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Policy
Handok takes over Eisai’s Aricept license from Daewoong
by
Lee, Tak-Sun
Jun 03, 2020 06:25am
The Korean market license for the dementia treatment market leader Aricept (donepezil) has been transferred from Daewoong Pharmaceutical to Handok. Except for a few items, Handok is to manufacture the treatment in Korea. Daewoong Pharmaceutical has been importing active ingredient from a Japanese-based pharmaceutical company Eisai that developed Aricept and manufactured and supplied the finished product. Eisai Korea is in charge of the sales. On May 29, a pharmaceutical industry source reported Handok recently took over the Aricept license from Daewoong Pharmaceutical. The rights over five items including Aricept Evess 10 mg tablet, Aricept Evess 5 mg tablet, Aricept 10 mg tablet, Aricept 23 mg tablet and Aricept 5 mg tablet have been handed over. Daewoong Pharmaceutical would be the cosigned manufacturer of Aricept 5 mg tablet and Aricept 10 mg tablet, while Handok manufactures the rest. Meanwhile, Eisai Korea would maintain the license over Aricept 5 mg ODF and Aricept 10 mg ODF. Since the first approval won in 2000, Aricept’s license in Korea has remained with Daewoong Pharmaceutical. The partnership deal assigned the manufacturing to Daewoong Pharmaceutical and the sales to Eisai Korea. However, a slight change occurred in the deal as Eisai has decided to ink a joint sales deal with Chong Kun Dang. And now the license has been transferred from Daewoong Pharmaceutical to Handok. Technically, the shift in license ownership means Deawoong Pharmaceutical has ended the close relationship it had with the original Aricept. Regardless, the Korean company already owns a donepezil generic Dimenpezil tablet, which five items under the brand name so far have received approval since 2018. On the contrary, Handok with the new deal would expand its revenue source. According to pharmaceutical market research firm IQVIA, Aricept has generated 65.6 billion won last year. Eisai Korea’s official statement informed the pharmaceutical distribution industry of Aricept labeled with the new Handok product code valid from June 1, due to the change in manufacturer. Eisai also explained the healthcare reimbursement on Daewoong Pharmaceutical-manufactured Aricept products can be claimed until Nov. 30, 2020.
Company
'Champix' sales rebounded 13% in one year
by
Kim, Jin-Gu
Jun 03, 2020 06:25am
ChampixPfizer's anti-smoking supplement Champix (Varenicline) has been successful in rebounding sales. It increased by 13% compared to the first quarter of last year. It is an analysis that it benefited from winning the patent dispute with generics. According to the drug analysis agency IQVIA on the 29th, the sales of Champix in the first quarter was ₩6.9 billion. This is a 13% increase from the first quarter of 2019, compared to ₩6.1 billion. In terms of quarterly sales, it has increased significantly since the second quarter of last year. It is analyzed as the result of winning the patent dispute with generics. Champix' salt modified drug was first released in November 2018. However, when the supreme court ruled in January 2019 that patent evasion of salt-modified drug was illegal in Solifenacin formulations, most of them were discontinued. In December of the same year, for the same reason as the judgment of Solifenacin, it was illegal to release the drug before changing the substance patent for the Champix salt modified drug. As a result of this ruling, domestic pharmaceutical companies' marketing has been suspended. However, from 3Q this year, it will resume competition with generics. This is because the material patent of Champix will expire on July 19th. This is because it is possible to re-engage generics that have previously avoided or invalidated the salt patent of Champix. It is estimated that 37 pharmaceutical companies are waiting for patent expiration with 85 items on the 29th. In addition, the application for permission to change salts has recently increased. Since January of this year, there have been a total of 12 items for the application of permission to change salts for Champix. Champix quarterly sales trend (₩100 million, data IQVIA) Although Champix sales rebounded, they haven't recovered to the extent of regaining the glory of the past. Champix once had quarterly sales of ₩21.4 billion (first quarter of 2017). Compared to that time, it is only a third. This is because the number of participants in the anti-smoking support project has steadily decreased and the drug price has been cut by nearly 40%. In November 2018, the NHIS lowered the drug price from ₩1,800 to ₩1,100.
Policy
MFDS & FDA have different NDMA’s follow-up measures
by
Lee, Jeong-Hwan
Jun 02, 2020 09:13pm
The domestic pharmaceutical industry has pointed out that the MFDS and the US Food and Drug Administration (FDA) have made unusually different follow-up measures over NDMA detection Metformin. The MFDS caused an immediate and irreversible damage to pharmaceutical companies by disposing of manufacturing and sales prohibition along with the full recovery of items before the detection of impurities exceeding the standards, but FDA did not enforce the prohibition of sales other than the recovery of the existing distribution volumes. Some pharmaceuticals explain that there are aspects that minimize damage to the pharmaceutical industry through delicate regulation. In particular, about the cause of NDMA detection, the MFDS ordered the pharmaceutical companies to submit a compulsory order within three months, but the FDA also cooperated with the pharmaceutical company to find the cause of detection. .According to the pharmaceutical industry on the 1st, 22 pharmaceutical companies that detected NDMA above the reference level in Metformin are in the voluntary recovery process according to the recommendation of the MFDS .Nonetheless, the pharmaceutical industry is focusing on the differences between the MFDS and the FDA in responding to the NDMA crisis .22 companies holding 31 items that have been confirmed to have exceeded the standard have been affected by the withdrawal of their drugs from the pharmaceutical prescription market since The items detected by the MFDS were recovered and production·sale suspensions were announced on the 25th of last month .Compared to Valsartan or Ranitidine in the past, the number of items was small, so the damage to the entire pharmaceutical industry was minimal, but pharmaceutical companies such as JW Pharma and Hanall, which sold about ₩10 billion a year as a single item, were barred from selling for a day .So how did the MFDS and the FDA take other follow-up measures ?The MFDS, instructed the pharmaceutical company to verify the NDMA detection drug manufacturing process The MFDS went through the review of the Central Pharmaceutical Affairs Review Committee and announced further restrictions on the manufacture, sale and prescription of Metformin exceeding its own standards .It is mandatory to submit manufacturing process verification data that NDMA is no longer detected in the company's Metformin within 3 months until August 31 .Specifically, ▲ Process variables that can affect NDMA production ▲ NDMA generation possibility review data due to the effect between Metformin and other ingredients (main ingredients and other additives) ▲ Storage conditions tests such as acceleration and harshness and packaging and container review ▲ Preventive and corrective measures to prevent NDMA from occurring in the manufacturing process in the future or to be adjusted within the maximum allowable capacity per day ▲ Variability of NDMA detection between manufacturing numbers is the scope of verification data .As a result, 22 pharmaceutical companies were forced to focus on making NDMA process data along with recovering the total amount of their medicines scattered at the prescription sites such as medical institutions and pharmacies .It has long since been removed from physician's prescribed list .This is because the patient's sensitivity to NDMA is greatly increased, and sales are immediately banned .FDA has taken the lead in identifying the cause .Inspection by batch prior to manufacturing and sales ban. The pharmaceutical industry claims that unlike the MFDS, the FDA began to work with pharmaceutical companies to determine the cause, when and where NDMA was detected .In particular, even for items that detect impurities above the reference level, the pharmaceutical system view that FDA decides to recover the total amount of the existing distribution volume, while allowing subsequent distributions to be distributed immediately after the NDMA inspection before shipment rather than immediately stopping manufacturing and sales .In fact, according to a press release issued by the FDA on Metformin’s NDMA, the FDA ordered all Metformin to be tested for NDMA exceedingly, and each batch was individually inspected before shipment to the market, so that it would not be regulated for manufacturing and sales below the reference value .FDA has instructed not to market and report the detection of excess detection only for batches that exceeded the acceptance threshold .There is no immediate sale ban except voluntary recovery, even if NDMA is excessively detected in the collected items .Experts argue that these regulatory differences affect the pharmaceutical industry .It is explained that NDMA detection will result in market exit because the drug will be removed from the market immediately if the sale is prohibited due to excessive detection .In response to this, there is an opinion that the MFDS, like the FDA, requires a delicate regulation to prohibit the sale of detection batches by mandating NDMA inspection for each batch of Metformin for excess detection items .An official from the pharmaceutical industry said, "Unlike the MFDS, the FDA allows NDMA-detected items to be shipped consistently after inspection by batch .The items announced by the MFDSy have already been withdrawn from the prescription market .As a pharmaceutical company, the damage is severe .The official said, "If the MFDS applied batch-by-batch regulations like the FDA, 22 pharmaceutical companies would not have been accused of damaging prescription sales or immoral pharmaceuticals from the public." "The regulatory gap created by the FDA's recognition of the possibility that NDMA could be over-detected at any time and in any drug."
Policy
Janssen to import Ultracet as Hyangnam factory closes
by
Lee, Tak-Sun
Jun 02, 2020 06:09am
As Janssen Korea is closing down its Hyangnam factory next year, the locally manufactured pain reliever Ultracet fast-acting tablet (acetaminophen plus tramadol hydrochloride) would be imported, instead. However, the extended release tablet form of the drug, developed in Korea, would be manufactured by Handok. A pharmaceutical industry source reported that the Ministry of Food and Drug Safety (MFDS) has approved the imported Ultracet tablet on May 21. The imported tablet is manufactured in Janssen’s factory in Italy. It shares the same substance and dose as ‘Ultracet Tablet Janssen Korea’ approved in Korea in 2001 for export. The company explained, “The fast-acting tablet would be imported as the Hyangnam factory would be shut down.” However, Handok is apparently taking over the manufacturing license over Ultracet extended release (ER) tablet and Ultracet semi-ER tablet, which were developed by Janssen Korea in 2010 and 2012, respectively. The two drugs release the effect slower than the fast-acting tablet, which reduce the dosage regimen. The company official commented about the extended release tablet and said, “It is unclear when the manufacturing transfer would be completed.” So far in the year, Janssen Korea has announced Invega ER tablet, Topamax springkle capsule and Jurnista slow release tablet would be imported, instead of locally manufacturing them in Hyangnam factory. In 2018, Janssen Korea has announced the Hyangnam factory would stop operating in 2021. The factory was opened in 1983.
Company
New anticancer drugs by Bayer have been approved in Korea
by
Eo, Yun-Ho
Jun 02, 2020 06:09am
Two new drugs of Bayer's anticancer drugs will enter the domestic market. Androgen Receptor Inhibitor (ARi), Nubeqa (Darolutamide), treatment for nmCRPC and Orbital Selective Tropomyosin Receptor Kinase (TRK) inhibitor, Vitrakvi (Larotretinib) was recently approved by the MFDS. Nubeqa is an androgen receptor inhibitor with a unique chemical structure. It binds to androgen receptors and suppresses the growth of prostate cells through strong antagonism. This domestic permit is based on ARAMIS, a phase III clinical study that compared and evaluated the effectiveness and safety of Nubeqa and placebo controls in combination with androgen deprivation therapy (ADT). The study's main evaluation item, Metastasis-free Survival Period (MFS), was 40.4 months in Nubeqa and ADT combination groups, and demonstrated a significant improvement compared to 18.4 months in the placebo and ADT combination groups. Death risk was found to have decreased by 31% In addition, Vitrakvi has a high probability of severe morbidity during local, metastatic, or surgical resection among adult and pediatric patients who have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquisition-resistant mutation, and proceeds after existing treatments (or treatment regimens). It can be used for the treatment of patients with solid cancer who do not have a suitable treatment available or are currently available. The efficacy effect of Vitrakvi was approved on the basis of the overall response rate, and no clinical trials have demonstrated clinical benefits such as increased survival. This domestic permit includes clinical trials for adult and pediatric NTRK gene fusion advanced solid cancer patients (Phase I for adults 18 years of age and older, NAVIGATE Phase II for adults and children over 12 years of age, and primary CNS tumors). It is based on SCOUT Phase I/II trial in pediatric patients from 1 month to 21 years of age). According to the efficacy evaluation of a total of 55 patients in which NTRK gene fusion was confirmed from three clinical studies, Vitrakvi achieved an objective response rate (ORR) of 75% and a partial response rate (PR) of 53% in various carcinomas (soft tissue sarcoma, infantile fibrosarcoma, salivary gland cancer, thyroid cancer, lung cancer, melanoma, colon cancer, gastrointestinal stromal tumor)
Policy
The emergency introduction of Remdesivir was confirmed
by
Lee, Tak-Sun
Jun 02, 2020 06:09am
정은경 중앙방역대책본부장The government urgently introduced Gilead's 'Remdesivir' as a cure for COVID-19. Accordingly, the MFDS is planning to go through a special import procedure. Eun-kyung Jung, Head of the Central Disease Control Headquarters, said at the regular briefing on the 29th that the Central Clinical Committee on 28th suggested the need for the introduction of Remdesivir. Accordingly, the Central Disease Control Headquarters plans to apply for the special import (emergency introduction) of Remdesivir from the MFDS in response to the opinion of the Central Clinical Committee. The Committee evaluated that Remdesivir is safe and effective in the treatment of COVID-19 pneumonia, and that it is necessary to medically introduce Remdesivir in the absence of an alternative antiviral agent. In addition, it is said that the need for Remdesivir is given to patients with severe pneumonia from COVID-19 infection and who require oxygen treatment. The dosing period is about 5 days, and it is extended for 5 days depending on the patient's condition. However, the need for monitoring for effects or side effects is mentioned. Remdesivir is a drug that is currently undergoing clinical trials in Korea. The MFDS can import special drugs under the pharmaceutical affairs law at the request of the KCDC for drugs not approved for domestic use. If special import is recognized, it is possible to enter and use the imported items in Korea without the approval procedure. Pediatric Kaletra syrup, currently used to treat COVID-19, has also undergone this procedure. "Currently, there is not so much supply or production of drugs, so we plan to cooperate with related ministries as much as possible to secure drugs," said Jung. "It seems difficult to tell about the time now."
Company
Prescription drop amid COVID-19 finally emerges in April
by
Chon, Seung-Hyun
Jun 02, 2020 06:09am
The outpatient prescription volume in April has dropped by 10 percent against the same month last year. The outcome contrasts to this year’s first quarter prescription volume showing an increase against last year. Although the COVID-19 confirmed case curve in Korea seems to have gone down from April, the prescription volume shrunk even worse. As chronic disease patients have received long-term prescription in the first quarter to avoid visiting healthcare institutes amid COVID-19, a long break in prescription has seemingly occurred in the month of April. According to pharmaceutical market research firm UBIST on May 25, the total outpatient prescription volume in April was at 1.19 trillion won, which was brought down by 8.7 percent than in last year. In 2018 and 2019, the April prescription volumes have surged by 8.3 percent and 13.1 percent, respectively, compared to the previous year, but it bounced back down in last April. The April prescription volume this year has hit the lowest point in ten months since June last year. Monthly outpatient prescription trend (Unit: KRW 100 million) Source: UBIST The pharmaceutical industry experts evaluate that the COVID-19 impact on the prescription market has finally surfaced in the month of April. Since the first confirmed case of COVID-19 in Korea, the industry was deeply concerned that the prescription drug market would be shaken as pharmaceutical companies’ sales activities have been diminished and increasing number of outpatient refrained from visiting healthcare providers. But, the prescription volume up to March did not seem affected. Apparently, the prescription volume in the first quarter reached 3.70 trillion won, which was 2.7 percent higher than last year first quarter at 3.60 trillion won. The monthly prescription volume in January this year was dropped by 4.4 percent than last year by generating 1.22 trillion won. On the contrary, the February prescription volume this year was surged by 13.0 percent, generating 1.22 trillion. The industry experts analyze the number of business days in January and February have been affected by the early Lunar New Year holidays in Korea. This year’s January with less number of business days than last year had less prescription volume and February with more business days this year had increased volume. The total prescription volume in March was at 1.23 trillion won with 1.4 percent growth from last year. But the volume in April had the steepest fall so far in the year. In last year’s April, the prescription volume soared by 7.4 percent than the previous month, but this year’s April had a 3.2 percent dip from March. Many of chronic disease patients receiving long-term prescription to avoid visiting healthcare providers could have created a significant prescription drop in April. Apparently, the cases of patients receiving three to six months worth of prescription have skyrocketed when the confirmed case of COVID-19 peaked in Korea. The experts also suspect the postponed school semester, social distancing and better-managed personal hygiene could have reduced the disease prevalence in infants and children, which also affected the drop in the number of visit to healthcare institute. A majority of pharmaceutical companies in April had sluggish outcome in prescription volume. Among the top ten companies—Hanmi Pharmaceutical, Chong Kun Dang, Pifzer, Daewong Pharmaceutical, MSD, Novartis, Yuhan, Boehringer Ingelheim, HK inno.N and AstraZeneca—nine companies except for AstraZeneca had stagnating prescription volume in April than the year before. Top April outpatient prescription volume in 2020 by companies (Unit: KRW 100 million) Source: UBIST Hanmi Pharmaceutical recording the highest volume of prescription has made 52.9 billion won in April, falling down 8.7 percent than in last year. The Korean company’s first quarter volume was increased by 6.2 percent than in last year, but the volume was pulled back down in April. Chong Kun Dang and Pfizer’s April prescription volumes also had significant drop of 10.5 percent and 8.8 percent, respectively. Chong Kun Dang had a 1.7 percent growth in the first quarter, but the company took a steep fall in April. Pfizer’s first quarter prescription volume was dropped by 4.1 percent, and the figure got worse in April. The companies with the highest prescription volume, such as Daewoong Pharmaceutical, MSD, Novartis, Yuhan, Boehringer Ingelheim and HK inno.N, all performed worse than last year. Meanwhile, AstraZeneca made 9.3 percent more in this year’s April than last year. The multinational company’s first quarter prescription volume also grew by 9.7 percent from the year before. The pharmaceutical industry expects the prescription drug market would take a sharp upturn soon, as the number of confirmed COVID-19 cases has been dropping and the social distancing has been shifted to distancing in daily life.
Policy
Pfizer's non-steroidal eczema, under phase III in Korea
by
Lee, Tak-Sun
Jun 01, 2020 06:20am
A non-steroidal ointment that can be used for eczema in children is under clinical trial for domestic introduction. Pfizer's Crisaborole is a drug sold in the United States under the name of 'Eucrisa' after it was approved by the US in 2016. The MFDS approved a multinational clinical trial phase III for Pfizer’s Crisaborole on the 29th of last month. This clinical trial is aimed at verifying the efficacy and safety of 2% of Crisaborole ointment in Asian children and adult subjects (over 2 years of age) with mild to moderate eczema. Of the 510 subjects, the total number of domestic patients is 120. If safety and effectiveness are proved through this clinical trial, it is expected that the drug approval process will be conducted in Asia, including Korea. Eczema is a symptom of itching and dry skin, which usually starts in early childhood. the cause of the disease is still unknown, but it is said to be affected by genetic factors and environmental factors. Topical steroid ointments are used to moisturize the skin and suppress itching. However, the side effects of steroids are thinning the skin and there is a risk of infection, so long-term use should be avoided. Crisaborole is a non-steroid, and is a new ointment that can be used for eczema in the PDE-4 (phosphodiesteras). PDE-4 drugs that maintain immune homeostasis by increasing the release of inflammatory mediators include CDPD treatment, Daxas and psoriasis treatment, Otezlar, the first ointment to treat pediatric eczema. Accordingly, it is expected that the release of Crisaborole will act as an alternative to steroid ointments. Crisaborole was approved by the United States FDA in December 2016 for children over 2 years of age and adults with eczema. Recently, clinical trials have been conducted to lower the age group so that it can be used by children over 3 months of age. It is reported that there are about 950 thousand eczema patients in Korea, which is increasing every year. Treatment for non-steroidal eczema exists in Korea, but it is likely that attention will be focused on the introduction of Crisaborole in that it is rare for ointments that can be used in children.
Policy
Mabthera coverage extended and Strensiq newly listed
by
Kim, Jung-Ju
Jun 01, 2020 06:20am
Healthcare reimbursement would be granted on AbbVie Korea’s adult psoriasis treatment Skyrizi prefilled syringe (risankizumab) and Handok’s rare disease treatment Strensiq Injection (asfotase alfa) with new reimbursement standards. Korea’s Ministry of Health and Welfare (MOHW) announced the finalized changes in the revised Healthcare Reimbursement Standard and Method would be effective from June 1. ◆Skyrizi prefilled syringe: A new detailed standard of healthcare reimbursement would be established for the risankizumab injection based on the existing biological therapy options for psoriasis treatment. The coverage on the treatment would be granted to patients (age over 18) with chronic (expressed for over six months) psoriasis at a severe level, who qualify all following conditions—showing symptoms of plague psoriasis on 10 percent and more of their body surface area; scoring 10 or higher on Psoriasis Area and Severity Index (PASI); and demonstrating no reaction despite receiving UVB phototherapy for over three months or cannot maintain the therapy due to adverse reaction. However, those patients who cannot receive both photochemotherapy (PUVA) and UVB phototherapy should qualify following conditions—showing symptoms of plague psoriasis on 10 percent and more of their body surface; scoring 10 or higher on PASI; and demonstrating no reaction to three months of or longer administration of methotrexate (MTX) or cyclosporine, or cannot maintain the therapy due to adverse reaction. If the patient shows reduction of PASI by 75 percent or more after taking the treatment for 16 weeks (three doses), the coverage status is maintained for another six months. The PASI would be evaluated every six months and the coverage would be maintained if the patient shows the initial evaluation result. Risankizumab was added as an alternative option of TNF-α inhibitors like adalimumab, etanercept and infliximab or guselkumab, ixekizumab, secukinumab and ustekinumab have added risankizumab with the new reimbursement approval. ◆ Strensiq 40 mg/ mL injection and other: Handok’s Strensiq injection (asfotase alfa), the only enzyme replacement therapy indicated to treat infantile- and juvenile-onset hypophosphatasia (HPP). The injection would also be listed from June 1 for patients with infantile- and juvenile-onset HPP, who started treatment before the age of 19. Accordingly, provisional approval procedure and other reimbursement standards were added to manage careful use of the treatment with standard of initial administration and suspension. A patient with infantile-onset HPP would receive coverage when qualifying all following conditions—level of alkaline phosphatase (ALP) measures lower than normal range of the certain age and sex group but exceeds normal range of Pyridoxal-5’-phosphate (PLP); bone condition unique to HPP confirmed through radiograph prior to treatment; initial treatment received before the age of 19. The evaluation has to be conducted prior to the initial treatment, three and six months into the therapy, and clinical evaluation (height, weight, reparatory function, motor development stage, ambulatory function and pain) should be followed every six months from then on. The treatment has to be administered at a healthcare institute by principle, but self-administration would be allowed only when a properly trained patient demonstrates stable disease activity and no sign of adverse reaction. For a long-term prescription, a single dose is for maximum of four weeks. The patient also has to document ‘medication log’ to keep track of administration period and management for the responsible healthcare institute to follow. ◆ Lemtrada injection: Sanofi-Aventis Korea’s Lemtrada injection (alemtuzumab) indicated to treat relapsing remitting multiple sclerosis (RRMS) in adult patients is extending its reimbursement to cover third cycle for patients qualifying acceptable disease activity level after the second cycle. Patients, who have relapsed at least once, are eligible for the coverage if they meet two conditions out of following three; brain or spinal MRI detects new or enlarged T2 lesion, or new Gadolinium-enhanced lesion. ◆ Cyclosporine oral and injection and mycophenolate mofetil: The reimbursed indications are expanding for Cipol-N soft capsule and Sandimmun injection (cyclosporine), Cellcept capsule (mycophenolate mofetil), cyclophosphamides, Mabthera Injection (rituximab) and IV-Globulin SN injection (human immunoglobulin G). Specifically, the healthcare reimbursement would be granted for the off-label use of the drugs in immune tolerance induction as immunosuppressant to treat hemophilia A or B patients, if pre-approved by Health Insurance Review and Assessment Service (HIRA). The President of HIRA is stipulated to decide prerequisite conditions of the pre-approval, such as forming a committee, standard, procedure and method of the pre-approval. But the reimbursed off-label use of Pfizer Pharmaceutical Korea’s Benefix injection (Recombinant Blood Coagulation Factor Ⅸ) cleared is only for hemophilia B patients. ◆Desmopressin acetate and mirabegron: As Ferring Korea’s Nocdurna 25 μg sublingual tablet is to get listed, desmopressin acetate items exempted from reimbursement due to the revised standard would be stipulated. Also, the reimbursement standard for mirabegron would be revised with the listing of overactive bladder treatment by Hanmi Pharmaceutical, Mirabeg 50 mg SR tablet.
Company
Ilyang’s Supect were approved for phase III in Russia
by
Lee, Seok-Jun
Jun 01, 2020 06:19am
Ilyang announced on the 28th that its domestically developed new drug, Supect, will be conducting phase III clinical trials in Russia for the purpose of treating COVID-19. According to the company, Supect received phase III approval of 'COVID-19 treatment' from the Russian government under the supervision of R-Pharm, the No. 1 company in the Russian pharmaceutical industry. R-Pharm pays all costs for the phase III, and Ilyang provides the clinical drug Supect. Clinical trials are conducted in 145 mild and severe COVID-19 confirmed patients from 11 institutions in Russia and neighboring Belarus. After two weeks of dosing, Supect’s significance of treatment effect will be confirmed. An official from Ilyang said that Supect is a domestically proven new drug that is the first clinical trial among domestic pharmaceutical companies, and is likely to be commercialized as a therapeutic agent faster than other candidates.
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