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- 2026-05-03 21:03:14
- Policy
- Multiple myeloma drug Elrexfio receives conditional approval
- by Lee, Hye-Kyung Jun 17, 2024 05:46am
- The orphan drug ‘Elrexfio (elranatamab)' that is being imported by Pfizer Korea, has been approved subject to the submission of therapeutic confirmatory clinical trial data. Elrexfio is an orphan drug indicated as monotherapy to treat adult patients with relapsed or refractory multiple myeloma who have received three or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody Being a subcutaneously delivered B-cell maturation antigen (BCMA)-CD3-directed bispecific antibody (BsAb) immunotherapy, it owns the advantage of being able to be administered immediately compared to CAR-T cell therapy. After receiving accelerated approval from the U.S. FDA in August last year as a fifth-line therapy for multiple myeloma, the European EMA granted conditional approval in December of the same year. In Korea, the drug was approved on the 30th of last month, and according to the minutes of the Central Pharmaceutical Affairs Council meeting disclosed by the Ministry of Food and Drug Safety on the 12th, the approval was conditional, and the council requested the company to submit Phase III results after the approval. Results from the Phase II trial showed that 84% of 63 patients who received Elrexfio as a fourth-line treatment, including with the standard B-cell mature antigen therapy, maintained a response for up to 9 months. Of those who achieved a response, 72% maintained it for 15 months. By targeting B-cell maturation antigen (BCMA), which is found on multiple myeloma cancer cells, and CD3, which is found on immune T cells, Elrexfio Inj binds bispecifically to both cells, triggering an immune response that destroys multiple myeloma cancer cells. A CPAC member said, "Based on the safety, efficacy, and regulatory aspects of the submission, and considering its overseas approval status, it is reasonable to grant approval under the condition that the company submits the final results of a therapeutic confirmatory clinical trial.” Another member added, “Elrexfio monotherapy is already approved in the US and EU based on existing studies. The toxicity data reported in the literature is sufficient to support a conditional marketing authorization." Meanwhile, Elrexfio’s competitor is Janssen's ‘Tecvayli(talquetamab).’ In Korea, a Phase III trial comparing Talquetamab Plus Pomalidomide (Tal-P), Talquetamab Plus Teclistamab (Tal-Tec), and Elotuzumab, Pomalidomide, and Dexamethasone (EPd) or Pomalidomide, Bortezomib, and Dexamethasone(PVd) in Participants With Relapsed or Refractory Myeloma Who Have Received 1 to 4 Prior Lines of Therapy Including an Anti-CD38 Antibody and Lenalidomide’ was approved in November last year.
- Company
- Elafibranor receives orphan drug designation in Korea
- by Eo, Yun-Ho Jun 17, 2024 05:46am
- The biliary cholangitis drug 'elafibranor' has been designated as an orphan drug in Korea. The Ministry of Food and Drug Safety (MFDS) recently announced the designation through an announcement. Elafibranor, a dual peroxisome-activated peroxisome receptor alpha/delta (PPAR α,δ) agonist that is being developed by Ipsen, received accelerated approval from the U.S. FDA for the primary biliary cholangitis indication on Nov. 10. More specifically, the drug is indicated for the treatment of adult patients with primary biliary cholangitis who have had an inadequate response to ursodeoxycholic acid (UDCA) or who cannot tolerate UDCA monotherapy due to tolerability issues. The FDA’s accelerated approval is based on data from the Phase III ELATIVE trial, which did not demonstrate improved survival or prevention of liver function decline. Ipsen is currently conducting the ELFIDENCE trial, a confirmatory clinical trial. The results of this study will determine whether the authorities will maintain the authorization. The ELATIVE trial demonstrated that elafibranor is an effective second-line treatment for patients with PBC with favorable benefit and risk data. Meanwhile, at the European Association for the Study of the Liver (EASL) 2024 Annual Congress, 2 additional analyses from the Phase 3 ELATIVE study, which evaluated the safety and efficacy of elafibranor in 161 primary biliary cholangitis patients with inadequate response or intolerance to ursodeoxycholic acid (UDCA), were presented one after another. The presented results were from Week 72 analysis, which showed that 30 of 108 patients (28%) in the elafibranor arm and 13 of 53 patients (25%) in the placebo arm remained on treatment through Week 72. Among these patients, 70% achieved biochemical response in the elafibranor arm, whereas no patients achieved biochemical response in the placebo arm.
- Policy
- External reference pricing reevaluations are nearly ready
- by Lee, Tak-Sun Jun 17, 2024 05:46am
- The external reference pricing reevaluation system is expected to be soon launched by the Korean government. At the 9th meeting held on the 10th of this month, there were disagreements over the specific details, but no change had been made in the big picture. The health authorities are reportedly planning to finalize the discussions within this month. According to industry sources on the 14th, the health authorities are expected to hold another meeting with the pharmaceutical industry within the month and conclude the opinion-gathering process. At this pace, the reevaluations may begin as early as the second half of the year. An industry insider said, "I can't share specific details due to confidentiality, but the government seems to be firm in its intention to end the discussion within this month. A meeting will be held soon to coordinate the details, after which HIRA will start reviewing its initiation. The external reference pricing reevaluation involves adjusting the domestic insurance ceiling price of patent-expired same-ingredient drugs in comparison with the highest price in the A8 countries - Japan, France, Germany, Italy, Switzerland, the United Kingdom, and Canada. The government plans to conduct the re-evaluations by comparing the weighted average price excluding the highest and lowest prices among the A8 countries to the domestic ceiling price. The pharmaceutical industry is concerned that this method will result in large losses due to the large drug price cut rates. With the revaluations coming near, the industry has reportedly been proposing slightly more favorable options to the government. For example, in the case of combination drugs, the company requested that the total price of each single-agent drug be guaranteed even after the reevaluations. The government will divide drugs into 3 groups and reassess them every 3 years. The industry is predicting that high-costing drugs (those with a high claims amount) such as hypertension and digestive system drugs will be the first to be reevaluated.
- Policy
- CKD speeds up developing Duvie+Jardiance+metformin therapy
- by Lee, Hye-Kyung Jun 14, 2024 05:47am
- Photo of Chong Kun Dang Chong Kun Dang is conducting a clinical trial to develop a triple combination therapy, aiming to strengthen its competitiveness in the diabetes treatment market. On June 12th, the Ministry of Food and Drug Safety (MFDS) approved Chong Kun Dang’s application for a phase 1 trial for the “Evaluation of the Impact of Dietary Intake on Pharmacokinetic Profiles and Safety of CKD-383 in healthy adults.” CKD-383 is a triple combination therapy with CKD’s 'Duvie (lobeglitazone),' Boehringer Ingelheim Korea's 'Jardiance (empagliflozin),' and 'metformin,' which is used for the first-line treatment of type 2 diabetes. Chong Kun Dang has been conducting a phase 1 trial related to CKD-383 from February 2021 to develop a triple combination therapy. CKD-383 is under development with a combination of lobeglitazone 0.5 mg, empagliflozin 25 mg, and metformin 1000 mg. The company has completed a phase 1 trial, evaluating the safety and pharmacokinetic profiles of ▲CKD-501, D745, D150 combination therapy ▲CKD-501, D744, D150 combination therapy ▲CKD-501, D745, D150, D029 combination therapy, and ▲CKD-383 monotherapy and CKD-501, D745 ,D150 combination therapy in healthy adults. The ongoing phase 1 trial evaluates pharmacokinetics related to dietary intake, and its successful completion is anticipated to lead to approval. Chong Kun Dang has a line-up of 'Duvie,' the 20th Korea’s new drug, and 'Duvimet-S XR Tab,' a triple combination therapy containing lobeglitazone, metformin, and sitagliptin for the treatment of diabetes. Furthermore, the company has a completed line-up of various pharmaceuticals, including 'Duvie tab,' a lobeglitazone monotherapy, 'Duvimet XR Tab,' containing metformin plus lobeglitazone, 'Duvie S Tab,' containing sitagliptin plus lobeglitazone, and 'Exiglu M XR Tab,' containing dapagliflozin plus metformin. Since July, CKD acquired the license for 'Januvia' series from MSD Korea for exclusive marketing. According to the 'Korean Diabetes Fact Sheet (DFS 2022)' presented by the Korea Diabetes Association, the number of patients with diabetes who are over 30 years old has increased every year since 2018, recording 5,700,000 patients in 2020. Type 2 diabetes accounts for 90% of all diabetes patients. According to a medical market research firm UBIST, the market size for type 2 diabetes in Korea has seen a steady growth, with a sales of approximately KRW 1.5 trillion .
- Policy
- Yuhan’s NSCLC new drug earns approval for clinical trial
- by Lee, Hye-Kyung Jun 14, 2024 05:47am
- Yuhan Pharmaceutical receives approval to conduct a first-in-human phase ½ trial of YH42946. Yuhan Pharmaceutical has initiated the development of a new drug, 'YH42946,' a HER2 TKI, for the treatment of non-small cell lung cancer (NSCLC) in South Korea. On June 11th, the Ministry of Food and Drug Safety (MFDS) approved “A first-in-human 1/2 clinical trial to assess YH42946 treatment in patients with locally advanced or metastatic solid cancer harboring HER2 mutations and epidermal growth factor receptor (EGFR) exon 20 insertion mutations.” The clinical trial will be conducted in Severance Hospital. Yuhan Pharmaceutical has acquired new drug pipeline technology involving YH42946, which was at the preclinical stage, from J INTS BIO. Before receiving approval for a clinical trial in South Korea, the company received approval to conduct a phase ½ trial of YH42946 from the U.S. Food and Drug Administration (FDA) on May 30. YH42946 is a HER targeting TKI, and during a preclinical trial, it showed anti-tumor effects on exon 20 insertion commonly found in NSCLC and mutations in the HER 2 tyrosine kinase domain (TKD). Additionally, YH42946 has demonstrated anti-tumor effects on mutation subtypes found in major solid cancers, including breast cancer and colorectal cancer. As a result, the company is considering expanding its indication goal. NSCLC, which accounts for 85% of all lung cancer patients, is a cancer type with frequent occurrence of HER2 or EGFR mutation. Especially for NSCLC harboring HER2 exon 20 insertion mutations, there are unmet medical needs due to the lack of approved oral treatments. The upcoming study is a first-in-human phase ½ trial of YH42946. It will assess the safety, drug tolerance, pharmacokinetics, and anti-tumor activation following oral administration of YH42946 in patients with locally advanced or metastatic solid cancers harboring HER2 mutation and EGFR exon 20 insertion mutations.
- Company
- Pfizer immediately reapplies to extend reimb for Lorviqua
- by Eo, Yun-Ho Jun 14, 2024 05:47am
- Pfizer Korea has quickly reapplied for reimbursement of Lorviqua, its third-generation ALK anticancer drug whose reimbursement review process recently broke down at the drug pricing negotiation stage. According to Dailypharm’s coverage, Pfizer Korea submitted an application to expand insurance reimbursement for the ALK-positive non-small-cell lung cancer (NSCLC) treatment Lorviqua (lorlatinib) to the first-line treatment on the 12th. The drug's drug pricing negotiations with the National Health Insurance Service broke down in late May. It remains to be seen whether Lorviqua will be able to secure reimbursement in its second attempt and how quickly the discussions will move forward. In January, Pfizer submitted an application to convert the drug’s reimbursement status to general listing. At the time, its reimbursement expansion process was already underway, and given that Lorviqua has already undergone a pharmacoeconomic evaluation in the first-line setting and has completed the Health Insurance Review and Assessment Service review, the drug’s conversion to general reimbursement listing status is expected to be discussed in conjunction with the first-line reimbursement expansion Regardless of whether reimbursement is expanded or not, the pharmaceutical company’s will and the government’s flexible administration will be required to achieve a quick result. Lorviqua was specifically designed to penetrate the blood brain barrier (BBB). The drug’s high clinical value as a first-line treatment was recognized in the 5-year long-term follow-up results of the CROWN study that was presented at ASCO. Study results showed that Lorviqua reduced the risk of disease progression or death by 81% compared to crizotinib, with 60% of patients surviving without disease progression at 5 years. The risk of brain metastasis progression was reduced in 94% of patients, with only 4 of 114 Lorviqua-treated patients without brain metastases developing brain metastases. The reason the drug pricing negotiations broke down the last time is believed to be related to the ‘expenditure cap amount’ rather than 'drug price'. Lorviqua was granted pharmacoeconomic evaluation exemptions when it was first listed for reimbursement. PE exemption drugs are required to be reimbursed through the RSA Expenditure Cap type scheme. As such, a new cap amount would have been derived to account for the increased usage due to the expanded reimbursement during negotiations, which Pfizer was likely unable to accept. Press conference in front of the main gate of the National Assembly on the 13th
- Product
- 92 patient groups implore doctors to stop the strike
- by Kang Hye-Kyung Jun 14, 2024 05:46am
- “We strongly demand the doctors withdraw their resolutions to take a collective leave of absence and indefinite leave of absence as they threaten the patients' lives and health." Ninety-two patient advocacy organizations have called for the withdrawal of the medical community's collective strike that is set to start on the 18th. Ninety-two patient advocacy organizations, including the Severe Atopic Dermatitis Association, the Union of Korea Breast Cancer Patients, the Korean Alliance of Patients Organization, and the Korean Organization for Rare Diseases, held a press conference in front of the main gate of the National Assembly on the morning of the 13th to criticize the medical community's plans for a collective leave of absence. The PAGs said, "We are deeply concerned about the Korean Medical Association's collective leave of absence and the indefinite leave resolution of the Seoul National University College of Medicine and Seoul National University Hospital Faculty Council. We strongly demand that they withdraw the collective leave of absence and indefinite leave resolutions that threaten the lives and health of patients.” "Over the past four months, patients have suffered great anxiety and harm due to the prolonged medical gap caused by the collective action of doctors. We are devastated to see another collective strike launched at a time when we are just beginning to see hope for solving the situation." The PAGs called on the government and the National Assembly to enact relevant systems and laws to prevent the recurrence of collective actions by doctors.
- Company
- Industry concern rises over the spread of the medical strike
- by Kim, Jin-Gu Jun 14, 2024 05:46am
- Some large hospitals are restricting access to pharmaceutical company employees’ access in the wake of a medical gap created by their resident doctors’ leave of absence. The pharmaceutical industry's situation worsens as the medical community is threatening to take a collective leave of absence due to conflict with the government over increasing medical school admissions. There are voices that say if the leave of absence, which is being made by doctors and some medical professors, spreads throughout the medical community, it will inevitably affect the industry’s Q2 performance results. There are already reports of companies predicting operating losses for their second quarter and some entering a state of emergency management. Medical representatives (MRs) in charge of general hospitals are on the verge of nervous breakdown, being unable to meet with medical professors. Pharma industry closely monitors the development of the medical strike ..." de facto emergency management system in place" According to industry sources on the 13th, the Korean Medical Association will take a collective leave of absence on the 18th. The association also announced a general strike at Yeouido Park in Seoul. In addition to the Big 5 hospitals, an increasing number of university hospitals have announced their participation in the strike. The faculty council of Seoul National University Hospital and Seoul National University Bundang Hospital decided to take a complete leave of absence on the 17th. Doctors at Severance Hospital will also take an indefinite leave of absence from the 27th. The Samsung Medical Center has also joined the collective leave of action, with other large hospitals also discussing plans. The medical strike, which had been ongoing amongst doctors and some medical school professors, seems to be spreading to large hospitals and clinics. The pharmaceutical industry is also watching the situation closely. Industry insiders say that if the medical community continues to take a leave of absence, the move will inevitably hurt the industry’s second-quarter earnings. Some companies are already forecasting losses for the second quarter and have effectively gone into emergency management. "Since last week, meetings involving executives from all departments have been held frequently," said an official from a large pharmaceutical company, "and it has been concluded that the company’s Q2 results will fall far short of the original target. We are currently discussing ways to minimize the damage." An official from another pharmaceutical company said, "If you look at our results through May, we're looking at a loss for the second quarter. The problem is that we don't have a good way to make up for it. We are keeping a close eye on the situation in the healthcare industry." An MR in charge of general hospitals confesses, "I haven't done anything for 2 months," The departments in charge of sales and marketing are also concerned about the spread of the medical strike. Departments that have launched or are planning to launch new products are said to be particularly affected by the prolonged medical-government conflict. An official from the marketing department of a domestic pharmaceutical company that recently launched a new product said, "Companies with existing products that have a high market share may not have a big problem, but companies that are planning to launch new drugs or new products are facing difficulties. We originally planned a large-scale launch symposium, but it has now been postponed indefinitely." The official added, "Recently, many medications are being prescribed in the long-term, for 6 months, making it very difficult for new drugs to be prescribed. This is a big risk for new drug sales and marketing teams." For departments related to general hospitals, the situation is worse as the MRs in charge could not meet with their medical professors since the start of the strike at the beginning of the year. Some surgeons and residents have returned to work, but in the internal medicine department, most full-time doctors and residents have not returned, with faculty members on call 2-3 times a week in rotation. An MR from a domestic pharmaceutical company in charge of a general hospital in Daejeon said, "I haven't worked since last month. Before that, I was at least receiving training, but now I am doing nothing. The company is just telling me to wait and see what happens. I don't want to force meetings with professors because it could backfire." An official in charge of clinical affairs at a multinational pharmaceutical company said, "It is also difficult to enroll patients in global late-stage clinical trials. Doctors are reluctant to attend even when we offer meetings to encourage participation in multicenter investigator-initiated trials (IITs). There are many restrictions to them attending not only investigator meetings but also pharmaceutical company events held in the evening or on weekends."
- Policy
- Drug pricing negotiations complete for Idelvion in KOR
- by Lee, Tak-Sun Jun 13, 2024 05:48am
- The hemophilia B treatment Idelvion is soon expected to be reimbursed in Korea, with CSL Behring completing drug pricing negotiations for the drug with the regulatory authorities. The drug’s advantage is in its convenience in administration, as it can be administered once every 1 to 3 weeks. According to industry sources on the 12th, the National Health Insurance Service recently disclosed that it has completed drug pricing negotiations for Idelvion. The NHIS has been disclosing its drug pricing negotiation results since April. Idelvion Inj had been in drug price negotiations since April after passing the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee review in March. CSL Behring received domestic approval for Idelvion in March 2020 and has been pursuing reimbursement since then. In July 2021, DREC gave a conditional pass, deeming that reimbursement is adequate if the company accepts a price below the assessed amount, but the conditional pass did not lead to negotiations with the NHIS at the time. The company then aligned its strategy and applied to receive DREC review the second time, and in March, it was deemed adequate for reimbursement and received unconditional approval. The drug is indicated for the ▲control and prevention of bleeding episodes, ▲ control and prevention of bleeding in the perioperative setting, and ▲ routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia B (congenital factor IX deficiency). Hemophilia B is a congenital bleeding disorder caused by a single gene defect and is caused by a deficiency in coagulation factor IX (blood coagulation factor 9), a protein that helps blood coagulation and is mainly produced in the liver. Hemophilia B accounts for about 20% of all hemophilia patients. Pfizer’s ‘BeneFIX Inj’ is the top-selling product in Korea’s hemophilia B treatment market. According to IQVIA, BeneFIX sold KRW 7.2 billion’s worth last year. Hemophilia B is treated using intravenous injection to supplement the missing clotting factor. BeneFIX’s advantage was in its convenience in administration, being able to be injected once weekly. Idelvion also has an advantage in its convenience in administration. Its recommended dose is 35 to 50 IU/kg once weekly for routine prophylaxis. Patients aged 12 years or older who are well-controlled on once weekly dosing regimen may switch to 10 to 14-day interval regimen of 75IU/kg. Also, patients aged 18 years or older who are well controlled with the 14-day regimen for at least 6 months may receive 100 IU/kg every 21 days. The extended dosing interval, administered once weekly to up to every three weeks, is expected to improve convenience in dosing and quality of life for patients. If Idelvion is reimbursed, the Australian pharmaceutical company CSL Behring will own treatments for both hemophilia A and B in the country. CSL Behring also owns the rights to ‘Afstyla,’ a single-chain recombinant factor VIII for hemophilia A that was developed and licensed-out by SK Chemicals. Afstyla has been reimbursed in Korea since May 2021.
- Company
- The first APDS drug 'Joenja' gets orphan drug status in KOR
- by Eo, Yun-Ho Jun 13, 2024 05:48am
- Pharming Group A rare disease treatment 'Joenja' has received orphan drug designation in South Korea. The Ministry of Food and Drug Safety (MFDS) states this through the report on the designation of Orphan Drugs. Joenja (leniolisib), developed by the Dutch company Pharming group, is the first treatment for activated phosphoinositide 3-kinase delta syndrome (APDS). The drug was approved by the U.S. Food and Drug Administration (FDA) in March of last year. APDS is caused by a mutation in either the PIK3CD or PIK3R1 gene, essential to immune cell development and function. It occurs in 1 per 1-2 million. APDS patients commonly develop autoimmunity and inflammatory symptoms. They may suffer from ear, paranasal, and upper and lower respiratory infections. Moreover, APDS patients are susceptible to swollen lymph nodes and enlarged spleen, as well as an increased risk of cancer, such as lymphoma. Joenja’s approval was based on results from a multinational, triple-blind, placebo-controlled, randomized phase 2/3 clinical trial evaluating the efficacy and safety of the drug in 31 patients with APDS aged 12 years and older. Open label extension data of 38 patients receiving Joenja for an average of two years were also submitted. Randomized and placebo-controlled clinical results at 12 weeks demonstrated the clinical effects of Joenja 70 mg administered twice daily. It obtained a significant finding from the co-primary endpoints, which evaluated lymphoproliferation as measured by the reduction in lymph node size and increase in naïve B cells. It reflected the impact on immune dysregulation and normalization of immunophenotype. The change between Joenja and placebo for lymph node size was –0.25, and for the percentage of naïve B cells was 37.30. The most common adverse reactions were headache, sinusitis, and atopic dermatitis. Meanwhile, Pharming Group signed a license agreement with Novartis for Joenja in 2019. Novartis received US$10.5 million from Pharming Group when Joenja launched in the United States in April last year, as well as additional milestone and recurring royalty revenue.
