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- 2026-05-08 14:31:39
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- CKD Bio & Cutia Therapeutics signed a supply contract
- by Chon, Seung-Hyun Jan 21, 2022 05:55am
- CKD Bio is targeting overseas markets for botulinum toxin drugs under development. CKD Bio announced on the 19th that it has signed a supply contract with Cutia Therapeutics for Tyemvers, a botulinum toxin. The size of the contract is 8.3 billion won, which supplies the product to China, Hong Kong, Macau, and Taiwan for 15 years after licensing Chinese products. The step-by-step milestone is a condition that receives $2.5 million when applying for a clinical trial plan in China and $1 million and $1.5 million when approving product licenses in Korea and China, respectively. Tyemvers is the product name of a botulinum toxin drug under development by CKD Bio. This contract is the first overseas expansion signed by CKD Bio since it started developing botulinum toxin drugs. In June 2019, CKD Bio signed a contract with a European-based research institute to introduce a license for commercialization of botulinum strains and prepared to enter the botulinum toxin market. The completion ceremony of the CKD Bio Osong plant held at Osong Life Science Complex in December last year. (From the right), Korea Bio Chairman Ko Han-seung, KPBMA Chairman Won Hee-mok, Cheongju City Vice Mayor Lim Taek-soo, CKD Bio CEO Lee Jung-jin, CEO of Chong Kun Dang Holdings Kim Tae-young, Director of Economic and Trade Bureau Shin Hyung-geun, and CEO of Bell E&C Lee Hwan-young CKD Bio completed the construction of the Osong plant, a production facility exclusively for botulinum toxin, at Osong Life Science Complex in Cheongju, North Chungcheong Province, in December last year. CKD Bio Osong Plant is a production plant dedicated to botulinum toxin drugs at the level of cGMP in the United States. It was completed two years after the construction began in June 2019. It was built with a total floor area of 13,716㎡ on 21,501㎡ of land with an investment of about 45.7 billion won. It has an annual production capacity of 6 million vials of botulinum toxin and plans to expand its production to 16 million vials in the future. CKD Bio went through a full-time trial of botulinum toxin and received approval from the MFDS on the 18th and entered the full-fledged development stage. In a clinical trial conducted at Chung-Ang University Hospital, the safety and effectiveness of CKDB-501A are compared with Botox in adults who need to improve middle or severe wrinkles. CKD Bio said, "CKDB-501A does not use animal-derived ingredients, so higher safety can be expected. Through phase 1 clinical trials, we can expect the economic effects of the country through import substitution and export in the botulinum toxin market, which aims to improve wrinkles between our eyes."
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- 60 billion won worth of neutropenia market fluctuates
- by Kim, Jin-Gu Jan 20, 2022 05:55am
- The market for neutropenia treatments worth 60 billion won a year is expected to fluctuate significantly. The copyright of the No. 1 and No. 2 items in the second-generation neutropenia treatment market has shifted in succession, and new drugs have joined the competition in six years, signaling a upheaval. ◆Boryung and Jeil will change the top 2 items in the market and announce competition According to the pharmaceutical industry on the 20th, Boryung Pharmaceutical recently signed a co-promotion contract for Neulasta (Pegfilgrastim) with Kyowa Kirin Korea. Boryung Pharmaceutical will start selling Neurastar in earnest starting this year. GC Pharma's Neulapeg (Pegteograstim)' contract, which had been jointly sold until last year, ended. With the end of the business with Boryung, Jeil will jointly sell it with GC Pharma from this year. Neutrophilia refers to an abnormally low neutrophil level in the blood. If neutrophils decrease, they become vulnerable to bacterial and viral infections. Cancer patients' neutrophil levels decrease during chemotherapy, and neutrophil reduction drugs prevent this. The first-generation treatment was administered four to six times per cycle of chemotherapy. The second-generation treatment can be effective only with one administration per cycle. Neulasta and Neulapeg are the No. 1 & No. 2 items in the second-generation neutropenia treatment market. According to IQVIA, a pharmaceutical market research firm, Neulasta posted sales of 18.9 billion won and Neulapeg posted sales of 16.5 billion won until the third quarter of last year. Sales in 2020 are 25.1 billion won for Neulasta and 15 billion won for Neulapeg. Interestingly, Boryung and Jeil's reversed position. Jeil, Neulapeg's new partner, has co-sold Neulasta from 2014 to 2017. Boryung Pharmaceutical co-sold Neulapeg from October 2018 to last year. In other words, Jeil Pharmaceutical, which used to sell Neulapeg in the past, and Boryung, which sold Neulapeg, took charge of Neulasta. ◆ Neulasta with new engine vs Neulapeg with replaced power The key is whether Neulapeg's growth will continue. Neulapeg was somewhat sluggish until Boryung joined. In 2018, the fourth year of its launch, sales were only 4 billion won. It more than doubled to 8.9 billion won in 2019 when Boryung joined in earnest. In 2020, it rose 69 percent again to 15 billion won.Last year, Neulapeg almost caught up with Neulasta. Quarterly sales of Neulasta and Neulapeg differed by about five times from 6.2 billion won to 1.3 billion won in the first quarter of 2019, but narrowed the gap to 6.5 billion won to 6.3 billion won in the third quarter of 2021. In this situation, Boryㅕng Pharmaceutical's contract, which was evaluated as the biggest driving force behind Neulapeg's rise, was terminated. Jeil, which took over Neulapeg from Boryung, was burdened with maintaining the existing upward trend. Boryung, which has market-leading products, is also inevitable to establish a new strategy. If a sales and marketing strategy has been established from the perspective of a chaser until last year, a new strategy should be established to shake off such pursuit from this year. ◆ Rolontis, the first new drug in 6 years Another variable is Hanmi Pharmaceutical's Rolontis(Eflapegrastim). Hanmi Pharmaceutical received domestic approval for its own new drug Rolontis in March last year. It is the first new drug in six years as a treatment for neutropenia. Rolontis is a long-term persistent drug that is applied with Hanmi Pharmaceutical's own platform technology "Labscovery (once a month)." It is administered once per anticancer cycle. It was on the health insurance benefit list in November last year. Hanmi Pharmaceutical plans to start selling Rolontis in earnest starting this year. Although it is a newly released drug, the patient's economic burden is the lowest. The insurance price of Rolontis is 489,796 won. It is the lowest price among the second-generation neutropenia treatments. Neulasta's price is 785,525 won, Neulapeg 576,230 won, Dulastin 586,643 won, and Lonquex 594,429 won. It remains to be seen whether Dulastin and Lonquex, which were pushed back by Neulasta and Neulapeg, will rebound. Dong-AST's Dulastin, licensed in 2014, generated 2.7 billion won in sales in 2020. Teva-Handok's Lonquex, licensed in 2015, recorded 3.3 billion won in sales in the same year. Accumulated sales in the third quarter of last year were 2.4 billion won in Dulastin and 2.3 billion won in Lonquex.
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- Second new migraine drug ‘Ajovy’ aims at reimbursement
- by Eo, Yun-Ho Jan 20, 2022 05:55am
- ‘Ajovy’ is also following the steps of ‘Emgality’ and seeks health insurance benefits in Korea. According to industry sources, Teva-Handok Pharma applied for the reimbursement of its calcitonin gene-related peptide (CGRP) targeting migraine drug Ajovy (fremanezumab). The company quickly applied for reimbursement since launching the drug without reimbursement in October last year. With slow progress being made for the reimbursement of Lilly's Emgality (galcanezumab),’ which applied for reimbursement in April last year, whether the addition of Ajovy to the game will create a synergistic effect remains a point of focus. Both drugs are currently prescribed without reimbursement. Although Emgality and Ajovy are same class drugs, they differ in dosage and administration, allowing patients to be prescribed the drugs according to their characteristics. Emgality is administered in a loading dose of 240mg (two consecutive subcutaneous injections of 120 mg each) followed by monthly doses of 120mg injected subcutaneously. Ajovy is administered in a monthly dosage of one 225 mg subcutaneous injection each month or a quarterly dosage of 675mg subcutaneous injection (three consecutive 225mg injections) every 3 months. Meanwhile, Ajovy demonstrated its efficacy at the HALO EM/CM clinical trial that was conducted for 12 weeks on 2,000 episodic migraine (EM) and chronic migraine (CM) patients. In the HALO EM study that was conducted to verify the efficacy and safety of Ajovy in comparison to the placebo, Ajovy met the primary endpoint by significantly reducing the monthly number of migraine days in both of the monthly and quarterly dosed groups. The proportion of patients with a 50% reduction in migraine days was also higher for the Ajovy administered group than the placebo group. The proportion of subjects that showed a 50% or more reduction in migraine days was 44.4% in the monthly Ajovy and 47.7% in the quarterly Ajovy group compared to the 27.9% of the placebo group. In the HALO CM study, the monthly average reduction in migraine days in the monthly dosing Ajovy group was 4.6±0.3 days, and the quarterly dosing Ajovy group was 4.3±03 days, a significant reduction compared to the placebo group’s 2.5±0.3 days. WonGu Lee, Professor of Neurology at Kosin University Hospital, said, “Unlike existing preventive drugs that required daily dosage, patients may manage their migraines with once-a-month injection with CGRP-targeted antibody drugs. The treatment cost remains an issue, however, we neurologists have high expectations for these drugs because the more the patient receives the targeted therapy, the easier it is to treat.”
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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”
- Company
- 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.
- Company
- 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.
