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- 2026-03-18 15:06:10
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- The outpatient Rx market is shrinking in this winter
- by Chon, Seung-Hyun Mar 18, 2021 06:22am
- With the winter flu season, the outpatient prescription drug market is shrinking. In January and February of this year, the prescription size decreased by 6% from last year. The outpatient prescription drug market has been sluggish since the end of last year. It is analyzed that the prescription drug market has also been affected by a sharp decline due to the prolonged COVID-19. According to the drug research institute UBIST on the 17th, the cumulative outpatient prescription amount in January and February was ₩2,315 billion, a 6.3% decrease from the same period last year. The prescription amount in January was down 7.0% from the previous year, followed by a 5.6% decline in February. Monthly outpatient Rx amount trend (Unit: ₩100 million, Source: UBIST) In last December, the amount of outpatient prescriptions dropped by more than 5% for three consecutive months after falling 6.0% from the previous year to ₩1,235 billion. Last month's prescription amount was the lowest in two years since February 2019. Compared to previous years, sales in the prescription market in January and February are unusual. In last January and February, prescriptions amounted to ₩2.47 trillion, an increase of 3.4% from the same period last year, and the amount of prescriptions in January and February of 2019 increased by 6.3% from the previous year. Despite COVID-19 variable last year, the prescription drug market generally made good progress, but it has been sluggish since winter. Last year, the total outpatient prescription amount was ₩14,855.9 billion, an increase of 0.2% from the previous year. Until November of last year, the cumulative prescription amount was ₩12,385 billion, an increase of 0.8% from the same period last year, but it has declined since December. 지난해 전체 원외 처방금액은 14조8559억원으로 전년보다 0.2% 증가했다. 지난해 11월까지 누적 처방금액은 12조3850억원으로 작년 같은 기간보다 0.8% 늘었지만 12월부터 하락세로 돌아섰다. Monthly outpatient Rx amount increase/decrease from the previous year (Unit: %, Source: UBIST) Since the spread of COVID-19, it is highly likely that the incidence of infectious diseases has greatly decreased due to reinforced personal hygiene management such as hand washing and wearing a mask, leading to a decrease in visits to medical institutions. Since the end of last year, no flu pandemic warning has been issued this winter. According to The KCDA, the number of suspected flu patients per 1,000 outpatients from week 1 to 8 this year is 2.4, 2.4, 2.6, 2.3, 1.9, 1,9, 1.9, 2.0, etc., half of the epidemic standard of 5.8. Compared to 49.1, 47.8, 42.4, 40.9, 28.0, 16.4, 11.6, and 8.5 outpatients per 1,000 outpatients during the 1st to 10th week of last year., there have been few cases of flu recently. Number of suspected flu patients per 1,000 outpatients (Unit: # of patient, Source: The KCDA) It is also possible that visits to medical institutions have further decreased as the social distancing stage has been elevated due to the rapid increase in the number of COVID-19 confirmed patients since the end of last year. As more than 300 confirmed cases occurred from November 18 last year, the government raised the social distancing from November 24 to level 2 from the previous level 1.5. From then on, only packaging and delivery were allowed from cafes regardless of business hours, and only packaging and delivery were allowed after 9 o'clock from restaurants. As the number of COVID-19 confirmed rapidly increased, the government raised the social distance in the metropolitan area to level 2.5 from December 8 last year. Accordingly, in the metropolitan area, operations such as singing rooms and indoor sports facilities in addition to the existing five types of entertainment facilities such as entertainment bars were additionally suspended. Shops, marts, department stores, movie theaters, PC cafes, and other facilities that are closely related to daily life must also close after 9 p.m. Despite social distancing campaign, the number of COVID-19 confirmed cases surpassed 1,000 and the Seoul Metropolitan Government implemented a super-precipitation measure that banned ``private gatherings with more than 5 people'' from December 23 last year, and the same measures have been applied across the country afterwards. In this month, social distancing in the metropolitan area was eased to level 2, but Strengthened distancing measures are being implemented, such as “private gatherings for more than 5 people” are still banned.
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- Industry to yet again drive for flexible use of ICER
- by Eo, Yun-Ho Mar 18, 2021 06:20am
- The pharmaceutical industry is to push for the versatile use of incremental cost-effectiveness ratio (ICER). Related industry sources reported, a third meeting for the public-private consultative council to improve the drug pricing would be held on Mar. 19. Director Yang Yoon Seok and Deputy Director Choi Kyung-Ho of Pharmaceutical Benefits Division at Ministry of Health and Welfare (MOHW), representatives from National Health Insurance Service (NHIS), Health Insurance Review and Assessment Service (HIRA), Korean Research-based Pharmaceutical Industry Association (KRPIA), Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) and Korea Biomedicine Industry Association (KoBIA) would participate in the meeting. And KRPIA, representing the multinational pharmaceutical companies in South Korea, is to reiterate the needs to flexibly apply ICER, as the organization has been pursuing the change for a long time. While the healthcare coverage enhancement initiative on pharmaceuticals tends to focus on severe and disease and anticancer treatments, the public is demanding for the expansion of ICER range, which decides the reimbursed pricing (upper limit pricing with healthcare coverage) of increasingly expensive new drugs. Particularly, the ICER in South Korea is quoting GDP in 2013, and the industry is pointing out the value does not reflect the latest trend. Even before the Moon Jae-in Care, ICER on new drug treating severe and rare diseases was double the general new drug, or flexibly applied up to GDP 50 million won (2 ICER). And the industry insists more versatile approach is needed. As of 2019, the industry urges the actual value would be over 2 ICER, or 50 million won. An industry insider noted, “We do not mean the ICER used on adjusting the upper limit pricing should be used for all. Literally, using the ICER ‘flexibly’ would make it feasible. The ICER should be lowered for a mild disease treatment, whereas the value for absolutely necessary treatment should be raised.” But the government and the industry would have to see if they can settle on a middle ground. Although the issue of ICER has been addressed at the National Assembly audit, the government has been maintaining conservative stance. In fact, at the National Assembly audit session for NHIS and HIRA last year, HIRA Kim Sun-min answered, “The accessibility problem with the expensive anticancer treatment is regrettable, but it is socially challenging to make the change.” At the time, he said, “Regarding the ICER, we need to predict the effect of the additional cost. Anticancer treatments recently listed would cost about average of 1 billion won for extending one year of life expectancy. Considering patients other diseases, we need further social consensus and discussions.”
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- Chinese regulator cracks down on illegal Botox distribution
- by Nho, Byung Chul Mar 18, 2021 06:19am
- Chinese regulators are expected to strengthen crackdowns on unauthorized procedures in the local medical and beauty market, effectively blocking exports of illegal botulinum toxins to China. According to the Chinese media, Xinhua, etc. on the 15th, the public security authorities said they would strictly crack down on illegal activities related to unauthorized procedures in the Chinese medical and beauty market. It is understood that in China, the treatment of illegally distributed drugs causes fatal side effects to patients, as well as frequent medical disputes. It is known that the National Medical Products Administration (NMPA), Ministry of Culture of the People's Republic of China, and the Cyber Investigation Unit are working together to block the distribution of unauthorized and illegal drugs. The Chinese medicine, medical device, and beauty product market is divided into institutional products that have been approved by the NMPA and the gray market distributed by Daigong. According to Article 418 of the Drug Administration Act of the People's Republic of China, all drugs used in China must be approved in accordance with the laws of the Chinese government, and it is illegal if they are sold without obtaining permission for production or import. The Yanzhi economy in China is attracting attention as a new consumption trend. It refers to consumption activities related to appearance, such as plastic surgery, surgery, and cosmetics. With the spread of the trend, the establishment of illegal medical institutions and the distribution of illegal drugs are also increasing. Korea's botulinum toxin is the number one target for such regulation and management, and more attention and attention are being paid to it. A domestic industry official predicted that "Letybo is the only botulinum toxin product that has been officially licensed by the NMPA. Some companies that are estimated to have distributed the product to China through Daigong will suffer much damage." In October 2019, China's national broadcaster CCTV2 reported that the MFDS issued an order to forcibly collect and dispose of many of the botulinum toxin products exported to China by domestic parent companies. At the time, CCTV2 said, "The test report data of this company's product was manipulated, and the lot number that was discarded due to defects was changed to the normal lot number. Products with unstable medicinal effects were distributed." It is sold without a registration permit from the China Pharmaceutical Supervisory Service and requires a lot of attention from consumers." Another industry insider said, “Unauthorized distribution of Korean botulinum toxin products in China is an offense that undermines market order and destroys the status of K-Toxin and K-Bio. Exporting to China through illegal distribution channels is prohibited. It's time to find a solution to eradicate it."
- Company
- Repurposed drugs for COVID-19 unveil clinical trial findings
- by Moon, sung-ho Mar 18, 2021 06:19am
- A series of clinical trial results in repurposing already-commercialized drugs for COVID-19 treatment is unveiling one by one, and the outcome seems to be contrasting among the pharmaceutical companies. For some pharmaceutical companies, their highly anticipated clinical trials have failed and the results are affecting different drugs by other companies. The companies without an outcome, yet, are busy covering up the market’s anxiety and concern by presenting interim status report or requesting for authorization. # According to pharmaceutical industry sources on Mar. 9, Il-yang Pharmaceutical broke the news that it became the first South Korean company to have failed the clinical trial for repurposing the drug for COVID-19 treatment. The company initiated a Phase III trial on a leukemia treatment Supect (radotinib) to repurpose the drug, but it was unable to confirm the expected effect. With the announcement, the pharmaceutical industry was instantly thrown into turmoil with the stress of uncertainty in a successful drug repurposing trial. To resolve the concern, pharmaceutical companies conducting the clinical trials are reporting their current status with the trial, requesting for conditional approval to the Ministry of Food and Drug Safety (MFDS) and unveiling plans to execute a large-scale Phase III trials with 600 participants. For instance, Shin Poong Pharm unveiled the current progress in the locally conducted Phase II clinical trial on Pyramax (artesunate plus pyronaridine phosphatein) to confirm its effect to treat COVID-19, and explained the company has expanded the number of clinical institutes to accelerate to outstanding process. On top of the 10 healthcare institutes initially conducting the trial, the company added three more institutes including Eunpyeong St. Mary Hospital. But as the plan was finalized under the tight confidentiality, the associated hospitals apparently got the news from the company’s official statement. For the Phase II trial, Pyramax has been administered to 76 patients and Shin Poong Pharm aims to call for another 110 patients. According to the company’s plan, the trial should be completed in April. Moreover, Chong Kun Dang has submitted an application to MFDS of requesting conditional item approval and Phase III trial on Nafabelltan (nafamostat) as a COVID-19 treatment. For the Phase III, the South Korean company also submitted a clinical trial protocol involving 600 participants. Chong Kun Dang official explained, “The Phase III trial targeting about 600 patients in South Korea with severe level of high health risks would be conducted in 10 healthcare institutes including the Seoul National University Hospital. As we are aware of the challenges in calling for patients, the company plans to push global clinical trial to promptly register clinical trial participating patients.” On the other hand, Bukwang Pharm is currently working on repurposing its own hepatitis B virus treatment Levovir (clevudine) as a COVID-19 treatment. Recently, 60 patients participating in a Phase II trial have been administered with the drug, which their data is currently being analyzed. Daewoong Pharmaceutical has also started a Phase III trial on Foistar (camostat mesilate) to confirm its effect to treat COVID-19. The company struggled to get statistically meaningful data during the Phase II trial, but the company is to confirm the drug’s efficacy with a Phase III trial. While the South Korean pharmaceutical companies are dealing with different outcomes of repurposing existing drug and developing COVID-19 treatment, the pharmaceutical industry expects to see the outcomes within this year. A pharmaceutical company employee, who requested to be anonymous, commented, “Many of South Korean pharmaceutical companies are seeking for COVID-19 treatment by repurposing their existing drugs. And we are expecting to see the results within this year. But the companies seem to be heavily burdened by the exceptionally heightened interest from the industry and investors.”
- Company
- Lynparza, to be approved for prostate & pancreatic cancer
- by Eo, Yun-Ho Mar 17, 2021 06:10am
- Lynparza, a PARP inhibitor, is expected to be approved as a treatment for prostate and pancreatic cancer in Korea. According to related industries, AstraZeneca is currently expanding the license to Lynparza (Olaparib) for two indications of maintenance therapy for patients with metastatic castration-resistant prostate cancer with a homologous recombination recovery (HRR) mutation and patients with metastatic pancreatic cancer with a BRCA mutation (gBRCAm). Approval is expected in July. Lynparza's indication for prostate cancer was approved by the U.S. FDA in May of last year and in December of 2019 for pancreatic cancer. The efficacy of this drug in prostate cancer has been demonstrated in PROfound study. In this study, Lynparza showed a risk ratio (HR) of 0.34 in patients with mCRPC with BRCA or ATM mutant genes compared to hormone therapy based on Abiraterone acetate or Enzalutamide, reducing the risk of death, a key efficacy evaluation index, by 66%. In general, when the risk ratio is less than 1, it indicates that the risk of the experimental group decreases. Lynparza recorded an HR value of 0.49 compared to the group administered with Abiraterone or Enzalutamide even in the patient group with the total HRR mutant mCRPC, reducing the risk of death by 51%. The patient group with the HRR mutation included patients with 11 other gene mutations, including the BRCA 1/2, ATM, or CDK12 gene mutations. Lynparza also showed statistically and clinically significant improvement in radiographic progression-free survival (rPFS). In the cohort group with BRCA or ATM mutations, the median rPFS was 7.39 months for Lynparza and 3.55 months for the hormone drug-treated group. In the case of pancreatic cancer, the efficacy was confirmed through the phase III POLO trial. As a result of the study, the median progression-free survival (PFS) of the Lynparza first-line maintenance therapy group was 7.4 months, which reduced the risk of disease exacerbation and death by 47% compared to 3.8 months in the placebo group. At both 1 year (Lynparza 34% vs. placebo group 15%) and 2 years (Lynparza 22% vs. placebo group 10%), progression-free survival was confirmed in patients treated with Lynparza more than twice the placebo group. Lynparza was first approved for treatment of ovarian cancer. The indications are for▲adult patients with ovarian cancer (including fallopian tube cancer or primary peritoneal cancer) who have responded (partial or complete) to primary and secondary platinum-based chemotherapy and ▲ patients who have received more than 3 lines of chemotherapy.
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- General hospitals to prescribe Dupixent for adolescents
- by Eo, Yun-Ho Mar 17, 2021 06:10am
- An atopic dermatitis treatment for children and adolescents Dupixent is to be prescribed at general hospitals in South Korea. A related industry source reported Sanofi Genzyme’s atopic dermatitis treatment Dupixent (dupilumab) 200 mg has been passed by drug committees at Seoul National University Hospital, National Medical Center, Korea University Ansan Hospital, Ulsan University Hospital, Chonnam National University Hospital, and Kangdong Sacred Heart Hospital. Other Big Five tertiary healthcare institutes are also currently reviewing the drug for prescription. The low-dose (200 mg) Dupixent is indicated to treat adolescents aged over 12 weighing less than 60 kg with severe atopic dermatitis. After administering an initial load of 400 mg, the maintenance load of 200 mg can be injected every other week. The injection also expanded its indication to treat pediatric patients at age six through 11 with severe case of atopic dermatitis. The 200 mg dose is also applicable for the expanded indication. However, the 200-mg dose of Dupixent is not covered by the National Health Insurance (NHI). NHI-covered Dupixent is eligible for treating adult patient over the age of 18 with severe chronic atopic dermatitis apparent for over three years, who has uncontrolled condition after four-week topical treatment as first-line treatment, and not showing more than 50 percent improvement in Eczema Area Severity Index (EASI) score after three-month systemic immunosuppressant therapy; has EASI score over 23 before administrating the treatment. The coverage is, however, only applicable for 300 mg dose. The LIBERTY AD ADOL trial has confirmed the efficacy and safety profile of Dupixent 200 mg. The trial, participated by 251 adolescent patients with severe atopic dermatitis, found the drug improved the size and severity of the skin lesion by 66 percent at week 16 in patient groups administered with 200 mg and 300 mg, who also demonstrated statically significant improvement in quality of life. And a Phase III LIBERTY AD PEDS study conducted on 367 pediatric patients age six through 11 observed Dupixent improving the skin lesion, itchiness and quality of life in pediatric patients with severe atopic dermatitis. About 75 percent of the patient group administered with a combination of Dupixent and topical corticosteroids scored EASI 75, which was far better improved than 26.8 percent among the placebo group. From January 2021, Dupixent was applied with a special case reimbursement for the patients with severe case of atopic dermatitis, dropping their copayment rate from 60 percent to 10 percent. Initially, the patients had to pay about 12 million won for administering 27 loads annually at a tertiary healthcare institute, but now they can pay only 2 million won annually with the special case coverage.
- Company
- Yuhan to sell Samsung’s biosimilar for Humira in Korea
- by An, Kyung-Jin Mar 17, 2021 06:09am
- AdalloceSamsung Bioepis announced on the 15th that it has signed a marketing partnership with Yuhan for domestic sales of Adalloce, biosimilar for Humira. Adalloce is a biosimilar of Adalimuma with the largest global sales. It was the first in Korea to be approved for sale among the biosimilars for Adalimuma. It treats autoimmune diseases such as rheumatoid arthritis, ankylosing spondylitis, and Crohn's disease through a mechanism that suppresses the expression of tumor necrosis factor (TNF-α) in the body. Samsung Bioepis obtained a marketing license for Adalloce from the MFDS in September 2017, and has been preparing for domestic release through a licensing agreement with AbbVie, an original developer. Adalloce was released in Europe under the product name Imraldi in October 2018. Since then, it has recorded cumulative sales of $417 million (about ₩450 billion) until the end of last year. In May 2019, it was approved for sale by the FDA under the product name Hadlima. According to the licensing agreement with AbbVie, it is planned for July 2023. Adalloce's domestic release is expected in the first half of this year. After Adalloce is released in the domestic market, Samsung Bioepis will release all three biosimilars of blockbuster products in the field of TNF-α inhibitors in Korea. The market size is about ₩200 billion. Yuhan is in charge of sales of Etoloce, biosimilar for Enbrel and Remaloce, biosimilar for Remicade, previously released by Samsung Bioepis in the domestic market. Through this contract, Samsung Bioepis is in charge of the domestic sales of three autoimmune disease treatments, further strengthening the partnership between the two companies. Samsung Bioepis President Han-Seung Koh said, "We are pleased to be able to introduce biosimilar products of the world's most widely used drugs in Korea. We will continue to strive to expand treatment opportunities through high-quality medicines to patients."
- Company
- Praluent is in the process of listing insurance benefits
- by Eo, Yun-Ho Mar 17, 2021 06:09am
- Sanofi-Aventis' PCSK inhibitor Praluent is belatedly in the process of registering insurance benefits. It is slow compared to the rival drug Amgen's Repatha. According to the industry on the 12th, Praluent (Alirocumab) was recently judged appropriate for benefit from the HIRA's Pharmaceutical Benefits Advisory Committee. It is a PCSK9 inhibitor and was first approved in Korea in January 2017. Since April of the same year, Repatha(Evolocumab) was approved and was first listed as an indication of HOFH (Homozygous Familial Hypercholesterolemia) in August 2018. In January 2020 Repatha succeeded in expanding the benefit criteria to patients with ASCVD, atherosclerotic cardiovascular disease, HeFH, Heterozygous Familial Hypercholesterolemia, and statin intolerance. The PCSK9 inhibitor is a drug that has excellent efficacy but has a price issue. There were problems both at home and abroad, and Amgen cut the prices of their drugs by 60% in October 2018 and Sanofi in February 2019. Sanofi voluntarily withdrew Praluent's listing in October 2018, before the drug price cut, and passed the Pharmaceutical Benefits Advisory Committee, about two years later. Interest is focused on what changes Prarent will bring to the market after 4 years. Domestic treatment guidelines recommend that patients with ASCVD (AtheroSclerotic CardioVascular Disease) be adjusted to less than 70mg/dL LDL-C to prevent recurrence of cardiovascular disease. In 2019, the European Society of Cardiology lowered the target LDL-C level for ultra-high-risk groups to less than 55 mg/dL. Accordingly, there is increasing interest in the clinical field about PCSK9 inhibitors, which are useful for ultra-high-risk patients who cannot reach the target level with existing treatment regimens. Praluent has a tendency to reduce the risk of all-cause death, and there are Praluent 75mg and Praluent 150mg available. It is possible to select a dose for each patient based on the patient's condition and LDL-C level.
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- Takeda to chase Roche in ALK targeted therapy market
- by Mar 16, 2021 06:22am
- Product images of ALK-positive treatment. Clockwise from left: Xalkori, Zykadia, Alunbrig and Alecensa The follow-on drug competition within the anaplastic lymphoma kinase (ALK)-positive lung cancer treatment market is intensifying with more competitors joining the race. From next month, Alunbrig (brigatinib), receiving the National Health Insurance (NHI) reimbursement for the first-line therapy for lung cancer, and the market leader Alecensa (alectinib) are to engage in a fierce competition. On top of everything else, a third-generation new drug following after Xalkori (crizotinib) is to be introduced. The ALK-targeting treatment market has been dominated by Pfizer Pharmaceutical Korea’s Xalkori so far. As a first-generation ALK tyrosine kinase inhibitor (TKI), it has been generating 50 billion won annually in sales. Like the epidermal growth factor receptor (EGFR) targeted therapy market, ALK TKI market has been reshuffled since second generation drugs were released to the market. Particularly, Roche’s Alecensa has been strongly asserting its market presence as soon as it entered the market. Alecensa, approved as a third ALK targeted therapy in South Korea in 2016, has expanded its indication to treat ALK-positive patients with non-small cell lung cancer (NSCLC) as a first-line therapy in April 2018, and requested for the reimbursement listing in December of the year. Immediately after getting listed for the first-line therapy indication, Alecensa sales exceeded Xalkori’s. In 2018, Alecensa sales hit 10.4 billion won, or a quarter of Xalkori’s at 49.6 billion won, but after the listing in 2019, the drug generated 22.1 billion and surpassed Xalcori making 20.3 billion won. Technically, Alecensa took over a half of Xalkori’s market share. Even last year, Alecensa made 29.3 billion won and topped the ALK treatment market. Regardless, even Alecensa is to face another new comer. Takeda Pharmaceuticals’ Alunbrig is swiftly prepping to overtake Alecensa’s place. As a fourth ALK TKI drug in South Korea, Alunbrig was authorized in December 2018. In the following year, the drug was released in the second quarter and raised 1.2 billion won. Takeda Pharmaceuticals is speeding up the drug’s marketing procedure as it started late as a second generation drug. The multinational company has immediately requested for the reimbursement as soon as Alunbrig’s expanded indication for the first-line therapy was cleared in last August. The drug has been passed by Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation convened last January. The drug is expected to win the coverage for the first-line therapy within the first half of the year at earliest. Alunbrig is the first solid cancer treatment Takeda Pharmaceuticals launched. Backed by the company’s big ambition, the drug sales generated 3.9 billion won in 2020, which fell short of Alecensa and Xalkori’s, but it is looking forward to rapidly grow in the market with the first-line therapy expansion. Moreover, the market is going to open a door to a third generation ALK TKI new drug this year as well. Pfizer Pharmaceutical that developed Xalkori is preparing to launch Lorbrena (lorlatinib). Submitting the approval application last year, Pfizer is currently in process of reviewing Lorbrena with South Korea’s Ministry of Food and Drug Safety (MFDS). Lorbrena is also to accelerate the expansion to the first-line therapy. Already in the U.S., the drug successfully won the first-line therapy indication as of Mar. 8. Categorized as a third generation drug, Lorbrena can reportedly cover more resistance gene mutations. Meanwhile, Novartis’ Zykadia (ceritinib) was quickly introduced to the market, the prescription market seems to be disinterested in the drug. Zykadia has raised 800 million won in sales, which was lower than Alunbrig’s that entered the market last.
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- Binex is likely to be removed from the KPBMA member list
- by Nho, Byung Chul Mar 16, 2021 06:22am
- The KPBMA It is observed that Binex, which is suspected of changing the manufacturing of active pharmaceutical ingredients, has a strong expulsion from the KPBMA membership. The KPBMA is expected to hold a meeting of the board of directors on the 16th and refer the agenda on the Binex situation to the ethics committee. In a statement on the 11th, the KPBMA is highly likely to convene an ethics committee with the unanimous opinion of 14 directors and presidents in order to degrade K-Bio status and protect the right to public health. If the board of directors' opinion is gathered on this day, the ethics committee will convene within 3 days at the latest, and it is expected that a prompt decision will be made. Since the establishment of the KPBMA in 1945, Wales Korea has the only precedent for the withdrawal of regular members. Wales Korea was expelled from the KPBMA by changing the date of manufacture of the drug that expired in 2013. Pharmaking was prosecuted by the prosecution for a rebate in 2016 and voluntarily withdrew after being suspended from qualification by the association's ethics committee. If Binex is subject to disqualification, it will be the second expulsion case ever. However, the Ethics Committee may consider the pharmacy precedent as much as possible and refine it to suspension of qualifications rather than expulsion or forced withdrawal. Binex joined the association in 1957 under the name of the former Suncheondang and has been active as a member for 65 years. The ethics committee is chaired by Yun Sung-tae, vice-chairman of Huons Global, and consists of 7 members, including President Oh Heung-ju, DongKook (Vice Chairman) and Lee Won-beom, CEO of Whanin (a member). Looking at the membership management regulations of the association,'The chairman may request a deliberation by the ethics committee when it is recognized that a member has a reason for disciplinary action in the articles of association. The association shall notify the member in writing of the fact of the claim and the grounds for disciplinary action recognized, and give them an opportunity to clarify.' Therefore, Binex of the Ethics Committee, a member of the Pharmaceutical Association, has the strongest force. The meeting of the chairman and the directors on the 16th, deciding whether to refer to the ethics committee 2013 Wales Korea Pharm's first expulsion precedent, likely to follow the procedure of suspension of qualification → voluntary withdrawal. Immediate decision after convening of ethics committee within a few days, unanimous public opinion rises. It is observed that Binex, which is suspicious of a change in the manufacture of the main ingredient of pharmaceuticals, is likely to be expelled from The KPBMA as a full member. The KPBMA is expected to hold a meeting of the board of directors on the 16th and refer to the Binex situation to the ethics committee. In a statement on the 11th, the KPBMA is highly likely to convene an ethics committee with the unanimous opinion of 14 directors and presidents in order to degrade K-Bio status and protect the right to public health. If the board of directors' opinion is gathered on this day, the ethics committee will convene within 3 days at the latest, and it is expected that a prompt decision will be made. Since the establishment of The KPBMA in 1945, Wales Korea Pharm has the only precedent for the withdrawal (dismissal) of regular members. Wales Korea Pharm was expelled from the Association by changing the date of manufacture of the drug that expired in 2013. Afterwards, Pharmaking, who was prosecuted by the prosecution for a rebate in 2016, voluntarily withdrew after being suspended from qualification by the association's ethics committee. If Binex is subject to disqualification, it will be the second expulsion case ever. However, the Ethics Committee may consider the pharmacy precedent as much as possible and refine it to suspension of qualifications rather than expulsion or forced withdrawal. Binex joined the association in 1957 under the name of the former Suncheondang Pharmaceutical Company and has been active as a member for 65 years. Meanwhile, the ethics committee is chaired by Yun Sung-tae, vice-chairman of Huons Global, and consists of 7 members, including President Oh Heung-ju, DongKook (Vice Chairman) and Lee Won-beom, Whanin President (Committee). Looking at the membership management regulations of the association,'The chairman may request a deliberation by the ethics committee when it is recognized that a member has a reason for disciplinary action in the articles of association. The association shall notify the member in writing of the fact of the claim and the grounds for disciplinary action recognized, and give them an opportunity to clarify.' Therefore, when or after the convocation of the Ethics Committee this time, attention is also being paid to whether Binex's executives will appear in person to explain the overall situation or replace them in writing.
