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- 2026-04-14 03:36:12
- Policy
- Pfizer aims to commercialize PF-07321332 by the end of 2021
- by Lee, Tak-Sun Aug 03, 2021 08:09pm
- On the 29th, the MFDS approved 3 multi-national clinical plans for "PF-07321332," a candidate for COVID-19 oral treatment applied by Pfizer. The first clinical trial was the oral administration of PF-07321332 to prevent postmortem infections in adults who had contact with people with COVID-19, and the validity and safety of Ritonavir's two methods. The total number of test subjects is 2,634 and 22 people will be recruited in Korea. The test is conducted at Chilgok Kyungbuk National University Hospital. The second clinical trial assesses the mediated validity and safety of oral administration PF-07321332/Ritonavir in comparison to placebo in non-admission-bearing adult participants with severe cases and low risk of progression. The total number of test subjects is 800, and the number of subjects in Korea is 14. The test will be conducted at Busan National University Hospital, Seoul Medical Center, Boramae Hospital, Chonnam National University Hospital and Chilgok Gyeongbuk National University Hospital. The third clinical trial assesses the mediated validity and safety of oral administration PF-07321332/Ritonavir compared to placebo in non-admission-bearing adult participants with severe cases and high risk of progressive coronavirus. The total number of test subjects is 2,260, and the number of domestic recruitment subjects is 62. It is carried out in the same institution as clinicians earlier. Pfizer launched a clinical trial of PF-07321332 in the United States in March. It aims to release a treatment at the end of the year after going through a large-scale clinical trial. Ritonavir, administered in conjunction with PF-07321332, is the original of the antiviral drug Norvir of AbbVie in Korea.
- Company
- Samsung launches Humira Biosimilar ‘Adalloce’ in Korea
- by Eo, Yun-Ho Aug 03, 2021 07:04am
- Domestic supply of the domestic biosimilar of ‘Humira’ has begun in full scale. According to industry sources, Adalloce, a biosimilar of the TNF- alpha blocker Humira(adalimumab)’s that was developed by Samsung Bioepis and sold by Yuhan Corporation in Korea, passed the Drug Committees (DCs) of 20 medical institutions including the Big-5s such as the Samsung Medical Center (SMC), Asan Medical Center (AMC), and Severance Hospital. Adalloce was the first biosimilar adalimumab product to receive marketing approval in Korea. It is a tumor necrosis factor (TNF)-alpha-blocker that is used to treat autoimmune conditions including rheumatoid arthritis, ankylosing spondylitis, and Crohn's disease. The commercialization of Adalloce will enable a more affordable prescription of adalimumab products in Korea, including the originator Humira. Adalloce’s listing will lead to Humira’s price being cut. According to the ‘Criteria for Decision or Adjustment on Drugs,’ the government can make a single price adjustment to the original drug as well as the generic with the same route of administration, ingredient, and formulation or combined nutritional infusion fluids with the same ingredient to be set at 53.55% of the original price. After received marketing approval for Adalloce from the Ministry of Food and Drug Safety in September 2017, Samsung Bioepis has been preparing for its release through a licensing agreement with the original drug developer. Adalloce was first released in Europe in October 2018 under the brand name ‘Imraldi,’ and has generated cumulative sales of $417 million (₩450 billion) by the end of 2020. In the United States, the drug received marketing authorization in May 2019 under the brand name ‘Hadlima.’ Under the licensing agreement made with AbbVie, the company plans to release Adalloce in July 2023. Meanwhile, Yuhan Corporation is also in charge of domestic sales of Samsung Bioepis’ Enbrel biosimilar ‘Etoloce’ and Remicade biosimilar ‘Remaloce’ in the domestic market.
- Policy
- Peramivir has earned its generic exclusivity
- by Lee, Tak-Sun Aug 02, 2021 08:41pm
- JW Life Science is the first known Peramivir drug to win a generic for exclusivity. It is known to have been applied by JW Life Science's premium technology. Premix preparation is an injection that does not need to be diluted with saline water and is convenient to use. However, GC Pharma and Chong Kun Dang were also allowed to impose premix sanctions in May, signaling competition. The MFDS approved JW Life Sciences' Fluenpera on Wednesday. It is a premix formulation that does not require dilution, and can be used once. In particular, JW Life Science's premix technology is applied, and it is a multi-layered film plastic container filling injection. Peramivir is a single intravenous treatment for the flu. Oseltamivir (Tamiflu) preparation requires for five days PO. Peramivir premix was approved first by GC Pharma and Chong Kun Dang. In May, the two companies introduced the first Peramivir premix formulation, with Peramiflu Premix Inj and Peraonce Inj, respectively. Both products are produced in Chong Kun Dang. JW's "Fluenpera" is different in appearance, indication and doses from products licensed by GC Pharma and Chong Kun Dang. Therefore, JW has acquired generic for exclusivity this time, but it does not affect the sales of products of GC Pharma and Chong Kun Dang because it is not the same formulations. It will take effect from yesterday (28th) to April 28th next year. It also reflected the cited invalidation of the JW Life Science's claim to Peramiflu's patent on the original product.
- Company
- Beijing Hanmi's 2Q operating profit increased by 50%
- by Chon, Seung-Hyun Aug 02, 2021 08:37pm
- Hanmi Pharmaceutical's second-quarter performance improved. In the domestic market, self-developed new drug products have done well. Sales of Beijing Hanmi have more than doubled despite the sluggishness caused by COVID-19. Hanmi announced on the 29th that its operating profit in the second quarter increased 49.6% year-on-year to ₩15.9 billion. Its sales increased 14.7% year-on-year to ₩279.3 billion, while its net profit expanded 43.1% to ₩8.3 billion. Quarterly sales (left) operating profit (unit: ₩1 million, data: Financial Supervisory Service) Hanmi explained, "The stable prescription sales of self-developed products and the explosive growth of Chinese local Beijing pharmaceuticals caused strong sales." Rosuzet, Amosartan, and Esomzol are the reasons for this. The hyperlipidemia compound Rosuzet rose 11.% year-on-year to ₩26.9 billion in prescriptions in the second quarter. It is expected to surpass ₩100 billion in annual prescription amount this year, following the second-largest outpatient prescription among all medicines last year. Amosartan, a hypertension drug, recorded a prescription record of ₩18.9 billion in the second quarter. Although it decreased 7.4% year-on-year, it strengthened its position as a major drug. Amosartan is a combination of Amlodipine and Losartan. Esomezol posted a prescription amount of ₩12.2 billion in the second quarter, up 22.8% from the previous year. Beijing Hanmi overcame last year's slump and posted ₩59.5 billion in sales in the second quarter of this year, up 119.9 percent% year-on-year. It is the biggest sales in the first half of this year. Beijing Hanmi saw its sales drop 52% year-on-year in the second quarter of last year due to worsening market conditions caused by COVID-19. In the second quarter of this year, Ambrocol, one of Beijing Hanmi's flagship products, posted sales of ₩19.4 billion, more than 20 times the year-on-year. Sales of the children medicine Medilac-Vita increased by 147.6% to ₩13.6 billion, while constipation drug Lidong achieved sales of ₩15 billion.
- Policy
- Reimbursement criteria for Cosentyx and Taltz inj. expanded
- by Kim, Jung-Ju Aug 02, 2021 06:06am
- Secukinumab injections such as Novartis Korea’s Cosentyx injection and Ixekizumab injections such as Lilly Korea’s Taltz prefilled syringe injection will be covered as first-line biologics for active and progressive psoriatic arthritis refractory to DMARDs. Also, the monitoring cycle of liver and electrolyte levels in patients for orally administrated Tolvaptan spray-dried powder, such as by Otsuka Korea Pharmaceutical's Samsca Tablet 15mg, will be changed to match the indication. On the 30th, the Ministry of Health and Welfare revised and issued the details regarding the criteria and methods for applying pharmaceutical benefits that contained the abovementioned changes. The revision is effective from August 1st. ◆Cosentyx and Taltz PFS Inj. etc.= ◆ The insurance benefit criteria for secukinumab injections such as Cosentyx injection and Ixekizumab injections such as Lilly Korea's Taltz prefilled syringe injection will be expanded. The Health Insurance Review and Assessment Service has decided to expand the reimbursement of first-line biologics to DMARD refractory active and progressive psoriatic arthritis after reviewing domestic and foreign indications, textbooks, clinical treatment guidelines, clinical research papers, related academic opinions and etc. Also, reflecting the experts' opinions and the precautions in the use of biologics issued for the risk of tuberculosis infection, the phrase to test for latent tuberculosis was added like for the TNF-α inhibitor. In addition, the phrase directing three-time administration of the injections was deleted. Specifically, the reimbursement criteria now stipulate that patients eligible for administration are those who saw insufficient treatment effect with two or more types of DMARDs for over 6 months (3 months or more for each) or patients with active and progressive psoriatic arthritis who discontinued treatment due to side effects of the abovementioned drugs. Also, the conditions in the revised details specifically state that the patient should have 3 or more joints with tenderness and 3 or more joints with edema, and that the results should be from two consecutive examinations taken at a 1-month interval. In the evaluation method, the phrase to administer the drug '3 times’ has been deleted from the '3 times in 6 months' condition. In addition, a new criterion has been newly added, stating that the 'Guidelines for treating latent tuberculosis when using TNF-α inhibitor' should be followed when using such drugs. ◆Samsca Tablet = The monitoring cycle of liver and electrolyte levels in patients with autosomal dominant polycystic kidney disease (ADPKD) for orally-administrated tolvaptan such as Otsuka Pharmaceutical Korea's Samsca Tablet 15mg, will be changed to match the drug's indications. Looking at the changes in the detailed approval criteria, values such as AST, which were to be measured before the first administration and 'once a month' after administration, were changed 'to be examined before the first administration and every month for the first 18 months and once every three months thereafter during administration.' In addition, the criteria for blood test results that were limited by 'monthly' results when filing claims for reimbursement, was changed to 'according to monitoring' results to match the indications.
- Company
- ACRC "Hemlibra's reimb. standards need to be reexamined"
- by Kim, Jin-Gu Aug 02, 2021 06:05am
- On the 30th, the Anti-Corruption & Civil Rights Commission (ACRC) has expressed the opinion that the reimbursement standards for the hemophilia treatment Hemlibra should be reexamined. In addition, the ACRC forwarded their official statement to the Ministry of Health and Welfare (MOHW) and the Health Insurance Review and Assessment Service (HIRA). Whether the opinion will provide an opportunity for the Hemlibra issue, in which pediatric patients under the age of 12 are currently discontinued from receiving treatment using the drug, may be resolved is gaining attention. ACRC's opinion does not have legal force, however, as the MOHW already expressed its intention to reexamine Hemlibra's reimbursement standards, there is a high possibility the current standards could be improved. The ACRC had previously received civil petitions for grievances from hemophilia patients imploring reexamination of reimbursement standards for Hemlibra. Upon receiving the complaint, ACRC held a roundtable with HIRA and patient groups to exchange opinions regarding the standards involved. Under the current standards, pediatric patients with severe hemophilia A who are less than 12 years of age need to receive immune tolerance induction (ITI·antibody removal) therapies for 2-3 years before receiving prescriptions for Hemlibra with reimbursement. Hemophilia patients had to receive intravenous injections every 2-3 weeks for nearly 3 years to meet the criteria. However, a considerable amount of pediatric patients are unable to even attempt ITI therapy because it was difficult to secure venous blood vessels for the intravenous injection. HCPs of patients in this special condition had prescribed Hemlibra and claimed insurance benefits for such prescriptions from February to March this year. However, HIRA rejected the insurance claims on the grounds that there was insufficient objective data to prove that ITI therapy was impossible. This led to a discontinuation of Hemlibra administrations in hospitals from April. Some of the patients were unable to receive treatment with Hemlibra due to the burden of its uninsured cost, which costs nearly 7.2 million won for 4 weeks. As a result, the ACRC issued their opinion that the reimbursement standards for Hemlibra need to be reexamined so that severe Hemophilia A patients under the age of 12 that 'have difficulty attempting ITI therapy that requires the endurance of great pain in the long-term due to their young age and weak blood vessels' could receive reimbursement for Hemblibra. ACRC referred to how ▲No prerequisite ITI therapy conditions exist for reimbursement of Heblibra in the U.K or Australia ▲ The guidelines by the World Federation of Hemophilia does not restrict Hemlibra's administration to after ITI therapy, and that ▲ it is too harsh to require ITI therapy, a treatment which is accompanied by immense pain, to patients under 12 years of age, as its grounds for making the recommendation. Also, the academic society's opinion that the 'long-term use of Hemlibra can reduce the development of various complications in the long-term' was taken into account. The ACRC's recommendation for correction has no legal force, however, the institution that receives the recommendation needs to inform the ACRC on whether it will or will not accept ACRC's recommendation within a month. Jin Hong Lim, the ACRC adjudication for civil petitions for grievances said, "It is unreasonable to require younger patients to receive a treatment that brings long-term pain to receive reimburse prescription of an effective treatment." Lim continued, "The current insurance benefit standard needs to be reexamined." Pic. of HemlibraPrior to delivering the ACRC's opinion delivery, the Minister of Health and Welfare Kwon Deok-Cheol said in June that he would comprehensively review improving the reimbursement standard of Hemlibra in consideration of the characteristics of pediatric patients with many experts when the National Assembly pointed out that the Hemlibra benefit standard for pediatric patients was too strict. Hemblibra is the first subcutaneous injection formulation for hemophilia treatment introduced by JW Pharmaceutical to Korea from Chugai Pharmaceutical in Japan. The drug was approved in 2019, and granted reimbursement in May last year. Unlike existing treatments, Hemlibra can be easily administered subcutaneously and has its strength in its convenient method of administration. Patients had to find their own veins to directly inject the previous drugs. Moreover, the intravenous injection method was more inconvenient as many of the patients were children.
- Company
- Daewoong recovers with record 2Q sales of ₩289.7 billi
- by An, Kyung-Jin Jul 30, 2021 05:48am
- Daewoong has continued its good performance for 2 consecutive quarters. By overcoming the heavy blows it took from the impurity issue in ranitidine and the lawsuits from its botulinum toxin strain dispute, the company was able to raise its quarterly sales to the highest level despite the COVID-19 crisis. Daewoong Pharmaceuticals has posted its operating profit of ₩26.7 billion in Q2 this year and marked a turnaround compared to the same quarter of the previous year. The company turned into a profit this quarter with its sales revenue increasing 20.8% to ₩273.1 billion and a net income of ₩14.5 billion. Its cumulative sales revenue in the first half of this year was ₩514.7 billion, a 13.3% year-on-year increase. Daewoong Pharmaceuticals had suffered from a poor performance last year. The detection of impurities in the heartburn treatment ingredient ranitidine led to a large sales gap in its key product ‘Albis.’ Also, the company had spent much expense in lawsuit over the botulinum toxin strain dispute with Medytox. In this year, the company has seen an improvement in its profitability with the revenue accrued from ‘Fexuprazan,’ which the company is developing as a treatment of gastroesophageal reflux, and the risk from ‘Nabota’ lawsuits being resolved. Also, the increase in sales became greater due to strong performance in the domestic market and in exports. Sales of the botulinum toxin product ‘Nabota’ has more than quadrupled in Q2 to record ₩23.2 billion, compared to the ₩5.6 billion in Q2 last year. With the risk from suits in the U.S. fully resolved, its U.S. market share has started to expand in earnest, and Daewoong Pharmaceuticals is also stepping up its efforts to expand to new markets overseas for ‘Nabota,’ including in Latin America and the Middle East. Sales in the prescription drugs sector recorded ₩196.1 billion, an 8.7% increase compared to the ₩179.4 billion in the same period of the previous year. Sales of Daewoong’s self-developed drugs including the liver drug ‘Ursa (ETC),’ anticancer drug ‘Luphere Depot,’ and combination hyperlipidemia drug ‘Crezet,’ as well as the drugs it introduced to Korea such as the anti-diabetic ‘Forxiga,’ anti-coagulant ‘Lixiana,’ and its 3-drug combination for hypertension ‘Sevikar’ had all increased evenly. In the OTC sector, the company recorded average sales - from ₩29.6 billion in the same period last year to ₩28.6 billion this year. Its high-dose vitamin B complex, ‘Impactamin,' and the liver function enhancer ‘Ursa(OTC)’ have maintained stable sales. Also, the technological fee from R&D projects has become a new source of revenue for the company. In Q2, the company made ₩11.1 billion from a U.S. licensing-out contract for ‘Fexuprazan,’ a new drug for gastrointestinal reflux.
- Company
- SK Group's Pharma companies make successive success
- by Lee, Seok-Jun Jul 30, 2021 05:48am
- SK Group’s pharmaceutical companies have successively succeeded in raising large-scale funds. The analysis is that being able to invest in independent corporations differentiated by business characteristics attracted market investment. SK Group’s pharmaceutical companies, which all use the SK name, are operated in different areas by SK or SK Discovery without mixed shares. SK operates SK Biopharmaceuticals (new drug development) and SK Pharmteco (CMO). SK Discovery operates SK Chemical (pharmaceutical business), SK Plasma (blood products), and SK Bioscience (vaccines). SK Plasma, a non-listed company, recently raised ₩110 billion through a third-party allocation paid-in capital increase. SK Plasma receives ₩40 billion from SK Discovery and ₩30 billion each from Tiumbio and Korea Investment Partners as an investment. SK Plasma was established in March 2015 as a spin-off from SK Chemicals. It manufactures and sells various plasma-derived products including the Human Normal Immunoglobulin Liv-Gamma SN Inj., Human Plasma-derived Hepatitis B Immunoglobulin Hepabulin SN Inj., Human Albumin Solution Albumin inj., SK Antithrombin III Inj., Tetabulin SN Inj., etc. COVID-19 vaccine developer SK Bioscience raises ₩1.4918 trillion at IPO SK Bioscience and SK Biopharmaceuticals raised large-scale funds through IPOs. SK Bioscience, which made its debut on KOSPI on March 18th, raised ₩1.4918 trillion at an offering price of ₩65,000 a share. SK Bioscience is a company specializing in vaccines that was spun off from SK chemicals in July 2018. It carries out the total process from R&D in the vaccine sector, production, sales to distribution. SK Bioscience was the first Korean company to apply for a Phase III trial for a COVID-19 vaccine candidate (GBP510) on the 28th of last month. The company is also developing another COVID-19 vaccine candidate (NBP2001). SK Biopharmaceuticals, which has two US-approved new drugs, raise ₩959.3 billion SK Biopharmaceuticals also raised ₩959.3 billion in funds at an IPO price of ₩49,000 on July 2nd of last year. SK Biopharmaceuticals is a new company that is in charge of new drug development and sales that was founded after a spilt-off of SK’s life science business in 2011. 2 new drugs that have been developed by SK Biopharmaceuticals are currently released globally. 'Sunosi,' a treatment for sleepiness developed by SK Biopharmaceuticals in 2011 and licensed out to Jazz Pharmaceuticals, was approved in the U.S. in March 2019. Also, its independently developed epilepsy treatment ‘ExcoFree’ was approved in the U.S. in November 2019.
- Company
- Emgality and Ajovy were also approved
- by Kim, Jin-Gu Jul 30, 2021 05:47am
- Following Lilly's Emgality (Galcanezumab), Teva's Ajovy (Fremanezumab) were released in Korea as a new medicine for migraine prevention. Attention is focusing on whether CGRP (calcitonin gene-related peptide) drugs, which have entered the domestic migraine treatment market without suitable treatments, will become popular. Emgality, Ajovy, and Aimovig Aimovig is not yet authorized in Korea. On Wednesday, the MFDS approved Teva Handok's migraine prevention drug Ajovy. It is the second CGRP drug after Lilly's Emgality. Emgality was granted permission in September 2019. It was released in December of that year as non reimbursed drug. Amgen is reportedly aiming for another CGRP drug, Aimovig (Erenumab), to enter Korea. If Aimovig is released, competition for three drugs is expected to proceed as well as in the global market. The three drugs combine with CGPR, known as migraine-causing substances, to block the action of receptors. It is the first preventive treatment that targets migraines only. In the U.S., it was approved one after another from May to September 2018 in order of Aimovig, Ajovy, and Emgality. As of last year, global sales include Aimovig $378 million, Emgality $199 million, and Ajovi $165 million. There have been no suitable migraine treatments in the domestic market. Although both acute and preventive treatments were possible, existing treatments had clear limitations. General painkillers such as Acetaminophen and Ibuprofen, which are used to treat acute conditions, and triptans-based drugs have different effects, and they have caused drug-induced headaches when overused. The triptane series has also reported side effects of excessive blood vessels contracting. In the case of preventive treatment, beta blockers, CCB (calcium channel blockers), ABR (angiotensin receptor blockers), antidepressants, and epilepsy treatments, which are high blood pressure drugs, were partially. However, it was not widely used in that it was not developed for the purpose of treating migraines. Recently, Botulinum toxin injections have been actively attempted. However, it is only for chronic migraines, and it was burdensome for patients to get about 30 injections every three months. The market size of migraine drugs in Korea is not large. According to UBIST, prescription amount of triptans-related drugs in Korea was only ₩15.5 billion as of last year. If the remaining drugs are added to this, it will be around ₩30 billion per year. The new line of drugs is expected to increase sales in the migraine market. According to the Korea Headache Society, the prevalence of migraines in Korea is around 6%. In fact, 2.6 million people have migraines. However, the actual number of patients treated for migraines in hospitals was 550,000 (the HIRA's statistics) as of 2020. In other words, there are about 2 million potential patients. The key is whether or not the benefit will be applied. Emgality, which was first released in Korea, submitted an application for health insurance benefits in March. Currently, it is between ₩500,000 and ₩700,000 at a time as non-reimbursement in Korea. Ajovy from Teva Handok is also expected to apply for insurance benefits soon.
- Company
- Chong Kun Dang applied for Lucentis biosimilar
- by Chon, Seung-Hyun Jul 30, 2021 05:47am
- Chung Kun Dang announced on the 28th that it has applied to the MFDS for permission for the item of the macular denaturation drug CKD-701. CKD-701(Ranibizumab) is a biosimilar product from Lucentis. Lucentis, sold by Roche and Novartis, is a drug used to treat ophthalmic diseases such as macular degenerative diabetes and macular edema. Lucentis' annual global sales amounted to about ₩4.6 trillion. Chung Kun Dang confirmed clinical equivalence with Lucentis through phase 3 of CKD-701, which was conducted at 25 hospitals including Seoul National University from September 2018 to March this year for 312 patients with 312 patients with age-related macular degeneration. Chung Kun Dang administered CKD-701 and original drugs respectively to patients with wet macular degeneration and analyzed the maximum calibration vision (BCVA) after three months. The assessment found that the proportion of patients with vision loss of less than 15 characters was 97.95%, or 143 out of 146 in the CKD-701 administration group, and 98.62%, or 143 out of 145 in the original drug administration group, which met the equivalence range. The average change in maximum calibration vision also showed no statistical difference between the two drugs as the CKD-701 administration group improved to 7.14 words and the original drug to 6.28 words. There were no statistically significant differences in drug efficacy and other pharmacokinetics, immunogenicity and safety in indicators such as the proportion of patients with less than 15 letters of vision loss and better vision, average changes in maximum calibration vision, and changes in central retinal thickness, respectively. If CKD-701 is approved, Chong Kun Dang will produce a second biosimilar. Chung Kun Dang was approved by Nesp's biosimilar Nesbell in late 2018. "If CKD-701 is approved, we expect patients to have a variety of treatment options. Starting with the domestic market worth ₩37 billion, we will expand the market to Southeast Asia and the Middle East," said an official at Chong Kun Dang.
