the academic world. Already, adjuvant therapy has begun to be listed in the guidelines of world-renowned academic societies, with higher and higher grades of recommendation. So this is now the time for all those involved to ponder. Carefully examine the necessity of adjuvant anticancer therapy for each drug, and weigh the practical benefits rather than the indistinct and vague worry about its 'burden.' Treating patients with recurrent cancer may be less cost-effective. Recurrence and metastasis are fatal factors that increase cancer mortality. Since there is no right answer, we have to weigh the good and the bad. It is not possible to leave the piling number of applications for drugs to be used as adjuvant or maintenance therapies unattended. It is not just about the profits and losses. The stakeholders should also consider the specificity of each drug and the patient's situation and find consensus that takes into account Korea’s unique health insurance system and the pharmaceutical industry’s ecosystem.
- Policy
- The method of revaluation of wages that Godex has changed
- by Lee, Tak-Sun Jun 05, 2023 05:36am
- It is noteworthy whether HIRA will act as a variable by changing the evaluation method starting with the re-evaluation of benefit adequacy this year. The improved evaluation method is to increase the objectivity of the social demand part, which is the third evaluation item. Accordingly, in the case of drugs whose clinical usefulness is unclear but whose cost-effectiveness has been recognized, the evaluation of social needs is expected to be evaluated in more detail. The Ministry of Health and Welfare announced on the 30th of last month that the Health Insurance Policy Deliberation Committee deliberated on ways to partially improve the 2024 benefit adequacy re-evaluation target and benefit adequacy re-evaluation method. The proposal to improve the re-evaluation of benefit adequacy reported to this committee was prepared at a meeting held in December of last year to reinforce the method of evaluating social needs. The beginning was because of the Godex capsule. Although the clinical usefulness of Godex Capsule was unclear in the re-evaluation of reimbursement adequacy last year, the cost-effectiveness was recognized due to the drug price cut, and the benefit was finally maintained. In response, the members of the relevant committee raised an issue, and after re-submitting the agenda, the deliberation was finalized. At the same time, it was requested to strengthen the evaluation method such as social demand. The HIRA prepared and reported an improvement plan by reflecting only the part of the evaluation method requested by the committee in the 'review of drug benefit adequacy rationalization plan', which ended in March. In the improvement plan, the terms of the clinical usefulness item were changed to specify the purpose of the evaluation contents, and the quality level was considered in addition to the literature ratio that recognized the effect when evaluating clinical effectiveness. Accordingly, it was decided to judge that it is clinically useful only when it is evaluated above 'some' in terms of medical recommendation and clinical effectiveness. In addition, the social demand item is greatly improved. It will be specified in three evaluation items, including medical factors, and will be evaluated in a score method by determining details. Afterward, the scores were summed up and the final evaluation was decided by a committee composed of 11 members. In the meantime, social demand items have not been evaluated with points, but have been assessed by reviewing society's opinion collection, civic and patient group opinion submissions, financial impact through calculation of financial impact, medical importance, age, and patient's economic burden. In order to maintain benefits, it is possible if it is judged to be primarily clinically helpful or if the clinical usefulness is unclear, but cost-effective and social demand is high. In the revised plan, the conditions for maintaining reimbursement for drugs with unclear clinical usefulness are expected to become much more stringent. In particular, as this improvement plan is decided to be applied for re-evaluation this year, it is expected to affect drugs whose clinical usefulness is unclear. A total of six ingredients are in the process of being re-evaluated this year. Rebamipide, Limaprost Alfadex, Loxoprofen Sodium, Levosulpiride, Epinastine, and Sodium Hyaluronate eye drops will likely have mixed results for pharmaceutical companies.
- Company
- Forxiga will maintain its price for 10 months in KOR
- by Jung, Sae-Im Jun 02, 2023 05:38am
- The prices of AstraZeneca’s SGLT-2 inhibitor ‘Forxiga (dapagliflozin)’ and combination drug ‘Xigduo’ will stay as is until February next year. On the 1st, the Seoul Administrative Court’s 1st Administrative Division accepted the suspension of execution filed by AstraZeneca against the Ministry of Health and Welfare to cancel the drug price cut disposition for Forxiga and Xigduo. With the court’s ruling, Forxiga and Xigduo will be able to maintain their price until February 29, 2024. The litigation date for the merits of the lawsuit has not been set yet. The SGLT-2 inhibitors Forxiga and Xigduo are blockbuster diabetes treatments that contain dapagliflozin which has been raising KRW 90 billion in outpatient prescriptions a year. The two products were subject to price cuts due to the entry of many dapagliflozin generics in April. With the listing of their generics, the government had announced that it will make an ex officio adjustment to the prices of Forxiga and Xigduo, reducing it by 30% as of May 1st. In objection, AstraZeneca filed an administrative lawsuit and at the same time applied for suspension of execution. As Forxiga and Xigduo also have indications for chronic heart failure and chronic kidney disease that for which the patent had not expired yet, the company argued that the listing of generics that only have the diabetes indication cannot serve as a basis for lowering the price of the original drug. The company also claimed that the damages incurred from the non-acceptance of the suspension of execution will be irrecoverable. In April, the court temporarily suspended the enforcement of drug price cuts for the two products and extended the stay of execution by 2 more after examining the suspension of execution on the 16th, until a decision was made on whether to accept the claim. As the court ruled to suspend execution on the 1st, AstraZeneca Korea will now able to continue its main lawsuit while maintaining the current price for Forxiga and Xigduo. During the 10-month term the suspension of execution is applied, AstraZeneca Korea will be able to prevent a loss of about KRW 23 billion (based on UBIST) that could have risen due to drug price cuts. If the main lawsuit is not ruled upon by February 29, 2024, the suspension of the execution period may also be extended further.
- Company
- BMS and Gilead compete tightly in HBV drug market in KOR
- by Nho, Byung Chul Jun 02, 2023 05:38am
- BMS’s Baraclude and Gilead Science’s Viread are fiercely competing in the KRW 200 billion original hepatitis B treatment market. Based on drug distribution results, sales of Baraclude and Viread, the No.1 and No.2 products in the HBV market in 2022, were tallied at KRW 69.5 billion and KRW 62.8 billion, respectively. Just last year, Baraclude’s sales slightly surpassed that of Viread, however, in 2018, 2019, and 2021, Viread (KRW 116.7 billion, KRW 83 billion, KRW 63.1 billion) posted higher sales than Baraclude (KRW 70 billion, KRW 69.8 billion, KRW 62.1 billion). However, Gilead Sciences' steep rise in sales of its total corporate product lineup of HBV products is noteworthy. The company also owns Vemlidy, which posted sales of KRW 34.9 billion last year. When combining sales of Viread and Vemlidy, the two drugs occupy 55.9% of the total market share with KRW 97.7 billion, far ahead of Baraclude’s 39.8%. The 4th to 8th in line, GSK’s Zeffix, Ildong Pharamceutical’s Besivo, GSK’s Hepsera, Novartis’s Sebivo, and Bukwang Pharmacuetical’s Levovir made sales of KRW 3 billion, KRW 1.7 billion, KRW 1 billion, KRW 1 billion, and KRW 600 million, respectively, occupying 0.4% to 1.8% share of the market. Sales performance of all of the lower-ranking product groups, excluding Besivo, had been on a range-bound downward slope for the past 5 years. Sales of Besivo, a new homegrown drug introduced in Korea, on the other hand, have been growing steadily. In 2018, 2019, 2020, 2021, and 2022, the drug sold KRW 400 million, KRW 900 million, KRW 1.2 billion, KRW 1.5 billion, and KRW 1.7 billion, and is expected to settle as a new growth engine for Ildong Pharmaceutical in the future. Meanwhile, Baraclude (entecavir) 1mg and 0.5mg is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults (aged 16 or older) and pediatric patients aged 2 years or older with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis. Viread and Vemlidy Tab (tenofovir disoproxil fumarate) are indicated for the ‘treatment of chronic hepatitis B and HIV 1 infection in adults and pediatric patients 12 years or older,’ and ‘treatment of chronic hepatitis B in adults,’ respectively. Zeffix (lamivudine), Besivo (Besifovir dipivoxil), Hepsera (adefovir dipivoxil), Sebivo (telbivudine), and Levovir (clevudine) are indicated for the treatment of chronic hepatitis B infection. Baraclude is a guanosine nucleoside analog with specific activity against HBV DNA polymerase that inhibits the synthesis of the HBV DNA positive strand. It has demonstrated a long-term treatment effect and safety with a high virus suppression effect and low resistance. Viread’s mechanism of action is similar to adefovir, a nucleotide analog, but has a much stronger antiviral effect, and has achieved 0% resistance until recently. Vemlidy is an HBV treatment that Gilead released as an upgraded version of ‘Viread (tenofovir).’ It contains the same active ingredient, tenofovir, but comes in a 1/10 dose, demonstrating improved safety with comparable efficacy to the existing product. Meanwhile, GSK’s adefovir dipiboxil hepatitis B treatment Hepsera Tab., which currently maintains an insurance listed price of KRW 3,839, is set to be deleted from the reimbursement list on August 1st, and expected to be withdrawn from the Korean market then.
- Company
- K-Pharma Bio ASCO launch table
- by Hwang, Jin-joon Jun 01, 2023 05:43am
- Pipeline clinical results of major domestic pharmaceutical bio companies such as Yuhan Corp. were disclosed at ASCO. According to the industry on the 31st, the abstract of a paper scheduled to be presented at ASCO, which will be held in Chicago, USA from June 2nd to 6th (local time), was recently released. ASCO is a major international academic conference that celebrates its 59th this year. About 400 biopharmaceutical companies from all over the world participate every year. There are more than 2,900 paper abstracts published this year. Most of the research results are made public in the form of posters. At this ASCO, Yuhan Corp. and GC Cell's US affiliates Artiva, Genexine, AbClon, and Abion disclosed research results of major pipelines under development. Four studies related to Yuhan Corporation's third-generation lung cancer drug Lazertinib were announced. Lazertinib is an oral third-generation EGFR tyrosine kinase inhibitor (TKI) drug with high selectivity for EGFR T790M-resistant mutations. Some details of clinical trials using Amivantama and Lazertinib in combination with EGFR mutation advanced non-small cell lung cancer (NSCLC) with no treatment experience were disclosed. These are the results of circulating tumor nucleic acid (ctNDA) liquid biopsy using plasma samples and long-term follow-up of 20 patients as of November 15 last year. Median follow-up and treatment periods were 33.6 and 33.5 months, respectively. In terms of efficacy, PFS and OS could not be estimated. At 12 months, 85% (n = 17) of the patients showed the expected PFS. At 24 months and 36 months, it was 65% (13 people) and 51% (10 people), respectively. 50% of patients are continuing treatment with PFS. In phase 2 clinical trial for NSCLC patients with brain metastasis, Lazertinib showed an intracranial objective response (iORR) in 22 out of 38 patients. Treatment-related side effects were identified in 85% (n = 27) of patients. The most common side effects were skin rash and paresthesia. Grade 3 or higher adverse events were reported in 10% (3 patients). Grade 3 or higher side effects are side effects that could potentially endanger the patient's life if not treated. Professor Min-hee Hong of Yonsei Cancer Center explained, "This study means that using Lazertinib instead of topical treatment can be a potential treatment strategy for NSCLC patients with brain metastases." The results of a study to identify biomarkers for the treatment of Amivantamab and Lazertinib in a tumor environment after administration of Osimertinib, a major third-generation lung cancer drug, were also disclosed. "The MET mutation identified by tissue immunohistochemical analysis (IHC) can be a predictive biomarker for the response to Amivantamab/Lazertinib administration after Osimertinib administration," said Professor Benjamin Besse and others at the Gustave Roussy Cancer Center in France. Analysis using tumor nucleic acid (ctDNA) did not identify some groups." Clinical results were also announced comparing the incidence of venous thromboembolism (VTE) side effects in EGFR mutant NSCLC patients with the combined administration of Amivantamab and Lasertinib and single administration of each drug. VTE is one of the common side effects of lung cancer patients. In a study of 540 patients, the incidence of VTE was higher with combination therapy than with each monotherapy. Artiva, a US affiliate of GC Cell, announced the first human administration data for 'AB-101', a CAR-NK cell therapy. These are the results of a phase 1/2 clinical trial of monotherapy of AB-101 and the combination of AB-101 and the anticancer drug 'Rituximab (product name: Rituxan)' in patients with relapsed/refractory B-cell non-Hodgkin's lymphoma. AB-101 responded in 3 out of 4 patients who had previously failed CD19-targeted CAR-T treatment. In the AB-101 monotherapy group, ORR was 27% (3/11 patients). Genexine disclosed the results of phase 2 clinical trial led by head and neck cancer researchers on the triple combination therapy of 'GX-188E', a DNA vaccine for the treatment of cervical cancer, 'GX-I7', and 'Keytruda', candidates for immuno-anticancer drugs for lymphopenia. This clinical trial was led by Professor Kim Hye-ryeon of the Department of Oncology at Severance Hospital. The study was conducted on 11 patients with head and neck cancer who were about to undergo surgery. After surgery, 63.6% (7 patients) showed MPR and 36.3% (4 patients) showed pCR. AbClon disclosed the efficacy and safety of the CAR-T treatment 'AT101' confirmed in phase 1 clinical trial. In this phase 1 of 18 patients with relapsed or refractory B-cell non-Hodgkin's lymphoma, an ORR of 66.7% (4/6 patients) was confirmed in subject group 1. AT101 showed an ORR of 100% (3/3 patients) in phase 1 clinical trial subject group 2. There was no cytokine release syndrome of grade 3 or higher in each subject group. Abion presented the results of the pilot expansion cohort analysis of NSCLC's new drug candidate 'ABN401'. The pilot expansion cohort is a clinical trial designed to predict the direction of phase 2 clinical trial after the phase 1 clinical trial. Patients with c-MET mutation NSCLC were selected and administered the same dose of ABN401 as in the ongoing phase 2 clinical trial. Through data analysis, the efficacy, safety, and tolerability of ABN401 were confirmed. No adverse events of grade 3 or higher were observed.
