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- 2026-04-08 22:18:31
- Company
- AZ will withdraw its KRW 50 bil Forxiga from KOR mkt
- by Kim, Jin-Gu Dec 12, 2023 05:38am
- Forxiga (dapagliflozin), an SGLT-2 inhibitor class diabetes drug worth KRW 50 billion a year, will withdraw from the domestic market. According to industry sources on the 11th, AstraZeneca Korea recently made the decision to discontinue supply of Forxiga in Korea. However, the company will continue to supply its dapagliflozin and metformin combination drug Xigduo in Korea. An official from AstraZeneca told Dailypharm, "We have decided to discontinue the domestic supply of Forxiga in Korea to reorganize our portfolio. We have started discussions with the Ministry of Food and Drug Safety regarding withdrawing our marketing authorization. We will do our best to ensure that there is no interruption in domestic supply before withdrawing the drug in the first half of next year." The decision to discontinue the supply is deemed to have been made upon the expiration of Forxiga’s patent. Forxiga’s substance patent expired in April. Since then, a total of 60 companies have launched generic versions of Forxiga simultaneously, heralding fierce competition. Forxiga’s prescription performance has been declining ever since the launch of its generics. According to market research institution UBIST, Forxiga’s outpatient prescriptions in Q3 totaled at KRW 13.7 billion, up 4% YoY. However, this is the second consecutive quarter the drug saw a decline in sales from the KRW 14.5 billion it had posted in Q1 this year, just before its patent expiry. This is likely due to the increased competition following the release of the large number of generics. In fact, Forxiga’s generics generated prescription sales of KRW 5.9 billion in Q2 and KRW 10.6 billion in Q3. The generic's share of the dapagliflozin diabetes drug market has increased to 30% within 6 months of its launch. Quarterly prescriptions of Forxiga andn Xigduo Forxiga’s full withdrawal is expected to create a void worth KRW 50 billion in the diabetes treatment market. And this void is expected to be filled by Forxiga genetics and generics of another SGLT-2 inhibitor, Jardiance (empagliflozin). Also, generic competition is expected to intensify in the process. Forxiga was previously copromoted in Korea by Daewoong Pharmaceutical. Daewoong plans to fill the Forxiga gap with based on its SGLT-2 inhibitor diabetes drug, Envlo (enavogliflozin).
- Policy
- MOHW agrees to review current prior authorization system
- by Lee, Jeong-Hwan Dec 12, 2023 05:38am
- Director Chang-hyun Oh Medical professionals are raising concerns about significant disparities in approval rates of the 'rare diseases drug prior authorization system,' which differ by patients and by diseases, and the ambiguity of the criteria. The government appears to be failing to provide a direction for system improvement and address these concerns. However, the government also agreed that significant disparities do exsit in the approval rates of prior authorization by diseases and by medical institutions. Thus, it has expressed plans to improve the approval rate through case-by-case feedback. On 11th, Oh Chang-hyun, Director of Pharmaceutical Benefits at the Ministry of Health and Welfare, spoke at the National Assembly roundtable discussion for the institutional improvement of the rare disease drug prior authorization system, saying, “We’re considering various systemic improvements to enhance patient access to high-cost drugs, and investigating why approval rates vary for the same drug in different diseases." The low approval rate of Soliris (eculizumab) for aHUS (atypical hemolytic uremic syndrome) sparked this issue of disparity in the reimbursement approval rate following prior authorization review. aHUS is a severe genetic rare disease. Up to 79% of patients die, require dialysis or experience permanent renal damage within 3 years of diagnosis. The prior authorization system allows reimbursement eligibility decisions to be made for each individual patient prior to treatment so that high-priced rare diseases treatments can be provided to patients in need. Individual cases are determined by an expert prior authorization subcommittee. The review started in 1992 and was expanded to include medications in 2007. The approval rate for Soliris, a treatment for aHUS (atypical hemolytic uremic syndrome), is currently below 30%. In contrast, the approval rate for the same drug for Paroxysmal Nocturnal Hemoglobinuria (PNH) is around 90%. Medical professionals and patients have consistently raised concerns that the disparities in prior authorization rates for the same medication by different diseases and by medical institutions, are causing difficulties in patient treatment. In response, Shin Hyun-Young, a member of the Democratic Party of Korea, hosted a symposium to discuss improvements to the prior authorization system, gathering opinions from government agencies and experts. Oh Chang-hyun, Director of Pharmaceutical Benefits at Ministry of Health and Welfare, who attended the symposium said that he is aware of the concern regarding the disparity in pre-approval rates, and is committed to finding solutions to the issue. Director Oh revealed that out of the 18 new drugs approved this year (2023), only two are subject to the prior authorization system. He explained, "The decision was not due to financial reasons, but because of the high cost, uncertainties, and misuse concerns. The Health Insurance Review and Assessment Service (HIRA) is working on an improvement plan." "The prior authorization rate for most drugs is above 80%, but in the case of Soliris, its approval rate last year for PNH was 90.7%, while being below 50% for aHUS," said Director Oh, adding, “There is a need to scrutinize why there are disparities in approval rates by different diseases and to strictly enforce compliance requirements for medical institutions seeking approval.” Director Oh stated, “Approval rates would improve if we conduct a statistical analysis on the reasons behind the many rejections that were made, and providing this feedback to individual medical institutions and doctors." Oh stressed, “The reliability of the data will go up during the process, and the Ministry is considering transitioning drugs with a long-term stable approval rate from prior approval to post approval.” Likewise, the MOHW acknowledged the problem regarding disparities in the prior authorization system rates, but hadn't yet established a specific and finalized improvement plan. However, improvements are expected soon, as the Ministry is working to address the issue quickly in collaboration with HIRA. Panelist Choi Seungwon, Director of Doctors News, suggested that the MOHW should create and reinforce a channel for clear communication and discussion with medical professionals and patients about the reasons for rejections. Director Choi said, “Patients should not suffer due to systemic uncertainties. The prior authorization system should be based on the principle that it’s better that nine guilty ones escape, rather than let one innocent suffer,” he stressed, “It’s the doctor’s duty to their patients to provide an explanation. The government should be able to explain how it will communicate its decisions in cases where medical professionals and patients find rejection decisions unacceptable." "A system that specifies which person and method of inquiry should be used to inquire about the government’s disapproval decision, is necessary and must be included as part of the prior authorization system," said Director Choi Seungwon, adding, “We ask Director Oh to preprare this."
- Company
- Reimb at a halt for one-shot IRD drug Luxturna
- by Eo, Yun-Ho Dec 12, 2023 05:38am
- Reimbursement discussions for the one-shot retinal disease treatment Luxturna is being delayed in Korea. According to Dailypharm coverage, Novartis Korea failed to reach an agreement with the National Health Insurance Service on the drug price of uxturna (voretigene neparvovec) for inherited retinal dystrophy (IRD) within the 60-day deadline and will enter into extended negotiations. This suggests that the two parties involved (government-pharmaceutical company) were unable to reach an opinion regarding finances for the drug. Although the company had applied for reimbursement of the drug in September 2021, no progress had been made on its listing for a while and was finally presented as an agenda for deliberation by HIRA’s Drug Reimbursement Evaluation Committee in March this year. However, the drug failed to pass DREC review and receive reimbursement standards at the time. The company supplemented and reapplied for the drug’s reimbursement thereafter, thanks to which the company was able to start reimbursement negotiations. As disagreements over the terms of the risk-sharing agreement (RSA), including the refund rate, had previously stalled DREC deliberations, this may have played a role in stalling the pricing negotiations between NHIS and Novartis Korea as well. An official from Novartis said, “Luxturna is the only treatment option available for patients with IRD. As both the company and the government are well aware of this, we will do our best to overcome our differences within the extended negotiation period." Meanwhile, the efficacy of Luxturna was demonstrated through a Phase III trial that was conducted on IRD patients with confirmed biallelic RPE65 mutations. Study results showed that the group of patients that received Luxturna demonstrated statistically significant improvements in their functional vision compared to the control group at one year of treatment. Using the mean score of the multi-luminance mobility test (MLMT), which evaluates the ability to complete the obstacle course at low light levels by recreating the daily walking environment, as the primary endpoint at one year of treatment, the MLMT score change in the Luxturna treatment group was 1.8 points, 1.6 points higher than the 0.2 points in the control group.
- Policy
- Roche’s DLBCL treatment Columvi approved in Korea
- by Lee, Hye-Kyung Dec 11, 2023 05:02am
- Commissioner Oh Yu-Kyoung of the Ministry of Food and Drug Safety (MFDS) announced on the 7th that MFDS has approved Roche Korea's rare disease drug 'Columvi (glofitamab)' for the treatment of diffuse large B cell lymphoma (DLBCL). The drug is a CD20/CD3 bispecific monoclonal antibody that binds to CD3 on the surface of T cells and CD20 on B cells. Columvi provides a new treatment opportunity for DLBCL patients who had relapsed or were refractory after two or more lines of systemic therapies. Columvi (Glofitamab) binds to the CD3 and activates the T cells, it simultaneously binds to CD20, to redirecting B cells closer to activated T cells and inducing cytosis. The MFDS stated that based on their regulatory science expertise, they will continue to promptly supply treatments that have proven safety and effectiveness.
- Policy
- Pfizer conducts trial for its RSV drug sisunatovir in KOR
- by Lee, Hye-Kyung Dec 11, 2023 05:02am
- Pfizer will be conducting a clinical trial for its Respiratory Syncytial Virus (RSV) treatment PF-07923568 (sisunatovir) on infants and children in Korea. On the 7th, the Ministry of Food and Drug Safety approved Pfizer Korea's ‘Interventional, phase 1B, randomized, double-blinded, sponsor-open, placebo-controlled, multicenter, dose-finding study to evaluate the safety, tolerability, and pharmacokinetics of sisunatovir in pediatric participants up to 60 months of age with respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI).’ The study will be conducted at Seoul National University Bundang Hospital, Severance Hospital, Seoul National University Hospital, and Korea University Anam Hospital. As a type of common cold, RSV is an acute respiratory infection caused by the infection of the respiratory syncytial virus. It is highly contagious, affecting nearly all children by the age of 2. Most children and adults recover within a week or two without treatment, but it requires attention as it can progress to severe cases in high-risk groups such as infants, those immunocompromised, and the elderly. According to the U.S. Centers for Disease Control and Prevention, RSV causes up to 120,000 hospitalizations and up to 10,000 deaths in the U.S. each year among those aged 65 and older. Currently, AstraZeneca's ‘Synagis’ is the only licensed antibody preventive treatment for RSV that can be administered to pediatric patients. Pfizer acquired sisunatovir, a novel candidate substance for RSV when it acquired the UK-based antiviral drug developer ReViral last year. Pfizer paid up to $525 million to ReViral, including an upfront payment and future development milestone payments. Pfizer expects ReViral’s programs to generate annual sales of $1.5 billion or more. Meanwhile, other large multinational pharmaceutical companies have also jumped into the RSV prophylaxis game, and are making tangible results. Just this year, the US FDA approved GSK’s ‘Arexvy,’ Pfizer’s ‘Abrysvo,’ and AstraZeneca and Sanofi’s pediatric RSV treatment ‘Beyfortus.’ In Korea, companies such as SK Bioscience and EUGiologics have been working to develop RSV vaccines.
- Company
- Taked’a new CMV drug Livtencity passes DREC review in 1 yr
- by Eo, Yun-Ho Dec 11, 2023 05:02am
- The reimbursement adequacy evaluation for the cytomegalovirus (CMV) treatment ‘Livtencity’ has been completed in 1 year since the drug received approval in Korea. According to industry sources, Takeda Pharmaceuticals Korea submitted its reimbursement application for Liventity (maribavir) in Q3, and the agenda has passed the review of the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee on the 7th of this month. Therefore, the company will now proceed to drug pricing negotiations with the NHIS if the Ministry of Health and Welfare gives the negotiation order. Whether negotiations will be successful, and a new treatment option will be introduced and rise as an alternative for patients who are resistant to existing drugs, remains to be seen. CMV is a type of herpes virus that's extremely common worldwide. Over 60% of all adults are infected with CMV within their lifetime and typically develops in patients who use immunosuppressants after hematopoietic stem cell transplantation (HSCT). Around 30-70% of HSCT patients experience CMV viremia. In HSCT patients, CMV causes multisystemic diseases such as pneumonia, hepatitis, gastroenteritis, retinitis, and encephalitis. Among these, pneumonia’s mortality rate is near 60%. Because CMV in immunocompromised patients is fatal, patients had generally received preemptive treatment mainly with ganciclovir, valganciclovir, foscarnet, and cidofovir, and hospitalization had been essential. Additionally, because these drugs have similar mechanisms of action, if resistance to one drug develops, likely, that the patient will not respond to other treatments as well. However, the introduction of Livtencity brings hope to these patients for secondary treatment. Livtencity has almost no side effects compared to existing drugs and offers an alternative if resistance to the existing treatments develops. Livtencity’s antiviral activity inhibits CMV multiplication and migration through a differentiated multi-modal mechanism of action that inhibits the protein kinase of the HCMV enzyme UL97. It not only inhibits DNA from coming out of cells, but also interferes with viral DNA replication, encapsidation, and nuclear egress. Meanwhile, Livtencity was first approved in November 2021 by the US FDA as the first treatment for patients with post-transplant CMV infection/disease and was approved in Korea in December last year. Also, Livtencity has passed the Drug Committees (DCs) of tertiary hospitals in Korea including Samsung Medical Center, Saint Mary's Hospital, Asan Medical Center, and Sinchon Severance Hospital, as well as other medical institutions such as the Kyungpook National University Hospital, Jeonbuk National University Hospital, and Chonnam National University Hwasun Hospital.
- Company
- Trulicity sales fall 30%...affected by supply shortage
- by Kim, Jin-Gu Dec 11, 2023 05:02am
- Sales of the GLP-1 receptor antagonist class treatment Trulicity had fallen 30% in 1 year. This is estimated to have been due to the prolonged domestic supply disruptions. Major insulin products that experienced sporadic supply shortages have experienced a sharp decrease in sales. In the case of Xultophy, its sales, which had surged to KRW 4.8 billion in Q2 fell to KRW 3.1 billion in Q3. In the case of Soliqua, its sales, which had remained at the KRW 2 billion level, sur soared to KRW 4 billion in Q3. On the other hand, the two other insulins that have been experiencing shortages – Tresiba and Ryzodeg - saw stable sales in Q3 this year. Trulicity posts record high sales in Q2→sales drop in Q3 due to prolonged supply disruption Pic of TrulicityAccording to the market research institution IQVIA on the 11th, Eli Lilly’s Trulicity’s sales in Q3 were KRW 11 billion. This is a 30% drop from the KRW 15.8 billion it posted in Q3 last year. Trulicity is a GLP-1 receptor antagonist class diabetes drug. GLP-1 analogs are developed using the hormone glucagon-like peptide-1 (GLP-1), which is involved in the regulation of blood sugar in the body. GLP-1 hormone stimulates insulin secretion immediately after a meal to lower blood sugar and reduces insulin secretion when blood sugar falls below a certain level to help prevent hypoglycemia. The drug’s performance this quarter is in stark contrast to last quarter's record quarterly revenue. Trulicity's revenue had been growing rapidly until Q2 this year. It crossed the KRW 15 billion mark for the first time in Q3 last year and soared to USD 18 billion in Q2 this year. However, sales fell sharply in Q3. The industry analysis is that its performance is finally experiencing the aftermath of the domestic supply disruption that has been in full swing since Q3, which led to a sharp drop in sales. Trulicity's supply issues began to surface in Q2 this year. In late June, Lilly notified its sales and marketing partner, Boryung, of its difficulties in supplying Trulicity 0.75mg/0.5ml in Korea. Quarterly sales of Trulicity (Unit: KRW 100 million Data: IQVIA) Then, the company started to have difficulties supplying the 1.5mg/0.5ml dosages as well. Initially, Lilly estimated that it would be able to resume domestic supply in mid-October, but in mid-October, the company pushed back the estimate to November. And this was only for the 1.5mg/0.5ml dose, with no exact timeline set still for the 0.75mg/0.5ml dosages. The industry expectation is that if the disruption continues beyond Q4, Trulicity's sales will decline further. Xultophy’s sales fall, Soliqua’s sales rise… Major insulin sales fluctuate due to shortages Sales of major insulin injections, which have been in short supply for most of the year, are also showing fluctuations in sales. In Korea, Novo Nordisk’s Tresiba, Ryzodeg, Xultophy, Sanofi-Aventis’s Xultophy, Tuojeo, and Lilly’s Humalog have been experiencing shortages one after another since Q2 this year. Sales of major products have fluctuated greatly in the process. For example, Xultophy’s sales plummeted from KRW 4.8 billion in Q2 this year to KRW 3.1 billion in Q3. In the case of Xultophy, its domestic supply began to be disrupted around August. Novo Nordisk initially predicted that it would be able to resume supply in September, but pushed back its prediction to November. On the other hand, Sanofi-Aventis' Soliqua saw a significant increase in sales in Q3. The company reported sales of KRW 4 billion in Q3, up 63% from KRW 2.4 billion in Q3 last year. Since Q2 2021, Soliqua has consistently generated sales of KRW 2 billion to 2.4 billion every quarter. However, in Q3 this year, the company first marked sales of KRW 4 billion with Soliqua since its launch in Korea. The industry analysis shows that the demand for Soliqua’s sales rose due to the unstable supply of other insulin products. Quarterly sales of major insulin products (Unit: KRW 100 million, Data: IQVIA) However, sales of products saw little change. Novo Nordisk's Tresiba, Ryzodeg, and Lilly's Humalog have been experiencing sporadic shortages, but on the surface, their sales have remained stable. Tresiba sold KRW 10.9 billion in Q3 this year, flat YoY. Tresiba has been consistently generating sales in the high KRW 10 billion to low KRW 11 billion range since Q3 last year, after posting sales of KRW 10.9 billion. In the case of Ryzodeg, the company recorded sales of KRW 8.8 billion in Q3 this year. This is a 4% increase from KRW 8.4 billion in Q3 last year. Humalog posted sales of KRW 5.2 billion in Q3. This is a 4% decrease compared to the KRW 5.4 billion it posted in Q3 last year The industry analyzed that Tresiba, Ryzodeg’s sales remained level due to the spread of the stock shortage issue in the market, which led to an increase in temporary demand for stockpiling.
- Company
- Double-dose Trelegy Ellipta in reimb process for asthma
- by Eo, Yun-Ho Dec 11, 2023 05:02am
- The double dose of Trelegy Ellipta, which was approved for asthma, not COPD, is making rapid progress for reimbursement listing in korea. According to the pharmaceutical industry, GSK Korea has recently started reimbursement pricing negotiations with the National Health Insurance Service for its Trelegy 200 Ellipta (fluticasone furoate ·umeclidinium ·vilanterol). On the 9th, Trelegy 200 Ellipta has successfully passed the Health Insurance Review and Assessment Service (HIRA)'s Drug Reimbursement Committee. Therefore, industry eyes are on whether Trelegy Ellipta's reimbursement would be expanded to asthma in addition to its COPD indication. Trelegy 200 Ellipta has demonstrated its efficacy through the Phase 3 CAPTAIN study, which compared Trelegy Ellipta and dual combination therapy FF/VI(fluticasone furoate / vilanterol) in 2436 adult asthma patients who are age 18 and over and whose asthma is uncontrolled despite treatment with dual combined therapy ICS/LABA. As the primary endpoint, each cohort’s Forced Expiratory Volume in 1 second (FEV1) changes at Week 24 were evaluated. The results demonstrated statistical significance as the Trelegy Ellipta treated cohort showed 110mL improvement in FEV1 compared with the FF/VI treated cohort. The safety profile of Trelegy Ellipta for asthma treatment in the CAPTAIN study was also consistent with the known profile of the individual drug components and their combinations. The common side effects were nasopharyngitis v(13-15%), headache (5-9%), upper respiratory tract infection (3-6%), and the adverse reactions were comparable in all treatment cohorts. Trelegy Ellipta was the first triple combination therapy for COPD to be approved in Korea in May 2018. Its specific indication for COPD is as a maintenance therapy for patients with moderate to severe cases that are inadequately controlled by a combination of a long-acting beta2-agonist (LABA) and an inhaled corticosteroid, or a LABA and a long-acting muscarinic antagonist (LAMA). Currently, patients who use Trelegy Ellipta are granted reimbursement when they meet one of the following three standards: ▲patients whose FEV1 values are less than 60% of the predicted normal value despite combination therapy with LABA and LAMA or those who have experienced acute exacerbations more than twice a year, ▲patients whose symptoms such as dyspnea are not adequately controlled despite combination therapy with LABA and inhaled corticosteroids, ▲patients receiving a combination of vilanterol trifenatate /fluticasone furoate inhaler, which has the same dosage as Trelegy Ellipta, and umeclidinium inhaler, as well as those on a combination of ICS/LABA and LAMA monotherapy with the same dosage as Trelegy, who wish to switch to Trelegy in compliance with its approved indications.
- Company
- Chong Kun Dang receives attention for its 'R&D potential'
- by Chon, Seung-Hyun Dec 08, 2023 05:28pm
- Chong Kun Dang Pharmaceutical (CKD Pharm) has reported over 10 billion won of its R&D costs as assets for the first time. The cost includes increased clinical trial costs for the commercialization of its biosimilars and incrementally modified drugs (IMD). The company has gained recognition for its R&D potential following a major technology export recently, which has drawn significant attention to its drug development pipeline. Chong Kun Dang Headquarters According to the Financial Supervisory Service (FSS) on 8th, the CKD’s development costs that were accounted for as intangible assets at the end of Q3 amounted to 11.6 billion won, up 2.3 billion won from 9.3 billion won reported at the end of the first half of the year, marking over 10 billion won for the first time. In 2019, the FSS issued a guideline that only R&D projects with technical feasibility such as new drugs could be accounted for as assets. FSS’s R&D cost capitalization guideline set was the initiation of Phase 3 clinical trials for new drugs and approval of Phase 1 clinical trials for biosimilars. As for generics, approval of bioequivalence test plans. CKD’s intangible R&D assets were only 3.8 billion won at the end of last year. This year, it has rose to 6.6 billion won, increasing by 2.8 billion won in Q1 and 2.8 billion and 2.2 billion won in Q2 and Q3, respectively. With its drug development pipeline nearing commercialization, more R&D costs were reported as assests. The company's combination drugs contribute to a big part of the CKD’s R&D costs recognized as intangible assets. As of the end of Q3, the hypertension combination drug CKD-828's clinical costs were capitalized at 3.2 billion won. The development costs of 2.6 billion won and 1.8 billion won, for the dyslipidemia combination drug CKD-391 and the diabetes combination drug CKD-371 were recognized as intangible assets, respectively. The biosimilar CKD-701, which is a biosimilar of the macular degeneration treatment Lucentis, has capitalized R&D costs of 600 million Korean won. CKD received approval from the Ministry of Food and Drug Safety in October last year for Lucent-BS, and launched it in Korea in January after receiving health insurance coverage. Lucent-BS is the second biosimilar released by CKD. In Nov. 2018, the company received domestic approval for Nesbell, a biosimilar to the anemia treatment NESP. CKD developed Nesbell after securing a differentiated raw material manufacturing technology in 2008 and establishing biopharmaceutical production infrastructure in 2012. The amount of R&D costs capitalized by CKD had not been extensive, but its drug pipeline has attracted attention following a recent major technology export deal. On the 6th of last month, CKD signed a technology export contract with Novartis for the drug candidate CKD-510. The deal includes a non-refundable upfront payment of US 80 million (106.1 billion won) dollars. CKD is set to receive milestone payments up to US 1.225 billion (1.6241 trillion won) dollars dependent on development and regulatory approvals. This was the first major technology export contract the company had signed that exceeded 100 billion won. CKD-510, which is a new drug candidate developed by CKD, is a highly selective non-hydroxamic acid (NHA) platform technology-based HDAC6 inhibitor. It has shown efficacy in preclinical studies for various HDAC6 related diseases, including cardiovascular diseases. It has demonstrated safety and tolerability in Phase 1 clinical trials in Europe and the USA. CKD has completed a European Phase 1 trial of CKD-510 for Charcot-Marie-Tooth disease (CMT). CMT is a rare hereditary peripheral neuropathy where genetic mutations lead to motor and sensory nerves damages, complicating normal walking and daily activities. There is currently no definitive cure for CMT. CKD’s strategy is to derive optimal drugs for various diseases based on the basic structure of HDAC6 inhibitors. Currently, CKD is developing new drugs, with a platform technology for CMT, Huntington's disease, Alzheimer's disease, blood cancer, and autoimmune diseases. Chong Kun Dang CKD is also developing a new bio-drug in the oncology field. CKD-702 is an anti-cancer bispecific antibody that inhibits both hepatocyte growth factor receptor (c-Met) and epidermal growth factor receptor (EGFR), which are essential for cancer growth. CKD-702 binds to each receptor to block cancer cell proliferation signals and decrease receptor numbers, making it a first-in-class bio new drug from CKD. A domestic Phase 1 clinical trial is currently underway. To verify the efficacy and mechanism of action of CKD-702, CKD conducted research on its use as monotherapy, using non-small cell lung cancer animal models. The study has shown that CKD-702 exhibits anti-tumor effects by simultaneously inhibiting the hepatocyte growth factor receptor and the epidermal growth factor receptor. It was also found to be highly effective in animal models that had developed resistance to existing c-Met and EGFR targeted cancer drugs. Currently, phase 1 trials evaluating its indications for non-small-cell lung cancer are underway, and there are plans to expand the indications to stomach cancer, colon cancer, and liver cancer for global clinical trials. CKD's new drug, CKD-508, which is being developed as dyslipidemia treatment, has been undergoing Phase 1 clinical trials in the UK since 2020. The drug is expected to lower LDL cholesterol and increase HDL cholesterol by inhibiting the CETP enzyme. It is regarded as the most effective CETP inhibitor developed to date, having improved upon the drawbacks of first-generation CETP inhibitors. CKD aims to complete the Phase 1 clinical trials within the year.
- Company
- Gardasil dominates HPV vaccine mkt in KOR
- by Kim, Jin-Gu Dec 08, 2023 05:55am
- The human papillomavirus (HPV) vaccines Gardasil and Gardasil 9 have established dominance in the cervical cancer vaccine market. As of Q3, their market share has reached 99.9%. Following the expanded vaccination age limit and increase in domestic supply price, the quarterly sales of these vaccines increased to 35.3 billion won. Gardasil 9’s sales may increase even further if President Yoon Suk Yeol include it into the National Immunization Program (NIP), as pledged. Q3 Gardasil and Gardasil 9 sales 35.3 bil…Market share of 99.9% According to clinical research firm IQVIA, the sales of MSD's Gardasil and Gardasil 9 in Q3 were 35.3 billion won, a 5% increase from 33.6 billion won in the same quarter last year. Gardasil and Gardasil 9 are vaccines for preventing HPV, which causes cervical cancer. Gardasil prevents four types of HPV, and Gardasil 9 prevents nine. Gardasil and Gardasil 9 were approved in 2007 and 2016, respectively. As the company's more recent vaccine, Gardasil 9, is leading the market. Its sales increased from 40.5 billion won in 2019 to 42.5 billion won in 2020, and to 72.6 billion won in 2021. Last year, it posted 117 billion won, and it has already accumulated 80.2 billion won in sales by Q3 this year, making it likely to surpass 100 billion won in sales for the second consecutive year. Gardasil also had shown good performance with sales of 20.6 billion won in 2019, 20.4 billion won in 2020, 21.3 billion won in 2021, and 26.7 billion won in 2022. During these periods, Gardasil and Gardasil 9 have overtaken the competing drug GSK’s Cervarix, and established a lead. As of the last quarter, their market share has reached 99.9%. Since Q4 2021, their share has exceeded 99.0% and has been getting closer to 100%. Cervarix managed to maintain quarterlsy sales of over 300 million won until Q4 of 2021, but this dropped to less than 100 million won from Q2 of last year. Since the Q4 of last year, its quarterly sales have shrunk further to below 50 million won. The pharmaceutical industry perceives it as discontinued sales-wise in the domestic market. With expanded vaccination age limit and increased supply price….NIP inclusion likely to increase sales The surge in the Gardasil and Gardasil 9 usage is attributed to the expansion of the vaccination age limit and increased supply price. As of July 2020, the vaccination age limit for Gardasil was extended from 9-26 years to 9-45 years. At the same time, the awareness that not only women but also men should be vaccinated has become widespread. MSD has consecutively raised the domestic supply price of Gardasil 9 in 2021 and 2022. The Gardasil 9 price, which was 106,300 won (excluding VAT) in 2021, increased to 122,245 won in April of the same year. In July of last year, it rose again to 132,636 won. The price increase over two years amounts to 25%. Inclusion of Gardasil 9 in the NIP is expected to significantly boost sales. President Yoon Suk Yeol, during his presidential candidacy, pledged to include Gardasil 9 to the NIP. As a follow-up, Korea Disease Control and Prevention Agency (KDCA) is currently reorderd research services for Gardasil 9. Previous research service had concluded that Gardasil 9 lacked cost-effectiveness. However, the KDCA has decided to conduct additional research to analyze the cost-benefit. The KDCA re-ordered the related research service in May. After obtaining results within this year, the KDCA plans to include Gardasil 9 in the NIP in Q1 next year. With Gardasil 9’s NIP inclusion, the supply price may decrease because of the bidding process. However, the widespread forecast is that the substantial increase in the number of vaccinated people will ultimately lead to related sales increase.
