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- 2026-03-17 16:20:01
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- PCSK9i Praluent can be prescribed after 5 years of approval
- by Eo, Yun-Ho Jan 19, 2022 06:07am
- Praluent can be prescribed at general hospitals. As a result, practical competition for PCSK9 inhibitors began five years after domestic approval. According to related industries, Sanofi-Aventis Korea's Praluent (Alirocumab) passed the Drug Committee of medical institutions such as Seoul National University Bundang Hospital, Gangnam Severance Hospital, Chonnam National University Hospital, and Pusan National University Hospital, including Asan Medical Center. Praluent was approved in Korea in January 2017, but it was not until June 2021 that insurance benefits were listed. Amgen Korea's Repatha(Evolocumab) was approved in April 2017, and the willingness to register was stronger. Repatha was first listed as an indication for homogeneous family hypercholesterolemia (HOFH) in August 2018. There were two PCSK9 inhibitors, but in fact, Repatha was the only option. Since last year's registration, Sanofi has carried out the landing process at a general hospital, and the competition between the two drugs is expected to begin in earnest as they show results this year. Repatha, which has advanced into the benefit right, has already entered the medical institution code and is attracting prescriptions. It can be prescribed at major medical institutions nationwide, including Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, Asan Medical Center, and Sinchon Severance Hospital. PCSK9 inhibitors had a wide range of areas requiring prescriptions other than HoFH, and in January 2020, Repatha succeeded in expanding the benefit criteria to patients with high risk of atherosclerotic cardiovasic disease (ASCVD), Heterozysocial Hypercholesterolemia (HeFH), and statin-insensitive patients. The competitive areas of the two drugs are actually expected to be ASCVD and HeFH. Praluent added HoFH indications in the United States in April last year. Meanwhile, Praluent tended to reduce the risk of all-cause death, and was approved in two doses of 75 mg and 150 mg, and patient-specific dose selection is possible by referring to patient status and LDL-C levels. Listed Repatha has already entered the medical institution code and is attracting prescriptions. Prescriptions are available at major medical institutions nationwide, including Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, Asan Medical Center, and Sinchon Severance Hospital.
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- 3 Korean companies accelerate Stelara biosimilar development
- by Ji Yong Jun Jan 19, 2022 06:06am
- Korean companies are rushing to get a share of Stelara’s autoimmune disease treatment market that brings in ₩9 trillion in annual sales. Samsung Bioepis, which had been late in starting the development of Stelara biosimilars than its competitors like Dong-A ST and Celltrion, completed patient recruitment for its Phase III trial and pulled forward its study completion date. All three companies are expected to complete clinical trials for the commercialization of their Stelara biosimilars within this year. According to ClinicalTrals.gov, the clinical information website operated by the US National Institutes of Health, on the 19th, Samsung Bioepis had recently completed patient enrollment for its global Phase III clinical trial for SB17 (Name of Stelara biosimilar in development). The company completed patient recruitment in only 6 months since the company started Phase III trials in July last year. This Phase III trial that is being conducted in patients with moderate-to-severe plaque psoriasis registered 503 patients, exceeding the company's initial goal of enrolling 464 patients. The expected completion date was also pulled forward from March 2023 to December this year. Such moves are interpreted as Samsung Bioepis’s effort to accelerate the development of SB17. Stelara is an IL-12 and 23 inhibitor developed by the multinational pharmaceutical company Janssen. It is used to treat autoimmune diseases such as psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. In 2020, the drug raised $7,707,000,000 (approximately ₩9,155,900,000,000 based on exchange rates on the 18th) in global sales. However, Stelara will soon face competition with latecomers as its substance patent expires in the US in September 2023 and Europe in July 2024. In other words, the mega-market that brings in ₩9 trillion a year will soon be open for entry by biosimilars from September next year. With Samsung Bioepis pulling forward its clinical trial completion date, Celltrion and Dong-A ST are also planning to complete their clinical trials for their Stelara biosimilar within this year. Celltrion will be completing its trial in the first half of this year, and Dong-A ST in the second half of this year. Celltrion’s Stelara biosimilar, CT-P43, is being developed the fastest. Celltrion started Phase III trials for CT-P43 in January last year and completed patient enrollment with 509 patients in May of the same year. The company is in its final stages of the trial and is expecting trial completion by May this year. Celltrion plans to commercialize CT-P43 in line with Stellara's substance patent expiry in the US and Europe. If the company keeps up its pace of development, the company is expected to be able to easily enter the global core market. Dong-A ST is also speeding up its clinical trial for DMB-3115, its Stelara biosimilar in development. Dong-A ST started global Phase III trials for DMB-3115 in April last year. In November of the same year, the company completed enrolling 605 patients for the trial. Dong-A ST plans to complete the Phase III trial for DMB-3115 in November this year. Dong-A Socio Holdings and Meiji Seika Pharma had been jointly developing DMB-3115 since 2013. In July 2020, the right to develop and commercialize DMB-3115 was transferred from Dong-A Socio Holdings to Dong-A ST. Currently, the drug is being jointly developed by Dong-A ST and Meiji Seika Pharma. The two companies have also completed preparations for the global commercialization of the drug. In July last year, Dong-A ST and Meiji Seika Pharma signed a global license-out agreement for DMB-3115 with Intas Pharmaceuticals, transferring the rights for approval and marketing of DMB-3115 in the global region, excluding Korea, Japan, and some Asian countries. An industry official said, “Biosimilars earn a profit by taking a piece of the original’s market share of the pie. Therefore, earlier entry is beneficial to accumulate prescription data, etc.”
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- Exporting medicines to North America ↑ 2.6 times in 2 years
- by Kim, Jin-Gu Jan 19, 2022 06:06am
- Exports of domestic drugs hit an all-time high last year, especially exports to the North American market surged, the report showed. Exports to the U.S. and Canada have increased 2.6 times in two years. 2017-2021 Amount of medicines exported to the North American market Germany is still the largest exporter, but it is estimated to have decreased slightly compared to last year. In addition, exports of medicines to Japan, Italy, and Vietnam have increased significantly. ◆Last year's US exports amounted to $1.1 billion, 71% compared to $600 million in 2020 ◆ According to the Korea Customs Service on the 16th, pharmaceutical exports amounted to $8.12144 billion last year, up 18% from $6.8935 billion in 2020. Exports to the North American market have increased significantly. U.S. exports amounted to only $643.04 million in 2020. Last year, it rose 71 percent to $1.097.85 billion. Canadian exports increased 130% from $32.99 million to $75.99 million during the same period. The total exports to the North American market increased 1.7 times from $676.03 million in 2020 to $1.173.83 billion last year. Compared to $44329 million two years ago, it has increased 2.6 times. ◆ Biosimilar, K-new drug and botulinum toxin are in full swing Celltrion and Samsung Biologics account for a large portion of exports to the North American market. Celltrion exports Remicade biosimilar "Remsima," Mabthera biosimilar "Truxima", and Herceptin biosimilar "Herzuma" to the North American market through Celltrion Healthcare. Celltrion Healthcare's cumulative exports to the North American market in the third quarter of last year amounted to 491.4 billion won. Remsima occupies the highest market share among Infliximab biosimilars in the US market. Samsung Biologics entrusts and produces antibody drugs from global pharmaceutical companies. Last year's exports amounted to 377.6 billion won until the third quarter. The annual exports to North America in 2020 exceeded 289.5 billion won early. On top of that, domestic new drugs and domestic botulinum toxin drugs have been adding strength since last year. Sales of SK Biopharm's new epilepsy drug Xcopri (Cenobamate) in the North American market have begun in earnest. SK Biopharm's cumulative exports in the third quarter of last year amounted to 187.9 billion won, up 19 times from the cumulative 9.9 billion won in the third quarter of 2020. Almost all are estimated to be Xcopri sales. SK Biopharm received Xcopri marketing approval from the U.S. FDA in November 2019. It went on sale in May 2020. Since then, sales in the North American market began in earnest last year, and SK Biopharm's exports have also soared. The full-fledged sale of domestic botulinum toxin in the U.S. market after the "Strain Dispute" agreement is also cited as the background of the increase in exports to the region. Last year, domestic botulinum toxin exports amounted to $235.85 million, up 15% from $2528 million in 2020. In particular, exports to the United States increased significantly. Domestic botulinum toxin exports to the U.S. stood at $15.8 million in 2020, but more than doubled to $31.3 million last year. Early last year, Daewoong Pharmaceutical and Medy Tox concluded the dispute over botulinum toxin strains through an agreement. From the second quarter, sales of Daewoong Pharmaceutical's "Nabota (Jeubeau)" in the North American market began in earnest. Sales of Xcopri (left) in North America have begun in earnest North American market. ◆Germany, the largest exporter, fell 5% year-on-year, while exports to Japan and Vietnam surged Although exports to the U.S. have soared, Germany is still the largest exporter of domestic medicines. Last year, exports of medicines to Germany amounted to $1.76922 billion. Compared to 2020, it decreased by 5%. Germany's share of pharmaceutical exports fell from 26.9% to 21.8% during the same period. Exports to Japan, Vietnam, and Italy surged. Last year, exports of medicines to Japan amounted to $48699 million. It increased 42% from $265.17 million in 2020. Exports to Vietnam increased 70% from $144 million to $253.11 million , while exports to Italy rose 187% from $65.28 million to $187.2 million.
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- Pharma exports exceed ₩9 trillion in 2021
- by Kim, Jin-Gu Jan 18, 2022 06:05am
- Pharmaceutical exports in Korea have exceeded ₩9 trillion last year. With exports increasing around biopharmaceuticals, sales of the drugs increased over 2.2 times over the past 2 years. Imports have also reached record-high, influenced by the increased import of Pfizer and Moderna’s COVID-19 vaccines. On the other hand, the export of diagnostic kits that have surged after the COVID-19 outbreak has slowed down. ◆Export of pharmaceuticals exceed $8 billion… led by Samsung Biologics and SK Bioscience According to the Korea Customs Service on the 16th, pharmaceutical exports last year amounted to $8,121,440,000 (approximately ₩9.69 trillion) (based on the exchange rate on the 16th of $1 to ₩1,190). This is a 18% increase from the $6,893,550,000 (approximately ₩8.20 trillion) in 2020. With such a surge in exports for 2 consecutive years, exports increased 2.2 times last year compared to 2 years ago. In 2020, exports increased 87% from the $3,695,910,000 (approximately ₩4.4 trillion) in 2019. Annual Pharma exports 2010-2021 The export of biopharmaceuticals has led the increase in exports. In 2021, export of biopharmaceuticals recorded $6,007,230,000 (approximately ₩7.15 trillion). This is a 24% increase from the $4,906,870,000 (approximately ₩5.84 trillion). In the same period, export of chemical drugs increased only 3% from $1,986,680,000 (approximately ₩2.36 trillion) to $2,049,150,000 (approximately ₩2.44 trillion). This increased export of biopharmaceuticals was led by Samsung Biologics and SK Bioscience. The accumulated exports of Samsung Biologics by Q3 last year was ₩930 billion, a 50% increase from the ₩620.4 billion in Q3 2020. In the same period, exports of SK Bioscience increased by over 14 times from ₩11.3 billion to ₩161.3 billion. CMOs of COVID-19 vaccines are expected to have directly influenced this increase in exports in the two companies. Samsung Biologics signed a CMO agreement with Moderna for the COVID-19 vaccine in May last year. Manufacture of Moderna’s vaccine began in earnest from Q3, sharply increasing the company’s exports this year. SK Bioscience signed a CMO contract with AstraZeneca to manufacture its COVID-19 vaccine from July 2020. Although the contract has expired at the end of last year, the company had recorded record amounts through exports of vaccine solutions and finished products. This year, the company plans to manufacture the Novavax COVID-19 vaccine in full this year. ◆Import of pharmaceuticals exceeds ₩10 trillion … due to the import of COVID-19 vaccine Imports of pharmaceuticals in Korea had also exceeded ₩10 trillion for the first time. Import of pharmaceuticals recorded $9,828,760,000 (₩11.7 trillion) last year, a 32% increase from the $7,432,960,000 (₩8.85 trillion). Such a great increase in exports is analyzed to have been greatly influenced by the import of COVID-19 vaccines. The import of COVID-19 vaccines in Korea had recorded $345,230,000 (₩410 billion) in 2020 and increased over 6 times last year to record $2,355,260,000 (₩2.8 trillion). Monthly imports showed that the amount was around $300,000,000 (₩360 billion) until March before Pfizer’s COVID-19 vaccine started to be imported in earnest, then jumped to $500,000,000 (₩600 billion) since April. Since June when Moderna’s vaccine was added to the imports, the amount surged to exceed $1,000,000,000 (₩1.19 trillion). Vaccine imports in September last year recorded the highest amount with $6,800,000,000 (₩8.9 trillion). ◆Export of the once-leading export product ‘K-diagnostic kits’ fell 6% … due to intensified global competition Sales of diagnostic kits that had settled as a leading export item in Korea since the COVID-19 outbreak had somewhat faltered. Its amount fell 6% from the $2,170,870,000 (₩2.58 trillion) in 2020. Last year, export of diagnostic kits recorded $2,046,670,000 (₩2.44 trillion). This was a 6% decrease from the $2,170,870,000 (₩2.58 trillion) in 2020. The domestic diagnostic kits have enjoyed a surge in sales since April 2020, when the COVID-19 broke out in full. Demand had risen across the globe to the extent that was unable to be met by the short supply. The performance of domestic diagnostic kit companies that quickly entered the market had improved greatly. However, since Q4 2020, the prolonged COVID-19 outbreak had increased the competition and reduced the unit price of products, consequently reducing the export amount. In fact, the export weight of domestic diagnostic kits had increased 48% from 5832 tons in 2020 to 8659 tons last year. In other words, the export weight increased by 1.5 times but the amount earned from exports had actually decreased.
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- First PIK3CA-targeting ‘Piqray’ lands in general hospitals
- by Eo, Yun-Ho Jan 17, 2022 05:51am
- ‘Piqray,’ the first targeted anticancer drug that targets the PIK3CA gene, may now be prescribed at general hospitals. According to industry sources, Novartis Korea’s ‘Piqray (alpelisib)’ passed the drug committee (DC) reviews of 2 of the ‘Big 5’ hospitals in Korea - the Seoul Samsung Medical Center, and Seoul Asan Medical Center. Piqray, which was approved in Korea in May last year, is a PIK3Caα inhibitor that blocks the overactivation of the PI3K pathway by inhibiting the overactivation of PI3K-α that is caused by PIK3CA mutation. This targeted therapy is prescribed in combination with ‘Faslodex (fulvestrant)’ for patients with HR-positive/ HER2 negative metastatic or advanced breast cancer who have progressed on or after prior therapies. However, as the drug is yet to be reimbursed, it is expected that some time would be needed for its active prescription even after it lands in hospitals. The efficacy of Piqray was demonstrated in the SOLAR-1 trial that studied 572 men and postmenopausal women with HR-positive, HER2-negative, advanced, or metastatic breast cancer whose cancer had progressed while on or after receiving an aromatase inhibitor. Study results showed that the median progression-free survival improved to 11 months in patients with a PIK3CA mutation who used Piqray in combination with Faslodex, compared with the median PFPS of 5.7 months in those who used Faslodex alone. The objective response rate (ORR) that shows the proportion of patients whose tumor size had reduced by 30% or more was 35.7% in the combination therapy (Piqray+Faslodex) group, which was over a twofold increase compared to the 16.2% in the Faslodex monotherapy group. The secondary endpoint, overall survival (OS) in the PIK3CA-mutated cancer group, was 39.3 months in the combination therapy group. Although this was 8 months longer than that of 31.4 months in the monotherapy group, the results were not statistically significant. Joo-Hyuk Sohn, professor of Medical Oncology at Sinchon Severance Hospital, said, “Piqray in combination with fulvestrant is recommended as Category 1 in the NCCN guidelines for breast cancer patients with a PIK3CA mutation. The introduction of this treatment option is raising hope of overcoming resistance to endocrine therapy”
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- Shortening the completion of Samsung Biologics plant 4
- by Kim, Jin-Gu Jan 17, 2022 05:51am
- Samsung Biologics announced that it will start partial operation within this year in connection with its fourth plant currently under construction. It also introduced that it has already won orders for consignment production from three global pharmaceutical companies. John Lim, CEO of Samsung BioLogics, made the remarks at a press conference at the JPMorgan Healthcare Conference held online on the 13th. He explained that the completion schedule of the four plants currently under construction has been moved up by about six months. Samsung Biologics announced its plan to establish a 256,000-liter plant in 2020. The fourth plant, which is under construction with a total floor area of 240,000 square meters in Songdo, Incheon, is originally expected to be completed by 2023. CEO John Lim predicted that plant 4 will be able to operate partially within this year as the construction schedule is shorter than the previous plan. "We will start partial operation after October this year," he said adding, "60,000 liters are expected to be operated first." He added, "The rest will be in operation in the second quarter of next year as originally planned," adding, "It will be possible to obtain cGMP in the second quarter of next year." In particular, he said, "We are winning orders for existing clients or potential clients before the full operation of the fourth plant," stressing, "We have already won five projects from three global top tier pharmaceutical companies and are continuing discussions with 20 pharmaceutical companies about 30 projects." Samsung Biologics will secure a total of 620,000 liters of plants 1 to 4 when it enters full operation next year following partial operation of plant 4 within this year. It will be reborn as the world's largest producer of biopharmaceuticals. On top of that, CEO John Lim explained that the establishment of new plant 5 & 6 with a size of 326,400 square meters (100,000 pyeong) is also speeding up. We are talking to Incheon City about the site of BioCampus 2 for the construction of plant 5 & 6, he said. "We will sign a contract to secure the site within the 2nd quarter of this year." In addition, it also proposed strategies for the development of cell gene therapy. Samsung Biologics denied rumors of the acquisition of Biogen, a U.S. bio company that developed Aduhelm (Aducanumab), an Alzheimer's dementia treatment, late last year. CEO John Lim said, "We are considering various measures, including M&A, regarding cell gene therapy." He said, "It could be a new business or an M&A. "It's not that we're not doing M&A, but we're continuing to push for it," he said.
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- Korean companies' progress in developing COVID-19 treatment
- by Moon, sung-ho Jan 17, 2022 05:51am
- News of the decision to introduce Pfizer’s oral COVID-19 treatment ‘Paxlovid’ in Korea from earlier this year has increased interest in the progress made in the development of oral COVID-19 treatments at Korean pharmaceutical companies. The interest in when the homegrown oral COVID-19 treatments will be commercialized was triggered by the earlier-than-expected introduction of oral COVID-19 treatments from multinational pharmaceutical companies. # According to the Ministry of Food and Drug Safety and industry sources on December 29th, Shin Poong Poong Pharmaceutical, Daewoong Pharmaceutical, Ildong Pharmaceutical, and Genencell are developing oral COVID-19 treatments. The MFDS comprehensively had previously granted emergency use approval (EUA) of ‘Paxlovid (nirmatrelvir·ritonavir)' based on a comprehensive review of the results of the expert advisory meeting among others. Paxlovid is indicated for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older, at least 40kg) who have positive COVID-19 results from PCR tests and are at high risk for progression to severe COVID-19. In addition, the government purchased the oral treatment ‘molnupiravir’ from the US company MSD (Merck & Co.) in advance, confirming the introduction of COVID-19 treatments in Korea earlier this year. Meanwhile, the oral COVID-19 treatment being developed by the domestic companies is in clinical stages. The well-known Shin Poong Pharmaceutical’s ‘ Pyramax (pyronaridine-artesunate combination),’ the repositioned COVID-19 treatment in development, has entered Phase III trials after registering its first patient at the end of October. # Daewoong Pharmaceutical has repositioned its Foistar tablet and is in clinical trials to develop the drug under the name ‘Coviblock’ for the ‘treatment of patients with mild-to-moderate COVID-19’ and ‘treatment of patients with severe COVID-19.’ Also, Ildong Pharmaceutical and Genencell have received MFDS approval for Phase II and III trials respectively for their oral COVID-19 treatments in development. Dailypharm found that Ildong is planning to conduct a clinical trial and aims to register more than 200 patients with asymptomatic, mild, or moderate COVID-19 symptoms in Korea, and is currently recruiting participants from medical institutions, centered around Inha University Hospital. An Ildong Pharmaceutical official said, “The Inha University Hospital is the lead clinic for our trial. We are recruiting participants at 23 medical institutions including Inha and is also conducting a global clinical trial with the goal of receiving approval in the first half of this year.” The issue is that it is difficult to recruit participants in the course of clinical development for domestic oral treatments, which raises concerns over the disruption it may cause. This issue has been repeatedly raised since the start of the development of homegrown COVID-19 treatments, and the pharmaceutical companies have set out to resolve the issue by conducting global clinical trials rather than domestic trials. However, some expect that these latecomers will have sufficient competitiveness if they are sold at a lower price than that of Pfizer's or Merck's. Price-wise, 30 tablets of Paxlovid are classified as a single course, and the US government has made an agreement for 10 million treatment courses of Paxlovid at 530 dollars (approximately 630,000 won) per course. The US government has also signed for Merck’s molnupiravir at 700 dollars (approximately 830,000 won) per course.
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- ₩200 bil schizophrenia treatment market is changing
- by Kim, Jin-Gu Jan 14, 2022 05:50am
- Change is in the air in the schizophrenia treatment market that was once led by global pharmaceutical companies such as Otsuka Pharmaceutical and Janssen. Domestic companies are acquiring rights of originals and introducing new products to chase the multinational leaders in the market. In response to the change, the global pharmaceutical companies are also preparing strategies such as adding a new dose to their product line for the first time in 6 years. ◆ Boryung rises to the rank as No.3 after securing ‘Zyprexa’ According to industry sources on the 13th, the schizophrenia treatment market in Korea is estimated to be around ₩200 billion. The market had been led primarily by multinational pharmaceutical companies, with Korea Otsuka Pharmaceutical, Janssen Korea, and Lilly Korea owning the top 3 items in the market. Pic of Zyprexa. Boryung acquired the rights, including sales and licensing for Zyprexa from Lilly in October last yearHowever, a change has been forewarned in the market with Boryung’s acquisition of ‘Zyprexa (olanzapine).’ Boryung Pharmaceutical had acquired all sales and licensing rights for Zyprexa in Korea from Lilly in October last year. At the same time, the company announced its plans to reinforce its CNS (central nervous system) treatment portfolio around Zyprexa. The company’s goal is to raise its CNS sales, which are currently around ₩30 billion to ₩50 billion by 2025. Boryung’s confidence in setting such an aggressive sales goal lies in its securement of an original drug. Preference for originals is very high in the CNS treatment market that includes schizophrenia treatments. In the case of olanzapine, Whanin Pharm, Myung In, Hanlim Pharm own generic versions of olanzapine, but the companies had earned very little. In 2020, Whanin’s ‘Zyrepin’ earned ₩5.9 billion, Myung In’s ‘Neurozapine’ ₩3.1 billion, and Hanlim’s ‘Zyzapine’ ₩2.7 billion. In other words, the original drug that has been in the country for 25 years since its approval in 1997 holds an overwhelming influence over the market. This is why Boryung Pharmaceutical also made the decision to acquire the license of Zyprexa rather than release a generic version. ◆ Whanin plans to introduce ‘Cariprazine’…first new drug to be introduced in 11 years After acquiring original schizophrenia drugs, Boryung and Whanin are preparing to chase its leaders in the market This is why other Korean companies are also intent on securing their own originals. In this sense, Whanin Pharm set a strategy to introduce a new drug for schizophrenia to Korea. For the past decade, no new drugs had been introduced in the schizophrenia treatment market. ‘Abilify(aripiprazole),’ the No.1 leader in the market, was approved in 2002, and the No.2 ‘Invega (paliperidone) was also first approved in 2010. Whanin’s new drug ‘Cariprazine’ therefore is the first new drug to be introduced to the Korean market in a decade. Cariprazine is an atypical antipsychotic developed by the Hungarian company Gedeon Richter. The drug is being sold under the brand names Vraylar in the United States and Reagila in the European Union Whanin Pharm received approval to conduct a bridging study for the introduction of the drug to Korea in April last year. The trial is being conducted on 342 patients who have acute-phase schizophrenia at 30 institutions including the Seoul National University Hospital. Considering that it takes around a year for a bridging study to be complete, it is expected that the company will be completing the study within the year and receive marketing authorization for the drug. Samil Pharm has also jumped into the schizophrenia treatment market with an original of its own. In December last year, Samil Pharm had entered into a co-promotion agreement with Viatris Korea for the sale of three drugs - schizophrenia treatment ‘Zeldox (ziprasidone),’ antidepressant ‘Zoloft,’ and anxiolytic ‘Xanax’- to expand its CNS business. Dong Wha Pharmaceutical had previously been selling and distributing the drugs for the past 6 years. Samil is known to have set up a team dedicated to CNS to increase the influence of the three drugs. ◆MNCs in defense…Otsuka receives approval for a new dosage for the first time in 6 years With the entry of such new contestants companies that are already in the lead are preparing measures to defend their ranks in the market. Korea Otsuka Pharmaceutical newly received approval for its ‘Abilify 1mg’ in December last year. Previously, the company had 2mg, 5mg, 10mg, 15mg dosages of Abilify in the market. This is the first change made to the pipeline in 6 years since ‘Abilify Maintena Inj.’ was introduced in 2015. When limiting the product to the table formulations, it is the first new dosage to be introduced in 13 years, since the company received approval for the 2mg product in 2008. The industry believes this move was made conscious of the competition with domestic pharmaceutical companies that entered with original drugs at their forefront. Otsuka expects the ultra-low-dose product to play a positive role in securing their lead in the market as prescriptions of low-dose products are increasing in practice. No.1 and 2 in the schizophrenia treatment market, Abilify(left), Invega(right) According to the market research institution IQVIA, Korea Otsuka Pharmaceutical’s Abilify series makes the most sales among all domestic schizophrenia treatments. It recorded sales of ₩50.9 billion in 2020 with its three products -Abilify Tab, Abilify OD Tab, and Abilify Maintena Inj. Last year, in the first half year alone, the company had made ₩27.4 billion with the product line. The runner-up in the ranks is Janssen Korea’s Invega series. Janssen Korea recorded sales of ₩25.3 billion with Invega ER Tab, Invega Sustenna Inj, and Invega Trinza Inj in 2020. The company had sold ₩13.1 billion in the first half of last year. The third-most sold is Zyprexa, which sold ₩14.2 billion in 2020.
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- One clinical trial of NeoImuneTech's new immuno-cancer drug
- by Ji Yong Jun Jan 14, 2022 05:50am
- NeoImuneTech has suspended one clinical trial for the treatment of COVID-19 of NT-I7 (efineptakin alfa), which is being developed as a new immuno-cancer drug. According to ClinicalTrials.gov operated by NIH in the U.S. on the 12th, it was confirmed that NeoImuneTech withdrew one phase 1 clinical trial related to NT-I7 in the second half of last year. Earlier, NeoImuneTech was approved by the U.S. Food and Drug Administration (FDA) in June 2020 for two clinical trials related to COVID-19. The withdrawn clinical trial corresponds to a pilot study. Pilot research is a small-scale study conducted to minimize errors before entering large-scale clinical trials of new drugs. Regarding the reason for the suspension of clinical trials, the company explained, "We withdrew it because the situation in the United States changed rapidly due to the emergence of vaccinations and treatments because it did not match the planned clinical design in the early stages of the COVID-19 incident." NeoImuneTech attempted to develop NT-I7 treatments as the number of patients increased rapidly due to the COVID-19 pandemic. From June 2020, 30 adult patients with mild COVID-19 were recruited and NT-I7 was administered as muscle injection to conduct clinical trials for treatment effectiveness and safety evaluation by dose with the NIH. A month later, an additional phase 1 clinical trial of NT-I7 was approved to obtain more detailed data than the existing clinical trial. The study was conducted by Jian Campian of Washington University in St. Louis. This clinical trial planned to confirm the immune effect of COVID-19 due to an increase in lymphocytes in the blood after NT-I7 administration. However, the additional clinical trial was withdrawn due to Professor Jian Campian's resignation without registering a single subject for more than a year since it was approved. In addition, the clinical trial conducted with NIH is in the process of recruiting patients. NT-I7 is a hyleukin-7 T cell amplifier developed by NeoImuneTech as a new immuno-cancer drug. NT-I7 has a mechanism to remove cancer cells and infected cells by increasing the number of T cells in the body. According to NeoImuneTech, NT-I7 was clinically confirmed to amplify and activate T cells in cancer patients and patients with lymphocytopenia. Currently, NeoImuneTech is examining clinical effects with a combination of immuno-cancer drugs such as Merck's Keytruda, Roche's Tecentriq, and BMS' Opdivo and NT-I7. There are only 10 global clinical trials aimed at securing indications for various carcinomas such as gastric cancer, breast cancer, and non-small cell lung cancer.
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- SK Bioscience, speeding up its development of COVID Vaccine
- by Kim, Jin-Gu Jan 13, 2022 06:05am
- SK Bioscience is speeding up the commercialization of its own COVID-19 vaccine. In particular, it is predicted that the approval of the Novavax vaccine will have a positive effect at a time when the GBP510 is aimed at licensing items in the first half of this year. On the 12th, the MFDS approved Nuvaxovid PFS, NovaVax's COVID-19 vaccine. The item approval of this vaccine was carried out by SK Bioscience, not Novavax. Novavax handed over the right to sell Novavax vaccines to SK Bioscience in Thailand and Vietnam, including Korea, through an expansion contract with SK Bioscience late last year. ◆Nuvaxovid-GBP510 The pharmaceutical industry believes that this experience of product approval will be of great help to SK Bioscience. It is evaluated that SK Bioscience succeeded in solving similar types of practice questions before applying for GBP510, which is expected in the first half of this year. SK Bioscience is developing its own COVID-19 vaccine GBP510, which is similar to Novavax vaccine. Phase 3 clinical trials are currently underway. The goal is to obtain item permission within the first half of this year. GBP510 adopted a gene recombination vaccine platform. It is a method of inducing antibody production that can respond to viruses by injecting antigen proteins directly. Nuvaxovid, which was approved this time, was also developed as a gene recombination platform. Item licensing strategies are similar, such as obtaining "basic inoculation" permission first and "additional inoculation (booster shot)" permission later. SK Bioscience started clinical trials for GBP510 booster shots in December last year. The target number of test subjects is 550. When the clinical trial is completed, the company plans to apply for a change in permission to inoculate GBP510 with booster shots after completing the second vaccination of Pfizer and Moderna. ◆ NovaVax vaccine stock solution + finished product and sales are expected to be 200 billion won+ SK Bioscience is also expected to benefit from the approval of Novavax vaccine items. At the end of last year, the government decided to pre-purchase 10 million doses of SK Bioscience's vaccine. To this end, the company plans to invest 192 billion won in the budget allocated to the KDCA. Fees for consignment production of NovaVax vaccine stock solution (DS) and finished product (DP) are also profits that SK Bioscience can earn. SK Bioscience signed an expansion contract with Novavax in December last year regarding consignment production of vaccines. The contract period is until December this year. SK Bioscience uses three out of nine lines of Andong L House to produce Novavax vaccines. Of the three lines, two are responsible for the production of undiluted solutions and one is responsible for the production of finished products. SK Bioscience receives consignment fees based on undiluted production and sales fees based on complete sales from NovaVax. The undiluted solution produced in L House is supplied to Korea, Thailand, and Vietnam. If SK Bioscience receives additional item permits in Thailand and Vietnam, SK Bioscience's profits are expected to increase further from 192 billion won purchased by the Korean government. The finished vaccine is expected to adjust production at the request of NovaVax. Novavax has announced its vaccine production at 2 billion doses this year. Among them, SK Bioscience is also said to account for a considerable portion. It is expected to be responsible for most of the supply to Asian countries except Japan. Depending on how many Novavax requests for consignment production, SK Bioscience's fees are expected to increase. According to SK Bioscience, L House's production capacity is up to 450 million to 500 million doses per year. Arithmetically, it is possible to produce 50 million to 55 million doses of vaccines per year on one line.
