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- 2026-05-14 01:42:42
- Policy
- MFDS prepares clinical trial guidelines for COVID-19 drugs
- by Lee, Hye-Kyung Oct 06, 2022 06:05am
- The Ministry of Food and Drug Safety (Minister: Yu-Kyung Oh) published and distributed the ‘Clinical trial guideline on antiviral treatments for mild-to-moderate COVID-19 infections’ to support the rapid development of COVID-19 antivirals by guiding companies on the new clinical outcome parameters and methods for designing flexible clinical trials. The guideline was prepared to promote the preparation of a rapid clinical support platform to support the development of COVID-19 vaccines and treatments, which was part of the 100 Tasks for Food and Drug Regulatory Innovation that the MFDS had announced on August 11th. The guideline contains the additional new clinical outcome parameters required for clinical trials on mild-to-moderate COVID-19 patients and includes considerations that need to be made in selecting subjects, clinical treatment effect evaluation methods, efficacy evaluation, and in designing and performing clinical trials. The existing clinical outcome parameter was effective in preventing severe COVID-19, however, due to the decrease in severe COVID-19 patients, this parameter had made it difficult to perform clinical trials. Therefore, a new indicator had to be inevitably set in line with the COVID-19 situation, which is why the government added symptom improvement as a new parameter. The MFDS said, “the addition of the new clinical outcome parameter will aid rapid development of treatments by enabling easier progress of clinical trials, including faster recruitment of clinical trial subjects. We have improved the predictability and transparency of the trials by allowing companies to introduce an adaptive design in preparing clinical trial protocols so the number of test subjects can be appropriately changed based on the results of the interim analysis.” Also, if the company has received approval for a clinical trial plan in advance, the trial can be conducted without additional approval, which is also expected to help reduce the period. As the trial is conducted on infectious patients, the guideline also guides companies on the major considerations that require attention when conducting non-face-to-face clinical trials and case studies. More information can be accessed on the MFDS website (www.mfds.go.kr) > Legislative data > Resources > Guide/Guidelines.
- Company
- Daewoong Pharmaceutical launches botulinum drug in the UK
- by Chon, Seung-Hyun Oct 06, 2022 06:05am
- The botulinum toxin drug developed by Daewoong Pharmaceutical has been released in earnest in the European market. Daewoong Pharmaceutical announced on the 5th that Nabota, a botulinum toxin drug, was officially released in the UK under the product name Nuceiva. It started selling in the UK last month through Daewoong Pharmaceutical's overseas partner Evolus. The UK is the largest single market in Europe, accounting for about 30% of the European botulinum toxin market worth 650 billion won per year. Evolus, a North American and European beauty indication partner of Daewoong Pharmaceutical, is in charge of Nuceiva's distribution and marketing in the UK. Evolus formed a strategic partnership with Wigmore, a local British distributor with a history of more than 35 years, and established a specialized distribution network. Since the beginning of this month, the latest knowledge and Nuceiva product training have been conducted for local medical personnel. Daewoong Pharmaceutical and Evolus will also enter other European countries with high marketability, such as Germany and Austria, to target the European market in earnest. Park Sung-soo, vice president of Daewoong Pharmaceutical, explained, "With the release of Nuceiva in the UK, we have officially entered the U.S. and Europe, the world's No. 1 and No. 2 botulinum pharmaceutical markets." "We will actively promote Nabota's excellent product power in the global market and contribute to enhancing K-Bio's status," he said.
- Company
- ILSUNG signs 3rd generation CCB HTN tx co-promotion
- by Lee, Seok-Jun Oct 06, 2022 06:05am
- ILSUNG, Intro Bio Pharma, and Pharmavision, have signed a partnership for Azelnidipine copromotion. According to ILSUNG on the 4th, Intro Bio Pharma received the first approval in Korea for Azelnidipine-based medicine in September 2021. Azelnidipine is a third-generation CCB hypertension treatment (Calblock) developed by Daiichi Sankyo Korea in Japan. Compared to Amlodipine, it has excellent blood pressure drop effect and fewer side effects, so it is most commonly used in Japan along with ARB hypertension treatment. It is known to have an excellent blood pressure control effect when used in combination with ARB series. Intro Bio Pharma and Pharmavision selected ILSUNG, which has strength in general hospitals, as a partner for Azelnidipine. Amlodipine has recently passed the Pharmaceutical Affairs Evaluation Committee and is expected to be listed. What is unique about this three-way contract is that Pharmavision, a research, and development venture that was established in 2019 and has completed the transfer of about 20 pharmaceutical technologies to many pharmaceutical companies so far. Based on R&D technology, Azelnidipine cooperation between Intro Bio Pharma, a pharmaceutical R&D venture company Pharmavision, and ILSUNG, which is taking a leap forward through innovation, can be a new B2B model. Kim Byung-jo, head of ILSUNG's development division (executive director, Ph.D. ), said, "Azelnidipine can be a new alternative for hypertension patients who have difficulty controlling blood pressure with Amlodipine or Lercanidipine HCl CCB hypertension treatment." Through three-way cooperation, it will become a necessary and differentiated item for patients.
- Company
- Koselugo is keen to discuss the registration of benefits
- by Eo, Yun-Ho Oct 05, 2022 06:11am
- Attention is focusing on whether Koselugo, a drug-free treatment for neurofibroma, will succeed in registering insurance benefits. According to related industries, AstraZeneca's new neurofibromatosis drug Koselugo is under final coordination at the Drug Benefit Standards Subcommittee. AstraZeneca quickly supplemented the data in May and resumed discussions on registration at the HIRA Drug Benefit Evaluation Committee in March. As it is a rare disease area where there were no treatment options, it remains to be seen whether Koselugo will be able to draw a decision this time. Neurofibroma has relied on symptomatic treatment without proper treatment. Neurofibroma is a rare disease in which tumors occur in nerve tissue, bones, and skin, and about 85% are type 1 in which the NF1 gene of the 17th chromosome long arm is mutated. This disease begins with 1~3cm sized cafe au lait macules appearing in children. It experiences symptoms such as brain tumors at the age of 6 and scoliosis at the age of 6 to 10. In adults, Lisch nodule, which occurs in the iris, is mostly found. It is a method of removing possible areas through surgery or chemotherapy and radiation treatment. However, most of the surgeries recur, and most of them are major surgeries, so both medical staff and patients are burdened. In particular, pediatric patients often have to take painkillers even after several surgeries and suffer from speech and motor disorders. Koselugo is a treatment jointly developed by AstraZeneca and MSD. It blocks MEK activity and inhibits cell line growth. In the SPRINT phase 2 clinical trial on which the permit was based, Koselugo reduced tumor size by more than 20% in 68% of administered patients, achieving the primary evaluation index, ORR. In addition, 82% of patients who showed partial reactions continued to respond for more than 12 months. Half of the patients who did not receive treatment suffered from disease progression after 1.5 years, and only 15% of the patients who used Koselugo developed the disease up to three years ago.
- Opinion
- [Reporter’s View] Real crisis will come after COVID-19
- by Kim, Jin-Gu Oct 05, 2022 06:11am
- Contrary to the hopes that peace will come with the end of the COVID-19 crisis so near, another crisis of the ‘three highs’ - high exchange rates, high interest rates, and high inflation – has now arrived. Experts are predicting shock waves at the level of the 1997 IMF crisis and the 2009 global financial crisis or severer. Externally, the exchange rate, trade balance, and current account are shaking at the same time. Internally, red lights are flaring in Korea’s growth rate, price level, and interest rates. The future outlook is also bleak. Negative prospects are pouring in, that the low growth will continue for the time being, resulting in fewer jobs and a contraction in investment. Some analysts believe we have already entered stagflation, in which high inflation and economic downturn occur at the same time. Obviously, the domestic biopharmaceutical industry cannot be immune to this macroeconomic trend. The high exchange rates, high interest rates, and high inflation constrain the pharma and bio companies from all directions. Anxiety is growing bigger and bigger, and with the growing anxiety, companies contract. Given that the long-term investments made by the industry are just beginning to bear fruit, concerns are being voiced that the potential of the K-pharmaceutical and bio industry will be nipped in the bud, without blooming to its full potential. The Korean pharmaceutical and bio industry is considered to have made good progress during the past 3 years in the COVID-19 crisis. Some companies have used the crisis as an opportunity to grow significantly or to attract large-scale investments. It is not that the industry has fared well, but it is difficult to say that the COVID-19 crisis has been overcome solely by the capabilities owned by Korea’s pharmaceutical and bio industry. Pharmaceuticals are consumer staples, therefore, the industry was not greatly affected by the surge of confirmed COVID-19 cases or strengthened social distancing measures, etc. Also, much of the cash released through the quantitative easing measures competitively carried out by countries had flowed into the industry. In such a sense, it is true COVID-19 did not greatly impact the pharmaceutical industry as much as other industries. The government believes that COVID-19 will turn into an endemic by early next year. The pandemic is finally coming to an end. With the declaration of an endemic so near in sight, the pharmaceutical and bio companies are now on the testing bed. How well the companies have built their foundation will be tested in the era of the ‘three highs.’ Experts have contrasting views on how long the factors of concern represented by the ‘three highs’ will last. However still, one thing certain is that the companies must now brace for the long-term recession that is certain to come. Executives would need to make cool-headed judgments about the situation and set the right direction. The real crisis has only just begun.
- Company
- Moderna's Spikevax bivalent Original/Omicron BA.1
- by Oct 05, 2022 06:11am
- Moderna announced on the 4th that it conducted Spikevax bivalent Original/Omicron BA.1 launch Webinar, a divalent vaccine containing omicron, on September 29. At the event, Jin Beom-sik, head of the Infectious Medicine Center at the National Medical Center, was the chairperson, and Kim Hee-soo, vice president of Moderna Korea's medical department, was the speaker. With a total of 2,124 participants, the next generation of COVID-19 showed keen interest in the vaccine by domestic medical staff. Spikevax bivalent Original/Omicron BA.1 is a next-generation bivalent vaccine that combines 25μg of the existing Moderna COVID-19 vaccine and 25μg of a vaccine candidate substance targeting the omicron mutation (BA1). On the 8th of last month, it was approved for emergency use by the Ministry of Food and Drug Safety as a vaccine to prevent COVID-19 over the age of 18. From the 11th, a divalent vaccine can be vaccinated. The main announcement on this day is phase 2/3 clinical data that evaluated the efficacy of Spikevax bivalent Original/Omicron BA.1. In this clinical trial, Spikevax bivalent Original/Omicron BA.1 met all major evaluation variables, including neutralizing antibody responses, compared to existing COVID-19 vaccines in participants without a history of COVID-19. The divalent vaccine booster shot increased the GMT for Omicron by eight times. Spikevax bivalent Original/Omicron BA.1 induced stronger neutralizing antibody transliteration for omicron sub mutants BA.4 and BA.5. Based on pre-vaccination, the geometric mean multiple increases (GMFR) for BA.4 and BA.5 mutations was 6.3 times that of the divalent vaccine, which was 3.5 times greater than that of the conventional vaccine. These results were consistent regardless of the presence or absence of COVID-19, including those aged 65 or older. Spikevax bivalent Original/Omicron BA.1 showed an effect consistent with the reactivity and safety profile of the currently approved booster. An official from Moderna Korea said, "According to the recently announced government's COVID-19 vaccination plan, timely vaccination with the latest vaccine is an effective way to protect the health of the public from the potential re-proliferation of COVID-19 this winter."
- Policy
- Data for reevaluation to be submitted from the 24th
- by Lee, Tak-Sun Oct 05, 2022 06:11am
- The data submission system for reevaluation of listed drugs that was set to be operated as of the 1st of this month will be operated from the 24th. The authorities plan to receive data submitted before then through the Health Insurance Review and Assessment Service’s e-mail. With the data submission system not being initiated in time, the industry has repeatedly been pointing to the administration's lack of preparation. Voices are continuing to rise in the industry to postpone the reevaluation of listed drugs in consideration of the circumstances, including the COVID-19 situation. According to the industry on the 3rd, HIRA has been notifying through associations that the data submission system for reevaluation of listed drugs that was set to be serviced from the 1st will be serviced from the 24th. Data submission is important to prove as the drugs subject to evaluations need to meet the reevaluation requirements or receive discounted ceiling prices depending on their degree of satisfaction. The health authorities have been requiring companies to submit data proving that the standard requirements were met to HIRA from the 1st of this month to February 28th next year. The standard requirements that need to be submitted are self-bioequivalence test data or evidence of clinical trial performance; and documents proving the use of APIs registered in the Drug Master File (DMF). If the subject drug satisfies both requirements, the ceiling price is maintained as is; however, if the drug satisfies only one of the two requirements, the price is reduced to 85%, and to 72.25% if both requirements are not met. As most listed drugs satisfy the DMF requirement, the self-bioequivalence test data will become the determining factor for the price discounts. The Ministry of Health and Welfare first applied the requirements to drugs that were newly listed from July 2020, and provide a grace period of 3 years for previously listed drugs. Therefore, the price adjustments for the listed drugs are planned on July 2023. To meet the self-bioequivalence test requirement, companies have switched their consigned products to in-house production and conducted self-bioequivalence tests. However, the COVID-19 outbreak in 2020 rendered the progress of the tests difficult, raising the suggestion that the entire revaluation schedule should be postponed. However, the MOHW decided to conduct the reevaluation of listed drugs as scheduled with some exceptions, with the goal of making price adjustments in July next year at the Health Insurance Policy Deliberative Committee meeting that was held on the 29th. However, the Ministry of Food and Drug Safety extended the data submission deadline for some oral preparations and sterile preparations among prescription drugs that were designated and subject to bioequivalence tests by 5 months, and the reports will be accepted if they are submitted by the end of May. Data on all other items will have to be submitted to HIRA by February 28th next year, as initially scheduled. Data submissions started on October 1st, but the authorities will have to wait another 20 days before the electronic window opens. Of course, the companies may submit their data via e-mail, but complaints about the delay in the industry are fierce as they are already pressed for schedule. An industry official said, “The government seems to not be ready to conduct the reviews that they have hurried the companies to prepare. With the 20-day delay in the data submission system, I wonder whether HIRA will be able to complete the review within the set period for the NHIS to complete pricing negotiations.
- Policy
- Pfizer Corona vaccine passed a verification advisory group
- by Lee, Hye-Kyung Oct 05, 2022 06:10am
- The Ministry of Food and Drug Safety (Director Oh Yoo-Kyung) announced on the 30th that Pfizer Pharmaceutical's COVID-19 vaccine "Comirnaty 2 0.1mg/mLP (Initial Virus of COVID-19, Omicron (BA.1)") passed the COVID-19 vaccine safety and effectiveness verification advisory group. The advisory group held a meeting on the 29th and proved its effectiveness in comparing the immune response of the neutralizing antibody with the existing vaccine after inoculating "Comirnaty 2 0.1 mg/mL", and judged safety to be similar to the existing vaccine. Seven people, including infectious medicine specialists and vaccine and pharmaceutical experts, attended the meeting of the verification advisory group. The Ministry of Food and Drug Safety will refer to the results of vaccine experts' consultation on the safety and effectiveness of the vaccine, including infectious medicine specialists, and quickly and closely review the submitted clinical, nonclinical, quality, and GMP data to decide whether to approve it. The Ministry of Food and Drug Safety said, "We will continue to do our best to supply safe and effective vaccines to our people."
- Policy
- Post-marketing surveillance of breast cancer drug Kadcyla
- by Lee, Hye-Kyung Oct 04, 2022 06:07am
- A total of 31 serious adverse reactions (ADRs) whose causal relationship cannot be ruled out had been reported as results of the 8-year post-marketing surveillance (PMS) on Roche Korea’s second-line breast cancer treatment ‘Kadcyla (trastuzumab emtansine).’ With 163 additional cases of unexpected ADRs whose causal relationship cannot be ruled out also being reported in the same period, Kadcyla’s label will be changed. The Ministry of Food and Drug Safety announced it will change the label for Kadcyla inj. 100mg and 160mg according to the reevaluation results as of December 28th. Kadcyla received domestic marketing authorization in January 2014 to treat patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who had previously received trastuzumab and a taxane (separately or in combination). The drug has been approved for reimbursement since August 2017 in Korea. Also, the drug was also additionally approved by the MFDS as an adjuvant monotherapy for patients with early HER2-positive breast cancer who had residual invasive disease after completing neoadjuvant therapy containing trastuzumab and taxane in August 2019 and was listed for reimbursement in July this year. At the time of the Health Insurance Review and Assessment Service’s reimbursement evaluations, the committee deemed Kadcyla’s pharmacoeconomic evaluation results to be at an acceptable level compared to its competitor Herceptin and acknowledged that the drug was listed in all A7 countries. Through drug pricing negotiations with the National Health Insurance Service this year, the company agreed with the authorities on adopting the utilization cap type of the Risk Sharing Agreement and set the price at KRW 1,956,328 per vial for the 10mg dose and at KRW 2,930,920 per vial for the 160mg dose. Results of the post-marketing surveillance that was conducted on 520 patients over the past 8 years showed that the incidence rate of adverse events were 74.63% (338/520 patients, 1590 cases) regardless of causal relationships. Serious adverse events were reported in 12.69% (66/520 patients, 90 cases) of the patients. As a result of the 6-year post-marketing surveillance conducted in 307 patients for the reevaluation, pleural effusion will be deleted and erythema and infection in the catheter area, bacterial arthritis, COVID-19, infectious spondylitis, and mastitis added as serious adverse events. Among these, 4.23% were serious adverse drug reactions (22/520 patients, 31 cases), based on which vomiting, shortness of breath, and pulmonary edema will be added to the label. The MFDS said, “We plan to change the label according to the Pharmaceutical Affairs Act and the Regulation on Safety of Drugs, etc. We ask hospitals, clinics, and pharmacies to ensure proper use of the drug.”
- Opinion
- [Reporter's view] Reimbursement of Zerbaxa
- by Eo, Yun-Ho Oct 04, 2022 06:07am
- Super antibiotic Zerbaxa will receive insurance benefits from this month. It is the first time in about five years that a domestic permit has been granted. The government's response to the application of the PE system to some of the national essential drugs, especially in the face of the seriousness of antibiotic resistance issues internationally, has made new antibiotic drugs. Even though it is not a "life-threatening disease," the need for important drugs has been recognized. Zerbaxa was approved in Korea in April 2017, but the prevailing view was that it was difficult to register under the system at the time. This is because new antibiotic drugs are not easy to prove cost-effectiveness compared to existing conventional drugs, and it is difficult to prove clinical superiority due to the nature of the drug. In fact, an application for Zerbaxa was submitted in the second half of 2018 and went through the procedure, but failed to pass the HIRA Drug Benefit Evaluation Committee in 2019. Since then, the government has implemented an improvement plan to include essential drugs such as antibiotics in PE targets as a way to expand coverage. The government designated antibiotics as PE targets, limiting the scope of antibiotics to antibacterial agents such as Zerbaxa. The medical concept of antibiotics refers to antimicrobial medics, which encompasses antimicrobial agents (treatment of bacterial infections), antimicrobial agents (treatment of fungal infections), and antiviral drugs (treatment of viral infections). This continuous increase in antimicrobial resistance is considered the most important public health agenda worldwide. The WHO defines the concept of AMR as 'a threat to the effective prevention and treatment of continuously increasing infections caused by bacteria, parasites, viruses and fungi'. AMR is not limited to the well-known superbacterial outbreak problem. Antibiotic resistance, also called Superbugs, refers to changes that occur when microorganisms (such as fungi, viruses, parasites, etc.) that cause infection, including bacteria, are exposed to antibiotics, antifungal drugs, and antibacterial drugs. In fact, the real liberation of antibiotics has not been achieved. As the benefits of step by step one goes a long way. Zerbaxa began, the medical environment in Korea has improved little by step. With a round of applause, it adds to the remaining concerns.
