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- 2026-03-18 05:51:35
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- [Reporter's view] Korean patients to name specific drugs
- by Eo, Yun-Ho Jul 07, 2021 05:54am
- A growing number of patients are looking for specific "Rx drugs." Patients who wanted certain OTC by visiting pharmacies are now finding a doctor and wanting certain Rx drugs. It is said that the demand for prescription, which was made in the past in the line of original and generics, is even spreading to the area of anticancer drugs. Times have changed. Patients or their families are now searching for new drugs or the clinical trial database (clinicaltrial.gov). When domestic licensed drugs are not covered by insurance benefits, complaints are poured out to the HIRA, the MOHW. Cheongwadae's petition is no exception. A professor at a university hospital said, "Patients already know the concept of reimbursement and non-reimbursement, and they demand a combination of prescriptions for the drugs. Of course, I try to reflect the patient's expression as much as possible, but sometimes I'm embarrassed by ridiculous demands." For example, diabetes patients who were taking Sulfonylurea are asking for DPP-4 inhibitors or hypertension patients who were taking ARB single drugs are actually asking for prescription of ARB+CCB complex drugs. But the right to prescribe Rx is a doctor's own right. The public has delegated them to doctors with expertise for their health. Even if the public's level of knowledge is high and there is distrust in the current medical society, the prescription of Rx drugs should be prioritized by professionals' medical judgment.
- Company
- The NPS bought shares in Samsung BioLogics & SK Bio
- by Kim, Jin-Gu Jul 06, 2021 05:51am
- The National Pension Service (NPS), the nation's largest institutional investor, significantly reduced its investment in the local stock market in the first half of last year. Investment in pharmaceutical bio stocks has rather increased. Investments in Samsung BioLogics, SK Bioscience, and SK Biopharm were significant. It sold more than ₩300 billion in shares of Celltrion. According to the KRX on the 5th, The NPS bought Samsung BioLogics shares worth ₩586.4 billion in the first half of this year. Not only pharmaceutical bio shares but also all stocks ranked first in net buying. The NPS' stake in Samsung BioLogics rose 0.12%p to 5.10% at the end of June from 4.98% at the end of last year. As of the end of June, Samsung BioLogics' stock valuation held by the NPS is close to ₩3 trillion as of the closing price of the 5th. In addition to Samsung BioLogics, four out of the top 10 net purchases of the NPS were pharmaceutical bio shares. SK Bioscience (3rd), SK Biopharm (6th), and Celltrion Healthcare (9th) ranked high. Net purchases of The NPS amounted to ₩259.1 billion from SK Bioscience, ₩157.6 billion from SK Biopharmaceutics, and ₩116.4 billion from Celltrion Healthcare. In addition, it sold ₩69.3 billion in GC LabCell shares, ₩49.5 billion in Hanmi Science, ₩45.2 billion in Daewoong Pharmaceutical, ₩41.6 billion in LegoChem Bioscience, ₩36 billion in Hugel, ₩35.5 billion in Medy Tox, ₩35.3 billion in ST PharmaReaserch, ₩26.2 billion in Celltrion, PharmaReaserch ₩17.5 billion in Pharmicell, ₩15.6 billion in Dong-A Socio Holdings, ₩15.2 billion in Alteogen, ₩13.4 billion in Daewoong, ₩12.5 billion in Macrogen, and ₩12 billion in Huons Global. The NPS' share of these companies has also increased. GC LabCell increased 1.12%p (4.99%→6.11%), Dewoong increased 1.05%p (5.09%→6.14%), and Hanmi increased 2.02%p (6.84%→8.86%). The NPS is said to have continued its all-time selling spree in the domestic stock market in the first half of this year. Net sales in first half of this year alone amount to ₩24.598 trillion. According to the fund management guidelines, the government decided to lower the portion of investment in domestic stocks to 16.8% by the end of this year, leading to large-scale net selling. As of the end of last year, it had a share of 21.2%. However, investment in pharmaceutical bio shares has increased even among large net sales. The cumulative net purchase amount of pharmaceutical bio shares by June is estimated at ₩836.7 billion. The NPS sold Celltrion shares the most. It bought ₩1.1447 trillion for six months and sold ₩1.507 trillion, reaching ₩362.3 billion in accumulated net sales. The NPS sold ₩182.8 billion in shares of SK Chemical, ₩85.5 billion in GC Pharma shares, ₩46 billion in Bukwang shares, ₩28.9 billion in JW-Lifescience shares, ₩28.4 billion in Chong Kun-dang shares, ₩24.5 billion in G-TreeBNT shares, ₩18.8 billion in Seegene shares and ₩15 billion in Shin Poong. Celltrion shares in the NPS fell 0.88%p to 7.48% at the end of June, compared with 8.36% at the end of last year. SK Chemical's shares fell 3.99%p from 10.13% at the end of last year to 6.14% at the end of June. In addition, shares of GC Pharma fell 0.04%p (9.12%→9.08%) and shares of Bukwang fell 1.12%p (8.18%→7.06%) respectively.
- Company
- Hemlibra & Afstyla were released
- by Kim, Jin-Gu Jul 06, 2021 05:50am
- Domestic pharmaceutical companies have challenged the hemophilia treatment market one after another. JW Pharma released Hemlibra and SK Plasma released Afstyla in the last year. The domestic hemophilia treatment market is maintained by GC Pharma and Takeda. While Bayer, Sanofi, and Pfizer, which have challenged the market in the past, are struggling, attention is focusing on whether domestic pharmaceutical companies will produce meaningful results. ◆GC Pharma is virtually monopolizing the domestic market with a size of ₩230 billion According to the pharmaceutical industry on the 30th, SK Plasma started selling Afstyla to major general hospitals in South Korea after entering its benefit early this month. SK Plasma is a company that specializes in blood products that were separated from SK Chemical in 2015. In 2009, SK Plasma exported the drug, which was a candidate material at the time, to Australian pharmaceutical company CSL Behring. The development was completed by CSL Behring. SK Plasma CEO Kim Yun-ho (left) and CSL Behring Korea CEO Son Ji-young are signing a sales contract for Afstyla Prior to SK Plasma, JW Pharma has entered this market. JW Pharma was approved by Japan's Chugai Pharmaceutical in January 2019. It released its products in earnest in May last year. The two companies should target the hemophilia treatment market, which is dominated by the GC Pharma. The domestic hemophilia drug market is effectively monopolized by GC Pharma. GC Pharma co-sells its own items, GreenMono and Greenene F, as well as Takeda's Advate and Adynovate. They are all top sales products. Pharmaceutical industries estimate size of South Korea's hemophilia treatment market is about ₩230 billion. Among them, four products sold by GC Pharma are estimated to generate sales of ₩140 billion to ₩150 billion. ◆ Hemophilia medicine must be passed by the committe of the Korea Hemophilia Foundation Pfizer, Sanofi, Bayer and others challenged this market before JW Pharma and SK Plasma. Except for Pfizer, however, their performance does not meet expectations. This is because the proportion of prescriptions through the Korea Hemophilia Foundation is large. The Korea Hemophilia Foundation, which consists of patients with hemophilia, operates a separate drug review committee. This Committee shall deliberate on medicines that may be prescribed by members of the Foundation. It is necessary to pass this committee to prescribe. The drugs currently being prescribed by an associate doctor are Adynovate and Adynovate in Takeda, GreenMono in GC Pharma, Greengene F and Xyntha Solofuse in Pfizer. Bayer's Kogenate FS and Sanofi's Eloctate failed. Kogenate FS and Eloctate are prescribed only in general hospitals, which account for 40% of the total market. Bayer and Sanofi are not making as much sales as expected. Pfizer's Xyntha Solofuse took nearly five years to be reviewed after its release in 2014. "The domestic market for hemophilia is called the tomb of a new drug," said PM, a global pharmaceutical company. "That's how hard it is to overcome the wall of the Korea Hemophilia Foundation." ◆JW Pharma and SK are targeting general hospitals first In the case of Hemlibra and Afstyla, sales can be stable only after passing the Korea Hemophilia Foundation's deliberation committee in the long term. The two companies are not planning to directly target the Korea Hemophilia Foundation. JW Pharma emphasizes the advantages of SC (subcutaneous) injection for general hospitals and it emphasizes that administration is possible regardless of whether antibodies are produced or not. Patients also have high expectations for this. Hemlibra is the first SC formulation. Existing patients had to find their own veins and inject themselves. Moreover, many of the patients were children, making them uncomfortable. JW Pharma said it is convenient to inject under the skin, not by finding and injecting blood vessels on its own. Hemlibra has limited benefit standards. The National Assembly pointed out, and the MOHW said it would reconsider expanding the benefit range. SK Plasma is planning to focus on targeting general hospitals. SK Plasma is said to have started marketing activities at major general hospitals at the time of the release of Afstyla. "We have no specific plans right now, such as sponsorship for the Korea Hemophilia Foundation," an official at SK Plasma said. "We plan to focus on expanding our influence in general hospitals."
- Company
- Ipsen established a union led by MZ generation
- by Jul 05, 2021 05:54am
- A labor union led by MZ generation (1980-2000s) is also being established in the pharmaceutical industry. According to the pharmaceutical industry on the 2nd, a labor union consisting of Ipsen sales workers officially launched on the 2nd after reporting on the 29th of last month. The union leader is Choi Chang-woo (35 years old), a young employee who has been employed for three years. "It was established to improve the unreasonable and closed company policy implemented by senior managers," he explained. "Ipsen Korea is using sexual harassment, harassment at work, violations of the Labor Standards Act, power abuse, and disadvantages to certain employees," the union said in a statement. "We are creating working conditions and corporate culture that are inconsistent with Ipsen Global." The labor union set the goal of ▲ establishing labor's three primary rights ▲ democratization of corporate management and establishing fairness and transparency in performance distribution ▲ improving working conditions equivalent to multinational pharmaceutical companies. "The top priority is to normalize Ipsen Korea, which is operating abnormally," Chairman Choi said. "We will gradually increase the number of union members to form a majority union."
- Company
- Metformin with excess NDMA was removed from the market
- by An, Kyung-Jin Jul 03, 2021 05:56am
- Most of the prescriptions for 31 types of Metformin, which had been suspended for detection of excess impurities a year ago, have disappeared. Sales of drugs, including Metformin, rose, but some companies were virtually kicked out from the market. There are many opinions that the government should take a more careful suspension of sales. According to the drug research agency UBIST on the 1st, JW Pharm's Guardmet had no outpatient prescription until May this year. It posted ₩4.2 billion in prescription performance during the same period last year, but has not sold since June. Guardmet is a combination of JW Pharma's DPP-4 inhibitor Guardlet(Anagliptin) and Metformin. Although it emerged as JW Pharma's main product as prescription performance rose sharply to ₩5.6 billion in 2017, ₩8.2 billion in 2018, and ₩9.7 billion in 2019, all three doses, including "Guardmet" 100/500mg, 100/850mg, and 100/1000mg, disappeared from the prescription market in May last year. Sales amounting to ₩10 billion a year have been lost due to unexpected detection of impurities. In the case of Hanall's Glucodaun OR, the company posted a cumulative sales of ₩3.3 billion from January to May last year, but no sales this year. Glucodaun OR has been temporarily suspended. It recorded ₩8 billion in accumulated prescriptions in 2019. The MFDS said on May 26 last year that it has temporarily suspended manufacturing and sales and imposed prescription restrictions as 31 items were found to contain excess carcinogenic N-nitrosodimethylamine (NDMA). It has been about six months since the risk of impurities erupted in Singapore. Singapore's Health and Science Administration (HSA) recalled three products in December 2019 on the grounds that more than NDMA was detected as a result of investigating 46 items of Metformin on sale locally. The MFDS is applying the maximum daily allowance of based on NDMA 96ng provisional management standards. 31 items from 22 companies, which were suspended from sale at the time, accumulated ₩10.3 billion in five months from January to May last year, but only ₩800 million this year. It is down 91.8% year-on-year. There were no sales of 25 items except for Jeil's Lipito-M, HKinno.N's Atomet SR and Daewoong Bio's Diformin XR. Products from 19 companies, including JW Pharm, Hanall and Jinyang, have virtually left the market after the impurity measures. Several companies have induced prescription changes to other drugs or similar products of their own that have not been suspended from sale. For example, Daewoong Bio's "Diaformin" made a prescription record of ₩25 million for five months this year. Although the three capacities, Diformin XR 500 mg, Diformin XR 750 mg and Diformin XR 1000 mg, were suspended for NDMA provisional over-detection, Diformin 250 mg, Diformin 500 mg and Diformin 1000 mg products were available for sale. However, compared to ₩546 million in the same period last year, the amount of prescriptions decreased 62.5% in a year. In the case of Lipito-M and Atomet, only some of them were suspended, recording prescription results of more than ₩300 million and ₩100 million, respectively, this year. Except for JW Pharma and Hanall, of course, the rest of the companies are not losing much. Of the 31 items, Hutecs' Gluless-M and Nelson's Glutamin, which were among the top prescriptions, managed to exceed ₩200 million in cumulative prescriptions by May last year. During the same period, Hanmi's Grimefol SR, Shin Poong's Dybis and Unimaryl M have less than ₩200 million in prescriptions. The prescription loss is only less than ₩1 billion. Metformin had little influence on the entire pharmaceutical market. Last year, the prescription amount of a single metformin drug was ₩77.3 billion, up 4.1% from the previous year. Considering that it increased 2.9% year-on-year in 2019, the increase was even greater. Last year, the amount of prescriptions for Metformin combined with DPP-4 inhibitors was ₩458.4 billion, up 10.5% from the previous year. Similarly, it rose 8.2% year-on-year. Despite the spread of COVID-19 infections and the detection of impurities, there was little damage to the prescription market. The reason is that discontinued products account for a small percentage of the product and that there is no drug to replace Metformin that can be prescribed for type 2 diabetics. It is diagnosed that some of the learning effects of the high blood pressure treatment Valsartan, Ranitidine, and Nizatidine have been shown to have minimal harmful effects. However, some say that the MFDS should be more careful in taking measures related to impurities. The MFDS suspended the sale of the entire product if even one lot number of NDMA excess raw material was found for Metformin agents. They say they will allow sales if the problematic product is recovered and proven suitable for carcinogens by lot numbers. However, it has been a year since the temporary suspension of sales, but it is confirmed that no companies have attempted to sell them. Due to the characteristics of generics, it is recognized that it will be kicked out of the market once it is suspended. They say that the unexpected detection of impurities and suspension of sales during manufacturing process are damaging pharmaceutical companies. An official from the pharmaceutical industry said, "In the U.S., in the case of Valsartan and Ranitidine, only the lot numbers that used impurities detection raw materials were recovered. they did not suspend sales of the entire item," He said. "We need to be more careful about temporary sales suspension measures due to the detection of impurities."
- Company
- Lilly applies for listing of its fast-acting insulin Lyumjev
- by Eo, Yun-Ho Jul 03, 2021 05:56am
- The reimbursement benefit listing process for Lilly’s fast-acting insulin ‘Lyumjev’ will begin. According to industry sources, Lilly Korea had recently applied for the reimbursement of Lyumjev (insulin lispro). The drug, which has been approved in Korea on the 28th of last month, is attempting quicker market entry using the Drug Approval – Benefit Evaluation Linkage System. Lyumjev is a mealtime insulin that contains the fast-acting active ingredient, ‘insulin lispro’ which helps patients with Type 1 and Type 2 diabetes control their high blood sugar levels after meals or maintain their blood sugar in the target range. The domestic approval of Lyumjev was based on the results of the PRONTO clinical trial program that was conducted on adult patients with Type 1 and Type 2 diabetes. The PRONTO-T1D and PRONTO-T2D trials evaluated the safety and efficacy of Lyumjev compared to Humalog in people with type 1 and type 2 diabetes, respectively. The studies were designed as treat-to-target trials in which each arm was treated to achieve the same level of blood glucose control and evaluated for other important treatment effects, such as rates of hypoglycemia and post-meal glucose control, as well as maintenance of appropriate blood sugar levels. Results from both studies showed that Lyumjev was found to be non-inferior to Lilly’s existing fast-acting insulin ‘Humalog (insulin lispro) with regard to HbA1c reduction from baseline to week 26 (primary endpoint) when administered after meals. Also, Lyumjev demonstrated a superior reduction in blood glucose spikes at both one hour and two hours after a test meal compared to Humalog. Results of Phase 1 clinical trial on Type 1 diabetes patients had also shown that Lyumjev is absorbed faster than ‘Humalog,’ ‘insulin aspart’ and ‘fast-acting insulin aspart.’ Also, blood glucose excursions over the first 3 hours after administration of Lyumjev were comparable to those in participants without diabetes.
- Company
- Takeda's Susoctocog alfa has been designated as a rare drug
- by Jul 03, 2021 05:56am
- Korea Takeda's "Susoctocog alfa," a bleeding treatment for patients with acquired haemophilia A, was designated as a rare drug by the MFDS on the 1st. Hemophilia is a major hemorrhagic disease caused by a lack of clotting factors in the blood due to mutations in genes located on the X chromosome. Hemophilia A, caused by lack of coagulation factors, accounts for about 70% of all hemophilia patients. Among them, acquired hemophilia A is an autoimmune antibody to coagulation factor VIII, which is a very rare condition in which coagulation factor VIII in the blood is suppressed and depleted, resulting in bleeding-related complications. It is reported that 0.2 to 1.48 out of 1 million people occur per year. Unlike congenital haemophilia, which usually occurs in boys, most of them appear at a similar rate for both men and women aged 65 and older. Kim Na-kyung, general manager of Takeda's Hematology BU, said, "We are pleased that the designation of rare drugs will help patients with acquired hematology A more stable treatment of the disease.""We will not only research and develop innovative treatments to positively change the lives of patients with rare hematopoietic diseases, including patients with acquired hemophilia A, but also do our best to improve the treatment environment." Rare drugs are treatments used for diseases with a population of less than 20,000 patients in Korea, meaning drugs that are used for diseases without proper treatment methods and medicines, or that have significantly improved safety or effectiveness than existing alternative drugs.
- Company
- Martín Corcoll, Boehringer Ingelheim Korea's new GM
- by Jul 03, 2021 05:56am
- Boehringer Ingelheim Korea announced the appointment of Martín Corcoll as the company’s new GM and Head of Human Pharm as of July 1st. Since joining Boehringer Ingelheim in 2006, the new GM Corcoll had accumulated extensive experience and expertise in the industry, serving in various positions and divisions for over 15 years. After graduating from the University of San Andrés in Argentina with a Bachelor’s degree in Business Administration, he obtained an MBA from ESADE Ramon Business & Law School in Barcelona, Spain. In 2006, Corcoll joined Boehringer Ingelheim Mexico as a central nervous system (CNS) and urology brand manager. After establishing a solid foothold as a cardiovascular marketing leader until February 2010, Corcoll moved on to the Boehringer Ingelheim's headquarters in Germany as a global brand manager of the company’s diabetes division. During his time in Germany, Corcoll was recognized for his expertise and successful contribution to the company’s growth in establishing international alliances for its diabetes division and leading the global launch of the company’s diabetes products. Until 2018, Corcoll served as the Marketing Head of Human Pharma at Boehringer Ingelheim Spain and oversaw the primary care and specialty care brands, after which he moved to the Austrian branch to serve as the Regional Business Manager and as became the Head of Human Pharma and GM of Boehringer Ingelheim Austria in 2019. “I am pleased to be joining Boehringer Ingelheim Korea. I had a great interest in our Korean branch as I often heard of the performance and growth it has made during my time in Boehringer Ingelheim.” said Corcoll. “Based on the company’s corporate vision, ‘create value through innovation,’ the company will strive to improve the health of our patients and animals in Korea by providing effective new drugs and healthcare solutions for diseases with a high unmet need.”
- Company
- Opdivo+Yervoy's negotiations failed to reach an agreement
- by Jul 01, 2021 05:56am
- Drugs for the combination of the immuno-cancer drugs Opidivo (Nivolumab) and Yervoy (Ipilimumab) in primary treatment for kidney cancer were not negotiated within days. In the end, it is expected to take longer to apply the benefit. According to related industries on the 1st, Ono Pharmaceutical and BMS have extended drug price negotiations with the NHIS for Opdivo and Yervoy kidney cancer primary treatment benefits. Earlier, Opdivo and Yervoy combination therapy was recognized for their benefit adequacy and began drug negotiations with the NHIS for "median or high-risk progressive neocyte cancer treatment" at the HIRA. Pharmaceutical price negotiations run for up to 60 days, and the recent period has expired. The NHIS and pharmaceutical companies never reached an agreement. However, they decided to extend it because they believed that additional negotiations were needed. PD-1 inhibitor immuno-cancer drugs Opdivo and CTLA-4 inhibitor immuno-cancer drugs Yervoy demonstrated excellent effectiveness in primary treatment of kidney cancer. In June 2020, and it passed the HIRA's Cancer Drugs Benefit Appraisal Committee. Later, it took about nine more months for the HIRA's Pharmaceutical Benefits Advisory Committee to recognize the benefit adequacy. In clinical trials of CheckMate-214 compared to the standard treatment of Sutene (Sunitinib Malate) in intermediate and high risk groups, Opdivo and Yervoy combined therapy showed a significant effect compared to the median (mOS) of 48.1 months, compared to 26.6 months. The objective response rate was also significantly higher at 41.9% to 26.8% and the rate of patients maintaining it was higher (65.2% to 49.6%). In particular, 10.4% of patients treated with combination therapy reached full response and received attention. Professor Park Soo-hyung of Kaist GMSE said, "In immune mechanism, CTLA-4 activates priming, which is the first antigen-specific immune response, to induce T-cell reactions, and anti-PD-1 prevents degradation of T-cells, which can create synergies." If Opdivo and Yervoy therapy are listed, the use of immunocancer drugs in kidney cancer is expected to become more active. This is also the first case in which immuno-cancer drug combination therapy is applied in chemotherapy. Both companies are also seeking to expand insurance coverage for Opdivo and Yervoy combined therapy in primary care for non-small cell lung cancer.
- Company
- Yuhan’s Leclaza reimb. held back by companion diagnostics
- by Eo, Yun-Ho Jul 01, 2021 05:56am
- Reimbursement of the novel domestic drug ‘Leclaza’ that was due today (July 1st) was postponed. The listing process of Yuhan Corporation’s new drug which had been progressing at an unprecedented pace came to a full stop due to ‘companion diagnostics.’ Dailypharm found that the Ministry of Health and Welfare had pulled a temporary stop on the enforcement of the notice related to Leclaza (lazertinib). Leclaza was supposed to be listed from July after passing the Health Insurance Policy Deliberative Committee’s review on the 25th of last month. The brakes were pulled by an objection that was registered during the pre-announcement of administration period regarding the lack of a companion diagnostics device Delayed listing of a drug that has already passed the HIPDC deliberations is rare. Since 2018, the Ministry of Food and Drug Safety had regularized a sort of ‘customized use’ of in-vitro companion diagnostics devices through the ‘Guideline on the Review & Approval of companion diagnostic medical devices,’ under which a drug and the companion diagnostics device used as the basis for medications and prescriptions are reflected together in the license. The measure was implemented to precisely screen patients eligible for each prescribed drug target. The problem was that no MFDS-approved diagnostic device existed for the purpose of prescribing Leclaza even though the drug already passed the HIPDC review. Under the current regulations, 3rd generation EGFR TKIs like ‘Tagrisso (Osimertinib)’ and Leclaza may only be prescribed to ‘patients whose EGFR T790M mutation status has been confirmed with an in-vitro diagnostic medical device approved by MFDS.’ In-vitro diagnostic medical devices that are approved and used to identify the EGFR T790M mutation status in Korea include the blood-based ‘Cobas EGFR Mutation Test,’ and ‘PANAMutyper EGFR Kit,’ among others. However, these devices are only approved to be used to screen patients for Tagrisso. In other words, the objection was that Leclaza prescriptions, if made, are all off-label prescriptions, and therefore unfit for reimbursement. As the health authorities have been limiting reimbursement of anticancer therapies with targets such as Tagrisso, the immunotherapy ‘Keytruda (pembrolizumab).’ ‘Tecentriq (atezolizumab),’ the ALK-inhibitor ‘Xalkori (crizotinib), and 'Alubrig (brigatinib)' to those that have used approved diagnostic devices to prescribe the therapies, it was difficult for the government to overlook the objections made regarding this matter. Accordingly, the MFDS had requested the Ministry of Food and Drug Safety to deliberate on whether the in-vitro diagnostic device needed for the prescription of Leclaza should be regarded as a 'companion diagnostics device.' To add an in-vitro companion diagnostic device to a drug's license, additional data that demonstrates that the diagnostic device used in the clinical trial and the device the company wishes to register is equivalent in identifying EGFR T790M mutations need to be submitted. Generally, it takes around 3 to 4 months for the tests to be conducted and the MFDS license to be updated.
