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- 2026-05-09 18:49:57
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- 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.
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- 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.
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- 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.
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- 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).
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- 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.
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- EC market, occupied more than 70% of Bayer and Hyundai
- by Nho, Byung Chul Jul 25, 2022 05:58am
- In the emergency contraceptive market worth 15 billion won, Hyundai Pharmaceutical and Bayer have a market share of more than 70%, effectively dominating the market. Bayer Mirena has performed in the 6 billion won range for loop-type emergency contraceptives, and Hyundai's Norebwon and Ellaone have performed in the 5 billion won range for emergency contraceptives. PO emergency contraceptives are divided into two drugs, Levonorgestrel and Ulipristal Acetate, and the leading products consisting of these main ingredients are also Norebwon and Ellaone. As of 2021, Levonorgestrel's market share accounted for 77%, and the 2018~·2021 external appearance recorded 9.9 billion won, 10.5 billion won, 11.2 billion won. During the same period, sales of Ulipristic Acetate, which has a market dominance of about 23%, have been showing negative growth of 5.2 billion won, 5.2 billion won, 3.8 billion won, and 3.2 billion won. There are 18 products that are competing in the market with Levonorgestrel as the main ingredient, including Mirena, NorLevo, 72H Tab, Kyleena, PHOSTINO-1, Levonia, Noges One, Imeotra, and Sexcon. Among them, Bayer's Mirena, which has IUD, made 6.5 billion won in sales last year. Mirena's performance in 2018-2020 was 4.7 billion won, 6 billion won, and 5.7 billion won, which has remained unchanged for the past four years. Norebwon's sales in 2021 were 2.2 billion won, which is a -21% decrease in appearance after achieving its biggest performance of 2.8 billion won in 2018. In the case of Mirena, Hyundai's No. 1 PO product is maintained through the IUD method. Sales perfromance of THEU's 72H, Bayer's Kyleena, GI Medicine' PHOSTINO-1, and Myungmoon's Levonia 2021 is 900 million won, 600 million won, 400 million won, and 200 million won, respectively. Ulipristal Acetate is competing with Hyundai Pharmaceutical's Ellaowon and Shin Poong's Inisia, but the trend seems to be Ellaowon. Ellaowon earned 3.2 billion won in sales last year, and has consistently maintained sales in the early and mid 3 billion won range, becoming the No. 1 player in the same ingredient market. Inisia achieved 2.3 billion won in the second quarter to fourth quarter of 2017, and was expected to reverse its appearance due to a 200 million won gap with Ellaowon, but it has been showing sluggish sales compared to competitive drugs since 2018. Inisia's sales from 2018 to 2020 are 1.8 billion won, 1.6 billion won, and 560 million won, and it is expected that it has virtually lost its market dominance as its performance in the first quarter of 2021 and 2022 has not been determined. Ellaowon should take one tablet within 120 hours (5 days) at the latest after failing contraception, and if vomiting within 3 hours after taking it, immediately take one tablet again. It can be taken regardless of meals and can be taken at any time during the menstrual cycle. In the case of Norebwon, in principle, it should be taken as soon as possible (recommended within 12 hours) after the failure of contraception, and it can be used at any time during the menstrual cycle. If vomiting within 3 hours of taking it, one tablet should be taken again immediately, as in Ellaowon.
- Company
- He Young Lee appointed new head of BMS Korea
- by Eo, Yun-Ho Jul 25, 2022 05:57am
- Country Manager He Young Lee He Young Lee, the current Country Manager of Viatris Korea, has been appointed the new head of BMS Korea. According to industry sources, BMS Korea had carried out the recruitment process after the current General Manager (46), Jinyoung Kim, was transferred to the Global Compliance Organization, after which He Young Lee was nominated as the new head. With the appointment, Lee will resign from Viatris as of this month (July) and join BMS. Lee, who was appointed the first CEO of Viatris Korea after its spin-off from Pfizer, accumulated over 20 years of experience in the industry after graduating from the Seoul National University School of Pharmacy and acquiring an MBA from Korea University. Since joining Pfizer Korea in 2000, Lee served various posts in various departments, from clinical research, project development, to strategy&planning and served as the Marketing Director of the Primary Care Business as well as the CV TA Lead of the GEP (Global Established Product) Business in Shanghai and Hong Kong. Lee then served as the Country Manager of Pfizer Singapore, after which she was appointed the Vice President and Korea Lead of Pfizer Established Health to return to Korea. In November 2020, Pfizer Upjohn Korea became part of Global Viatris, and Lee was appointed Country Manager of Viatris Korea. A company official said, “Viatris’s business will continue as usual. Amr Ammar, Head of Commercial Development, Emerging Markets at Viatris will work closely with executives in Korea to ensure that operations run smoothly as planned."
- Company
- Heart failure guidelines revised for the first time in 6 yrs
- by Jul 25, 2022 05:57am
- The clinical practice guidelines for heart failure have been completely revised for the first time in 6 years. The new guideline contains all the latest drugs ranging from SGLT-2 inhibitors that demonstrated an effect in heart failure, angiotensin receptor-neprilysin inhibitors (ARNIs) that are represented by the Entresto, to the recently approved vericiguat. On the 22nd, the Korean Society of Heart Failure (KSHF) held an online press conference to celebrate the publication of the “Completely Revised Heart Failure Clinical Practice Guidelines 2022,” and announced the significance of the revision and the 10 important changes that were made. KSHF presents the “Completely Revised Heart Failure Clinical Practice Guidelines 2022,” The guideline had been completely revised for the first time in 6 years. The development of the Korean heart failure clinical practice guidelines started in 2016 when the KSHF first published a guideline for chronic heart failure, and then for acute heart failure in 2017. The guidelines underwent two partial updates in 2018 and 2020. Completely Revised Heart Failure Clinical Practice Guidelines 2022” consists of 64 chapters and 300 pages that reflect all the changes that were made over the past 5-6 years as well as the latest Korean and global research results. The major revisions include ▲the Definition and Classification of HF ▲HF diagnosis algorithm ▲Treatment of HF with reduced ejection fraction, ▲Changes in the roles of HF medicines (focusing on ARNI and SGLT2) ▲HF patients with improved ejection fraction ▲Treatment of HFmrEF and HFpEH ▲Treatment of comorbidities in HF patients ▲ Diagnosis and Treatment of cardiac amyloidosis ▲Period for transferring HF patients to tertiary hospitals or HF specialists ▲Treatment of acute HF patients and severe HF. The revision first made a more detailed classification and definition of HF. In the past, patients with an ejection fraction rate of 41-49% were considered to have a similar condition to “heart failure with preserved ejection fraction (HFpEF).” However, with studies reporting that the patient group shows similar drug treatment effects with the “Heart Failure with reduced EF (HFrEF)” group, the KSHF decided to classify the patient group as “Heart Failure with mildly reduced EF (HFmrEF)” The society also presented appropriate treatment methods in line with the newly set HF classification, as new treatments were introduced to treat HFpEF, a field that had high unmet needs with no suitable available treatment. While reflecting the international HF guidelines, such as those that were revised in the US in April 2022 and Europe in 2021, KSHF provided a standardized, optimal HF treatment guideline for Koreans whose recommendations align with the contents necessary and real to Korea. Source : KSHF In the guidelines, ARNI (angiotensin receptor-neprilysin inhibitors) or angiotensin-converting enzyme inhibitor (angiotensin receptor blocker for intolerant patients), beta blocker, saline corticoid receptor antagonist (aldosterone antagonist), and SGLT-2 inhibitors were recommended (Class I, Level of Evidence) as first-line standard of care in HFrEF. SGLT-2 inhibitors were recommended for administration regardless of the patient’s diabetic status to reduce hospitalization from HF or cardiovascular deaths. In addition, the new guidelines recommended patients continue receiving the standard of care treatment even if the patient’s symptoms improve and EF increases to 40% or higher after standard of care. (Class I, Level of Evidence B). If EF continues to decrease despite standard drug therapy, the guidelines recommend treatments such as ivabradine, vericiguat, or digoxin as second-line treatments Also, diuretics, SGLT2 inhibitors, and ARNIs were recommended as primary treatments for HFmrEF and HFpEF, In the HFmrEF and HFpEF group, diuretics and SGLT2 inhibitors (empagliflozin or dapagliflozin) were recommended as a priority (Class I), and ARNI was then recommended (Class IIa, Level of Evidence B) Hyun-Jae Cho, Director of Clinical Practice Guidelines in KSHF (Professor of Cardiology at SNUH), said, “The revised guidelines contain updated definition and classification of HF that is more detailed than before. The changed treatment methods and drug recommendations are also included in detail.”
- Company
- How will the prescription market react?
- by Chon, Seung-Hyun Jul 25, 2022 05:57am
- Pharmaceutical companies are also paying keen attention to the rapid increase in the number of COVID-19 confirmed cases this month. Since the spread of COVID-19 in the past two years, the prescription market seems to be closely watching recent changes in the situation. According to the Central Disease Control Headquarters of the Korea Centers for Disease Control and Prevention on the 20th, a total of 76,402 new COVID-19 confirmed patients were counted as of 0 o'clock that day. The figure was 73,582 on the 19th, the largest in 83 days since April 27 (76,765), and the figure was 70,000 for two consecutive days. The "double" phenomenon, in which the number of confirmed cases doubled compared to the previous week, has continued for three weeks. The pharmaceutical industry seems to be closely watching the impact of the surge in COVID-19 confirmed patients on the prescription market. The domestic prescription drug market seems to have regained its previous year's upward trend this year after slowing down until last year after the spread of COVID-19. According to UBIST, a pharmaceutical research institute, the total amount of outpatient prescriptions in the first half of this year was 8.2874 trillion won, up 6.1% from 7.8129 trillion won in the same period last year. It increased 6.5% year-on-year to 4.1248 trillion won in the first quarter, and increased 5.7% year-on-year in the second quarter. It has achieved higher growth than in 2020 and 2021. The prescription amount in the first half of 2020 and 2021 grew only 2.9% and 2.6%, respectively, compared to the previous year. This year means that the growth rate of the prescription drug market is more than twice as high as that of the past two years. Analysts say that this year's recovery in the prescription drug market is related to a surge in the number of COVID-19 confirmed patients. Earlier this year, as many as hundreds of thousands of COVID-19 confirmed patients poured out a day, prescriptions for antipyretic painkillers, cold medicines, and antibiotics used to alleviate COVID-19 symptoms increased significantly. As the supply of cold medicines has not kept up with demand, the government has encouraged pharmaceutical companies to increase production and even received weekly reports of production and inventory. This is quite different from the two-year slowdown in the prescription drug market in the aftermath of COVID-19 until last year after the spread of COVID-19. In 2020, when COVID-19 began to spread, the amount of outpatient prescriptions was15.6365 trillion won, up 2.7% from the previous year. Outpatient prescription performance last year was 16.1126 trillion won, an increase of only 3.0% from the previous year. The amount of prescriptions in 2018 and 2019 increased by 8.1% and 8.2% compared to the previous year, respectively, and the growth rate fell by one-third for the second consecutive year since the spread of COVID-19. It is analyzed that COVID-19 has directly contributed to the sluggish prescription drug market over the past two years. After the spread of COVID-19, strengthening personal hygiene management such as hand washing and wearing masks has greatly reduced the incidence of infectious diseases, leading to a decrease in visits to medical institutions. Looking at the quarterly prescription market trend until last year after the spread of COVID-19, the growth rate exceeded 5% in the third quarter of 2020 and the fourth quarter of last year alone. For the rest, the growth rate of quarterly prescriptions remained between 0 and 3.2 % compared to the previous year. In the second quarter of 2020, the prescription scale growth rate was only 0.7%, and as COVID-19 spread in earnest, chronic patients such as HTN and DM avoided visiting medical institutions and received long-term prescriptions, there was a gap in the prescription market. In the fourth quarter of 2020, the growth rate of the prescription market was 0.0%. At that time, the market for prescription drugs seems to have been reduced due to a decrease in hospital visits due to a decrease in people's external activities as the operation of entertainment bars and singing practice centers was suspended and the number of restaurants was limited. Despite the same COVID-19 spread issue, the prescription market was also affected by the opposite depending on the social atmosphere.
