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- 2026-05-12 00:18:37
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- Enhertu's petition subcommittee is announced
- by Eo, Yun-Ho Mar 17, 2023 05:46am
- The 'answer' to the national petition urging insurance coverage for the next-generation ADC anti-cancer drug Enhertu is expected to come out soon. According to the related industry, Daiichi Sankyo Korea and AstraZeneca Korea's HER2-positive breast cancer treatment, Antibody-drug conjugate (ADC) Enhertu, will be submitted to the Petition Review Subcommittee next week. As a result, attention is paid to how it will affect the Enhertu benefit listing process. The drug was referred to the Health and Welfare Committee of the National Assembly last month after a petition urging health insurance approval at the beginning of this year gained the consent of 50,000 people. Enhertu, based on the DESTINY-Breast01 and DESTINY-Gastric01 clinical studies from the Ministry of Food and Drug Safety in September of last year, Enhertu is ▲unresectable or metastatic HER2-positive breast cancer who have previously received two or more anti-HER2-based therapies and ▲previously anti-HER2 anti-HER2 approved for the treatment of locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received two or more therapies, including treatment. Also, in December, based on the DESTINY-Breast03 clinical trial, it received approval for an expanded indication for the treatment of patients with unresectable or metastatic HER2-positive breast cancer who had previously received one or more anti-HER2-based therapies. Enhertu is an antibody-drug conjugate. The antibody-drug conjugate uses the selectivity for the target and the killing activity of the drug to selectively act only on cancer cells, thereby increasing the therapeutic effect and minimizing side effects. Ra Seon-young, a professor of oncology at Yonsei Cancer Hospital, said, "Enhertu is the first and only HER2-targeted therapy that has demonstrated a survival period of more than one year as a treatment for advanced gastric cancer after treatment with Trastuzumab. "Considering the small number of patients, we hope that the reimbursement will be applied as soon as possible," she said. In the Enhertu DESTINY-Breast03 study, a head-to-head treatment with T-DM1 showed a significant improvement in PFS in patients with unresectable or metastatic HER2-positive breast cancer who had previously received one or more anti-HER2 therapies. In the interim analysis updated in 2022, mPFS was 28.8 months in the Enhertu group, 22 months longer than 6.8 months in the T-DM1 group, and overall survival (OS), a major secondary endpoint, was higher in the Enhertu group than in the T-DM1 group It showed a statistically significant result that reduced the risk of death by 36% compared to Enhertu's DESTINY-Breast01 trial confirmed sustained antitumor effects in patients with unresectable or metastatic HER2-positive breast cancer who had previously received two or more anti-HER2 therapies including T-DM1, Trastuzumab, and Pertuzumab. As a result of the study, Enhertu showed a confirmed ORR of 60.9%) and mPFS of 16.4 months. The mDOR was 14.8 months, showing a sustained antitumor effect even in severely ill patients with a median number of previous anticancer drugs reaching 6 (range 2-27).
- Company
- MSD ‘Januvia’s NTTP impurity level is at low risk’
- by Jung, Sae-Im Mar 17, 2023 05:45am
- On the 16th, Regarding the issue of excess nitrosamine impurities detected in some Januvia 50mg products, MSD Korea said, “The company has detected impurities that exceed the acceptable limit in two 50mg packaged batches among all Januvia products that were imported to Korea until October 2022. As a precautionary measure, the company has decided to voluntarily recall these products, and the level of impurity detected in the batches poses a negligible risk to patient safety." According to MSD Korea, the company has been updating the Ministry of Food and Drug Safety on the company’s measures and plans for control since August last year when the company first became aware of possible detection of the nitrosamine carcinogen, 'Nitroso-STG-19 (NTTP),' in Januvia. Upon MFDS request, the company has recently conducted a full inspection of impurities on all distributable Januvia products among those imported to Korea by October last year. Results showed that Januvia 50mg products with batch numbers ▲U010253 ▲U012914 were detected to have excess nitrosamine impurities. MSD Korea explained, “The detected level of impurities slightly exceeds the temporary accepted interim limit (maximum 246.7 ng/day).” The company had decided to make voluntary recalls for the batches detected with excess impurities on the 15th. The detected batches were last supplied to the Korean market on November 1, 2021, and have a use-by date that expires in February 2024. MSD Korea added, “The number of products that were detected to have excess impurities account for 0.35% of all formulations of Januvia products that were distributed in the same period.” MSD Korea also estimated that most stock of drugs with the corresponding lot numbers would have been exhausted by now at pharmacies when considering the prescription rate, frequency of orders, and order volume of Januvia in Korea. NTTP was first found as an impurity last year. As a nitrosamine compound, it is naturally found in low levels in drinking water, pickled/grilled meats and fish, vegetables, and dairy products. It is also produced in the drug manufacturing process. In June last year, the European Medicines Agency (EMA) raised the possibility of NTTP detections and requested inspections for the substances ▲sitagliptin, ▲varenicline, ▲methylphenidate, ▲ rifampicin, ▲rasagiline, ▲amitriptyline, ▲nortriptyline, and ▲dabigatran. At the time, the impurity test on Januvia showed that detected levels of NTTP did not exceed the accepted level. Since then, MSD Korea has been additionally conducting NTTP tests on all samples of drugs that contain sitagliptin manufactured from July last year. In other words, drugs that were manufactured after July last year are only allowed to be released to the market if they pass testing for NTTP impurities, and therefore have no impurity issues. The company said, “We have been conducting additional quality control measures and supplying drugs that meet the temporarily accepted release standards, and are making rapid efforts to strengthen process control to further minimize the NTTP level so that we can meet the long-term intake standards.”
- Product
- It is difficult to solve the problem of expensive generics
- by Mar 16, 2023 05:46am
- The Pharmaceutical Association for a Healthy Society (CEO Hyung-geun Shin) submitted an opinion against the 'Partial Amendment to the National Health Insurance Act' proposed by Representative Kim Min-seok, saying that the problem of expensive generics cannot be solved with penalty-type rebates. On the 14th, the pharmaceutical association said, "The proposed amendment contains the contents of replacing existing drug price cuts and reimbursement suspension administrative measures with penalty surcharges, and applying the changed statute when the standard for pharmaceutical disposition is lighter. "It is a law to make fools of pharmaceutical companies that do not provide rebates, and it is self-evident that it will continue to increase the price of Korean generics, which are famous for being the most expensive among OECD countries," he said. They pointed out that practical measures have not been prepared for the rebate issue. In 2014, the National Assembly and civil society joined forces to enact the 'rebate two-out system' to punish illegal kickbacks. It is that they continue to claim that access is restricted. They said, "Although this claim threatens the basic principle of 'same ingredients can be substituted for preparation', which has been maintained by the NHIS for a long time, the NHIS accepts the pharmaceutical company's argument and imposes a penalty of 30-50% of the drugs subject to suspension of reimbursement. "Even in this situation, citing the patient's right to access medicines as a reason is no different from simply arguing for the rebate itself to be allowed," he pointed out. The Pharmaceutical Association said, "Korea is known to be the most expensive country for generic drugs among OECD countries through various studies, and accordingly, pharmaceutical companies provide various rebates to healthcare institutions to promote sales, and healthcare institutions pay more than to purchase cheaper drugs. In order to receive more money and valuables, prescriptions for more expensive drugs are induced, and the structure in which the proportion of Korean pharmaceutical expenditures continues to rise is repeating itself,” he emphasized. “Pharmaceutical rebates are not just punishments for unfair trade, but an act that threatens health insurance finances, patients’ wallets, and patients’ health,” he said. “The current drug pricing method, which guarantees high generic prices, must also be improved as soon as possible,” he urged. He also ordered the National Assembly to "strengthen the rebate punishment and eliminate rebates from medical sites, and this will protect the health of patients and the finances of the NHIS."
- Company
- Exclusive domestic sales of JW Shinyak, Galderma hair loss
- by Mar 16, 2023 05:45am
- Kim Yong-gwan, CEO of JW Shinyak (right), and Kim Yeon-hee, CEO of GaldermaJW Shinyak announced on the 15th that it has signed a domestic exclusive sales contract with Galderma for hair loss treatment Ell-cranell and nail athlete's foot treatment Loceryl nail lacquer. According to the contract, JW Shinyak will be in charge of domestic sales and marketing of the two products. Ell-cranell is an androgenetic alopecia treatment that can be used by both men and women. It minimizes hair loss by suppressing the production of dihydrotestosterone, which is the cause of hair loss, threefold. It is easy to apply to the scalp with an applicator once a day, increasing convenience. As a result of clinical trials on 51 female patients with androgenetic alopecia in Korea, the number of hair increased by 9.8% and the thickness of hair by 13.2% after 8 months of Ell-cranell application. Also, more than 80% of the clinical participants rated it as 'easy to apply and not sticky to the scalp and hair'. Loceryl nail lacquer is the first product of Galderma launched in Korea in 1999 and is the most-sold topical treatment for toenail fungus (onychomycosis) in the world. It is a manicure-type external application that is applied directly to the nails, and the antifungal effect is maintained for 7 to 14 days just by using it once or twice a week. It is quickly absorbed into the nail, is not easily erased by water or sweat, and forms a protective film on the surface to prevent infection. With this contract as an opportunity, JW Shinyak plans to further enhance its competitiveness in the domestic skin disease treatment market. Kim Yong-gwan, CEO of JW New Drug, said, "The introduction of Galderma products, which have proven their excellence in the global market, has allowed us to build a more diverse lineup along with existing self-produced drugs." will go," he said.
- InterView
- ‘Reimbursing Revlimid as maintenance therapy beneficial’
- by Eo, Yun-Ho Mar 16, 2023 05:45am
- Professor Hyeon-Seok Eom The multiple myeloma treatment ‘Revlimid’ has finally been listed for reimbursement after 4 long years of await as maintenance therapy, starting from the new year of 2023. Reimbursement of Revlimid as maintenance therapy had undergone various twists and turns in Korea. Since 2019, BMS Korea had actively sought to list the drug for reimbursement, but was unable to make progress. The agenda has been deliberated by the Cancer Disease Drug Committee during meetings that were held in September 2019, June 2020, then again in September last year. The last meeting gained attention due to its deliberation of the CAR-T therapy ‘Kymriah (tisagenlecleucel),’ but to no avail for Revlimid. After passing CDDC deliberations in June last year, Revlimid’s reimbursement was finally extended to cover its use as maintenance therapy after 4 years. That a drug can prevent or delay the recurrence of cancer is an extraordinary concept that all cancer survivors would opt for. Revlimid has presented such an option for the first time in the field of multiple myeloma, a type of blood cancer that has a recurrence rate of 70-80%. Dailpharm met with Hyeon-Seok Eom, Professor of Hemato-Oncology at the National Cancer Center to seek insight into the significance and value brought by Revlimid's reimbursement as maintenance therapy. -It took a long time for Revlimid to receive the reimbursement extensions. How do you believe the reimbursement extension will affect the field? When considering how research on Revlimid’s use as maintenance therapy started in the mid-2000s, quite some time had been taken for its reimbursement approval. After the 5-year, and 10-year study data were published, I remember demand started to rise for the reimbursement of the drug as maintenance therapy around 2015. Even patients recognized the need and filed petitions to the National Assembly. Despite such efforts, it took quite some time for Revlimid to receive reimbursement as maintenance therapy. Patients were unable to use the drug as maintenance therapy or had to pay the full non-insured price for such use. In fact, from the late 2000s to early 2010s, this difference in treatment options led to a difference in the 5-year survival rate of multiple myeloma patients in Korea and the U.S. This is an example of how access to drugs directly affected the survival rate of patients. In the same context, patients in Korea will enjoy an improvement in their survival rate with the reimbursement extension. Improvement in the patient's quality of life and survival rate is of the greatest significance in terms of treatment as well. -The reimbursement approval of RVd (lenalidomide+bortezomib+ dexamethasone) therapy last year has greatly changed the prescription pattern of HCPs in Korea. The reimbursement of the maintenance therapy will also bring much change in the prescription environment. I believe the reimbursement of Revlimid as maintenance therapy will change how HCPs progress with treatment in the first line as well as the second line for multiple myeloma. For example, a patient’s overall survival may improve further if he or she uses Revlimid as maintenance therapy after VRd (bortezomib+lenalidomide+dexamethasone) therapy. This is why many studies abroad investigated the use of Revlimid as maintenance therapy following VRd therapy. In this aspect, the reimbursement approval of Revlimid has great significance. -Ultimately, how well the disease can be cared for in the front line (as first-line therapy) seems to be key in managing multiple myeloma as well. That’s true. Despite the increasing diversity of treatment options available in the field, it is still most important to see a good prognosis in the earlier stages. Considering how about 30% of patients die while transitioning from first-line treatment to second-line treatment and the prognosis of patients generally worsens with later lines of treatment, it is very important to increase the time to recurrence and survival rate of patients by treating patients well in the earlier stages. Therefore, it is most important to improve the prevention of recurrence, PFS, and OS with first-line treatment after considering various treatment options. Many HCPs abroad use many drugs in the first line to prolong the treatment period as much as possible. -What improvements do you wish for in treating multiple myeloma? The reimbursement of Revlimid as maintenance therapy has improved the front-line treatment environment, therefore, we now need to focus on improving the second-line treatment environment. We need to use more diverse options to treat multiple myeloma in the second line as well. The survival period of the patients is greatly reduced when patients go through further lines of treatment. The PFS is only a few months, and even the OS does not exceed 1 year in later lines of treatment, so it is important to use drugs well in the earlier stages. Also, good drugs remain unreimbursed in Korea. It is a pity that these effective drugs cannot be used earlier due to environmental issues like lack of reimbursement and are therefore used in the later stages of treatment. As in the United States, we should allow the use of effective drugs in earlier lines of treatment, and discretion should be given to the doctors for the combined use of drugs with reimbursement. - Are there any drugs you are looking forward to in the field of multiple myeloma in the future? With treatments continuing to evolve, I expect new treatment methods like CAR-T therapies would also eventually be introduced to the field. Development of such treatments will significantly improve the OS and quality of life of patients in the earlier lines of treatment, in the first- or second-line. Currently, patients with multiple myeloma generally recieve chemotherapy and autologous hematopoietic stem cell transplantation. However, some patients may experience side effects such as hair loss due to strong drugs and the process itself is also cumbersome as it requires weekly hospitalization. I hope that positive changes would come to foster a better treatment environment for patients in the future.
- Company
- SPC Korea to exclusively distribute 2 new COPD drugs in KOR
- by Eo, Yun-Ho Mar 16, 2023 05:45am
- SPC Korea will now be in charge of the domestic supply of two new COPD drugs in Korea. The company announced it had signed an exclusive agreement for the sales and distribution of two Chronic Obstructive Pulmonary Disease (COPD) treatments with the multinational pharmaceutical company, Covis Pharma GmbH. Under the agreement, SPC Pharm has been exclusively selling and distributing Eklira (Aclidinium bromide)’ and ' Duaklir (aclidinium bromide/formoterol fumarate dihydrate) in Korea from March 1. Covis Pharma had previously acquired the global rights for Eklira and Duaklir from AstraZeneca. Upon signing the agreement, the exclusive distribution and sales rights for the drugs in Korea will be transferred to SPC Korea, and their license transfer process is currently underway. The two drugs are delivered via the Genuair device and used as maintenance treatment for patients with COPD. SPC Pharm plans to strengthen marketing for the products to increase the market share of these products in Korea's COPD treatment market. A company official said, “Through the agreement, we plan to strengthen the company's existing respiratory treatment portfolio and continuously introduce global new drugs to provide new treatment options in Korea ."
- Policy
- Upper limit re-evaluation of drugs in the negotiation stage
- by Lee, Tak-Sun Mar 16, 2023 05:45am
- The re-evaluation of the drug cap amount according to the standard requirement has now moved to the negotiation stage with the NHIS. Pharmaceutical companies that submitted their primary drugs to the HIRA by last February will proceed with prior consultation with the NHIS in March. After that, the main negotiations will be completed and the final drug price adjustment results will be announced in July. The NHIS announced on the 15th that it will hold prior consultations with pharmaceutical companies from this month in accordance with the re-evaluation of the standard requirements for the maximum amount of drugs. Accordingly, the NHIS plans to hold a briefing on the reevaluation negotiations on the 27th. An official from the corporation said, "We recently shared matters related to negotiations on standard requirements through a meeting with pharmaceutical organizations." About 15,000 drugs will be targeted for the first round, and prior consultations will be held until May. During the preliminary consultation period, the items to be negotiated will be checked and an agreement will be sought, so it is expected that the agreement will be concluded during the main negotiations in June. Based on this, the contents of the final drug price adjustment will be announced in July after going through the review committee in June. Negotiations are underway for the second target drug. The secondary target drugs are about 5,000, and if data are submitted to the HIRA by July, negotiations will proceed with the NHIS again. Negotiations will be conducted by the NHIS Pharmaceutical Control Office's Generic Management Division. An official from the generic management department explained, "Based on our experience over the past two years, we are thoroughly preparing to complete the negotiations within the deadline." The re-evaluation of the upper limit amount is being carried out by maintaining or lowering the upper limit amount depending on whether the company's own BA test and DMF registration criteria are met. If both of the BA and DMF requirements are met, the upper limit is maintained, and if one is met, the price is reduced to 85% of the adjusted standard price, and if both are not met, the price is reduced to 72.25%.
- Policy
- MFDS, approval of Vadadustat for anemia tx of renal disease
- by Lee, Hye-Kyung Mar 15, 2023 05:56am
- Vadadustat, which is used to treat anemia in patients with chronic kidney disease, has received domestic product approval. The Ministry of Food and Drug Safety (Minister Yu-Kyoung Oh) announced on the 13th that it had approved two doses (150 and 300mg) of Vadadustat from Mitsubishi Tanabe Pharma Korea Co., Ltd., a new drug for the treatment of anemia in patients with chronic kidney disease. Vadadustat is a treatment for anemia in adult patients with chronic kidney disease undergoing hemodialysis. Vadadustat is a treatment for anemia in adult patients with chronic kidney disease undergoing hemodialysis. The drug promotes red blood cell production by inhibiting proline hydroxylase, which breaks down hypoxia-inducible factor (HIF). Sufficient iron stores should be ensured when Vadadustat treatment is initiated, and transferrin saturation (TSAT) and ferritin concentrations should be checked. If not previously treated with erythropoiesis-stimulating agents (ESAs), the criterion for initiation of this drug is a hemoglobin (Hb) concentration of less than 10 g/dL. Patients receiving erythropoiesis-stimulating agents (ESAs) may be switched to this drug. As Vadadustat, 300mg once a day is orally administered as a starting dose, and after the start of treatment, the dose is appropriately increased or decreased according to the patient's condition. The highest dose can be up to 600 mg once daily. If looking at the precautions for use, there is a risk of death due to serious thromboembolic events such as stroke, cerebral infarction, myocardial infarction, deep vein thrombosis, and pulmonary embolism during the administration of this drug. Since the administration of this drug may cause liver dysfunction, liver function tests should be performed regularly. The Ministry of Food and Drug Safety said, "We will continue to do our best to expand treatment opportunities for patients by promptly supplying treatments whose safety and effectiveness have been sufficiently confirmed based on regulatory scientific expertise."
- Company
- IIT seeks use of Leclaza in the first line in Korea
- by Jin-Joong Hwang Mar 15, 2023 05:56am
- New third generation lung cancer drug developed by Yuhan Corp Investigator-Initiated trials (IIT) are being conducted on the use of ‘Leclaza (lasertinib),’ Yuhan Corp’s new third-generation drug for non-small-cell lung cancer (NSCLS), as a first-line treatment. Over the past 3 years, a total of 11 IITs have been approved for Leclaza, indicating the high interest among HCPs in finding a new treatment method using Leclaza. According to industry sources on the 14th, the Ministry of Food and Drug Safety approved a randomized Phase IIb trial the day before that compares Leclaza monotherapy with Leclaza+Avastin combination in patients with advanced EGFR mutation-positive NSCLC who have a smoking history. The Phase IIb trial that compares Leclaza as monotherapy with the Leclaza+Avastin combination will be led by the National Cancer Center and conducted in 5 institutions including the Ajou University Hospital, Severance Hospital, Gangnam Severance Hospital, and St. Vincent Hospital. The trial is an investigator-initiated trial that uses Leclaza as the primary treatment. According to Yuhan Corp, this is the first clinical trial that investigates Leclaza’s use in the first line. Leclaza is a third-generation EGFR TKI class drug that received conditional approval in Korea in January 2021. It inhibits the signaling pathway involved in tumor cell growth and supresses lung cancer cell proliferation and growth. In Korea, Leclaza received conditional approval as a second-line treatment in patients with locally advanced or metastatic NSCLC who developed T790M resistance after prior treatment with a first- or second-generation EGFR TKI. Avastin is a drug used for the treatment of metastatic colorectal cancer, metastatic breast cancer, NSCLC, etc. The drug is approved for use in combination with platinum-based chemotherapy regimens to treat inoperable, locally advanced or metastatic non-squamous NSCLC. Also, the drug can be used in combination with erlotinib as a first-line treatment for inoperable EGFR mutation-positive, advanced, metastatic, or recurrent non-squamous NSCLC. During the past 3 years, a total of 11 IITs have been approved for Leclaza. This rise in number of clinical trials for Leclaza reflects the HCPs' rising interest in finding new treatment methods with Leclaza. Among the trials, major IITs include the Phase II trial being led by Seoul National University Hospital that is investigating the use of Leclaza+’Alimta (pemetrexed)’ combination in EGFR mutation-positive NSCLC patients with leptomeningeal metastases. The Phase II trial was approved in April 2021, and patient recruitement for the trial in complete, enrolling 43 patients. Also, patient recruitment is underway for a Phase II trial for NSCLC patients including those with rare EGFR mutations. The trial, which is led by Severance Hospital, has been approved in 2021 Since 2021, Seoul St. Mary’s Hospital has been conducting a Phase II trial studying the combined use of Leclaza, Alimta, and ‘Neoplatin (carboplatin)’ in EGFR mutation-positive metastatic NSCLC patients with asymptomatic or mild symptomatic brain metastases who have failed treatment with ‘Tagrisso (osimbertinib).’ Also, Samsung Medical Center has received approval for a single-arm Phase II trial investigating the use of Leclaza in EGFR mutation-positive NSCLC patients with no prior TKI treatment experience and is currently recruiting patients.
- Opinion
- [Reporter’s View] ‘The smart office system’s great, but…
- by Eo, Yun-Ho Mar 15, 2023 05:56am
- The smart office system has become an industry trend. The term, which originally refers to an IT-based office near a residential area that allows employees to work remotely from satellite offices rather than commute to an office downtown, is applied a bit differently in the pharmaceutical industry. Taking into account the characteristics of the industry, as employees often have to move from office to hospital or government office, the companies created workspaces fit for such mobile environment and implemented free seating systems. Due to the telecommuting culture that naturally settled during the pandemic, the number of resident workforce had also decreased. In their place, conference rooms with various concepts and phone booths for long-term calls were added like frosting to the cake. The transition to a smart office had let companies catch two birds with one stone. The reduced number of resident workforce allowed the company to save office expenses, while more space became available for those who came to work. In fact, many multinational pharmaceutical companies that have applied the smart office system moved their offices to relatively less expensive areas. The executive-level employees gave up their space as well. To embrace the horizontal organizational culture and make space for spacious conference rooms with a view, the executives left their rooms to work next to other employees. Even the ‘bosses’ gave up their office space. “I don’t have a room either. It was awkward at first, but the change has turned out for the better. Working next to the employees, we were able to become closer and communicate better." Some companies went on to further remove the honorific expressions altogether. These companies asked employees to call their bosses ‘Mr./Ms.OO’ or by their English names. Unlike in domestic companies, many multinational company employees are known to have a more candid relationship with their bosses. However, not everyone would agree that these changes are all for the good. For example, contrasting views exist on ‘owners that dine together at employee cafeterias.’ One employee confessed “You would naturally feel nervous and uncomfortable if your boss is sitting next to you. I understand the intention and my boss is a good person, but I can’t say I am all for the situation where I have to face the highest-ranking officer of my company continuously during work.” Just as in this employee's confession, although the changes are in the right direction and follow the trend of the times, the system may need to be somewhat adjusted to suit Korea. In the cutest sense, hold a friendly ear out to the complaint and let the ‘boss’ stay in his or her room.
