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- Hanmi Pharmaceutical's first technology export in a year
- by Chon, Seung-Hyun Nov 12, 2021 05:56am
- Hanmi Pharmaceutical is speeding up its efforts to secure profits from technology fees, which had slowed down for a while. It has secured a down payment of 10 billion won by exporting new drug technology in the past year, and expectations are high for subsequent new drug development. According to an industry on the 11th, Hanmi Pharmaceutical exported FLT3 inhibitor "HM43239," which is being developed as an innovative drug for AML treatment, to Aptose Biosciences on the 4th. Under the contract, Hanmi Pharmaceutical will receive a $12.5 million down payment (about 15 billion won) from Aptose Biosciences in cash and $7.5 million in Aptose Biosciences shares. After that, it will receive up to $47.5 million (about 485 billion won) in clinical, development, permission, and commercialization milestones for various indications. You will also receive a step-by-step royalty for sales. Hanmi Pharmaceutical completed the export of new drug technology in a year and three months. Hanmi Pharmaceutical exported a non-alcoholic steatohepatitis treatment to MSD in August last year. The GLP-1-based double agent whose rights were returned from Janssen was transferred back to MSD after a year. It is a double-acting treatment that simultaneously activates GLP-1, which helps secrete insulin and suppress appetite, and glucagon, which increases energy metabolism, and Hanmi Pharmaceutical's original technology for lapscovery, which increases drug efficacy duration, is applied. Hanmi Pharmaceutical's new technology export contract is also expected to expand technology fee profits. Hanmi Pharm is expected to temporarily recognize the down payment of $5 million (about 6 billion won) received in cash from Aptose Biosciences as technology fee revenue. Hanmi Pharmaceutical has established its technology fee revenue in earnest since 2015 when it began to produce technology export results in earnest. However, in recent years, when technology exports have become less successful, technology fee profits have decreased significantly. Until the third quarter of this year, Hanmi Pharmaceutical's technology fee revenue was only 200 million won. No technology fee revenue was generated in the first and second quarters, and 200 million won flowed in in the third quarter. Hanmi Pharmaceutical earned a total of 512.5 billion won in technology fees from down payments received from Lily, Beringer, Sanofi, and Janssen in 2015 and secured more than 10 billion won in technology fees every year. Hanmi Pharmaceutical posted 27.7 billion won in technology fees in 2016, which is the result of returning some of them due to the revision of the contract with Sanofi. Initially, Hanmi Pharmaceutical received a down payment of 400 million euros in 2015 when it signed three technology transfer contracts with Sanofi. At this time, Hanmi Pharmaceutical reflected only KRW 255.6 billion in its accounting books and chose a method of recognizing the rest in installments for 36 months. At the end of 2016, Hanmi Pharmaceutical returned 로를196 million through contract modification, including the return of the rights of some tasks (continuous insulin). Hanmi Pharmaceutical remitted about 160 million euros by revising the contract without recognizing about 160 billion won in down payment received from Sanofi as revenue (255.6 billion won in 2015 and 63.9 billion won in the first to third quarters of 2016). Hanmi Pharmaceutical earned 57.7 billion won in 2017, 44.6 billion won in 2018, and 20.4 billion won in 2019. During this period, the down payment received from Genentech was recognized in installments. Hanmi Pharmaceutical signed a technology transfer contract with Genentech in September 2016 for the RAF target anticancer drug "HM95573. If the down payment is $80 million and clinical development, permission, and commercialization are successful, the condition is to receive $830 million sequentially as a step-by-step milestone. Hanmi Pharm received a down payment of $80 million from Genentech on December 2, 2016. At that time, 93.8 billion won was deposited if 1,173 won was applied based on the won-dollar exchange rate. Hanmi Pharmaceutical recognized the down payment in installments for 30 months on its accounting books, and the period of recognition of the down payment in April 2019 ended. Last year, the company temporarily recognized $10 million in down payment secured through a technology export contract with MSD, generating 10 billion won in technology fee revenue. Hanmi Pharm has also secured additional milestones following the development of the anticancer drug "Auraxol" exported to Athensx. Hanmi Pharmaceutical can secure additional technology fees according to the development of technology export tasks. Belvarafenib, which transferred technology to Genentech, is currently conducting global clinical trials for commercialization by Genentech and Roche. "belvarafenib" is a pan-RAF inhibitor-based targeted anticancer drug. It acts as a mechanism to inhibit RAF, a type of mitogen-activated protein (MAP) kinase that mediates intracellular signaling. Genentech has proven excellent drug resistance and safety in combination with existing approved treatments and plans to expand global clinical trials for patients with NRAS melanoma. Roche added two cohorts of belvarafenib-related monologues and combination therapy to its ongoing large-scale clinical project, "TAPISTRY." "TAPISTRY" is a clinical trial aimed at providing customized treatments to metastatic solid cancer patients who cannot operate with certain mutations. According to a quarterly report submitted to the U.S. Securities and Exchange Commission by Hanmi Pharmaceutical's partner Spectrum Pharmaceuticals, Spectrum agreed to pay up to $358 million in milestones to Hanmi Pharmaceutical according to the commercialization performance of the anticancer drug Poziotinib. Spectrum plans to submit an application for FDA approval as early as this year. If "Rolontis," a treatment for neutropenia that has been applied for permission from the U.S. Food and Drug Administration (FDA), is approved, it will pay $10 million to Hanmi Pharmaceutical. Poziotinib is a pan-HER2 anticancer drug that Hanmi Pharmaceutical transferred to Spectrum in 2015. Rolontis, which was transferred to Spectrum in 2012, is a new biopharmaceutical applied with Hanmi Pharmaceutical's Labscovery platform technology that increases the duration of the drug's efficacy in the body.
- Policy
- More convenient new dementia treatments introduced to market
- by Lee, Tak-Sun Nov 12, 2021 05:54am
- Donepezil patch (Source : Icure PR material) With a series of new dementia treatments being approved in Korea, whether the market dominated by Aricept will falter is gaining attention. Aricept (donepezil hydrochloride, Eisai Korea) has been dominated the market with an 80% share in the Korean prescription market. The Ministry of Food and Safety approved Lundbeck Korea’s ‘Ebixa tablet 20mg’ on the 1st. Although Ebixa’s share in the market is much behind Aricept by performance, it is still the single Alzheimer’s treatment that ranks second after Aricept in the Korean market as a single product. The Ebixa tablet currently in the market is a 10mg formulation and is used to treat moderate-to-severe Alzheimer’s. The maximum daily dose of Ebixa is 20mg, and elderly patients over the age of 65 should take the 10mg dose twice a day. On the other hand, the recently-approved Ebixa 20mg can be taken once a day. This improved convenience in administration is expected to be received with a more positive response in the market. Previously on the 5th, the first donepezil patch was approved in Korea. The patch, which was co-developed by Icure and Celltrion, is expected to outperform oral treatments in terms of patient compliance. Icure’s Doneciv patch and Celltrion’s Donerion patch are used to treat dementia of the Alzheimer’s type and are alternately attached to the shoulder twice a week at 3-day and 4-day intervals. The patch only needs to be attached twice a week, therefore is more convenient than the existing oral formulations. With such products with improved convenience being introduced to the market, whether the products will be able to shake Aricept’s stronghold, which occupies 80% of the market, is also an area of interest. Based on UBIST, Aricept sold ₩83.9 billion in outpatient prescriptions and accounts for 80% of the original dementia treatment market. The runner-up is Ebixa, which recorded ₩13.7 billion. In particular, Ebixa’s sales have continued to increase after Daewoong Pharmaceuticals joined in co-promoting the products since July 2019. The industry expects Daewoong Pharmaceuticals to also conduct joint sales and marketing activities for Ebixa 20mg as well. Daewoong Pharmaceuticals had also pursued the development of a 20mg formulation of memantine, which is the same ingredient used in Ebixa, and received approval for its Phase I study, but did not initiate development. The analysis was that this may be due to the company’s plan to co-promote Ebixa 20mg with its original developer, Eisai. Also, the fact that Celltrion, which has a well-established domestic distribution network in biosimilars, has entered the dementia treatment market with the patch formulation may act as a variable in the market. Like all other drugs, the preference for originals is high for dementia treatments as well. However, as Celltrion has established as much trust as biosimilars in Korea for its biosimilars, this is expected to have a positive effect on its sales of the donepezil patch. The new products that were approved recently will be sole in earnest from next year after going through the reimbursement process. Therefore, the industry is paying keen attention to whether the introduction of these new drugs will shake Aricept’s sole lead in the dementia treatment market.
- GI innovation·Merck signed MOU to develop new drugs
- by Nho, Byung Chul Nov 12, 2021 05:54am
- CEO Hong Joon-ho of GI innovation (third to the left) Kim Yong-seok, head of Merck Life Science (fourth to the left) GI innovation announced on the 10th that it has signed an MOU with Merck for the manufacture and development of new biopharmaceuticals. This is the first time Merck, which has maintained cooperative relationships with CDMO (Consignment Production and Development) companies such as Samsung Biologics and Binex, has cooperated with Biotech in Korea to support the manufacture and development of new biopharmaceuticals. Merck is known to have highly appreciated GI innovation's know-how in developing CHO-produced cell lines and various pipelines. Hong Joon-ho, CEO of GI innovation, Cho Young-kyu, Oh Young-min, and Kim Yong-seok, general manager of Merck Life Science process solution business, attended the signing ceremony held at Ginnovation headquarters on the 9th. Through this cooperation, the two companies plan to create synergy in the development of new bio drugs through the use of the Merck CHOZN Platform and educational consulting for researchers. Merck's CHOZN expression system is a platform that can develop high productivity and stable production cell lines. In fact, creating biopharmaceuticals with Chinese Hamster Oval requires a long period of time (3 to 8 months), development know-how, and expensive large-scale facilities to reduce the risk of external contamination, and Merck's CHOZN expression system enables fast access to cell lines and biopharmaceutical production processes. As a result, GI innovation expects the development of high-protein cell lines that produce large-sized multi-targeted drug proteins that were difficult to manufacture through the close combination of its GI-SMARTTM platform technology and CHOZN expression system. In addition, it is expected to save time and money through the smooth supply of various subsidiary materials and increase the productivity of biopharmaceutical development. "GI innovation's own technology and global company Merck's bioprocessing technology are expected to meet to reduce time and cost in manufacturing and developing biopharmaceuticals," said Hong Joon-ho, CEO of GI innovation. He said, "As it is the first collaborative model with Biotech in Korea, not a large company, we hope that synergy between the two companies will produce excellent results." Merck aims to support GI Innovation's new fusion protein drug development process and further accelerate access to cancer and allergy drugs worldwide, said Kim Yong-seok, general manager of Merck Life Science process solution business. Through Merck's expertise in bioprocessing development, we expect to provide customers with the solutions necessary to solve the challenges throughout the new drug development process, he said.
- Company
- GX-17, aimed at treating COVID-19, resumes clinical trials
- by Kim, Jin-Gu Nov 12, 2021 05:54am
- Genexine's new anticancer drug candidate GX-I7, which had shown potential as a treatment for COVID-19, will launch a new clinical trial for anticancer drugs. On the 10th, the MFDS approved phase 2 clinical trials of Bevacizumab and Genexine GX-I7 in recurrent glioblastoma. Bevacizumab is the active ingredient of Roche's target anticancer drug Avastin. GX-I7 is a substance that Genexine is developing as a new anticancer drug. In 2017, the company launched phase 1b clinical trials for metastatic and recurrent solid cancer and began developing new anticancer drugs in earnest. Since then, he has initiated phase 1b combination therapy with cyclophosphamide in solid cancer in 2018, phase 1b/2 with Pembrolizumab (Keytruda) in recurrent and non-adaptive triple negative breast cancer, and phase 1/2 with Temozolomide (Temoram) in 2019. After the COVID-19 crisis began in earnest, the possibility as a treatment for COVID-19 was expected. In August 2020, it was approved for phase 1b clinical trials in Korea for mild COVID patients. In the United States, Genexine's U.S. affiliate NeoImuneTech launched phase 1 clinical trials for COVID-19 patients in November last year. However, in the case of COVID-19 clinical trials, it is prolonged than originally expected. The domestic clinical trial was to be conducted on 40 patients, but the recruitment of patients was still not completed after recruiting the first patient in March, seven months after clinical approval. US clinical trials of 30 people are also still recruiting patients. In this situation, Genexine is focusing again on clinical trials of GX-I7 anticancer drugs. In fact, it is confirmed that Genexine has recently been approved for clinical trials of anticancer drugs not only in Korea but also in the United States. Last month, NeoImuneTech launched phase 2 clinical trials for combination therapy with Atezolizumab (Tecentriq) of NT-I7 (US Development Name of GX-I7) in non-small cell lung cancer. Prior to this, in January this year, it was approved for phase 2 clinical trials with Opdivo for gastric and esophageal cancer patients. In August, phase 1b clinical trials were launched for patients with recurrent and refractory giant B-cell lymphoma. In addition to GX-I7, Genexine is developing GX-19N as a COVID-19 vaccine. Phase 1/2a clinical trials have been completed in Korea, and phase 3 global clinical trials are currently underway in Indonesia, Argentina, and Turkey. Genexine plans to release GX-19N in the first half of next year.
- Company
- Will BMS's 'Revlimid' be reimbursed as RVd therapy?
- by Eo, Yun-Ho Nov 11, 2021 06:01am
- Whether the multiple myeloma treatment ‘Revlimid’ will succeed in expanding reimbursement to its use in RVd therapy is gaining attention. According to industry sources, reimbursement of Revlimid (lenalidomide) for RVd therapy (Lenalidomide + bortezomib + dexamethasone) passed the Health Insurance Review and Assessment Services’ Cancer Disease Deliberation Committee review in September and is awaiting deliberation by the Pharmaceutical Benefits Appraisal Committee. The agenda is expected to be presented for PBAC deliberation in December. In Korea, the standard first-line therapy for multiple myeloma under reimbursement includes VMP (bortezomib+ melphalan+ prednisolone) and Rd (lenalidomie+dexamethasone) in patients who are not eligible for stem cell transplants, and VTd (bortezomib+thalidomide+dexamethasone) for patients eligible for stem cell transplants. However, the 5-year relative survival rate of multiple myeloma patients in Korea remains in the 40% range. RVD therapy is recommended as a priority in the first-line treatment of multiple myeloma in the US NCCN guidelines and EHA-ESMO guidelines. According to HIRA, among the 8,929 patients in Korea who were treated for multiple myeloma in 2020 (diagnosis code: C90, multiple myeloma, and malignant plasma cell neoplasms), 47% were over the age of 70 and were ineligible for transplant under the reimbursement standards. Elderly patients over the age of 70 have limited treatment options as they have difficulty receiving stem cell transplants, raising the demand for RVd reimbursement. Seok-Jin Kim, Professor of Hematology-Oncology at the Samsung Medical Center, said, “Treatment of multiple myeloma requires multiple considerations from the medical aspect as well as in the patient’s condition, treatment sequence, reimbursement conditions, etc. Both the patients and us HCPs will welcome a treatment option with a promising prognosis that can be used freely without reimbursement restrictions." He added, “I hope reimbursement for multiple myeloma treatments is extended to cover RVd therapy, maintenance therapy after autologous hematopoietic stem cell transplant, and R2 in follicular lymphoma to benefit more patients.” In a Phase III clinical trial, RVd therapy significantly extended PFS (progression-free survival) and OS (overall survival) compared to Rd therapy in patients with newly diagnosed multiple myeloma that are ineligible for stem cell transplant. In a network meta-analysis that assessed the relative efficacy of MM drugs used in newly diagnosed patients that are ineligible for stem cell transplant, RVd demonstrated significant extension in PFS and OS over Rd, and Rd over VMP.
- Product
- Claiming a more expensive drug than a generic
- by Kim JiEun Nov 11, 2021 06:00am
- Pharmacist A, who did not give a follow-up notice of general submission and charged for a drug that was more expensive than an alternative drug, filed a lawsuit claiming that it was an unfair disposition, but the court refused to accept it. The Seoul Northern District Court recently dismissed a claim filed by pharmacist A against the NHIS for the return of unfair gains. Pharmacist A did not notify the doctor after generic substitution of the drug from the MOHW in 2016, and was suspended for 50 days, claiming that the NHIS was unfairly paid about 34 million won. Afterwards, the NHIS disposed of the collection of about 34 million won in unfair claims through notification of the results of the on-site investigation by the MOHW. Since then, it has been executed in a way that deducts medical care benefits to be paid to pharmacies operated by pharmacist A. After the disposition, pharmacist A filed a lawsuit with the Seoul Administrative Court, and in 2018, the pharmacist won the case. For this reason, the court explained, "Some of the periods under investigation lack proof of the reasons for disposition, but the illegal parts of the disposition cannot be clearly distinguished, and some of the facts that were the basis for discretionary judgment are not recognized, forcing cancellation of all relevant dispositions." Immediately after that, the MOHW appealed to the Seoul High Court, but the pharmacist's victory was confirmed. Based on the ruling, the pharmacist filed a lawsuit against the corporation to recover unfair profits. Since the related disposition of the MOHW was canceled through administrative litigation, the disposition of the corporation, which recovered 34 million won in the name of unfair claims based on the same reason, is also illegal, so the recovered amount must be returned. However, the court did not accept it. It noted the reason why the court, which ruled in the previous ruling to cancel the administrative disposition of the MOHW, revealed it. The court explained that just because the MOHW's disposition was canceled, there was no reason to cancel the separate disposition, the NHIS' redemption measure, saying it was unfair. The court said, "The reason for canceling the disposition in an administrative lawsuit against the cancellation of the disposition of the MOHW is that there is a lack of proof of facts regarding 'part' of the reasons for the disposition." As a lack of proof of some of the reasons for disposition, it falls under the case where the presence or absence of the defect is revealed only when the facts are accurately investigated. It is difficult to say that the defect in the disposition of this case has reached a significant and obvious degree, it said. He then said, "It is a separate and independent disposition based on a separate provision of the (former) National Health Insurance Act, even though the facts and the previous disposition of the MOHW are common." The court said, "Even if the related disposition is canceled, the NHIS cannot be ordered to return the disposition because the degree of defect in separate disposition has not naturally reached invalidity. The pharmacist's claim is dismissed for no reason, it said.
- Policy
- Controversy rise over standards used in pricing negotiations
- by Moon, sung-ho Nov 11, 2021 06:00am
- “It may seem cruel for the smaller pharmaceutical companies, but it is important.” The National Health Insurance Services is expected to consider the ‘marketing and sales’ ability of pharmaceutical companies as a major criterion in estimating the ‘expected claims amount’ of the companies, which is an essential part in drug pricing negotiations. In other words, such abilities will be a major consideration in judging the ‘market share rate’ of drugs subject to negotiations. As marketing and sales abilities inevitably correspond to the size of the companies, controversy over this criterion will be inevitable in the future. # The NHIS held an online briefing session on ‘Guidelines for setting the expected claims amount’ for front-line pharmaceutical companies and explained the specifics of its implementation. The NHIS guideline could be considered as the standard used by the NHIS in setting the expected claims amount of a drug during pricing negotiations, a process that is mostly conducted for new drugs. The guideline will serve as a guide that shows what data is used to calculate the expected market size, growth, and share of a drug, depending on whether the drug has an alternative available, and how the expected claims amount is set. In the drug negotiation process, the NHIS had been continuously criticized for conducting ‘negotiations in the dark.’ The guideline is interpreted as the authorities’ groundwork to dispel such concerns and conduct transparent negotiations. The key item of focus among pharmaceutical companies was the method NHIS used to estimate the ‘market share’ of the drug subject to negotiation. This is because the NHIS will be estimating the market size and growth rate with predictable data such as the NHI claims data, claims amount, and the number of patients, but will reflect the characteristics of pharmaceutical companies to estimate the market share of the drug subject to negotiations. The ‘characteristics’ part of the pharmaceutical companies was designed so that the marketing and sales power of the companies will affect the results. In other words, marketing for the subject drugs and the number of sales representatives will be used to judge the expected market share of the drug, and this number could influence the drug pricing negotiations. Therefore, the NHIS said that the pharmaceutical companies will have to submit data on doctor surveys, hospital drug committee (DC) approval status, number of client clinics and hospitals, major pipeline, number of sales representatives, number of marketing PMs, and whether a domestic trial was conducted in the process of drug pricing negotiations. Se Rim Oh, Head of Team in the NHIS’s New Drug Management Division, said, “It may seem brutal for the smaller pharmaceutical companies, but new drug development requires more than just will. We need to be level in this aspect. Developing a new drug and future occupation of the market both require money.” Oh said, “Submitting a survey on doctors or data on the number of PMs or sales representatives at your company will help estimate the claims amount during the negotiation process. Even a small pharmaceutical company that has an excellent pipeline in its field and has enough clients, the aspects will be fully considered in our estimates.” In addition, the NHIS said that data from domestic claims companies may be used as a reference when the authorities estimate the total market size of the drug subject to pricing negotiations. However, this only applies when domestic or foreign data on the drug is virtually nonexistent. Some pharmaceutical companies have been submitting claims data from domestic pharmaceutical research institutions for support during the negotiation process, however, such data is not expected to be much help. Oh said, “NHIS’s claims data is more accurate than UBIST and IQVIA combined. However, we will consider using such data when identifying the market size. We may consider using the data if the domestic data or the NHIS claims data we have is limited.”
- Company
- What do scholars refer to as effective tx for myeloma?
- by Nov 11, 2021 06:00am
- With the release of various new drugs over the past decade, treatment results for multiple myeloma have been gradually improving. This is because as options vary, opportunities for "customized treatment" to select drugs depending on patients expand. Professor Eom Hyun-seok (left) and Professor Kwee Yong (right) who are conducting video talks Medical staff's attention is focused on which patients should be used to maximize the effectiveness. In particular, third-drug therapy centered on second-generation proteasome inhibitors (PI) is a trend in patients with first recurrence. As KRd therapy (Carfilzomib+ Revlimid +Dexamethasone) centered on Kyprolis and IRd therapy (Ixazomib+Revlimid+Dexamethason) centered on Ninlaro compete, the process of identifying appropriate drug choices considering drug characteristics and patient conditions continues. Takeda held an academic conference between British and Korean medical staff on the treatment of recurrent and refractory multiple myeloma according to patient characteristics such as disease risk and cytogenetic high-risk groups. Eom Hyun-seok, director of the National Cancer Center Hospital (Professor of Hematology and Oncology), an authority in the field of blood cancer, and Kwee Yong, a professor at University College London, participated in the meeting. Professor Eom Hyun-seok: What are the guidelines for selecting IRd and KRd as secondary therapies for patients with recurrent and refractory multiple myeloma? Professor Kwee Yong: Proteasome inhibitor and Lenalidomide combination therapy are very good methods in secondary treatment. Most patients will reach a therapeutic response with this combination therapy. The issue is which one to choose between IRd and KRd. The risk of the disease is first identified, and then whether it recurred early or aggressive. If the disease is aggressive and recurs early, has extra-bone marrow lesions, has high M protein levels, and the disease progresses quickly, KRd should be selected. However, patients should be young and able to visit the hospital every week. It is a very intensive treatment. On the contrary, if the condition is not aggressive and recurrence is not carried out early, so the progressive survival period (PFS) is at least 18 to 24 months, IRd will be selected. It is a fairly comfortable treatment for patients in many aspects. The side effects of KRd's Kyprolis require more careful attention. In particular, they have a history of heart disease or kidney damage. Professor Eom Hyun-seok: If so, can high-risk groups be classified into KRd according to the patient's risk and IRd if it is a general risk? Professor Kwee Yong: There is no clear standard. This is because IRd responses are very good even in patients who are genetically at high risk. If we have to make a distinction, the aggression of the disease, the pace of disease progression, and the burden of the disease will be more consistent. Professor Eom Hyun-seok: How do you see the use of IRd in multiple myeloma with advanced extra-bone marrow lesions? Professor Kwee Yong: Treatment is very difficult when extra-bone marrow lesions have progressed. In terms of experience, even if the reaction appeared, it did not last very long. I will choose a combination treatment based on proteasome inhibitors and IMiD, an immunomodulatory anticancer drug. Even when extra-bone marrow lesions progressed, there were cases in which the response was very good with IRd treatment. Professor Eom Hyun-seok: In the case of early recurrence, there may be characteristics of high-risk groups, and if the response appears slowly while presenting the case, the duration of the reaction will be extended. Is there anything additional to say about the reaction time and timing of recurrence? Professor Kwee Yong: First of all, I would like to tell you that there is not only one type of high risk of disease. Some high-risk factors speed up disease progression and respond quickly. Some patients with chromosome defects 17 are thought to have a single opposing genetic effect. The important thing is that treatment should be maintained. If treatment is stopped, it does not work. In some high-risk patients, such as chromosome 1 acquisition or chromosome 17 defect, it takes a long time to respond, but if treatment continues, it will be maintained well. Professor Eom Hyun-seok: In the case of the high-risk patients, it is important to continue treatment. Professor Kwee Yong: So the advantage of IRd is that it can continue to treat proteasomes inhibitors. It is difficult in VRd or KRd. Professor Eom Hyun-seok: Another part is about clinical practice. There are a variety of important clinical trials related to secondary treatment, which are slightly different from real world data, so you should be careful in interpreting these data. Professor Kwee Yong: There are several clinical trials and the number of previous treatments varies from one to three. However, most of the large-scale clinical trials were conducted before Lenalidomide was widely used. These clinical trials are not very useful these days because the proportion of patients exposed to lenalidomide was small and they were not refractory to lenalidomide. This is especially true if the patient has already received lenalidomide treatment. Clinical trials have shown good results for Renalidomide three-drug therapy such as Daratumab-Lenalidomide-Dexamethason, KRd, and IRd. However, when looking at the meta-analysis data, the margin benefit is similar. In addition, these clinical trials exclude many patients with poor performance data, patients with renal dysfunction, and patients with low platelet levels that we meet at the clinic every day. Professor Eom Hyun-seok: In Real World, it is very important whether the drug resistance or treatment continues. For patients, discontinuation of treatment is not the best, but I think excellent drug resistance is one of the biggest advantages of IRd.
- Policy
- RWD & RWE will be important means of use in post-evaluation
- by Kim, Jung-Ju Nov 11, 2021 06:00am
- Limited replacement is appropriate as a means of supplementing proven RC The quality of the site, which will be the standard, such as standardization of medical records at hospitals where data will be calculated. The task of government insurance authorities and the private sector is to increase patient access to very expensive and innovative new drugs, in other words, to make benefit entry smoother and faster. The government, the National Assembly, and the pharmaceutical community continue to consider revitalizing related systems such as the "the approval-benefit linkage system" and "post-registration evaluation," but the emergence of ultra-high-priced drugs cannot be covered by our evidence-based insurance system. The RWD and the work of processing it as RWE, and the movement and discussion to further systematize the evaluation area after the approach by reflecting the results in the policy are important. However, when this mechanism is actively used, there are many tasks to be prepared in the future, such as eliminating concerns about other harsh regulations or affecting all new drugs in the current system with RCT, and standardizing detailed standards in domestic clinical sites, which are one of private medical institutions. Several panels participated in the Innovation Research Symposium hosted by the HIRA on the 4th. Standards should be prepared at the level of field practice such as detailed standards, and guidelines. Like Kymriah, the emergence of ultra-high-priced drugs makes it possible to predict the future trend direction of new drug development and insurance-listed drugs. Therefore, it is clear that RWD and RWE will be important means of use in post-evaluation to enhance patient access and coverage when second, third, and fourth drugs challenge benefits one after another. On the premise of this justification, panels agree that detailed practical standards such as qualitative standardization and data collection at the current level and different medical records of private medical institutions should be established. Taking the case of Kymriah as an example, Bang Young-joo, an honorary professor at Seoul National University (CEO of Bang & Ock Consulting), said, "Kymriah is a drug that cannot be waited until 1,000 clinical patients are recruited. Since clinical characteristics and recruitment limits are different for each drug, we need to prepare a sample size setting standard. Park Jong-heon, head of the big data operation office at the NHIS, also mentioned the importance of setting practical standards through cases. When the corporation conducted a post-evaluation study of immuno-cancer drugs in the past, it conducted a study by linking health insurance-clinical data, and each hospital had different methods of providing data and doctors. Director Park said, "There are enough laws in place. However, he said, "I think it is necessary to form a sufficient consensus on the importance of RWD and RWE," and emphasized, "Since related guidelines have not been made, micro-linked methods and practical discussions such as standardization are needed." "Another regulation following RCT, limited use" vs "flexibility to enter benefits may be secured" The industry and the government's position on RWD and RWE was quite different. This could be an opportunity to make the hurdle barrier more flexible in the long run, as it is essential for the post-evaluation of ultra-high-priced drugs with high uncertainty, and questions about whether the new drug must be reevaluated as RWD's base production even after entering the benefit. First, Kim Joon-soo, chairman of the KRPIA Policy Committee, mentioned the case that Nice in the UK also prefers RCT and uses RWD limitedly if additional data are required when uncertainty is high in terms of cost effectiveness, such as anticancer drugs and rare disease treatments. Chairman Kim also stressed, "RCT is designed under the condition of pre-blocking for intermediate variables, so RWE is based on daily data, so it is not high in terms of reliability and low in level of evidence due to various environmental conditions and influencing variables." Lee Eun-young, director of Korea alliance of patients organization, said, "RCT is designed to be licensed and registered with data, but I know that RWE has emerged because the design and clinical results do not match at the clinical site. In addition, the government emphasized the justification for application. The government, which has introduced high-priced drugs into salaries, needs to look back on whether they were of appropriate value and reasonable cost afterwards. Choi Kyung-ho, an insurance drug officer at the MOHW, said, "Even if RCT is appropriate, I think RWE is necessary when registering ultra-high-priced drugs like Kymriah."
- Policy
- The MFDS consulted on Expedite Approval of COVID-19 PO
- by Lee, Tak-Sun Nov 10, 2021 05:55am
- The MFDS announced that it is conducting consultations with the company for rapid domestic approval on overseas developed COVID-19 oral treatments on the verge of commercialization. In the case of Molnupiravir, an oral treatment for MSD, the government plans to gradually introduce 404,000 people through a pre-purchase contract in February next year, which is expected to speed up discussions on the introduction of overseas COVID-19 treatments in Korea. Kim Mi-jung, head of the pharmaceutical standards division at the MFDS, briefly met with reporters at Osong on the afternoon of the 9th and made the announcement. Kim said, "In the case of oral treatments of MSD and Pfizer, we are conducting consultations on the scope and schedule of data submission for Expedite Approval," and explained, "However, actual data are not received." Kim added, "In principle, we plan to conduct safety, effectiveness, and quality screening for COVID-19 treatments," adding, "We plan to review them quickly when data are received." Prior to this, Kang Sung-sik, vice president of Pfizer Pharmaceutical's medical department, said at the 2021 Pfizer Press University held online on the 8th, "We are in close consultation with regulatory authorities including the MFDS." Paxlovid is expected to show that the hospitalization and death rate decreased by 89% compared to placebo when taken within three days of symptom onset as a result of interim analysis of phase 2 and 3 released on the 5th. MSD's oral treatment, which the government declared in February next year, also reduced the risk of hospitalization and death by about 50% as a result of a phase 3 interim analysis. Britain approved Molnupiravir, for the first time in the world on the 4th. As Korea promised to introduce it in February, it is expected to speed up its approval review. However, if the submission of data is delayed, it is highly likely to be introduced in Korea through procedures such as Expedite Approval. Kim said at a briefing that day, "Since the enforcement of the Data Limitation Act in July, the submission of a biological equivalence test plan has increased 2.5 times more than usual." Kim said, "If next year's result report is submitted, the MFDS will have more work." In addition, Kim said that she established a "comprehensive evaluation team for constant evaluation of impurities" consisting of about 20 people to prepare impurity evaluation technologies through information sharing with overseas regulators, as well as determine the cause. However, she added that there are no additional impurity issues other than the three Sartan types, which were decided to be recovered due to impurities in Azido in September. She is also considering recruiting about 50 people due to the expansion of overall permit screening work.
