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- 2026-05-12 09:47:17
- Company
- The power of FDA-approved new drugs
- by Chon, Seung-Hyun Dec 08, 2022 06:05am
- SK Biopharm announced on the 6th that it won the "Tower of Exporting $100 million" at the 59th Trade Day ceremony held at COEX in Gangnam-gu, Seoul on the 5th. SK Biopharm's independently developed innovative new drug, Cenobamate, surpassed $100 million in exports to the U.S. and Europe from July 1, 2021, to June 30, 2022. This is the first time that a domestic pharmaceutical company has won the top $100 million in exports with a single innovative new drug developed by itself. Cenobamate is a new drug for epilepsy that SK Biopharm has independently carried out the entire process from initial development to FDA approval. It is prescribed for adult epilepsy patients with partial seizure symptoms. It is an action mechanism that alleviates seizure symptoms by simultaneously controlling two targets related to excitatory and inhibitory signaling that cause epilepsy. Cenobamate has been licensed to market by the U.S. Food and Drug Administration (FDA) in 2019 and is being sold under the product name XCOPRI. Since May 2020, it has been selling directly through SK Life Science, a local subsidiary in the U.S. Cenobamate has been on the rise every quarter since its local release in the U.S. It exceeded 10 billion won in the first quarter of last year and exceeded 20 billion won in the fourth quarter of last year. It recorded 31.7 billion won in the first quarter of this year and achieved high gains in both the second and third quarters. Cenobamate's cumulative sales in the U.S. were estimated at 200 billion won. Last year, it joined hands with its partner Angelini Pharma to enter the European market under the product name "ONTOZRY." The Export Tower Awards are held on Trade Day on December 5 every year under the auspices of the Korea International Trade Association. The association awards the "Tower of Exports" to exporters who have contributed to Korea's international status and economic development over the past year.
- Opinion
- [Reporter's view] A plan to expand the reference country
- by Lee, Tak-Sun Dec 08, 2022 06:05am
- The pharmaceutical industry is strongly opposed to the government's plan to expand drug price reference countries. Although the Ministry of Health and Welfare says it has gone through a sufficient discussion process, the industry is strongly criticizing it as a one-sided push. The revision of the HIRA's administrative notice on the 21st of last month calls for expanding the comparative reference countries of PE drugs to two countries. It is to add Canada and Australia to the current reference countries such as the United States, Japan, the United Kingdom, Germany, France, Italy, and Switzerland. On the 5th, the KRPIA clarified its opposition that the amendment seriously undermines access to new drugs for patients with severe and rare diseases, as well as hinders the development of the domestic pharmaceutical industry. The KRPIA said, "There are cases where benefits are delayed or abandoned due to too low prices and difficulties in insurance registration in Korea, but this amendment will delay the introduction of new anticancer drugs and severe and rare diseases, seriously affecting patients' access to new drugs." Multinational pharmaceutical companies with many new drugs are expressing concerns that the expansion of reference countries could lower the price of related drugs. The domestic pharmaceutical industry, which focuses on generic business rather than new drugs, is also strongly opposed to the revision. This is due to concerns that the revision of the expansion of reference countries could be used to re-evaluate registered drugs in the future. Moreover, Australia argues that the price of generic drugs in Korea will inevitably be lowered further if the re-evaluation is carried out due to the low price of generic drugs. Based on the results of policy research conducted in 2019, the government claims that the revision has been sufficiently collected as it has been discussing the revision by forming a working-level association with the pharmaceutical industry for four months since May this year. However, as expected from the announcement of the implementation of the revision bill in January next year, which is opposed by the pharmaceutical industry as a whole, it cannot be said that the opinions of both sides have been well collected. The Korea RPIA also expressed regret that the government unilaterally pushed ahead with the announcement of policy results focused only on reducing drug costs without drawing a reasonable agreement with the industry. In order to push for a proposal that the parties are opposed to, there must be a good reason, but it is difficult to understand even if you look at the reasons for the Far from persuading the parties, it is questionable why this amendment is necessary to anyone who is a third party. The HIRA announced in advance that it has prepared the revision to enhance transparency and clarity and supplement validity due to the long and insufficient formula for calculating adjusted prices that convert drug prices from seven overseas countries. However, there is a lack of explanation as to why the existing calculation formula lacks evidence and whether additional inclusion of Australia and Canada complements transparency, clarity, and validity. The revision is known to be based on the "Measures to Improve Reference Standards for Foreign Pharmacists" conducted by Gachon University's Industry-Academic Cooperation Group in 2019. In this study, Taiwan as well as Canada and Australia were added to the existing seven countries. The reason for the addition is that Canada and Australia have similar economic levels as Korea, and HTA (medical technology evaluation) plays an important role in the process of determining drug benefits. In the case of Taiwan, it was added because the economic level and health insurance system were similar and geographically close. However, it is reported that Taiwan was excluded because it was conscious of China. However, this explanation seems to be insufficient as a justification for Canada and Australia to be added to the reference countries among many countries. In addition, it is not known why it is a problem to charge drug prices with the existing seven countries as reference countries. Although pharmaceutical companies strongly oppose the revision during the period of submitting their opinions on the revision, it is under the impression that the government is not properly explaining the legitimacy of the revision. In this way, even if the amendment is implemented, it is difficult to avoid criticism that it is a hasty push.
- Company
- Immunotherapy shows effect as first-line treatment for BTC
- by Dec 08, 2022 06:05am
- Biliary tract cancer has long remained an area in which no new drug has been developed. Following targeted therapies, immunotherapies have led to remarkable advances in anticancer treatment, but biliary tract cancer has been neglected in terms of developing new drugs. This is because it has a lower prevalence rate than other cancers like lung cancer or stomach cancer, and even lower incidence in the West, which has been leading the development of new drugs. In this area with minimal progress, AstraZeneca’s cancer immunotherapy Imfinzi obtained indication in Korea and abroad as a first-line treatment in biliary tract cancer. In Korea and abroad, Imfinzi became the first immunotherapy to be approved as a first-line treatment in biliary tract cancer, and this latecomer among immunotherapies beating its competitors like Keytruda and Opdivo and won the “first” title. One thing to note is that a Korean medical team led to Imfinzi’s global approval in biliary tract cancer. Professor Do-Youn Oh’s persuasion was what moved the pharmaceutical company to pursue this unattended area. At the European Society of Medical Oncology (ESMO) Asia Congress 2022 that had been held on the 2nd (local time) in Singapore, Professor Oh said, “I believe the biggest achievement that has been made is that Imfinzi’s first approval as a first-line treatment in biliary tract cancer opened the stage for other immunotherapies to take on research into the field of biliary tract cancer.” Professor Do-Youn Oh Around 10 years ago, Professor Oh proposed an investigator-led trial to pharmaceutical companies that own cancer immunotherapies after finding out that immunotherapies show relatively higher effects in biliary tract cancer. However, companies at the time were more focused on cancers that have many patients and showed little interest and a low understanding of biliary tract cancer itself. Oh recalled, “I proposed a clinical trial on biliary tract cancer to all companies that own cancer immunotherapies at the time. I offered to test the drug myself to AstraZeneca’s clinical team. The company accepted my offer, and so began the investigator-led Phase II clinical trial. The trial went well thanks to the AstraZeneca team's active engagement. Professor Oh and AstraZeneca designed a detailed and thorough clinical trial after long discussions. They added 2 cohorts and enrolled more subjects. Based on the anti-tumor effect and safety confirmed in Oh’s trial, a global Phase III trial was initiated, and Professor Oh took the role of principle investigator (PI) in the Phase III TOPAZ-1 trial. The TOPAZ-1 trial was a success. The Imfinzi arm (Imfinzi+ gemcitabine + cisplatin) showed a 20% improvement in overall survival (OS) versus the placebo arm (placebo+ gemcitabine + cisplatin). Further analysis showed a higher OS improvement of 24% in the Imfinzi arm. At 2 years, the 2-year survival rate in the Imfinzi arm was 23.6% compared with 11.5% in the placebo arm. Median PFS (mPFS) was 7.2 months for the Imfinzi arm, a 25% improvement over the 5.7 months shown in the placebo arm. Also, the Imfinzi arm achieved an objective response rate (ORR) of 26.7% (91 cases), 2.1% (7 cases) of which showed complete response, and 24.6% (84 cases) showed partial response. Based on Oh’s investigator-led trial and TOPAZ-1 results, the US FDA approved Imfinzi for the treatment of biliary tract cancer. Furthermore, the National Comprehensive Cancer Network recommended Imfinzi as the standard (Category 1) first-line treatment in biliary tract cancer. For the first time, a cancer immunotherapy drug was listed as a standard of care in a field that only had chemotherapy options. This was a very unusual case where a clinical trial initiated by a Korean healthcare professional led to global approval and a standard-of-care designation. Professor Do-Youn Oh is presenting her findings at the ESMO Asia Congress 2022 Even after the approval, Professor Oh is busy conducting further analysis on TOPAZ-1. At the ESMO Asia Congress, Oh presented results on the impact of mutation status on efficacy outcomes in the TOPAZ-1 trial. The result of the study, which was the first to analyze the effect of cancer immunotherapies according to mutation status, was that there was no significant difference in the effect of cancer immunotherapies depending on the presence or absence of major mutations. Professor Oh referred to the entry of Imfinzi in biliary tract cancer as a ‘starting point’ that opens the stage and drives the development of biliary tract cancer treatments. In other words, an area that has not been tried due to lack of knowledge and lack of interest has opened up for research. Oh said, “With the TOPAZ-1 study, people have come to recognize that immunotherapies can be developed for biliary tract cancer as well. With so many cancer immunotherapies of various mechanisms of action in development, the biggest significance held by the success of the TOPAZ-1 trial is that the stage has been set for these to be tested in biliary cancer as well.” Above all, Oh expressed pleasure in providing new hope for biliary tract cancer patients. Professor Oh said, “Polarization of treatment options exists in the field of cancer as well. Some cancers offer many treatment options, others less than few. Biliary tract cancer was one of those that had almost no available treatment options. Whenever my patients asked why they can’t use immunotherapies, all I could do was tell them that a research was underway. With an immunotherapy option now available for biliary tract cancer, I look forward to more progress being made in the field and various more studies to come.”
- Product
- MFDS' statement of consent to Rx of the active ingredients
- by Kang, Shin-Kook Dec 07, 2022 05:55am
- While Oh Yoo-kyung, the head of the Ministry of Food and Drug Safety, said, "I agree" with the prescription of the ingredient name, he took a step back, saying in an official letter sent by the Ministry of Food and Drug Safety to the doctors' organization. According to an official letter sent by the Ministry of Food and Drug Safety to the Korean Medical Association on the 5th, "As the current form of the division of medicine is agreed upon through consultation, the prescription of ingredient names and product names is considered to be a matter of social consensus such as medicine led by the competent ministry." The Ministry of Food and Drug Safety's official letter is a reply to a protest sent by the Medical Association to the Ministry of Food and Drug Safety. In an official letter to the Ministry of Food and Drug Safety in October, the Medical Association criticized, "Prescription of active ingredients is a serious matter that damages the doctor's right to prescribe and patients' right to care and health." Director Oh briefly responded to Seo Young-seok's claim to introduce a prescription for ingredient names during a parliamentary audit on October 20, saying, "I actively agree." Oh's remarks eventually drew opposition from the medical community. Led by the Pediatric and Adolescents Association, the Internal Medicine Association also criticized Oh's remarks, claiming "selective division of labor." Pharmacist groups also issued a series of counter statements, saying, "It is the professional selfishness of doctors to stick to the prescription of the product." In the end, the controversy over the prescription of the ingredient name turned into a lawsuit between the Pediatrics Association and the Seoul Pharmaceutical Association. Why were doctors so opposed to the remarks of the head of the Ministry of Food and Drug Safety, who was not in charge of prescribing active ingredient names? The analysis that the biggest reason is a special situation called the Corona pandemic is gaining traction.
- Policy
- Only K-CAB continues to be applied refund-type PVA
- by Lee, Tak-Sun Dec 07, 2022 05:55am
- HK Inno.N’s ‘K-CAB Tab’ is the only drug that is applied the refund-type Price-Volume Agreement (PVA) system in Korea. The fact that the system is only applied to homegrown new drugs, and some companies do not prefer double pricing caused by refunds are pointed to as reasons for the low utilization rate of the PVA system. The National Health Insurance Service announced this at a training session organized by the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) on the revision direction of the 'drug pricing negotiation guideline' and how to conduct drug pricing negotiations. The refund-type PVA is a system that allows pharmaceutical companies to maintain the insurance ceiling price of their drugs rather than undergo price cuts by refunding a portion of the pharmaceutical expenditures back to the authorities when a drug is subject to pricing negotiations with NHIS due to increased usage. The system is advantageous for domestic pharmaceutical companies that plan to emerge into overseas markets because their listed drug price is set higher than the actual drug price. The refund-type PVA system had been introduced in 2014 to encourage and foster exports of homegrown new drugs. However, the conditions required to be eligible for the system are strict. Only drugs from Korea Innovative Pharmaceutical Companies that meet the Health Insurance Review and Assessment Service’s standards as a ‘drug that affects healthcare’ may apply for the system. Therefore, drugs whose entire process was manufactured in Korea and was approved as a first-in-class drug, or drugs for which the clinical trials for approval were conducted in Korea, or whole annual R&D investment ratio to annual sales exceed that of the average invested by Korea Innovative Pharmaceutical Companies are eligible to apply for the refund-type PVA. When taking into account drugs that have given up domestic release and drugs that have not considered overseas expansions, only a few drugs are eligible to use the refund-type PVA system among the 36 approved homegrown new drugs, This is why only the new gastroesophageal reflux disease drug K-CAB and new hypertension drug Kanarb (Boryung Pharmaceuticals) had signed a contract for the refund-type PVA so far. In the case of Kanarb Tab, the company signed a refund-type PVA contract in August 2015. Without extending the contract term in 2018, its insurance price ceiling was lowered in August 2018 under the PVA system. Accordingly, the price of Kanarb 60mg, which was listed at KRW 665 in March 2016, was lowered to KRW 653. In the case of K-CAB, its company signed a contract with NHIS in June last year and applied the refund-type PVA. Although the drug was eligible for ceiling price cuts, the company decided to refund the increased pharmaceutical expense to the NHIS and maintain its ceiling price. Accordingly, the price of K-CAB 50mg is currently maintained at KRW 1,300 since its listing in 2019. This year, K-CAB became subject to monitoring under the PVA system for the second time. During the monitoring period, the refund amount is deducted from the claims amount for analysis. If K-CAB’s usage increases further, negotiations will be held to set an additional refund rate compared to the existing refund rate. If the refund contract is terminated or a generic is listed, the ceiling price is lowered to the predetermined price. Since K-CAB’s contract was signed last year, the ceiling price of KRW 1,300 will be maintained until June 2024. However, its actual price is expected to be less than this due to the two PVA negotiations that were conducted until now. The maximum price reduction rate during PVA negotiations is set at 10%. The industry is claiming that the system’s scope application should be broadened to activate the refund system. A pharmaceutical industry official said, "This system, which can only be used for homegrown new drugs, should be applied to incrementally modified drugs (IMDs) so that pharmaceutical companies can increase their options and decide between lowering their drug price or making refunds."
- Policy
- Vaccine sales reached 3.4178 trillion won in Korea last year
- by Lee, Hye-Kyung Dec 07, 2022 05:55am
- About half of the companies complain of difficulties due to lack of funds in the research and commercialization process. Last year, domestic sales in the vaccine industry totaled 3.4178 trillion won and exports amounted to 628.7 billion won. The Ministry of Health and Welfare (Minister Cho Kyu-hong) and the Ministry of Trade, Industry, and Energy (Minister Lee Chang-yang) selected 159 companies through a full survey and announced the results of the 2021 Korea Vaccine Industry Survey, including domestic sales, exports, employment, and investment. As a result, domestic sales totaled 3.4178 trillion won, with 2.6865 trillion won in vaccine finished products, 86.5 billion won in vaccine raw materials, 69.4 billion won in vaccine equipment, and 636.1 billion won in vaccine-related services. Exports to the vaccine industry totaled 628.7 billion won, with 563.7 billion won in vaccine finished products, 141 billion won in vaccine raw materials, 43 billion won in vaccine equipment, and 73.3 billion won in vaccine-related services. Investment in the vaccine industry is expected to increase year-on-year, considering the ongoing or planned facility investment of more than 13 trillion won, including 214 billion won in R&D and 117.4 billion won in facility investment. According to the survey, 159 domestic vaccine companies were found to have 29.6% of vaccine finished products, 32.1% of vaccine raw materials, 15.1% of vaccine equipment, and 35.8% of vaccine-related services. Based on the headquarters, these companies were concentrated in Seoul (53, 33.3%), Gyeonggi (51, 32.1%), and the size of the business was 3.1% (5), 26.4% (42), and 70.4% (112), which is quite high compared to the total manufacturing industry. Based on the established capital, 90% (143 pure domestic capital), 5% (foreign capital), and 5% (foreign capital) were found to be joint ventures (foreign capital + domestic capital). More than 10,758 people worked in vaccine-related departments, and my job, 4,715 (43.8%), 2,772 (25.8%) were researchers, and 3,271 (30.4%) were in other jobs such as sales and management. According to a survey of corporate difficulties experienced by vaccine companies, they cited the difficulties in R&D in the order of lack of funds (47.2%, 75 companies), lack of professional manpower (25.2%, 40 companies), and lack of infrastructure (22.0% and 35 companies). In the process of commercialization, there are difficulties in the order of lack of funds (40.3%, 64 companies), lack of information such as market trends (24.5%, 39 companies), and lack of professional manpower (20.8%, 33 companies). The survey was conducted by KPBMA, KSCIA, and KoDATA, a credit survey and evaluation agency, and is meaningful in that it conducted the first survey specializing in the vaccine industry. The government plans to start reviewing the domestic vaccine industry survey next year after consultation with the National Statistical Office, considering the connection, consistency, and population design with the bio-industry survey conducted annually by the Ministry of Trade, Industry, and Energy. Meanwhile, the Ministry of Health, Welfare and the Ministry of Trade, Industry and Energy jointly held a public-private vaccine industry innovation forum today (6th) to introduce private R&D and investment tax credits for vaccines and bio industries, K-bio and vaccine funds, smart factory construction, low-interest financing projects, and overseas expansion projects. The government plans to increase the size of the company and provide timely pan-ministerial support tailored to the growth cycle so that the vaccine industry can grow into a solid hub industry leading the bio-industry in the future, and provide customized support for each ministry.
- Policy
- Reimb of antidiabetic SGLT-2+DPP-4 combo near
- by Kim, Jung-Ju Dec 07, 2022 05:55am
- Reimbursement of antidiabetic SGLT-2+DPP-4 class combinations near Expanding reimbursement to the combined use of SGLT-2 inhibitors and DPP-4 inhibitors as treatment for diabetes has entered its final stages. As the reimbursement will be carried out through voluntary price cuts by pharmaceutical companies as intended by the government, the process may proceed faster than when companies take the drug price negotiation track. However, the fiscal burden on NHI finances, which remains the biggest issue, depends on the size of the voluntary price cuts that will be made by pharmaceutical companies. Therefore, agreeing on the amount of the price cuts may continue for several months. Extending reimbursement to the combined use of three ingredients including SGLT-2 inhibitor class and DPP-4 inhibitor class drugs had been deferred several years due to various reviews and procedures, such as integrating the opinions of the Korean Diabetes Association, analyzing their fiscal impacts, and revising phrases for reimbursement standards. Chang-Hyun Oh, Director of the Pharmaceutical Benefits Division of the Ministry of Health and Welfare explained to the multinational pharmaceutical company press corps, “We have completed analysis on the fiscal impact and selected drugs that will be sharing finances with the reimbursement expansion, and explained to the 10 companies that will be affected on how they will be required to share finances. We are currently collecting opinions from the companies.” As the reimbursement requires changes in the drug price, both the payer and the supplier must agree on the price cut. According to MOHW, all the companies have agreed on making voluntary price cuts and will be subject to voluntary price cuts rather than drug pricing negotiations. The time required for reimbursement can be shortened with voluntary price cuts, as it is a sort of fast track system that allows the omittance of pricing negotiations. This is beneficial for both the government and the payers as it can reduce the financial burden on NHI finances and the company can also raise more sales with extended reimbursement standards. However, the government and the companies still need to reach an agreement after comparing the scale of voluntary price cuts and the amount of NHI finances the government is willing to share. Even afterward, the agenda needs to undergo remaining administrative procedures including signing the quality supply contract and making reports to Health Insurance Policy Deliberation Committee. Therefore, the government explained that it is unsure how long it would take for reimbursements to be extended. Director Oh said, “I can't guarantee that the remaining procedures (such as the opinion collection from companies and other follow-up procedures) will be completed within the month. All companies must sign quality supply contracts with NHIS and complete other procedures. The reimbursement extension can be implemented quicker if its fiscal impact is not so large, but if the parties involved do not reach a complete agreement, the implementation may be further delayed.
- Company
- Oral Exon20 targeted Exkivity to apply for reimb in Korea
- by Eo, Yun-Ho Dec 06, 2022 07:55pm
- The EGFR Exon20 insertion mutation targeted oral therapy ‘Exkivity’ is attempting reimbursement listing in Korea. According to industry sources, Takeda Pharmaceuticals Korea is preparing to apply for reimbursement of ‘Exkivity (mobocertinib), its treatment for non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. Although the drug targets the same biomarker as Janssen Korea’s ‘Ryvrevant (amivantamab),’ Exkivity is different as an oral formulation. EGFR Exon20 insertion mutation is a new biomarker that is newly receiving attention in the field of NSCLC. Targeted anticancer therapies that are currently available for prescriptions include those that target the Exon19 deletion or Exon21 L858R substitution mutations that are commonly found in EGFR mutations, but an unmet need had existed for EGFR Exon20 insertion mutations. Therefore, the industry’s eyes are on whether Exkivity will succeed in reimbursement listing with Ryvrevant failing to pass deliberations by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee. Meanwhile, Exkivity demonstrated its efficacy through a Phase I/II trial which enrolled 114 patients with EGFR Exon20 insertion-positive NSCLC who received prior platinum-based therapy. In the trial, patients who were treated with a 160 mg dose of Exkivity showed an objective response rate (ORR) of 28% as well as a median duration of response (DoR) of 17.5 months per independent review committee (IRC). In particular, the median time to response after Exkivity treatment was 1.9 months, demonstrating the rapid effect it shows from the beginning of treatment. The median progression-free survival (mPFS) was 7.3 months, and the median overall survival (mOS) 24.0 months. The safety profile was also manageable. The most common adverse reactions were diarrhea, rash, fatigue, etc, and were manageable through dosage adjustments.
- Policy
- One-shot Zolgensma fulfills terms of its RSA contract
- by Kim, Jung-Ju Dec 06, 2022 05:57am
- Zolgensma (onasemnogene abeparvovec), the ultra-high-priced ‘one-shot treatment’ that succeeded in receiving reimbursement in Korea in May this year, will start fulfilling the terms of its risk-sharing agreements (RSA) contract. If the drug was administered at the time its reimbursement was approved in Korea, the medical institutions that administered Zolgensma would need to prepare a report on the effectiveness of the drug every 6 months and submit it to the Health Insurance Review and Assessment Service for 5 years. HIRA’s New Drug Performance Management Division issued a notice to the hospital community that contains the ‘Operation Plan for the Performance Management of Zolgensma inj’ to inform the medical institutions that use the drugs on the need to carry out the RSA contract. Zolgensma is a new treatment for spinal muscular atrophy (SMA) that had attracted social attention in the long term for being an ‘ultra-high-priced new drug.’ Despite being a one-shot treatment that can provide a transformative effect with a single administration, its insurance reimbursement listing had remained a challenge due to its very high price. In Korea, only 7 patients are expected to be eligible for its use, but the expected pharmaceutical expense for the 7 patients amounted to KRW 13.87 billion. The drug was applied for reimbursement in August. Its insurance ceiling price in Korea had been agreed on at KRW 1.98 billion under RSA after pricing negotiations with the National Health Insurance Service. The terms of the RSA contract were built around the financial-based RSA with an added outcome-based RSA. Zolgensma was applied the Refund type, Expenditure Cap type, and Patient-unit performance-based type RSA in its reimbursement. The refund type mandates the company to refund a certain rate (refund rate) of the claims amount, the Expenditure Cap type mandates the company to refund an amount that exceeds a prespecified amount (Cap), and the Patient-unit performance-based type where the pharmaceutical company refunds a certain proportion of the expenditures when treatment fails after following up on the treatment outcome of each patient. Therefore, to fulfill its patient-unit performance-based RSA, long-term follow-up evaluation data must be prepared and submitted to HIRA. Data must be submitted to HIRA on the progress of patients who have been administered Zolgensma every 6 months for a total of 5 years by the attending physician and the affiliated medical institution that signed an agreement to conduct the long-term follow-up study for administering Zolgensma. The attending physician can evaluate the treatment response and effect in line with the evaluation period after dividing the period into 10 terms. In addition, the patient's motor function evaluation result sheet and progress record sheet, etc., can be submitted to the system on the medical institution’s work portal by the end of the month of each evaluation period. However, HIRA’s system for the submission is in development, so the data must be submitted via notified email until the development is complete. HIRA plans to distribute related manuals in the future.
- Company
- ImmuneOncia targets niche market in cancer immunotherapy
- by Dec 06, 2022 05:57am
- “NK/T-cell lymphoma is a niche market that has no approved immunotherapy. After completing the trial in Q2 next year, we plan to promptly receive approval and extend our indication if we see good results.“ Heung Tae Kim, CEO of ImmuneOncia Therapeutics Inc On the 3rd (local time), Heung Tae Kim, CEO of ImmuneOncia Therapeutics, expressed his aspirations at the ‘ESMO Asia Congress 2022’ that was held in Singapore. ImmuneOncia is a new cancer immunotherapy drug-developing company that was established as a joint venture company between Yuhan Corp and the US bio-company Sorrento. The company owns various pipelines including the PD-L1 antibody IMC-001 and the CD47 antibody IMC-002, etc. The results that were presented were interim analysis results of a domestic Phase II trial that enrolled 13 patients with relapsed or refractory NK/T cell lymphoma who failed to see an effect with ‘L- asparaginase,’ the standard therapy. Professor Won-Seog Kim of the Hemato-Oncology Department at Samsung Medical Center presented the findings at the Mini Oral session on Haematological malignancies. Interim analysis efficacy results of Phase II IMC-001 trial (Source: ESMO Asia) Interim analysis results showed that of the 10 evaluable patients, 6 showed a response (ORR=60%), and all patients that showed a response had a complete response (CR=100%). 4 of the patients have continued treatment for at least 1 year. Based on the results, the evaluation was that the drug produced excellent results in terms of drug safety and continued response. The drug also was acceptable in terms of safety. No cytokine release syndrome hematologic toxicity that commonly arises with the use of immuno-oncology drugs was observed. Only 1 patient was observed with Grade 3 uveitis. During the clinical trial, 3 patients adjusted the medication period due to side effects, and 1 patient was delayed due to COVID-19 infection. The major adverse reactions were fatigue, headache, skin rash, and itching, most of which were mild and manageable. Interim analysis safety results of Phase II IMC-001 trial (Source: ESMO Asia) Professor Kim said, “Due to the small number of patients that were analyzed, we cannot conclude that IMC-001 is a far superior treatment, but I think it is at least similar or slightly superior (compared to existing immuno-oncology drugs). Although the survival period of recurrent patients is only 4-6 months, 4 out of 6 patients that responded to IMC-001 have survived long-term, receiving treatment for over a year. IMC-001 is a PD-L1 immunotherapy. Other drugs with the same mechanism of action include the global blockbuster ‘Keytruda (pembrolizumab)’ which sold over KRW 2.1 trillion and ‘Opdivo (nivolumab)’ which sold KRW 1 trillion globally. However, the two drugs do not indicate NK/T-cell lymphoma, the disease IMC-001 is being studied for. Professor Won-Seog Kim, Samsung Medical Center NK/T-cell lymphoma is a rare EBV-associated lymphoma. 90% of Asians are infected with the virus. Although an ordinary person would have no problem when infected, when immunocompromised, the dormant virus is activated and causes cancer. The current treatment option mainly consists of radiation and chemotherapy, but the 2-year recurrence rate is 75%. The company plans to start the approval process immediately after completing the clinical trial by Q2 next year and receiving the final data. ImmuneOncia will also actively promote the technical export of IMC-001 for its global entry. CEO Kim said, “We plan to first preoccupy the niche market through rapid domestic commercialization, then gradually expand its scope of indications. Also, we plan to promote technology exports to Asian regions including China, where many patients remain. We plan to reapply for the technical evaluation around Q3 next year."
