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- 2026-07-02 05:07:01
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- Medical institutions earned ₩7 trillion with COVID-19
- by Kang, Shin-Kook Jul 27, 2022 05:50am
- A whole ₩7.1028 trillion was spent on medical fees for COVID-19-related matters over the past two and a half years since the pandemic first hit Korea. The medical staff, acclaimed for their efforts in the pandemic, have also earned much for their incredible amount of hard work. In the same period, pharmacies have only earned around ₩59 billion in COVID-19 fees, as drug administration safety management fees (₩3,101) and face-to-face drug administration management fees (₩6,020). This accounts for less than 1% - 0.83% - of the total ₩7.1028 trillion that was spent on COVID-19. 'The current state of claims made for COVID-19 fees' that was reported to the Health Insurance Policy Deliberative Committee (Jan.2020 – June.2022) showed that the total medical expenses amounted to ₩6.244 trillion. An additional ₩858.8 billion was paid out for vaccinations to raise the total to ₩7.1028 in medical fee payments to medical institutions. Current medical fee claims for COVID-19 (2022 1~2022.6.30. cumulative claims ) By category, medical institutions filed claims for ₩2.3426 trillion in COVID-19 diagnostic tests and received ₩1.5948 trillion as residential treatment and at-home treatment fees, the fees received by pharmacies were included in this category. The payment of ₩1.2848 trillion that was made to support the treatment of hospitalized patients including severe patients went to COVID-19 dedicated hospitals. Also, ₩1.1026 trillion was used to support medical personnel and public health centers, ₩422.1 billion as non-COVID-19 personalized medical fees, and ₩263.5 billion as COVID-19-related infection prevention management fees, and ₩92.4 billion as emergency medical fee at screening centers. With no copayment, the claimed amounts have been fully supported by insurance premiums and the national treasury. In particular, the majority of the resources came from the supplementary budgets that were passed several times over the past 2.5 years. Meanwhile, the Ministry of Health and Welfare plans to continue applying the existing medical fees for in-patient treatment, diagnostic tests, face-to-face treatment and drug administration, diagnosis, and childbirth among others to prepare for the resurge of COVID-19. However, whether to apply individual fees will be decided upon after deliberation by the HIPDC’s subcommittee in accordance with the NHI Disaster Response Manual.
- Policy
- The revised COVID-19 in vitro diagnostic device guidelines
- by Lee, Hye-Kyung Jul 27, 2022 05:50am
- Due to the prolonged COVID-19, the in vitro diagnostic devices of the MFDS and the Korea Food and Drug Safety Evaluation Institute were very busy. Since the outbreak of COVID-19, the export performance of in vitro diagnostic medical devices has increased by 1.5 times, and the degree felt by in vitro diagnostic departments is said to be 10 times. Currently, in vitro diagnostic devices are operated on a small scale with four researchers and five examiners. However, five examiners are reviewing the workload for approval of in vitro medical devices from 800 companies. Jung Ho-sang, head of the in vitro diagnostic device division, said in a briefing to the journalists on the 26th, "Before COVID-19, there were many complaints about imported products of in vitro diagnostic devices used in hospitals." "However, after COVID-19, the development and permission management of product lines that used a lot and had a lot of complaints have decreased, and the situation has become to focus on COVID-19," he explained. He said, "The number of applications for permission from companies that have no experience in developing COVID-19-related devices has increased, resulting in a surge in complaints." "It is not easy to replenish manpower, so there are many difficulties," he said. Fortunately, applications for permission for new products have not increased despite the current COVID-19 resurgence. Foreign companies are reportedly putting in complaints for permission for cancer diagnosis and blood diagnosis devices, which have been stopped while focusing on developing COVID-19-related devices. Manager Jeong said, "Foreign companies are focusing on COVID-19 and restarting devices such as cancer diagnosis and blood diagnosis, which have rarely been developed. There are still many applications for permission for COVID-19-related devices, but foreign companies have completed the development of COVID-19 diagnostic test kits and are receiving a lot of complaints about devices that have already been developed or have now begun." There was also an explanation of the recently revised guidelines for the approval review of COVID-19 in vitro diagnostic devices. The MFDS deleted design restrictions that detected two or more genes only for COVID-19 gene test reagents, and added data on major mutation virus detection performance evaluation designated by the WHO as a prerequisite. He explained, "It is not true that the revision of the guidelines eased the criteria for approval of test reagents." Regardless of the revision of the guidelines, the COVID-19 gene test reagent must meet the same licensing criteria as before regardless of the number of detected genes, he said. "The clinical performance criteria with a sensitivity of 95% or higher and a specificity of 97% or higher are applied without change." In Korea, 46 gene test reagents have already been approved to detect two or more genes, and he added, "In accordance with the Korea Centers for Disease Control and Prevention's diagnosis guidelines, more than two genes are tested, so it does not affect the COVID-19 diagnosis system at all." However, as products targeting multiple genes are advantageous in detecting mutations in response to the new mutation virus, it is expected that the development of products targeting multiple genes will continue under the current epidemic and the Korea Centers for Disease Control and Prevention's diagnostic guidelines. Regarding the deletion of design restrictions on genetic test reagents, he said, "We decided that there was no need to limit the design of genetic test reagents anymore because many genetic test reagents were performing well at home and abroad." He said, "This is to promote the development of new products and additional product types according to changes in the COVID-19 quarantine situation."
- Company
- 5-year PDRN dispute comes to an end... PharmaResearch wins
- by Kim, Jin-Gu Jul 27, 2022 05:49am
- The long patent dispute between PharmaResearch and BMI Korea over the PDRN manufacturing method has finally come to an end, with the court ruling in favor of the original company, PharmaResearch. The industry expects the trial win to bring momentum to the rise of PDRN-based pharmaceuticals and devices, such as ‘Rejuran’ and ‘Conjuran.’ If the company also wins the patent infringement trial that follows, PharmaResearch will also be able to hold the generics in check, solidifying its position as the original product. ◆ Managing Director Kiseok Kang, “Court recognized our original technology" According to industry sources, the Patent Court of Korea ruled in favor of PharmaResearch in the reversed and remanded retrial on the PCRN manufacturing patent invalidation between PharmaResearch and BMI Korea on the 21st. This brought an end to the 5-year long legal dispute that started in 2017. In a phone interview with Dailpharm after the trial, Kiseok Kang, Managing Director of PharmaResearch, said, “After the long struggle, PharmaReserach was able to win the patent litigation and be recognized for our original technology. We plan to actively make this known to the market and solidify our position as an original product. He added, “With the final ruling made in the invalidation trial, the patent infringement suit that had been temporarily suspended due to the invalidation trial will be finalized soon. We are reviewing various strategies from multiple directions on how to proceed in the future.” The remark reflects Kang’s intent to hold generics in check through the patent infringement suit while strengthening the marketing and sales power of the original product while seeking new product development. ◆Twist after twist…PharmaResearch finally wins the patent invalidation trial after 5 years PharmaResearch had long been in a legal dispute over the patent for the PDRN manufacturing technology with BMI Korea. When BMI Korea received approval for ‘ HiDr injection,’ a same-ingredient latecomer drug in 2016, PharmaResearch pointed out that the drug’s API and manufacturing method were inappropriate. As a naturally-derived ingredient, PDRN has a more complex manufacturing method than chemical drugs. Therefore, PharmaResearch claimed that the difference in the origin of the raw material or manufacturing method can bring completely different efficacy and safety results, rendering BMI Korea’s drug completely different from its original. Also, the company claimed patent infringement, pointing out that optimizing DNA fragments extracted from fish for human use is PharmaResearch’s proprietary technology that requires demanding quality and manufacturing process control and management. PDRN patent invalidation trial progress BMI Korea confronted PharmaResearch’s claims with a patent invalidation trial. In January 2017, BMI Korea filed a trial against PharmaResearch to invalidate its PDRN manufacturing method. The legal battle that ensued showed reversal after reversal. PharmaResearch won the first trial with the Korean Intellectual Property Trial and Appeal Board rejecting BMI Korea's claim in January 2018. In January 2019, the Patent Court of Korea overturned the first trial's ruling. The court ruled that the PDRN patent was invalid. Once again, the victorious smile dawned on the other side at the Supreme Court. In January this year, two years after the hearing began, the court overturned the original ruling and decided to reverse and remand the trial. Following the decision, the Patent Court of Korea made the final ruling on the 21st of this month in favor of PharmaReserach. The 5-year long legal dispute has finally come to an end. With the win, PharmaReserach is expected to establish its own area in the market for PDRN-based pharmaceuticals and medical devices market. Currently, PDRN-based polydeoxyribonucleotide ingredient drugs come in two forms – pain treatment injections and eyedrops. 26 painkiller injections including PharmaReserach’s Placentex Inj and Rejuvenex Inj, and 10 eyedrops including the company’s Re-an Eye Drops are in competition in the market. PharmaReserach plans to actively use the court’s ruling to market its two market leaders. ◆Interest rises for the patent infringement suit…may halt the entry of generics depending on its results Results of the patent infringement suit that is being tried separately against BMI Korea are also gaining much attention. PharmaResearch, which owns the exclusive license for the PDRM manufacturing technology, had separately filed a ‘Damages Claim Based on a Patent Right Infringement (civil case)’ against BMI Korea in 2016, apart from the patent invalidation trial. However, the claim had been turned down by the Seoul Central District Court. Since then, the infringement suit had been temporarily suspended with the original suit continuing to the second and third trials. If PharmaResearch wins this case as well, sales of HiDr will be prohibited. From PharmaResearch’s view, this will allow the company to keep its biggest competition in check. PDRN is a pharmaceutical product extracted from the reproductive cells of salmon or trout and is used for skin regeneration, such as wound healing and tissue repair, etc. It selectively responds to act on damaged skin areas, reduce inflammation and regenerate tissue. The official name of the patent is ‘Polynucleotide fragments complex separated from fish's semen or egg and its manufacture. It is named ‘'DOT™(DNA Optimizing Technology).’ Its patentee is Mastelli in Italy, and PharmaResearch has the exclusive license for the patent in Korea. A product made from polydeoxyribonucleotide sodium, which is extracted from salmon semen, was first released in Korea through PharmaResearrch’s Placentex Inj that was approved in 2008. The company introduced the drug through a strategic partnership with Mastelli. PharmaResearrch, which had been importing and selling Placentex in Korea, set out to localize PDRN. Through joint research with KIST, the company developed a PDRN/PN extraction technology. Since it established the technology to extract-separate-refine the active material from salmon returning to the eastern coast of Korea in 2012, the company has been manufacturing its own PDRN ever since.
- Policy
- COVID-19 improved vaccines will be promoted
- by Kim, Jung-Ju Jul 27, 2022 05:49am
- The quarantine authorities said they have already begun work to quickly introduce an improved vaccine, an upgraded version of the COVID-19 vaccine. Currently, Pfizer and Moderna have signed a contract to introduce 60 million doses within the year, and if an improved vaccine is released in the meantime, the main point is to replace it with this. The details will be announced at the end of next month. According to the Korea Centers for Disease Control and Prevention on the 25th, the government is continuing to consult with pharmaceutical companies for quick introduction and safe and effective vaccination, and plans to announce the vaccination plan at the end of August. The U.S. and Japan have decided to actively use an improved vaccine that is more effective for omicron mutations in the fourth vaccination for the entire nation this fall. The amount of mRNA vaccine (Pfizer & Moderna) introduced within this year is about 60 million times. The Korea Centers for Disease Control and Prevention said, "Pharmaceutical companies have signed a contract to introduce the quantity as an improved vaccine if an improved vaccine is developed." The Korea Centers for Disease Control and Prevention explained, "This is enough for inoculation in the second half of the year." The government also held frequent monitoring and consultations with pharmaceutical companies on vaccine development trends to quickly introduce improved vaccines, and is always consulting experts. The Korea Centers for Disease Control and Prevention said, "The direction of the vaccination policy using the improved vaccine will be announced around the end of August after comprehensively reviewing the effectiveness and safety of the vaccine, development progress, introduction time and available quantity." The Korea Centers for Disease Control and Prevention said, "However, detailed inoculation strategies such as specific inoculation targets, timing, and method can be determined based on scientific grounds such as the type of mutation that is prevalent at the time of inoculation and the effect of improved vaccines on the mutation." The Korea Centers for Disease Control and Prevention added, "We are monitoring quarantine situations, new mutation trends, improved vaccine development trends, and overseas vaccination policies so that vaccinations through improved vaccines can be effectively carried out in a timely manner."
- Product
- MOHW meets Doctornow to listen to platform guidelines
- by Kim JiEun Jul 27, 2022 05:49am
- The timing of the announcement of the guidelines for the non-face-to-face treatment brokerage platform announced by the government is later than expected. In addition to the opinions of the medical and pharmaceutical sectors, the government's intention to reflect some of the opinions of platform companies is read. It has been confirmed that the MOHW plans to visit Doctornow's headquarters, the representative of the non-face-to-face treatment platform, at 2 p.m. on the 28th to hold an on-site meeting of the non-face-to-face treatment brokerage platform. Vice Minister of Health and Welfare Lee Ki-il will attend the meeting. The visit by the MOHW seems to be aimed at listening to opinions and suggestions from industries related to the "Temporary non-face-to-face treatment intermediation platform guidelines." At the Health and Medical Development Council held on the 12th, the MOHW also announced plans to announce the guidelines as soon as possible while collecting opinions from doctors and pharmacies on the guidelines for non-face-to-face treatment brokerage platforms. The MOHW received additional opinions from the Medical Association and the Pharmaceutical Affairs Association until the 15th, three days after the meeting, and also conveyed to the organizations that they would announce guidelines within this week. Shortly after the Health and Medical Development Council meeting, an official from the Ministry of Health and Medical Development told Dailypharm, "The basic framework was based on a temporary non-face-to-face medical notice, and each case was judged and subdivided." With the confirmation of the MOHW's visit to Doctornow's headquarters, guidelines for operating a non-face-to-face treatment brokerage platform are expected to be announced as early as next Thursday. According to officials from the MOHW and those attending the meeting, the guidelines are expected to include restrictions on services that match specific hospitals and pharmacies on brokerage platforms. The guidelines are likely to include restrictions on "getting prescriptions, storing desired drugs" on some recently controversial platforms, as well as sanctions on illegal medical care and drug advertisements. The Pharmaceutical Affairs Association said in additional opinions delivered until the 15th that it proposed disclosing the names of affiliated pharmacies of non-face-to-face treatment platforms and suspending Rx drug advertising. An official from the Pharmaceutical Association said, "Non-face-to-face treatment platforms are not disclosing specific pharmacies due to matching of short-range hospitals and pharmacies, but we additionally requested to stop this part. In addition, we demanded sanctions for illegal advertising of Rx drugs."
- Company
- One-shot treatment Zolgensma lands in GHs with reimb
- by Eo, Yun-Ho Jul 26, 2022 06:05am
- # The ‘one-shot’ treatment Zolgensma may be prescribed with reimbursement at general hospitals in Korea. According to industry sources, Novartis Korea’s spinal muscular atrophy (SMA) treatment Zolgensma (onasemnogene abeparvovec) passed the drug committees of the Big 5 tertiary hospitals in Korea including the Samsung Medical Center, Seoul National University Hospital, and Seoul Asan Medical Center. Zolgensma will be listed for insurance benefits from August. With only its insurance-covered cost being ₩1.98 billion, the drug has been applied the Refund type, Expenditure Cap type, and Patient-unit performance-based type of the risk-sharing agreement (RSA) in its reimbursement. With the reimbursement already set, deliberations for reimbursed prescriptions will be made for patients, and patients who pass deliberations will be prescribed Zolgensma at medical institutions that have completed the landing process. The drug demonstrated its efficacy through the Phase III SPR1NT study and STRIVE-EU study. Results of the cohort of patients with 2 copies of SMN2 in the SPR1NT study showed that all pediatric patients who received presymptomatic treatment survived without respiratory or nutritional support, and achieved sitting alone for at least 30 seconds, and most (11/14) were within the normal developmental window as defined by the World Health Organization. In the STR1VE-EU study, the majority of the patients that received treatment with Zolgensma (82%) achieved developmental motor milestones that were not observed in the natural history of SMA Type 1, including patients with more severe disease. Meanwhile, Zolgensma is a gene therapy that contains a genetic material that functionally replaces defective genes. The Ministry of Food and Drug Safety approved Zolgensma as the second advanced biologic product after Kymriah. Advanced biopharmaceuticals are cell therapies or gene therapies that use live cells, tissues, or genetic material as ingredients. Under the ‘Safety and Support Act for Advanced Regenerative Medicine and Advanced Biopharmaceuticals,’ advanced biopharmaceuticals can receive differentiated safety management including long-term follow-up studies and support for R&D and product commercialization.
- Company
- Daewoong to expand its diagnostic kit business globally
- by Nho, Byung Chul Jul 26, 2022 06:05am
- The number of new COVID-19 confirmed patients is increasing rapidly again. As of May this year, the number of confirmed patients in Korea has continued to decline, but it has rebounded since the record of 3,423 confirmed patients at the end of June, and the doubling of confirmed patients has continued for four weeks. In addition, face-to-face visits are restricted again in nursing hospitals and facilities. As COVID-19 enters a phase of re-proliferation, expert diagnostic kits are drawing attention again to determine whether COVID-19 is confirmed. Currently, there are a total of 32 antigen test kits for COVID-19 experts, including SD BioSensor, GenBody, SugenTech, and Calth, as of the 14th of this month. Among them, Calth, a startup specializing in in vitro diagnostic medical devices, has a contract with Daewoong Pharmaceutical to supply AllCheck COVID-19 Ag, Daewoong COVID-19 Ag. The Calth diagnostic kit supplied by Daewoong Pharmaceutical in Korea can be determined within 15 minutes by diagnosing the presence of viruses in the human nasopharynx and oropharynx using immunochromatography. Excellent performance of 92.11% sensitivity and 99.52% specificity have been proven through clinical trials. It is effective in diagnosing mutated viruses because it targets nucleocapsid proteins, which are easily mutated, as well as nucleocapsid proteins, and can be detected only with 0.1 ng of nucleocapsid proteins per ml in minimum detection limit analysis. Daewoong Pharmaceutical, which started selling in Korea in mid-February this year for the first time in the diagnostic business area, settled in the domestic market by selling to more than 1,000 open stores and small and medium-sized hospitals within two months of its release. With COVID-19 recently entering a phase of re-proliferation, it plans to expand its market share in Korea and expand its appearance to various screening areas such as COVID-19 and influenza dual test kits in the future. Daewoong Pharmaceutical signed a 12 billion won COVID-19 diagnostic kit export sales contract with Vietnam's large pharmaceutical company Vietha Pharma Corp at the end of last year and completed local quality testing approval and is proceeding with the final approval process. Daewoong Pharmaceutical plans to continue its diagnostic kit business globally based on its experience in entering the COVID-19 diagnostic kit business accumulated in Korea and Vietnam. According to an official from Daewoong Pharmaceutical, in addition to the COVID-19 diagnostic kit, it plans to expand its business to countries around the world in various fields such as ▲B, hepatitis C ▲ HIV antibody ▲ dengue fever antigen/antibody kit, and is recently negotiating visible contract conditions for entry into Thailand. According to the Global In-Vitro Diagnostics Market of Allied Market Research, a market research institute, the global in-vitro diagnostics market reached $71.4 billion (about 94 trillion won) in 2020 and is expected to grow 4.08% annually to $106.9 billion (about 141 trillion won) in 2030. Among them, the annual average growth rate of the infectious disease diagnosis market is the highest at 6.3%, which is expected to reach $35.8 billion (about 47 trillion won) in 2027.
- Company
- Rising status of antidiabetic SGLT-2 inhibitors
- by Jul 26, 2022 06:05am
- SGLT-2 inhibitors made an external growth of 16% in the first half of this year. SGLT-2 inhibitors, which were first approved as a type 2 diabetes treatment, expanded into the field of heart failure and made over ₩80 billion in prescriptions in the first half of the year. Being recently recommended as a major treatment option in treating chronic heart failure in domestic treatment guidelines, the growth in sales of SGLT-2 inhibitors is expected to continue to gain momentum. ◆ Makes ₩82 billion in total prescriptions …AZ ₩43.8 billion ·BI ₩35.7 billion According to the market research institution UBIST on the 25th, the total outpatient prescriptions made for SGLT-2 inhibitors in the first half of this year rose 15.7% from ₩70.9 billion YoY to record ₩82 billion. The SGLT-2 inhibitor market size, which had been ₩50 billion 5 years ago, has been steadily expanding with the introduction of combination drugs and indication expansions. In 2019, the half-year prescription amount exceeded ₩50 billion in 2019 for the first time and was on the verge of achieving annual sales of ₩100 billion. Last year, the annual prescription amount exceeded ₩150 billion. This growth in the SGLT-2 inhibitor market was led by AstraZeneca and Boehringer Ingelheim, which had been actively expanding their drug’s indications. Prescriptions of AstraZeneca’s monotherapy “Forxiga (dapagliflozin)” and its metformin combo “Xigduo” makes up 53% of the total SGLT-2 inhibitor prescription market. Boehringer Ingelheim’s single agent drug “Jardiance (empagliflozin)” and its combo drug “Jardiance Duo” accounts for 44% of the market. AstraZeneca’s Forxiga has solidified its lead in the market by being the first to obtain an indication as a treatment for chronic heart failure in 2020. Its outpatient prescriptions in the first half of the year were ₩23.4 billion, a 16.7% YoY increase from the ₩20 billion made in the same period of the previous year. The combo drug Xigduo’s sales also increased 18.5% from ₩17.2 billion to ₩20.4 billion from the previous year. The prescriptions of the two drugs amounted to ₩43.8 billion. The half-year sales of Boehringer Ingelheim’s Jardiance first exceeded ₩20 billion this year. Jardiance’s outpatient prescriptions in 1H this year were ₩21.2 billion, a 7.5% increase from the ₩19.7 billion in 1H of the previous year. Jardiance Duo’s sales also increased 28.1% from ₩11.3 billion to ₩14.5 billion. Total prescriptions of Jardiance and Jardiance Duo amounted to ₩35.7 billion in 1H this year. ◆Rises as a key drug in HF… Receives 'Class 1 recommendation’ in all areas of HF The status of SGLT-2 inhibitors, which are already likened to ‘21st-century statin,’ is expected to continue to rise with its recommendation as a standard of care therapy in the latest heart failure treatment guidelines in Korea. In the “Completely Revised Heart Failure Clinical Practice Guidelines 2022” that was published by the Korean Society of Heart Failure (KSHF) on the 22nd, SGLT-2 inhibitors were recommended for administration regardless of the patient’s diabetic status to reduce hospitalization from HF or cardiovascular deaths. In detail, in heart failure with reduced ejection fraction (EF of 40% or lower), SGLT-2 inhibitors were recommended in line with ARNI or ACE inhibitors (angiotensin-converting enzyme inhibitor), beta-blockers, and saline corticoid receptor antagonist (aldosterone antagonist) as a first-line standard of care for reducing cardiovascular deaths and rehospitalization from HF, regardless of the patient’s diabetic status. (Class I, Level of Evidence A). In heart failure with mildly reduced ejection fraction (EF of 41-49%) and heart failure with preserved ejection fraction (EF of 50% or higher), SGLT-2 inhibitors were recommended at a higher level than ARNI or ARB (angiotensin receptor blockers), etc. (Class I, Level of Evidence B) In addition, the guideline recommends SGLT-2 inhibitors as standard therapy for diabetic patients who already have cardiovascular disease or are at high risk of developing cardiovascular disease, even without heart failure. (Class I, Level of Evidence A).
- Company
- Keytruda indication has been expanded
- by Jul 26, 2022 06:05am
- The immuno-cancer drug Keytruda has expanded its treatment indication to early triple negative breast cancer following metastaticity. With the addition of Keytruda to adjuvant therapy before and after surgery, it is expected to contribute to reducing the recurrence rate by using immuno-cancer drugs early. MSD Korea held a press conference at the Bank Hall in Jung-gu, Seoul on the 22nd and highlighted the meaning of Keytruda's approval of adjuvant therapy before and after early triple negative breast cancer surgery. Keytruda expanded its scope to supplementary therapy before and after surgery for early triple negative breast cancer a year after obtaining indications for the first treatment of recurrent and metastatic triple negative breast cancer in July last year. It can be used as a kitruda-antio-cancer chemotherapy (Carboplatin+Paclitaxel, Doxorubicin or Epirubicin+Cyclophosphamide) as an auxiliary therapy before ▲ surgery in patients with stage 2 triple negative breast cancer who have no treatment experience, and ▲ after surgery, administer it alone as an adjuvant therapy. According to phase 3 clinical study of 1,174 people, Keytruda-antcancer chemotherapy group in preoperative adjuvant therapy significantly extended its safe survival by reducing the progression of non-permanent chemotherapy, local and remote recurrence, secondary primary cancer, and death risk from all causes by 37% compared to the risk. For 36 months, the Event-free Survival was 84.5%, significantly higher than the control group of 76.8%. At 15.5 months of median follow-up observation period, the pathological pCR of the adjuvant therapy before and after Keytruda surgery was 64.8%, showing a statistically significant difference compared to 51.2% of chemotherapy alone. The Keytruda group showed superior pCR tendency regardless of PD-L1 expression rate. Accordingly, the Ministry of Food and Drug Safety allowed Keytruda to be used as an adjuvant therapy before and after surgery without performing a PD-L1 expression test. Safety was similar to the safety profile of chemotherapy and Keytruda monotherapy used in patients with Triple-Negative Breast Cancer (TNBC), and no new safety issues were reported. Most immune-mediated adverse reactions appeared in preoperative adjuvant therapy, and in postoperative adjuvant therapy, they were manageable at a low grade. Professor Park Yeon-hee, head of the clinical trial center at Samsung Medical Center, who participated in the clinical trial, said, "Pre-operative chemotherapy options were in high demand for new treatment options because only cytotoxic anticancer drugs were available." TNBC is considered a cancer with poor prognosis due to frequent metastasis to other organs within two to three years after diagnosis and a short survival period after recurrence, but there is no target treatment. The socioeconomic burden is also high due to the relatively high proportion of young patients under the age of 50. Professor Park said, "TNBC has higher benefits for early chemotherapy. As a precautionary measure to reduce recurrence, Keytruda-based advanced chemotherapy is considered a cost-effective area, he said. "It would be great if many patients could benefit from the rapid payment." Kim Sung-pil, executive director of MSD Korea's anticancer drug business division, also said, "We will try to proceed with Keytruda's benefit as soon as possible at TNBC. As the indication of Keytruda has increased, we are recently discussing a new strategy for additional benefit at urothelial carcinoma."
- Company
- Evusheld can be prescribed in Korea
- by Eo, Yun-Ho Jul 26, 2022 06:05am
- COVID-19 preventive drug Evusheld has begun preparing for actual prescriptions. According to related industries, AstraZeneca's Evusheld passed the Drug Committee of 200 medical institutions nationwide, including the Big 5 Advanced General Hospitals such as Seoul National University Hospital and Samsung Medical Center through the Korea Centers for Disease Control and Prevention. In May, the government spent 39.6 billion won to introduce 20,000 doses of Evusheld, an antibody treatment for the purpose of preventing COVID-19 infections and severe diseases to protect severe immune deficiencies. Since then, the Ministry of Food and Drug Safety has confirmed the emergency use approval of Evusheld on the 30th of last month. As a result, Evusheld, the first antibody complex for preventing the COVID-19 virus in Korea, is expected to be prescribed to immunocompromised patients. It is judged that the subject of administration will be limited. The government limited the subjects of Evusheld to patients undergoing severe immunosuppressive treatment, which requires preventive antibody treatments, rather than those with diseases that require immunosuppressive treatment. People with a history of COVID-19 confirmed were also excluded. As a result of the report, it was confirmed that the health authorities conveyed their intention to the National Assembly to discuss the increase by using reserve funds in consideration of the future epidemic situation, the need to expand and re-administrate targets. The U.S. FDA approved Evusheld last December. The European EMA confirmed the introduction in March. In addition, France, Australia, and Singapore have completed pre-purchase contracts for Evusheld to prevent COVID-19. An AstraZeneca official said, "We hope it will help immunocompromised patients such as blood cancer and organ transplant patients who were in the blind spot of COVID-19 prevention, and we will continue to do our best to provide smooth domestic supply." Through various studies published in Nature Medicine, it has been confirmed that Evusheld is the only antibody agent to maintain neutralization activity against omicron mutations, covering both BA.1 and BA. 2. As a result of PROVENT study, Nature Medicine reduced the risk of symptomatic COVID-19 infection by 77% compared to placebo in the first analysis, and 83% decreased the risk in 6-month follow-up. During the 6-month follow-up period, there were no cases of severe or death in the Nature Medicine group. More than 75% of the subjects who participated in the study had companion diseases that were likely to develop into severe symptoms when infected with COVID-19, such as weakened immune systems at the baseline or not showing sufficient immune responses to vaccination.
