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- 2026-05-20 05:23:44
- Policy
- Generic exclusivity is on the verge of change
- by Lee, Tak-Sun Jul 20, 2020 06:19am
- The system of generic exclusivity, which grants the monopoly of the market for 9 months to patented generic drugs, is on the verge of change. It is expected that the measures to improve the right to generic exclusivity that were promoted through the public-private council will soon reveal its outline. As the process of the meeting is delayed, it is expected to be achieved through amendments to the pharmaceutical affairs law this year. The goal is to improve generic exclusivity items. Generic exclusivity was introduced in 2015. With the signing of the Korea-US FTA, a licensed patent linkage system was introduced in 2012, and through the phased implementation process, generic exclusivity system that grants rights to the patent challenge generics was also introduced. Three conditions are required to obtain the generic exclusivity. The first is to claim the original drug patent for a judgment (void, passive confirmation of rights (avoidance) (However, companies that claim within 14 days of the first judgment are also recognized), the second is to win the patent trial (to establish a trial claim), and the third is to apply for permission as a generic for the first time. It seems difficult to obtain a right to generic exclusivity because all three conditions must be completed, but in reality it was not. A request was made to avoid deliberately asking to complete the requirements for the first trial, and when the request for trial was established, a request for permission to continue was filed the day after the end of the PMS. In particular, dozens of companies were bound to secure the right to dominate due to the trusteeship. Of course, some companies were conducting product development and patent challenges alone. However, in the case of new patents for granting re-examination, it was dominant that the simultaneous acquisition of generic exclusivity had to be generalized. Therefore, it is estimated that the plan to improve the right to generic exclusivity, which will be released soon, will contain content that makes it difficult to obtain the right. In particular, there are many opinions that the first judgment requirement should be removed from the expert group, and the government is also expected to implement it. If the initial judgment requirement is removed, the generic exclusivity is expected to return only to the first successful company for a patent challenge. As such, companies with advanced patent avoidance products are expected to benefit from generic exclusivity. However, as many generics frequently apply for approval after the termination of the new drug PMS, it is analyzed that the number of right to generic exclusivity will not be decreased significantly even if the first judgment requirement is deleted. However, even if the first trial was not filed, the view of the deletion of the first trial requirement in a positive way is that the company that succeeded in the patent challenge lately has the right to take advantage of the system, and it is possible to prevent the trial by not asking to meet the requirements. Instead, the number of copyrights is expected to decrease significantly if the exclusion for generic exclusivity of consigned items issued by the MFDS announced on the 16th. This is because, in the case of simultaneous acquisition of copyright, it is connected to one trustee and multiple trustees. However, it is also criticized that it can weaken a company's willingness to challenge patents through a consignment business. In addition, since the domestic pharmaceutical industry is linked to consignment regardless of the size of the company's sales, it is unlikely that the process will be easy as the pharmaceutical industry's opposition to 'excluding the right to consign goods' will be large. In particular, as the law needs to be revised, it is unclear whether the MFDS will be able to push forward the system, as various arguments are mixed in the process itself and parliamentary passage cannot be guaranteed. Some argue that the expansion of incentives to support the effectiveness of the right to generic for exclusivity can be achieved additionally. It means that the patent challenge generic can succeed in the market only by extending the 9-month period of the current monopoly and incentives linked to the drug price.
- Policy
- Integrating PMS with RMP to protect new drug information
- by Lee, Tak-Sun Jul 20, 2020 06:19am
- The post-marketing surveillance (PMS) system that monitors new drug’s adverse reaction experienced by patients to maintain the drug safety would be integrated with the risk management plan (RMP) review system. The number of investigated subjects would be reasonably adjusted and the data protection system for the authorized new drug would be created separately. On July 16, Korea’s Ministry of Food and Drug Safety (MFDS, Minister Lee Eui-kyung) announced a plan to revise the post-marketing drug safety management system that mainly focuses on integrating the current PMS with RMP, which aims to manage a drug safety in all lifecycle. Implemented from 1995, Korea’s PMS reevaluates safety and efficacy of new drug or some prescription drug by investigating adverse reaction reported from uncertain number of samples. The PMS system not only monitors adverse reaction reports after the product release, but it also protects product information and restricts follow-on drug’s marketing approval. The RMP, in effective from 2015, basically enforces new drugs and rare disease drugs to draw up and comply with comprehensive safety management plan including pharmacovigilance plan and routine risk minimization activities. But apparently, the public has been raising their voices demanding for a systematic improvement, as 77.5 percent of the RMP subjects were selected again as subject for PMS. To prevent redundancy and harmonize with international standard, MFDS intends to gradually implement the changes. For the first phase to be implemented by the end of the year, the redundancy in RMP and PMS would be removed. And by the end of 2021, the second phase would enhance the efficiency in RMP and by the end of 2022, the integrated RMP would cover the entire post-marketing safety management system. The three key amendments of the plan are harmonizing with the international post-marketing drug safety management system, streamlining pharmacovigilance system by reinforcing collected safety information, and establishing data protection system. The first phase would be on reasonably adjusting information submission criteria to remove redundant data submission by conducting RMP and PMS review simultaneously. The overlapping materials for regular report would prioritize RMP review, and the ‘post-marketing investigation’ section would be replaced by PMS. And for the post-marketing investigation fitting to each quality of drugs, the government plans to revisit the calculation of the number of subject based on prevalence rate and indications. Currently, the sample subject number is limited to 600 to 3,000, but the bracket would be better calculated according to the qualities of each product. The phase 2 of the policy revision would establish a legal basis and raise the administrative predictability by clarifying the compliance criteria. The key amendments are on integrating PMS and RMP subjects, improvising RMP submission period and procedure, reinforcing submission of periodic safety update reports, and strengthening adverse reaction analysis by priority review types. The third phase intends to unify the entire post-marketing safety management as a RMP review. The government aims to harmonize with the international standard of post-marketing drug safety management system by integrating PMS with RMP, and opening a data protection system. Minister Lee Eui-kyung said, “The importance of post-marketing drug safety management has been highlighted by monitoring the adverse reactions of drugs unpredictable at the time of approval and using the safe drugs,” and “the ministry would continue to strengthen the post-marketing safety management by gradually improving the system efficiency between the government and the industry.”
- Company
- Prescription performance has been recovering since June
- by Chon, Seung-Hyun Jul 20, 2020 06:19am
- The overall outpatient prescription growth in the first half of this year has slowed. It remained at the same level as last year in the aftermath of COVID-19. However, prescription performance has been recovering since June, unlike April and May. As the fear of COVID-19 spread in the first quarter, patients received prescriptions all at once and total prescription volume decreased in April and May, but it is analyzed that the prescription market has also been revitalized after the return to normal social activities. According to UBIST on the 15th, the total outpatient prescription amount in the first half of last year was ₩7.35 trillion, a 0.02% decrease from the previous year. Although the prescription performance has been growing every year, it has been slowing down this year. Rx amount & increase/decrease rate in the first half of each year (Unit: ₩100 million, %, Source: UBIST)The prescription amount in the first half of last year rose 6.9% from the previous year. In the first half of 2017 and the first half of 2018, the prescription amount increased by 5.6% and 8.1%, respectively. The prescription amount in the first quarter was ₩3,703 billion, an increase of 2.7% from the previous year. However, the prescription amount in the second quarter decreased by 2.7% to ₩3,647.4 billion. In the first and second quarters of 2019, the outpatient prescription prices rose 5.5% and 8.3%, respectively, compared to the previous year, but the prescription market was sluggish in the second quarter of this year. It is analyzed that the prescription market in 2Q was slow in the aftermath of COVID-19. It is analyzed that a large number of prescription gaps occurred in the second quarter as patients who were reluctant to visit medical institutions, especially those with chronic diseases, were prescribed large quantities of medicines at a time. It has been reported that the number of patients receiving prescriptions for 3 to 6 months in advance increased significantly when the number of COVID-19 confirmed patients increased. In addition, it is estimated that the number of visits to hospitals may have decreased as the frequency of disease occurrence among infants and children has decreased due to factors such as postponement of school, social distance, and strengthening of personal prevention of epidemics. Quarterly Rx amount trend (Unit: ₩100 million, Source: UBIST) The size of the prescription market in January was ₩1.25 trillion, a 4.4% decrease from the same period last year. However, the prescription amount in February increased by 13.0% to ₩1.21 trillion. As New Year holidays were pulled to January earlier than the previous year, the increase/decrease rate of the prescription amount in January and February was analyzed to vary. In March, the total prescription amount increased to ₩1.23 trillion, up 1.4% from the previous year, and the prescription market in the first quarter remained stable despite the spread of COVID-19. In the second quarter, the outpatient prescription amount in April was ₩1.19 trillion, a 8.7% decrease from the same period last year. In April 2018 and April 2019, the prescription amount increased 8.3% and 13.1%, respectively, compared to the same period last year, but this year it has declined. In May, the total outpatient prescription amount was ₩1.16 trillion, a decrease of 9.4% from the previous year. It fell 1.8% from April, the lowest this year. Monthly outpatient Rx amount trend (Unit: ₩100 million, Source: UBIST) It is interesting to note that the prescription market has recovered rapidly since June. The prescription scale last month was ₩1.26 trillion, 11.7% higher than last June. Prescriptions in June 2018 and 2019 rose 5.0% and 3.0%, respectively, from the previous year. It was significantly higher than the previous year despite COVID-19 outbreak. the prescription drug market in April and May was temporarily sluggish due to the fear of COVID-19 in the first quarter, and it seems to have regained growth from June. In particular, when the number of COVID-19 confirmed patients surged mainly in Daegu & Gyeongbuk, the sales activities of pharmaceutical companies also contracted significantly. Since the first COVID-19 confirmed patient in Korea on January 20, pharmaceutical companies have refrained from visiting salesmen to medical institutions. Since the middle of February, the number of COVID-19 patients has increased rapidly, and most of the pharmaceutical companies' salespeople have entered telecommuting. A significant number of patients received long-term prescriptions at one time and it is analyzed that they caused a prescription gap in April and May. The prescription drug market seems to have recovered since the spread of COVID-19 patients began to stabilize in April and social distance campaign had shifted to distancing in daily life. The size of prescription amount in the market is also estimated to have stabilized since June. In the industry, it is continually increasing due to the increase of the elderly and chronic patients. It is said that the entire industry will not contract due to short-term issues such as infectious diseases. According to the analysis, unlike the tourism and cultural industries, it is difficult to lead to a sudden recession because the pharmaceutical industry is affected by patient demand rather than the external environment.
- Policy
- Minister Park is trying to preliminarily secure Remdesivir
- by Lee, Jeong-Hwan Jul 20, 2020 06:19am
- Minister Park Neung-Hoo, from the MOHW said he is trying to maximize the estimated number of seriously ill patients in Korea to preliminarily secure the Remdesivir, known as a cure for COVID-19. One of the criteria for the distribution of Remdesivir around the world is the number of seriously ill patients, so it aims to do its best to ensure that it meets domestic demands as much as possible. On the 15th, at the general meeting of the Welfare Committee of the National Assembly, Minister Park responded to the question of Kang Ki-yun, a member of United Future Party. Kang Ki-yun pointed out that if Remdesivir is effective in COVID-19 treatment, securing a lot in a short period of time is part of preemptive prevention. He pointed out that it was not enough that the KCDC had requested only 5,360 special import from Gilead, a developer of Remdesivir. "People are anxious about COVID-19," said he. "If there is no currently available remedy other than Remdesivir, it is necessary to secure them in reserve quickly and accelerate the development of COVID-19 treatments to relieve public anxiety." Minister Park responded that Remdesivir was proven to be effective, but it is not a totally curable drug, and is committed to negotiating preliminary security with the largest estimate of seriously ill patients in Korea. Minister Park said, “Remdesivir reduces the length of hospital stay by 31% in clinical trials. It is not a completely curable drug, and Seoul National University Hospital is participating in clinical trials and the results are coming out.” He added, “One of the criteria for distributing Remdesivir to countries around the world is how many patients are seriously ill and we are negotiating excessively with the expected number of patients." Minister Park said, "The government and Korean pharmaceuticals are working day and night to develop COVID-19 domestic treatments. I expect that there will be a domestic treatment available by the end of the year."
- Product
- Eventually, Fulcare’s YouTube Ad is deleted
- by Jung, Heung-Jun Jul 20, 2020 06:18am
- Deleted video capture When Mennarini Korea's athlete's foot drug Fulcare’s YouTube advertisement raised a problem saying that Ads excluded pharmacist skills, the pharmaceutical company deleted the video and began to rectify it. The content of the controversial advertisement is a scene where Another patient who was waiting for a patient who visited the pharmacy for athlete's foot symptom recommends Fulcare. Pharmacists protested that it was “an advertisement that ignored pharmacies and pharmacists,” and on the morning of the 15th, some local pharmacist societies called for an immediate cessation of advertising. When the controversy broke out, Menarini Korea apologized to the pharmacists for the inappropriate image, and immediately switched the controversial video to private. An official from Menarini Korea said, "The video in question was immediately removed. It will not be used in the future. This video has hurt the pharmacists who have worked hard and dedication in the front line of the public health." "We take the matter seriously and prepare a plan to prevent recurrence," he said. This is an explanation that the consultation and product recommendation were intended to be included in the video. However, it may be illegal for the pharmaceutical affairs law to be referred to as 'expert recommendation'. Also, it was intended to highlight the fact that it is OTC drug and can only be purchased at a pharmacy. Considering that it is an online video for consumers, he also conveyed the intention of making such as the point that the patient tried to express the part explaining his or her disease. The official said, "It is entirely wrong to fail to reflect carefully, and we are sincerely sorry for the confusion and inconvenience caused by this." also he added, "we will do our best to actively reflect the opinions of pharmacists in all future marketing activities and avoid recurrence." Then, the reason why this advertisement was controversial can be found by looking at the ‘Guidelines for Provision of Information on Drug Ads and Rx drugs’ by the MFDS. In the guidelines, doctors, dentists, and pharmacists are not allowed to recommend and guarantee medicines in advertisements. This is because, according to the guidelines, the characteristics of the social perception of the healthcare practitioner have a large impact on consumers perception of the medicine. In addition, it is judged that it is against the regulations for entertainer and the public to wear gowns to make them look like pharmaceutical experts. Accordingly, pharmaceutical companies produce advertisements in a manner recommended by the general public. "pharmacist should not recommend it. It can be seen as a violation for entertainer to wear a pharmacist's gown. Therefore, in the pharmaceutical industry, advertisements are presented in a way that the general public explains or recommends." he said. This Fulcare’s YouTube ad was shot especially in the pharmacy, so the pharmacists were against it. The official said, "There weren't many commercials in the background of the pharmacy. If this was done outside the pharmacy, the situation may have been different."
- Company
- Rx of NOAC is recommended in COVID-19 epidemic
- by Eo, Yun-Ho Jul 17, 2020 05:55am
- NOAC products in KoreaThe need for prescription of New Oral Anti-Coagulant (NOAC) is also emerging in COVID-19 outbreak. NOAC does not require periodic INR (International Normalized Ratio) monitoring, thus reducing visits to clinics unlike Warfarin. For this reason, NOAC is a good treatment option for patients who are unable to go to the hospital or need long-term prescription due to self-isolation. At the Anticoagulation Forum (AC Forum), which consists of antithrombotic therapists around the world, Warfarin-treated patients who can convert to NOAC are recommended to switch to NOAC to minimize the risk of COVID-19 exposure because frequent hospital visits increase the risk of exposure to COVID-19. Similarly, the National Institutes of Health (NIH) published in the '2020 COVID-19 Treatment Guidelines' included the need to consider switching from Warfarin to NOAC for isolated patients, and many societies including the Royal Pharmaceutical Society in the UK have worked together to establish guidelines for the safe switching from Warfarin to NOAC in March this year. The guidelines provide detailed information, including a patient population that can switch from Warfarin to NOAC, a safe switching process, and features and checklists for each NOAC product. .An official from the Korean Heart Rhythm Society said, “I agree with the recommendation to expand the NOAC prescription in COVID-19 situation .I think NOAC is a drug that can be prescribed by clinics ."Things are different now .I think it will not be a problem if the condition of the patient, such as renal function, is checked and prescribed according to the permission,." Meanwhile, according to the '2018 KHRS Expert Consensus Recommendation for Oral Anticoagulants Choice and Appropriate Doses: Specific Situation and High Risk Patients', 'Eliquis (Apixaban, NOAC)' is first recommended for high-risk patients with advanced age, decreased renal function, and gastrointestinal bleeding .This drug has been confirmed by ARISTOTLE, a major clinical trial, to reduce the risk of stroke and systemic embolism, and to reduce the risk of major bleeding and mortality, compared to Warfarin in patients aged 75 years and older.
- Company
- Korean-made IMD Rosuzet and Zemimet prevail over COVID-19
- by An, Kyung-Jin Jul 17, 2020 05:55am
- Apparently a number of incrementally modified drugs (IMDs) developed with Korean-made technology excelled in the prescription drug market amid novel coronavirus (COVID-19) pandemic. A dyslipidemia combination drug Rosuzet and an antidiabetic combination drug Zemiglo recorded two-digit growth and settled on the top chart in the prescription drug market. On the contrary, other off-patent drugs by multinational pharmaceutical companies seemed to have stagnated in the growth. According to pharmaceutical market research firm UBIST on July 17, Pfizer Pharmaceutical Korea’s Lipitor was prescribed the most in the first half of the year, making 94.1 billion won. Although the sales fell by 0.9 percent compared to 95 billion won in last year, Liptior made more than double the sales of Daewoong Bio’s Gliatamin. Lipitor product image Lipitor, indicated to treat dyslipidemia, is an atorvastatin Pfizer Pharmaceutical Korea has launched for the Korean market in 1999. When its patent was expired, over 130 generics flooded the market, but the dyslipidemia drug has never been ranked below second place in the prescription drug market. Daewoong Bio’s cognitive enhancer Gliatamin generated total 48 billion won in the first half of the year, and came second on the rank. Compared to last year same time with 46 billion won, the drug made 4.4 percent growth. Gliatamin is a choline alfoscerate generic. Another competitor Chongkundang Gliatirin has made 39.8 billion won with 6.9 percent growth from last year, but it could not narrow the gap of 8 billion won with Gliatamin. Rosuzet (left) and Zemimet product images Among the top products, Hanmi Pharmaceutical’s Rosuzet had the highest yearly growth. Rosuzet generated 46.9 billion won in the first half of the year and leapt 24.4 percent from last year. Bascially, it was prescribed 8 billion won a month. Released in late 2015, Rosuzet is a combination drug (rosuvastatin plus ezetimibe) indicated for treatment of hyperlipidemia. Hanmi Pharmaceutical signed a deal with the ezetimibe patent owner MSD over the use of the drug, and entered the market first. The drug is dominating the same substance market among other competitors by far. The monthly Rosuzet prescription volume maintained over 10 percent growth compared to last year, regardless of the difficulties in sales and marketing caused by COVID-19. When the confirmed case of COVID-19 in Korea skyrocketed from February through March, the prescription volume growth broke through the 30-percent and 40-percent line. Continuing the current trend, the drug could generate over 100 billion won at the end of the year. Zemimet, an antidiabetic combination drug by LG Chem, also scored a high growth rate. In the first half of the year, Zemimet’s prescription surged by 18.5 percent from last year at 32 billion won to 37.9 billion won this year. LG Chem independently developed the dipeptidyl peptidase 4 (DPP-4) inhibitor by combining the novel antidiabetic treatment Zemiglo (gemigliptin) and metformin. With the co-promotion deal signed in 2016, Daewoong Pharmaceutical has been in charge of the drug’s sales. Atozet, MSD Korea’s combination drug for hyperlipidemia treatment, also demonstrated two-digit growth. The accumulated prescription volume in the first half of the year was increased by 17.5 percent from last year and generated 36.4 billion won. Atozet is a combination drug, consisting of atorvastatin and ezetimibe, which competes against Rosuzet. The drug is currently in a co-marketing deal with Chong Kun Dang since 2018. Top 20 outpatient prescription drug market in 2020 H1 (Unit: KRW 100 million) Source: UBIST Similarly to previous years, the outpatient prescription drug market in the first half of this year was vastly dominated by off-patent drugs. But their growths were underwhelming than previous years. Two hepatitis B treatments once led the prescription drug market plummeted down the rank together. Gilead Science Korea’s Viread (tenofovir disoproxil fumarate) made 43.1 billion won with a 27.3-percent plunge from last year at 59.2 billion won. This year’s prescription of BMS Pharmaceutical Korea’s hepatitis B treatment Baraclude (entecavir) marked 34.8 billion won, dipping 10.8 percent from 39 billion won last year. Eisai Korea’s cognitive enhancer Aricept (donepezil) and Astellas Pharma Korea’s benign prostatic hyperplasia (BPH) Harnal-D (tamsulosin) generated 8.0 percent and 8.2 percent less than last year, respectively. AstraZeneca’s anticancer treatment Tagrisso (osimertinib) placed itself on the top sixth spot by generating 44.7 billion won with 7.9 percent growth from last year. Tagrisso is a second-line treatment for patients with non-small cell lung cancer, who developed tolerance after administering epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) like Iressa (gefitinib), Tarceva (erlotinib) or Giotrif (afatinib). After it was listed for healthcare reimbursement in December 2017, the treatment’s prescription volume has been surging significantly. Despite the expensive treatment costing 120,000 won even for a reimbursed prescription, it is the only anticancer treatment ranked high in the outpatient prescription drug market, due to its convenience in oral administration.
- Policy
- Generic pricing negotiation from Sept to protect patients
- by Lee, Hye-Kyung Jul 17, 2020 05:55am
- Korea’s National Health Insurance Service (NHIS) plans to negotiate pricing on generics from September. On July 15, NHIS submitted briefing material for the National Assembly provisional session that elaborated the outcomes of the healthcare coverage enhancement (Moon Jae-in Care) and the government’s prospective plan to lower medical expense and reinforce safety net system. According to NHIS, its plan is to sign a National Health Insurance (NHI) reimbursement contract with generic drugs listed without pricing negotiation to enforce quality management compliance for the protection of the patient safety. And with constant rise in treatment material expenditure, the government body would analyze expenditure increase by listing types, and manage the use volume based on reasonable pricing and adjustment. To lessen the medical expense burden of the people with the Moon Care, the government is also gradually expanding the coverage on eye, chest and breast ultrasound scan in the latter half of the year as the initially non-reimbursed female reproductive system ultrasound scan was covered from last February. Following are other plans NHIS has for the coverage enhancement initiative; publishing production cost manual to standardize production cost calculation and improving credibility by adding more panel institutes like a national university hospital to provide production cost information; inducing improvement in medical service use behavior by providing counseling and medical service use history of multiple healthcare institute users and general hospital users for mild condition; promoting adequate use of drugs in chronic disease patients taking multiple medications via counseling visitation. NHIS’ big data analysis center operating with 192 seats and 525 accounts at ten sites nationwide would be expanded to provide high-quality NHI big data for research purpose. Moreover, the government would provide support on developing customized health service model and healthcare policy. NHIS stated the non-contact operation format would get more prevalent within the agency amid the post-coronavirus, and infectious disease monitoring and notification system and infection control at long-term nursing hospitals would be established.
- Policy
- Domestic vaccine development for COVID-19 aims at 2021
- by Lee, Jeong-Hwan Jul 17, 2020 05:55am
- It is expected that the government will start a clinical trial of COVID-19 blood plasma therapy in early September and will be able to secure treatments throughout the year. Antibody therapies, except for blood plasma therapies, are scheduled to go through clinical trials, and the government expects that antibody therapies will be secured in Korea in the first half of next year. Although the government aims to complete vaccine development within 2021, it is difficult to determine the timing of development because of the many variables and the additional factors required for actual administration. Kwon Jun-wook, Deputy Director of the Central Disease Control Headquarters, said in a Q-and A session after a briefing on the current situation of COVID-19 in Korea. The Central Disease Control Headquarters explained that Forty-two serious ill patients are taking Remdesivir, an Ebola treatment, using a re-creation (repositioning) method related to COVID-19 treatment. In addition, he said that Plasma therapy is the first to be promoted as a therapeutic agent. He said that vaccine development is the key to COVID-19's response. The Central Disease Control Headquarters aims to mass-produce vaccines that have achieved safety and effectiveness within 2021. However, he said that the development of vaccines has many variables, so it is impossible to guarantee the final development time. In particular, it is explained that there are many additional tasks required for development of vaccines such as delivery strategies, supply and demand, transportation systems, inoculation personnel, inoculation priority, safety monitoring, and development formulation. "The development of plasma therapy is being promoted. Lilly, a large-scale multinational company, is currently conducting phase III clinical trials quickly," said he. Korea is expected to make a blood plasma therapy for clinical trials this week with the participation of COVID-19 confirmed patients. He said, "However, it takes a month for the blood plasma to be formulated. The manufacturing and processing process itself is complicated, and pooling, testing, and toxicity tests are also required." and he added, "In Korea, the clinical trial for blood plasma drugs begins in early September, and the goal is to secure blood plasma drugs within the year." "The development of antibody treatment systems other than blood plasma treatments are under development as planned. Antibody therapy drugs are clinically targeted to be secured in Korea in the first half of next year," said Vice President Kwon. “Vaccines have various platforms, different expert evaluations, and there are DNA vaccines or mRNA, etc.” He said that a lot of efforts are being made to develop vaccines around the world and Mainly, three domestic companies are trying to develop vaccines. "Our goal is to mass-produce vaccines that have demonstrated safety and effectiveness in Korea within 2021," he added.
- Company
- 2nd single-agent immunotherapy added for NSCLC first-line
- by Eo, Yun-Ho Jul 16, 2020 05:55am
- Another immunotherapy is expected to be added as a first-line treatment option in lung cancer. The pharmaceutical industry sources reported, Roche Korea has recently submitted an application to Korea’s Ministry of Food and Drug Safety (MFDS) to indicate programmed death-ligand 1 (PD-L1) inhibiting immunotherapy Tecentriq (atezolizumab) as a first-line treatment in non-small cell lung cancer (NSCLC). When Tecentriq’s indication expands in Korea, it would directly compete against MSD’s PD-L1 inhibitor Keytruda (pembrolizumab) in the NSCLC treatment market. Tecentriq’s efficacy as a first-line treatment in NSCLC was confirmed in a clinical trial ‘IMpower110.’ The study compared the immunotherapy against chemotherapy in treating 572 of PD-L1-selected, chemotherapy-naïve patients with Stage 4 or later NSCLC without ALK or EGFR mutations. The result found the efficacy of Tecentriq performed better than chemotherapy in patient group with PD-L1-stained in over 50 percent of tumor cells (TC), or PD-L1-statined tumor-infiltrating immune cells (IC) covering over 10 percent of tumor area. The Tecentriq administered group reached overall survival (OS) at 20.2 months, improving the figure by 7.1 months compared with chemotherapy at 13.1 months. Also for progression-free survival (PFS), the Tecentriq group (8.1 months) demonstrated better than the chemotherapy group (5 months). However, comparing the groups with TC over 1 percent but less than 50 percent, and IC over 1 percent but less than 10 percent, the improvement by Tecentriq is statistically insignificant. Accordingly, the U.S. Food and Drug Administration (FDA) has indicated Tecentriq for the first-line treatment of patients with TC over 50 percent or IC over 10 percent, and the company applied for indication expansion in Korea with the same standard. Meanwhile, Keytruda has been in a discussion with the government for over two years about extending the coverage on single and combined-agent first-line treatment in NSCLC. After the Cancer Deliberation Committee has deferred the decision last month, the coverage extension has returned to the Cancer Deliberation Subcommittee. But reportedly, the health authority and the company have not reached a clear agreement.
