- LOGIN
- MemberShip
- 2025-12-25 15:34:14
- Company
- Ildong started developing a treatment for COVID-19
- by Nho, Byung Chul Nov 29, 2021 05:58am
- Ildong Pharmaceutical and Shionogi Pharmaceutical have begun joint development of oral COVID-19 treatments, drawing keen attention to whether they will succeed in commercializing them in the future. Ildong Pharmaceutical officially announced on the 17th that it will participate in the development of S-217622 as a candidate for oral COVID-19 treatment along with Shionogi Pharmaceutical, and attention is being paid to whether it will create the third drug in the world to contribute to the end of the pandemic after Pfizer and MSD. Accordingly, Ildong Pharmaceutical plans to start the development process as soon as the recruitment of patients is completed after obtaining IND approval for the domestic clinical trial (P2/3) of S-217622 from the Ministry of Food and Drug Safety in Korea. According to Ildong Pharmaceutical, it aims to become the EUA of the Ministry of Food and Drug Safety within the first half of 2022. Although Pfizer and MSD, two global big pharmas, are already set to commercialize oral treatments for COVID-19, the pipeline should be expanded in terms of high drug costs worth nearly 850,000 won and protection of doctors and patients' drug options. In particular, S-217622 is a candidate substance for a new drug targeting the COVID-19 virus from the beginning, so it is different from drug re-creation development cases that utilize existing substances that have already been licensed or developed with other indications. According to previous studies, S-217622 prevents virus proliferation by inhibiting protease (3CL-protase), which exists only in the SARS-CoV-2 virus, the source of infection that causes COVID-19. It has also been confirmed that alpha, beta, gamma, and delta COVID-19 mutations all have similar levels of virus proliferation inhibition capabilities. More efficient medication convenience is also drawing attention. Pfizer's Paxlovid requires a total of 30 tablets, twice a day for 5 days, and the 5-day dose of MSD's Lagevrio reaches 40. On the other hand, S-217622 is being developed once a day for 5 days. It is expected to be smaller than the previous two treatments. The prospect that localization of treatments according to the terms of the joint development contract and improvement of access to domestic patients will have an advantage over other competitive drugs is also receiving positive reviews. If Ildong Pharmaceutical succeeds in developing the S-217622, it is planning domestic production through technology transfer. An official from Ildong Pharmaceutical said, "Korea's clinical design aims at more than 200 asymptomatic, mild, and severe patients. If development is successful, stable drug production and supply are expected by establishing sovereignty over treatments. Considering the data so far, it shows excellent safety, he said. Ildong Pharmaceutical and Shionogi Pharmaceutical have maintained a partnership for 40 years since the 1980s. Japan Pharmaceutical introduces and sells Shionogi Pharmaceutical's antibiotic Flumarin and Pirespa, a treatment for idiopathic pulmonary fibrosis, in Korea, and cooperates in the clinical phase for the first time. Shionogi is the world's top 50 pharmaceutical company that has focused on developing innovative treatments by focusing on treatment areas in the fields of anti-infectious diseases and central nervous system disorders, including antibiotics and antiviral drugs, for 144 years since its foundation in 1878. It has also developed large global new drugs such as flu treatment Xofluza, antibiotic Petroja, and hyperlipidemia treatment Crestor.
- Company
- Samsung BIOEPIS set a new sales record in a year
- by Chon, Seung-Hyun Nov 29, 2021 05:58am
- Samsung BIOEPIS has generated the largest quarterly sales since its launch. Overseas sales of biosimilars have increased, and milestones have flowed in due to overseas permits for subsequent biosimilar products. According to the Financial Supervisory Service on the 23rd, SAMSUNG BIOEPIS saw its sales rise 14.4% year-on-year to 271 billion won in the third quarter. It surpassed the previous maximum sales of 236.9 billion won recorded in the third quarter of last year in a year, breaking a new quarterly sales record. The company's cumulative sales in the third quarter were 625.2 billion won, up 9.2% from the previous year. Samsung Bioepis Most of Samsung BIOEPIS sales are generated through overseas sales of its own biosimilar products. SAMSUNG BIOEPIS succeeded in commercializing biosimilars of six products, including Enbrel, Remicade, Herceptin, Humira, Avastin and Lucentis. In Europe, all six products were approved, and in the United States, five products excluding Avastin were approved for sale. SAMSUNG BIOEPIS's performance has slowed slightly as sales have been on the decline for the second consecutive quarter since the third quarter of last year. Sales in the first quarter of this year amounted to KRW 166.7 billion, down 29.6% from the third quarter of last year. With the aim of securing inventory in preparation for the prolonged COVID-19, pre-orders from hospitals and wholesalers in Europe have recovered their performance. However, it rebounded in the second quarter and broke a new sales record in the third quarter, recovering from the sluggishness caused by COVID-19. Overseas sales sold by Biogen and Organon showed growth. Samsung Bioepis biosimilar's overseas sales in the third quarter were $342.8 million (about 406 billion won), up 11% from $369.9 million a year earlier. SAMSUNG BIOEPIS is selling five biosimilars in global markets excluding Korea through marketing partnerships with Biogen and Organon. Quarterly SAMSUNG BIOEPIS sales (unit: 1 million won, data: Financial Supervisory Service) Biogen is in charge of distributing and selling three types of autoimmune disease treatments in Europe, including Enbrel biosimilar Benepali, Remicaid biosimilar Flixabi, and Humira biosimilar Imraldi. Organon (formerly MSD) sells these three products under the product names Renflexis (Remicade biosimilar), Brenzys (Enbrel biosimilar), and Hadlima (Humira biosimilar) in the rest of the world except the United States, Korea, and China. Organon is also in charge of overseas sales of two types of anticancer drugs, Herceptin biosimilar Ontruzant and Avastin biosimilar Aybintio. Sales of biosimilars sold by Biogen reached $22.8 million in the third quarter, up 2% from the previous year. Organon's biosimilar sales in the third quarter rose 41% year-on-year to $140 million. The combined sales of biosimilars sold by Biogen and Organon in the third quarter amounted to $916.2 million (about 1.8 trillion won), up 11% from the previous year. In the third quarter, additional milestones were also introduced with the overseas approval of biosimilars. Lucentis biosimilar Byooviz, developed by Samsung Bioepis in August, was approved for sale by the European Commission (EC), and a month later, it was approved by the U.S. Food and Drug Administration (FDA).
- Company
- Keytruda's sales have been leading for two consecutive years
- by Chon, Seung-Hyun Nov 26, 2021 05:54am
- Keytruda, an immuno-cancer drug, has been leading the domestic pharmaceutical market for the second consecutive year. K-CAB continued to soar among new drugs from multinational pharmaceutical companies. According to IQVIA, a pharmaceutical research institute on the 26th, Keytruda of MSD Korea recorded 145.5 billion won in sales in the third quarter of this year, the largest number of all medicines. It recorded a high growth rate of 27.8% year-on-year, widening the gap with the second-ranked Lipitor by more than 30 billion won. Until the first half of the year, the gap between Keytruda and Lipitor was 19.9 billion won. Keytruda ranked first among all medicines for the first time with sales of 155.7 billion won last year. Keytruda, released in Korea in 2015, is an immune checkpoint inhibitor that treats cancer through activation of immune cells by inhibiting "PD-1" protein on the surface of immune cells T cells to prevent binding with PD-L1 receptors. In Korea, 18 indications were approved for 14 carcinomas, including melanoma, lung cancer, and head and neck cancer. Keytruda's quarterly sales remained around 3 billion won immediately after its release, but sales began to rise rapidly since August 2017 when insurance benefits were applied as a secondary treatment for non-small cell lung cancer. Keytruda surpassed 50 billion won in sales in the third quarter. If this trend continues, sales are expected to surpass 200 billion won this year. Keytruda also posted cumulative sales of $12.6 billion in the third quarter of this year in the global market. Perjeta and Prolia, new drugs from multinational pharmaceutical companies, also showed high sales growth. Roche's Perjeta recorded 69.1 billion won in cumulative sales in the third quarter, up 29.9% from the previous year. Perjeta is a drug administered in combination with Docetaxel and Trastuzumab in metastatic or localized HER2 positive breast cancer patients who are not operable and have never received HER2 targeted anticancer drugs or chemotherapy. Amgen's Prolia's cumulative sales in the third quarter amounted to 65.2 billion won, up 18.7% from the same period last year. Prolia, released in Korea in November 2016, is a biopharmaceutical osteoporosis treatment targeting protein RANKL. Since 2017, sales of Prolia have started to rise since salaries were applied only to secondary treatment therapy. Since April 2019, sales of Prolia have increased rapidly as insurance benefits have been recognized for primary treatment therapy. Chong Kun Dang is jointly selling Prolia with Amgen. It is an interesting phenomenon that Sanofi's antithrombotic drug Plavix increased 18.6% year-on-year to 46.8 billion won in cumulative sales in the third quarter. Plavix's patent expired in 2007, and more than 100 generics have entered. More than 10 years have passed since the patent expired, and sales have rather increased despite competing with more than 100 generics.
- Company
- Will the sale of impurity Losartan be okay?
- by Kim, Jin-Gu Nov 26, 2021 05:53am
- It is focusing on announcing the results of the MFDS. Anxiety in production and sales sites surrounding Losartan impurities is rising. As self-inspection results begin to come out for each manufacturer, consignment companies that received these results are agonizing over whether to preemptively suspend sales or continue sales. According to the pharmaceutical industry on the 24th, Arlico Pharmaceutical, Aju, and CTC Bio decided to stop selling Losartan-containing products. In the case of Arlico, the company decided to voluntarily withdraw along with the suspension of sales. At least five companies are confirmed to have officially decided to suspend sales about a week after concerns over Losartan impurities arose in earnest on the 16th. In addition to the three companies that decided to suspend sales on the 24th, Hutecs Pharmaceutical has begun to suspend sales. Mothers Pharmaceutical has not stopped selling Losartan, but has temporarily suspended the supply to new customers. On top of that, it is confirmed that many companies have unofficially suspended sales and supply. It is predicted that the number of companies suspended from sales is likely to increase further in the future. An official from the pharmaceutical industry said, "We have virtually stopped supplying it. "We don't know what measures the MFDS will take later, but it's to reduce the burden of voluntary recovery just in case," he said. Another company official said, "We have not yet received results from the consignee. However, if there is a problem, we plan to preemptively suspend sales", he explained. On the contrary, some pharmaceutical companies say they will continue to sell and supply until the MFDS announces. In this regard, a company official said, "There are many requests from suppliers. Since it has become difficult to obtain the product as several companies have stopped selling on their own, we will continue to supply it for now, even if we recover it later."
- Company
- Tabrecta and Tepmetko are approved simultaneously for NSCLC
- by Nov 25, 2021 05:56am
- Two new anticancer drugs that target the MET gene to treat non-small cell lung cancer have entered the Korean market. The two drugs are Novartis’ ‘Tabrecta (capmatinib)’ and Merck’s ‘Tepmetko (tepotinib)’ The Ministry of Food and Drug Safety approved Tabrecta and Tepmetko together on the 23rd. Both are targeted therapies that target MET mutations and have the same indications. Tabrecta and Tepmetko may both be used to treat locally advanced or metastatic NSCLC harboring MET exon 14 skipping mutations. Various mutations that induce cancer cell growth occur in NSCLC. Dysregulation in the proto-oncogene MET that is located in the long arm of chromosome 7 is also one of such many mutations. MET dysregulation can largely be divided into MET amplification or MET mutation. The MET exon 14 skipping mutation that is targeted by Tabrecta is one of the most commonly reported oncogenic MET mutations. MET exon 14 skipping mutation overstimulates the MET pathway that plays a key role in the signaling, proliferation, and survival of cells, resulting in the proliferation of cancer cells. MET exon 14 skipping (METex14) alterations are rare, occurring in only around 3% of all patients with metastatic NSCLC. However, its prognosis is poor due to its aggressive nature. In particular, retrospective analysis on patients with MET exon 14 skipping mutations showed that 37% of the patients had brain metastasis and 49% had bone metastasis at diagnosis. Tabrecta and Tepmetko are drugs that selectively inhibit the MET receptor tyrosine kinase. It blocks the MET phosphorylation response by binding to the intracellular kinase domain. In the US, Novartis’ Tabrecta was first approved and listed as the first MET targeted anticancer therapy. Tabrecta was approved in May last year, and Tepmetko in February of this year by the US FDA. In Korea, both were authorized simultaneously and are on an equal footing. At the pivotal GEOMETRY mono-1 trial, Tabrecta demonstrated a 68% objective response rate (ORR) and 41% ORR in treatment-naïve and previously treated patients, respectively. The duration of response (DoR) was 12.6 months and 9.7 months, respectively. Tepmetko demonstrated a 43% ORR in patients regardless of treatment experience, and DoR was 10.8 months ORR in treatment-naïve patients and 11.1 months in previously treated patients Both companies are also actively studying the combined use of their respective drugs with EGFR-targeted therapies with the hope that it could address the issue of resistance that patients acquire after treatment with EGFR inhibitors. MET mutation or amplification are key mutations that cause EGFR-TKI resistance. In this context, the companies are studying the combination of Tabrecta with Iressa, Tagrisso, etc, and Tepmetko with Tagrisso.
- Company
- Shionogi's stock price is soaring
- by Eo, Yun-Ho Nov 25, 2021 05:56am
- Shares of Japan's Shionogi Pharmaceutical, which is developing a treatment for COVID-19 with Ildong Pharmaceutical, are on the rise day after day. According to related industries, Shionogi's stock price has steadily risen since August, breaking this year's highest price. As of the 24th, Shionogi Pharmaceutical's stock price is trading at around 8,100 yen, up nearly 40% from 5,950 yen on July 27, when it announced the launch of phase 1 clinical trial for COVID-19. This is analyzed due to expectations for the oral COVID-19 treatment S-217622, which is being developed by Shionogi. In particular, in the case of the 17th, it has been on the rise since the announcement that domestic pharmaceutical company Ildong Pharmaceutical has started joint development of S-217622. On the 17th, Ildong Pharmaceutical announced in a media report that it received IND approval from the Ministry of Food and Drug Safety for phase 2/3 clinical trials of S-217622 and that it would immediately begin clinical trials. S-217622 clinical trials will be conducted simultaneously in Japan, Korea, and Singapore, and its strategy is to shorten the development period and secure sufficient data through multinational clinical and joint development to prove the value of drugs. According to previous studies, S-217622 showed excellent safety and drug resistance, and it prevents virus proliferation by inhibiting protease (3CL-protase) present only in SARS-CoV-2, the source of infection that causes COVID-19. It was confirmed that alpha, beta, gamma, and delta corona-19 mutations all have similar levels of viral proliferation inhibition capabilities. Above all, the convenience of taking oral medicine once a day is drawing attention as a strength over the selective treatment. Meanwhile, if commercialization of S-217622 is successful, Ildong Pharmaceutical is expected to promote its own production and distribution.
- Company
- Opdivo combo in review for esophageal cancer indication
- by Eo, Yun-Ho Nov 24, 2021 05:53am
- The cancer immunotherapy ‘Opdivo’ is attempting to add another esophageal cancer indication as a combination therapy in Korea. According to industry sources, the Ministry of Food and Drug Safety is reviewing expanding the indication for Ono·BMS’s PD-1 inhibitor Opdivo (nivolumab) in combination with Yervoy (ipilimumab) or chemotherapy as first-line treatment for unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma. The combinations are under review by the EU EMA for the same esophageal cancer indication. The efficacy of the Opdivo-based combination therapy as first-line treatment in esophageal cancer was demonstrated through the Phase III CheckMate-648 trial. In the trial, the two Opdivo-based treatment combinations (Opdivo+chemotherapy and Opdivo+Yervoy) demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit compared to chemotherapy in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma with tumor cell PD-L1 expression ≥1%, as well as in the all-randomized population. The CheckMate-648 trial was the first global Phase III trial that evaluated the immunotherapy and chemotherapy combination and a dual immunotherapy combination in advanced esophageal squamous cell carcinoma. Also, the Opdivo+Yervoy combination was the first dual immunotherapy combination to demonstrate a superior survival benefit compared to chemotherapy in this setting. The primary endpoints of the trial, overall survival (median OS) in patients whose tumors expressed PD-L1 was 15.4 months for the Opdivo+chemotherapy group and 9.1 months for the chemotherapy group. The secondary endpoint, median OS in the all-randomized patient population, was 13.2 months and 10.7 months respectively. The Opdivo+chemotherapy combination also demonstrated a statistically significant PFS improvement in patients whose tumors expressed PD-L1. The median PFS by blinded independent central review (BICR) was 6.9 months in the Opdivo+chemotherapy group, which was longer than the 4.4 months in the chemotherapy alone group. The primary endpoint, median OS of patients whose tumors expressed PD-L1 was 13.7 months for the Opdivo+Yervoy group compared to the 9.1 months in the chemotherapy alone group. The secondary endpoint, median OS in the all-randomized patient population, was 12.8 months vs. 10.7 months, respectively. The Opdivo-Yervoy combination did not meet its other primary endpoint of PFS by BICR, recording 4.0 months and 4.4 months, respectively. The median duration of response (DoR) per BICR was 8.4 months for Opdivo+chemotherapy, 11.8 months for Opdivo+Yervoy, and 5.7 months for chemotherapy alone in patients whose tumors expressed PD-L1, and 8.2 months, 11.1 months, and 7.1 months, respectively, in the all-randomized population. Opdivo+chemotherapy also showed a clinically meaningful increase in objective response rate (ORR). The ORR per BICR was 53% for Opdivo+chemotherapy, 35% for Opdivo+Yervoy, and 20% for chemotherapy alone in patients whose tumors express PD-L1 and 47%, 28% and 27%, respectively, in the all-randomized population. Meanwhile, Opdivo as monotherapy was approved in April 2020 for patients with unresectable advanced or recurrent esophageal squamous cell carcinoma that were refractory or intolerant to fluoropyrimidine and platinum-based chemotherapy.
- Company
- Bavencio cost support provided in non-reimbursed areas
- by Eo, Yun-Ho Nov 23, 2021 05:54am
- Pharmaceutical expense support for the cancer immunotherapy drug ‘Bavencio’ in non-reimbursed areas has begun. According to industry sources, Merck and Pfizer have started a patient support program to refund part of the expenses patients spend on Bavencio (avelumab) as first-line monotherapy for metastatic Merkel cell carcinoma and as first-line maintenance treatment for the recently approved locally advanced or metastatic urothelial carcinoma. Both companies plan to support part of the pharmaceutical expenses borne by patients who were prescribed Bavencio without reimbursement and must bear the full price. In particular, the Early Access Program (EAP) gained attention as it supports the recently approved urothelial carcinoma indication that lacks treatment options. Bavencio is an anti-PD-L1 immunotherapy that was first authorized in 2019 to treat Merkel cell carcinoma, then as a first-line maintenance therapy last August for patients with locally advanced or metastatic urothelial carcinoma who have not progressed after using platinum-based chemotherapy by the Ministry of Food and Drug Safety. The indication was approved based on the Phase III JAVELIN Bladder 100 trial that compared the outcomes between the best supportive care (BSC) and Bavencio+BSC. Study results showed the median overall survival (OS) was extended by over 7 months for patients who received Bavencio+BSC compared to BSC care alone, and the risk of death was also reduced by around 31%. Jae-lyun Lee, professor of Oncology at Seoul Asan Medical Center, said, “Urothelial carcinoma, which is the most common type of bladder cancer, accounts for around 90% of all diagnosed cases. Around 12% of patients are diagnosed at an advanced stage, and the 5-year survival rate of patients who have distant metastasis is only around 6%, showing the dire need for a suitable treatment that could treat or extend the life of these patients.” Bavencio was approved as second-line treatment for Merkel cell carcinoma in March 2019 and was first listed for reimbursement last October for the same indication.
- Company
- Myungin signed an exclusive license agreement for Parkinson
- by Nov 23, 2021 05:54am
- Myungin announced on the 22nd that it has signed a license and investment contract with Israeli pharmaceutical company Pharma Two B (P2B) for commercialization of Parkinson's disease treatment in Korea. P2B001, which is being developed by P2B, is a new combination of low-dose sustained-release drug Rasagilin and sustained-release drug Pramipexole, which is widely used for Parkinson's disease. It is manufactured to solve unmet demand while minimizing side effects by combining two drugs that act as different pharmacological mechanisms. P2B001 is taken only once a day, and dose control is not required. P2B completed multinational phase 3 clinical trials of P2B001 in 70 regions of North America and Europe. It is planning to announce the results of phase 3 top line within this year. The goal is to release the product in 2023 after applying for permission in the U.S. and Europe in the second quarter of next year. With this contract, Myungin has the right to commercialize and manufacture P2B001 exclusively in Korea. To this end, Myungin will invest $5 million (about 5.9 billion won) to make equity investments. "P2B001 has the potential to become a new treatment that combines different mechanisms for patients suffering from Parkinson's disease," said Lee Hae-myung, chairman of Myungin. "We hope that cooperation with P2B will provide necessary treatment for patients with Parkinson's disease in Korea."
- Company
- Maven Clad can be prescribed in Big 5
- by Eo, Yun-Ho Nov 23, 2021 05:54am
- Maven Clad, a new drug for multiple sclerosis, has completed its entry into the Big 5 Advanced General Hospitals. According to related industries, Merck's highly active multiple sclerosis treatment Maven Clad (Cladribine) has currently passed DC of medical institutions such as Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, AMC, and Sinchon Severance Hospital. MavenClad is the first short-term oral treatment to show overall significant effects in terms of the degree of progression of physical disability, annual recurrence rate, and number of active lesions shown in MRI (magnetic resonance imaging) tests. The efficacy of this drug was confirmed through long-term follow-up data of the 8-year prospective observational registry PREMIERE study, along with CLARITY Phase III study and CLARITY Phase II study, which corresponds to CLARITY expansion clinical trials. In a two-year CLARITY 2 and 3 study, post-analysis of patients with high disease activity showed a 67% reduction in annual recurrence rate in patients with Maven Clad, and an 82% reduction in extended disability status scale (EDSS) indicating disability progression in the Maven Clad administration group. However, lymphocytopenia and shingles can occur as significant adverse reactions when administered with Maven Clad, so patients' lymphocyte levels must be measured before and during administration of Maven Clad to patients with multiple sclerosis. Maven Clad administration is prohibited in certain groups, including patients with impaired immune function and pregnant women. Maven Clad recently released retrospective observational study data and analysis results related to COVID-19 vaccination in patients with multiple sclerosis. In the case of patients receiving immunosuppressive treatment for autoimmune diseases such as multiple sclerosis, vaccination is recommended because they are more vulnerable to COVID-19 infection and are more likely to be severely transmitted if infected. A recent independent study in Israel targeted 23 patients with recurrent dysplasia (at least 4.4 months after treatment) treated with Maven Clad. As a result of the study, all 23 patients were confirmed to have a protective IgG antibody response to the COVID-19. Dimitrios M. Karussis, a neurologist at Hebrew University in Israel, explained, "If immunity is reduced due to immunosuppressants, the immune response of the COVID-19 vaccine may decrease or affect its efficacy, so patients and medical staff were deeply concerned." In addition, he added, "This study is very encouraging data for multiple sclerosis patients and medical staff in such a situation, and it is also meaningful because no unexpected safety problems were found compared to healthy ordinary people when vaccinated with Maven Clad."
