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- 2026-04-15 14:23:32
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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.
- Policy
- Samsung Bioepis' biosimilar for Avastin was first approved
- by Lee, Tak-Sun Mar 16, 2021 06:21am
- Samsung Bioepis was the first in Korea to be licensed for the anticancer drug biosimilar for Avastin (Bevacizumab, Roche Korea). The MFDS licensed Samsung Bioepis' Onbevezy on the 11th. Onbevezy is a biosimilar for Avastin of Roche Korea. Onbevezy is the only approved biosimilar for Avastin in Korea. Like Avastin, Onbevezy is used for various cancers such as metastatic colorectal cancer, metastatic breast cancer, non-small cell lung cancer, advanced or metastatic renal cell carcinoma, glioblastoma, epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer, and cervical cancer. Last year, Avastin's domestic sales amounted to ₩118 billion based on IQVIA, ranking third. Domestic companies such as Celltrion are also developing biosimilar for Avastin.
- Policy
- COVID-19 vaccine vaccination rate has exceeded 64%
- by Kim, Jung-Ju Mar 15, 2021 08:24am
- COVID-19 vaccine vaccination rate has exceeded 60%. As the AstraZeneca vaccine is recommended for those over 65 years of age, the quarantine authorities decided to introduce an additional 7 million doses (for 3.5 million people) from the end of May. Joon-wook Kwon, the 2nd vice-president of Central Disease Control Headquarters, explained this trend through a regular briefing of COVID-19 Central Disease Control Headquarters during the day (11th). According to him, as of today's 0 o'clock, an additional 51,100 new people were vaccinated, and the first dose of COVID-19 vaccine was completed for 500,635 people, and the inoculation rate reached 64%. By vaccination institution and target audience, 175,454 people (85.9%) in nursing hospitals, 75,690 people (69.7%) in nursing facilities, 27,226 people (36%) in the first responder, and 209,334 (62.3%) in medical institutions and above, and 12,931 (22.7%) people were vaccinated in COVID-19 patient treatment hospital. Looking at the current status of COVID-19 treatment administration, the treatment 'Veklury (Remdesivir)' was administered to 4,975 patients in 122 hospitals as of 0 o'clock on the 10th. COVID-19 antibody treatment 'Regkirona (Regdanvimab)' was administered to 381 patients in 44 hospitals based on the same criteria. The vaccination promotion team announced that it will introduce 7 million doses (for 3.5 million people) of AstraZeneca vaccine from the last week of May to the end of June. This is the amount of individual contracts that will be introduced as the second, following 1.57 million doses of this product, which was first introduced from February 24th to 27th. The quarantine authorities are continuing to negotiate with pharmaceutical companies to secure quantities of Moderna and Janssen products that will be used for vaccination starting in the second quarter. He said that in medical institutions such as nursing homes and hospitals, there were cases in which the vaccine could not be used due to an accidental deviation in the temperature of the vaccine due to problems such as negligence during the storage of the vaccine. He said, “Due to a breakdown in the refrigerator, an abnormal thermometer, and carelessness of the person in charge of vaccine management, 770 doses of vaccines have been suspended at 7 medical institutions so far. We will continue to strengthen the supervision of consignment medical institutions in cooperation with local governments and the Ministry of the Interior and Safety.” He added, “Please keep and manage the vaccine thoroughly so that it does not happen that the vaccine is discarded due to minor carelessness even at the consignment medical institution.”
- Policy
- Cases of Vivozon & Binex need ‘1+3 Regulation Act’
- by Lee, Jeong-Hwan Mar 15, 2021 06:29am
- Following Binex, Vivozon illegally manufactured medicines in violation of the Pharmaceutical Affairs Act. As a result, the '1+3 Regulation Act' legislation that directly limits the number of drug became valid. The reason was the domestic licensing system and regulatory environment in which too many generics could obtain marketing licenses. Vivozon's incident made ‘1+3 Regulation Act’ even more necessary. According to the National Assembly and pharmaceutical industry officials on the 12th, Binex and Vivozon incidents further necessitated a legislative 1+3 Regulation Act for generics and data submission drugs. 1+3 Regulation Act was proposed by Rep. Yeong-Seok Seo (Democratic Party of Korea) and Rep. Jeong-sook Seo (People Power Party)'s ‘Drugs for data-based re-evaluation 1+3 restriction' amendment to the Pharmaceutical Affairs Act is pending in the National Assembly. Drugs for data-based re-evaluation 1+3 restrictions were opposed by some pharmaceutical companies and the MFDS' opinion was cautious, but the generic 1+3 Regulation Act was approved by many pharmaceutical companies and the MFDS. It is expected to pass if only the opportunity for examination is obtained at the temporary National Assembly in March. If the generic 1+3 Regulation Act is passed, the data submission drug (IMD) 1+3 regulation, which will be discussed, will be also valid. Binex and Vivozon incidents are accelerating the legislation of Drugs for data-based re-evaluation 1+3 restriction. Rep. Seo Young-seok appealed to the necessity of expediting the passage of the 1+3 Regulation Act immediately after Binex crisis. An MA (Market Access) manager at a top domestic pharmaceutical company said, "In fact, many pharmaceutical companies and the KPBMA have been consensus for a long time in the joint bioequivalence 1+3 regulation to resolve the generic mess." "Only some small pharmaceutical companies that are difficult to test for their own bioequivalence were opposed," he said. "But, as the government's regulatory policy on generic drug prices, generics without bioequivalence testing will no longer be sold on the market." He said, "The passing of the generic 1+3 Regulation Act (by Seo Young Seok) due to the Binex and Vivozon incidents is a pre-determined fact. The ruling party, the opposition party, and the government have the same opinions, so it is highly likely to pass." He added, “The quality manipulation situation has further increased the validity of the regulatory bill. It is pointed out that too many drugs have been released in the market, and the regulatory authorities are also not able to manage quality.” An official from the National Assembly's Health and Welfare Committee said, "The generic 1+3 Regulation Act was a bill that had a great influence on the domestic pharmaceutical industry, front-line medical institutions, and pharmacies, but it was a bill that was not well understood by the public." "If public opinion raises a strong issue in the case of low-quality drug distribution or quality-manipulated pharmaceutical companies, the National Assembly will inevitably have a legislative law reflecting public opinion." He said, "It is not because of the public opinion that the examination of the bill changes, but the speed of examination and promotion of the bill will be faster. In addition, the interest of the National Assembly members will also increase. The results of the internal investigation by the MFDS will also affect the validity of the 1+3 bill."
- Company
- SGLT-2 inhibitor Jardiance to expand HF indication
- by Eo, Yun-Ho Mar 15, 2021 06:28am
- Following after Forxiga, Jardiance is also preparing to introduce the heart failure indication in South Korea. According to a pharmaceutical industry insider, Boehringer Ingelheim Korea is waiting for the health authority’s review result in its sodium-glucose cotransporter 2 (SGLT-2) inhibitor Jardiance’ request to expand indication in treating adult patients with heart failure with reduced ejection fraction (HFrEF) regardless of diabetic status. The South Korean authority has approved the same indication in competing Forxiga (dapagliflozin) in last December. The U.S. Food and Drug Administration (FDA) has reportedly granted a fast-track status on Jardiance’ indication, which is also under review in other countries like Japan. The drug’s efficacy in heart failure treatment has been statistically confirmed by a Phase III EMPEROR-Reduced trial. The study verified Jardiance met the primary endpoint by demonstrating 25 percent lower risk in cardiovascular related death or hospitalization by a heart failure, compared against placebo. Evaluating the secondary endpoint, Jardiance lowered the risk of a first hospitalization by a heart failure and repeated hospitalization by 30 percent. And for a new indicator, the decrease in estimated glomerular filtration rate (eGFR) by the drug was significantly delayed compared to the placebo. In last year, American Society of Nephrology (ASN) also disclosed the result of sub-analysis on EMPEROR-Reduced trial at 'Kidney Week 2020.' The analysis studied various subgroups of patients, including groups with severe renal impairment, experienced the drug’s benefit regardless of the chronic renal disease. The president of the Korean Society of Heart Failure and a cardiology professor at Seoul National University Bundang Hospital, Dr. Choi Dong-ju noted, “The size of heart failure patients in South Korea has almost doubled within last decade. The prevalence in heart failure will increase continuously in the future due to the aging society. But it is satisfying to see the EMPEROR-Reduced trial showing a positive outcome in treating heart failure.” Meanwhile, the FDA has designated the fast-track review status on EMPEROR program, which consists of EMPEROR-Preserved and EMPEROR-Reduced trials on evaluating Jardiance’ efficacy in lowering the risk of cardiovascular related death and hospitalization by heart failure. The EMPEROR-Preserved trial aims to assess Jardiance’ effect on cardiovascular related death and hospitalization by heart failure in patients with Heart failure with preserved ejection fraction (HFpEF). Currently, the health condition does not have any specific treatment for it, and the trial result would be disclosed within this year.
- Policy
- AZ vaccination recommended for age 65 or older
- by Kim, Jung-Ju Mar 15, 2021 06:28am
- The Vaccination Specialist Committee recommended AstraZeneca COVID-19 vaccination for people 65 years of age or older. Accordingly, the quarantine authorities decided not only to immunize them, but also to immunize patients and workers in nursing hospitals and facilities during this month. The COVID-19 Vaccination Promotion Team (Director Eun-kyung Jung) announced on the 11th that it has decided in this way following the deliberation of the '6th Vaccination Specialized Committee in 2021' on the 10th. The committee reviewed the results of studies in the UK and Scotland and recommended the use of the AstraZeneca vaccine in hospitalization and severe prevention in the evaluation of the elderly. Previously, the UK said that Pfizer and AstraZeneca vaccines prevented similar levels of disease (about 70%) and confirmed the effect of preventing hospitalization among the elderly in their 70s or older. In Scotland, Pfizer and AstraZeneca vaccines showed up to 85% and 94% of hospitalization prevention effects, respectively. The COVID-19 Vaccination Promotion Team plans to immunize approximately 376,000 people aged 65 or older and workers in nursing hospitals and nursing facilities in accordance with the deliberation result of the Vaccination Committee. In addition, the Vaccination Committee deliberated on detailed implementation standards for the second vaccination for those who were confirmed as COVID-19 after the first vaccination and those who responded to anaphylaxis. As a result, the committee decided that if COVID-19 was confirmed among the first inoculations, the second inoculation should be performed, and that it is possible after the quarantine is lifted. For the timing of vaccination, if the confirmed person received passive antibody treatment, vaccination should be performed after at least 90 days, and otherwise, it was recommended to complete the vaccination according to the recommended vaccination interval for each vaccine. The recommended vaccination interval is 21 days for Pfizer vaccine and 8 to 12 weeks for AstraZeneca vaccine. Among the primary inoculations, the vaccination subjects with anaphylaxis reactions were decided not to perform the second vaccination because there is insufficient evidence for cross vaccination with another platform, Pfizer's mRNA platform, and AstraZeneca vaccine's viral vector platform vaccine. In addition, considering the current supply status of AstraZeneca vaccine and clinical trial results that the longer the vaccination interval, the longer the vaccination interval was applied, the 2nd vaccination schedule was decided to change to 10 weeks when the vaccination interval was applied. In fact, on the 10th of last month, WHO SAGE recommended that the vaccination interval of AstraZeneca vaccine is 8-12 weeks, considering that the longer the vaccination interval between the 1st and the 2nd vaccination increases, the more effective it is. The Vaccination Specialist Committee included in the 2nd quarter vaccination target group to block the outflow of mutant viruses for flight attendants who are subject to the exception of self-isolation, although they often come and go abroad due to their occupational characteristics. About 20,000 people, including crew members of international airliners belonging to Korean airlines, are covered. The COVID-19 Vaccination Promotion Team plans to establish a second quarter vaccination plan according to the deliberation result of the Vaccination Expert Committee and announce it next week.
- Company
- HER2 targeted therapy market exceeds KRW 200 billion
- by An, Kyung-Jin Mar 15, 2021 06:28am
- The South Korean market for targeted therapy prescribed to treat human epidermal growth factor receptor 2 (HER2)-positive breast cancer has exceeded 200 billion won in sales last year. Two domestically developed biosimilars increased the market influence and made up for the sale revenue void in the original by the original maker’s follow-on drugs, such as Kadcyla and Perjeta, breaking the market sales record. On Mar. 11, a pharmaceutical market research firm IQVIA reported the trastuzumab drug market size last year dropped to 99 billion won by year-on-year 4.8 percent. The market size increased for two consecutive years since it plummeted from 103.4 billion won in 2016 to 83.6 billion won in 2017, and recovered up to annual sales of 100 billion in 2019. But it took a slight fall after a year. Trastuzumab is the key substance in a targeted therapy Herceptin by Roche. The drug is prescribed to HER2-positive patients with metastatic breast cancer and stomach cancer. In South Korea, two biosimilars of the original Herceptin—Celltrion’s Herzuma and Samsung Bioepis’ Samfenet—were released to the market after the original’s patent expired. The original generated sales of 69.9 billion won last year. Compared against the year before, it was dropped by 11.2 percent. And compared against 103.4 billion won raised in 2016, before the biosimilars were released, one-third of the sales were evaporated. Herceptin’s pricing was brought down by 20 percent, from 517,628 won to 414,103 won per 150 mg injection, two months after Celltrion’s Herzuma was listed for National Health Insurance (NHI) reimbursement in April 2017. And with another pricing drop, the original drug is currently maintaining the pricing at 362,340 won since April last year. By principle of the South Korean drug pricing system, a biosimilar can be priced at 70 percent of the original’s pricing before the patent expiration. And from October 2016, an item ‘developed by a company recognized as an innovative pharmaceutical company or a company with collaborative deal between South Korean and global companies, released first time internationally in South Korea, or manufactured in South Korea’ can be priced up to 80 percent of the original. Meanwhile, an off-patent original’s pricing is reduced to 70 percent to 80 percent of the initial pricing when a biosimilar is launched. The trastuzumab drug market shrunk down to 83.6 billion won due the pricing reduction in Herceptin in 2017. But as biosimilars developed with South Korean technology pushed the sales, the market growth is catching up with the original’s gap. Celltrion’s Herzuma sales last year grew by 10.4 percent from the year before and generated 25.4 billion won. The Ministry of Food and Drug Safety (MFDS) authorized the sales of Herzuma in January 2014 and the drug started making sales revenue from the third quarter of 2017. The 2018 sales was stale with 7.7 billion won, but the sales surged to 23 billion won in 2019 and it is keeping the growth ever since. However, the domestic market share of Samsung Bioepis’ Samfenet is still insignificant. Samfenet generated 3.6 billion won last year. Although the sales grew by 65.8 percent compared to the year before, the gap with the competitor is rather substantial. Currently, Daewoong Pharmaceutical is in charge of Samfenet sales. Within three years of releasing the biosimilars, their market share in the trastuzumab drug market grew exponentially. The two biosimilars took 29.3 percent of the last year’s trastuzumab drug market sales. Herzuma’s share is at 25.7 percent, when Samfenet took up 3.6 percent. Basically, Herzuma led the biosimilar market expansion. And the targeted therapy market for the HER2-positive breast cancer patients expanded vastly as Herceptin developer Roche released follow-on drugs Kadcyla (trastuzumab emtansine) and Perjeta (pertuzumab). Around 15 percent to 20 percent of the total breast cancer patients are confirmed positively with HER2, which has fast relapse and short survival period. Roche’s Kadcyla generated 43.5 billion won last year, growing 22.7 percent from the year before. Kadcyla is the first antibody drug conjugate (ADC) Roche first show cased for the breast cancer sector. The drug can be prescribed to treat unresectable locally advanced or metastatic breast cancer in patients previously treated with trastuzumab and taxane. During the same time, Roche’s Perjeta generated 74.1 billion won. Growing 33.1 percent compared to the year before, the sales surpassed Herceptin for the first time. The drug, in combination with docetaxel and trastuzamab, can be prescribed to patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous HER2 targeted therapy or chemotherapy. As it was listed for selective reimbursement in May 2019, the combination therapy with trastuzumab became the standard adjuvant treatment before a surgery. Five drugs including the three trastuzumab drugs, Kadcyla and Perjeta, have raised 216.6 billion last year together and increased the market by 11.0 percent from the year before. Compared to 116.1 billion won in 2016, the market sales have almost doubled in four years and broke the record. The industry evaluates Roche has overcome off-patent Herceptin’s sales drop with the follow-on drugs. Also the HER2-positive breast cancer patients would benefit from the expanded treatment options.
- Policy
- MFDS drug review result to be disclosed within 2 months
- by Lee, Tak-Sun Mar 12, 2021 06:23am
- The pharmaceutical review result for new drug would be disclosed within two months from the completed date. Compared to four months taken at the moment, the information disclosure deadline would be cut by two months. Regardless of the affected company’s request for non-disclosure, the summarized information would be publicly opened to improve the people’s right to know. South Korea’s Ministry of Food and Drug Safety (MFDS) has convened an online seminar on pharmaceutical approval on Mar. 11 and explained the revised regulation. In last December, the ministry drew a guideline up and informed in advance of the information disclosure. Deputy Director Kim Byoung-sam at MFDS Approval Management Team explained, “The ministry has decided to disclose the relevant information due to the heightened social interest on the medical products with the growth in the healthcare industry, and increasing demand for transparency.” Even now, MFDS discloses an item approval review result on its website. The information disclosure scope not only includes new drug, but also the evidence-required drug and generics. However, the information disclosure has been frequently delayed by complicated procedure or even omitted when requested for confidentiality by the applicant company. MFDS is to shorten the time to information disclosure from four months to two months by streamlining the currently two-tracked pre and post-approval procedures into one. Particularly, the information disclosure subject review and report composition taking 60 days and company survey for the disclosure taking 30 days would be dropped. Instead, the ministry would survey the company’s opinion on the information disclosure while the approval review is ongoing, and the information would be posted on the official website after reviewing to opinion. And also the ministry would publish a summarized approval review report from now on, although it used to omit some information requested for confidentiality by the company. Deputy Director Kim elaborated, ”When the confidentiality request is adequate, the result could be undisclosed, but the summarized approval review would be disclosed.” The review summary report would include details on the final approval status, approval condition, incrementally modified drug designation, result of Central Pharmaceutical Affairs Deliberation Committee consultation, preliminary review summary and result, and review history.
- Policy
- 3 drugs including Baricitinib are covered for COVID-19 tx
- by Kim, Jung-Ju Mar 12, 2021 06:22am
- Baricitinib, Corticosteroids, low-molecular weight heparin, and anticoagulants are covered to be used to COVID-19 confirmed patients. Kaletra (Lopinavir + ritonavir), Hydroxychloroquine, and Ribavirin were decided to be removed from the benefit. The MOHW decided to partially revise the notification of details on the application standards and methods of pharmaceutical benefits for drugs in order to properly apply insurance for COVID-19 treatment drugs. and announced on the 11th that it will inquire industry opinions. The main goal of this amendment is to clearly define the target of confirmed patiens with COVID-19 in the COVID-19 treatment (general principle), and the main goal is to clarify the drugs to be covered by reflecting the opinions of the society and recommendations of clinical practice guidelines. Corticosteroids, low molecular weight Heparin and anticoagulants, and Baricitinib are newly added. According to the MOHW, Corticosteroid will be added in accordance with the recommendations for administration of Corticosteroid in severe COVID-19 patients in clinical practice guidelines. LMWH (Low-molecular-weight heparin) and new anticoagulants are recommended to be administered to hospitalized patients as COVID-19 increases the risk of blood clots in the opinions of related society and clinical practice guidelines. In the case of new anticoagulants, it was decided to be covered if the patient's condition is unable to administer low molecular weight heparin. In the case of Baricitinib, considering the fact that Remdesivir & Baricitinib can be administered as an alternative if Remdesivir cannot be administered in the clinical practice guidelines and related opinions of the society, it is planned to be added as a covered drug. Remdesivir decided to be covered when administered concurrently with Baricitinib. Kaletra, Hydroxychloroquine, and Ribavirin were excluded from treatment. The MOHW decided to delete it from the target drug due to the fact that it was not recommended in the clinical practice guidelines and the evidence for clinical usefulness was insufficient. and it is planning to inquire about the revised bill by the 24th and apply it as of April 1st if there are no specific issue, and conduct a review one year after the implementation.
- Company
- 3 companies have abandoned Pelubi's patent challenge
- by Kim, Jin-Gu Mar 12, 2021 06:22am
- Pelubi Pharmaceutical companies that were trying to overcome the patent of Daewon's anti-inflammatory pain reliever Pelubi (Pelubiprofen) gave up. After Mother's and Hutecs voluntarily withdrew the request for a referee last year, Nexpharm was recently added, leaving only three of the six challengers. Some of the companies that voluntarily withdrew are said to have failed to develop the formulation. According to the pharmaceutical industry on the 10th, Nexpharm withdrew the trial to confirm the passive scope of rights for the Pelubi recently filed against Daewon. The third step after Mother's and Hutecs. Hutecs gave up its patent challenge in September of last year and in October of the same year. As a result, only three companies are left to challenge the Pelubi patent. Youngjin Pharm, Huons, and Chong Kun Dang, who first requested a patent trial, are planning to continue the patent challenge. Pelubi is a Korean new drug No. 12 developed by Daewon. After launching in 2008, the initial sales did not meet expectations. Until 2014, Pelubi's outpatient prescription was less than ₩5 billion. Then, as Daewon released the Sustained Release type as a generic, sales increased as additional indications were secured through follow-up clinical trials. Daewon launched the Pelubi SR in June 2015. In 2017, Pelubi's prescription amount surged with the addition of an indication of antipyretic action. Since 2019, it has produced more than ₩30 billion in prescriptions. Then the patent challenge continued. Starting with Youngjin Pharmaceutical in December 2019, Huons, Chong Kun Dang, Nexpharm, Hutecs, Mother's, etc., challenged the drug patents that expire in November 2028. At the same time, it started to develop generic for Pelubi. Excluding Chong Kun Dang, the remaining five companies were approved for generic for Pelubi bioequivalence test. The bioequivalence test was recently completed. However, it is confirmed that some companies have failed to prove bioequivalence. An official in the pharmaceutical industry said, "Pelubi ( Pelubiprofen) is a product with improved dissolution rate and stability, and development is difficult due to the nature of the formulation." He said, "I know that some of the companies that gave up the patent challenge have failed to develop the formulation they were aiming for."
