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- 2026-04-15 15:34:46
- Company
- Hepatitis C treatment Vosevi was refocused
- by Eo, Yun-Ho Mar 05, 2021 06:26am
- Gilead is aiming to enter the market for hepatitis C treatment Vosevi, which has failed to designate an orphan drug in Korea. According to related industries, Gilead Science Korea is in the process of marketing approval of the three-drug combination Vosevi (Sofosbuvir + Velpatasvir + Voxilaprevir) along with the hepatitis C combination drug Epclusa (Sofosbuvir / Velpatasvir). Vosevi's designation as an orphan drug was canceled because it did not meet the criteria for orphan drug designation in 2018. This drug, like AbbVie's Maviret (Glecaprevir + Pibrentasvir), relieved the discomfort of using Ribavirin in combination with a pangenic hepatitis C treatment, or the duration of treatment. Indications for this drug include therapy with NS5A inhibitors, treatment with genotypes 1-6 or Sofosbuvir without NS5A, and treatment of adult hepatitis C patients with type 1a and 3 treatment experience. In the POLARIS-1 and POLARIS-4 studies, Vosevi achieved a primary endpoint in 340 out of 353 chronic hepatitis C patients with treatment experience (SVR12 96%). Gilead, through Sovaldi (Sofosbuvir), first established the concept of'cure' in the area of hepatitis C. However, the introduction of pangenetic therapeutics in Korea was relatively delayed. As the number of hepatitis C patients is decreasing and Maviret's sales are high, it is unknown how the entry of Gilead's generics will affect the market. The World Health Organization's (WHO) latest treatment guidelines for hepatitis C recommend pangenetic treatments such as Maviret that do not require additional testing.
- Opinion
- [Reporter’s Eye] Be aware of fake news trampling the hope
- by An, Kyung-Jin Mar 05, 2021 06:26am
- Recently, the South Korean media industry is intensely disputing over a bill imposing punitive damages. Democratic Party Lawmaker Noh Woong-rae issued a legislative notice on a bill to include general media and portal websites as subjects for the punitive damages, which awards compensation valuing maximum of triple the damages to a prevailing plaintiff of a libel case, where damages are caused due to intentional distribution of false and distorted information. Reportedly, the media industry is strongly resisting against the bill. The opposition party and the media labor union are criticizing that “The new bill is shackling the media in the name of media reform.” The public opinion survey result disclosed a day after the Democratic Party announced the bill would be brought to the National Assembly provisional session showed contrasting reactions. A South Korean public opinion survey firm Realmeter surveyed 500 adults aged over 18, as requested by Oh My News, about applying the punitive damages on media outlets, where 61.8 percent approved of it, which more than doubling the opposing opinion (29.4 percent). The distribution differed depending on the political view and supporting party, but the approving opinion was higher than the opposing opinion throughout most of the regions and age groups. Regardless of supporting or opposing the bill, the outcome was shocking. Basically, it portrayed how low the people’s trust in media has gotten. Issues with fake news were apparent even from the early stage of the novel coronavirus infection outbreak (COVID-19). Hateful comments burst out when the outbreak was out of hand for a while in Daegu, and misinformation of confirmed patients and their routes was shared through Youtube, KakaoTalk and online communities fast causing a massive damage to the affected ones. Since the MERS outbreak in 2015, the information technology has developed rapidly and the people’s dependency on social media hiked and fired up the fake news spreading. Concerned of the rapid distribution of the fake news, the World Health Organization (WHO) has warned of infodemic, a portamanteau of “information” and “epidemic,” and unfolded a relevant management plan. And a year has passed since. How are we doing amid COVID-19? The treatment and vaccines that used to feel unobtainable have been developed, and the COVID-19 vaccination started from Feb. 26 in South Korea as well. The government plans to achieve the herd immunity by coming November, and inoculate the first dose of COVID-19 vaccine to 70 percent of the people by September. However, the fake news creating insecurity is still found around every corner. What’s worse is that it is not spreading only by social media or individual media channel. Some of articles and their provocative headlines published by news outlet are implying a specific company’s vaccine could cause more adverse reaction. Without a proper investigation outcome in the cause of death, the public is thrown into turmoil with news articles reporting the death of COVID-19 vaccine recipients. Healthcare providers urge, “The vaccination is essential for us to end the COVID-19 pandemic.” Besides the government, Korean Society of Infectious Diseases (KSID), Korean Academy of Tuberculosis and Respiratory Diseases (KATRD) and Korean College of Rheumatology are raising their voices and plead “Do not get confused by fake news and participate in COVID-19 vaccination.” Looking back now, I am reflecting on myself with the thought of ‘what have I been doing as a reporter amid pandemic?’ The South Korean media should take COVID-19 as an opportunity to reflect back on themselves and regain the public’s trust.
- Policy
- 1 free dose of rare cancer treatment Lutathera
- by Lee, Tak-Sun Mar 05, 2021 06:25am
- Apparently, South Korea’s Ministry of Food and Drug Safety (MFDS) is to lessen the patient’s financial burden through a patient aid program for a rare cancer treatment Lutathera until it gets officially listed for reimbursement. The government program would grant a free dose of the treatment. MFDS announced the Lutathera patient aid program would run for 12 months as collaborated by Korea Orphan & Essential Drug Center (KOEDC, CEO Kim Nakyung), a foreign drug developer with an Advanced Accelerator Application, and Korea Alliance of Patients Organization (KAPO). Lutathera is indicated to treat patients with neuroendocrine tumor, which costs approximately 100 million won for a single treatment cycle (total four doses). In November 2019, MFDS acknowledged Lutathera as an emergency use drug and it has been supplying the drug with KOEDC. The ministry elaborated the government has been preparing the patient aid program to ensure patients with treatment opportunity by providing support in purchasing the drug and managing the safety. The patient aid program stipulates the foreign drug developer to provide at least one dose of the drug for free to patient, and KODC to give user guide to patient and healthcare provider for safe use and designate a Chief Safety Officer (CSO) to manage individual patient administration record and adverse reaction report. The program would be temporarily available for about 12 months from Mar. 2, but the program would still provide support to access the drug to patients, who participated in the program before the end date, during the planned treatment term. However, depending on the reimbursement listing date for Lutathera licensed by Novartis Korea, the program could end earlier than initially scheduled. Minister of Food and Drug Safety Kim Gang-lip stated, “We expect to grant access to the treatment opportunity to struggling patients with neuroendocrine tumor in South Korea through the patient aid program. The ministry would continue to provide support for the patients in pain fighting against disease to get them the needed treatment access.” For more information on the patient support program, contact and enquire KODC via hotline (02-2219-9815) and email (drugsafety@kodc.ac.kr).
- Company
- Sales of Tagrisso tripled in four years
- by An, Kyung-Jin Mar 05, 2021 06:25am
- The market for targeted anticancer drugs for EGFR, which is prescribed to patients with non-small cell lung cancer with specific mutation findings, set a record for sales last year. The benefit of Tagrisso, a third-generation drug that is effective in the treatment of resistance to existing drugs, has been listed. According to IQVIA on the 2nd, the domestic epithelial growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) market in Korea was ₩152 billion, up 15.0% from the previous year. Compared to ₩57.6 billion in 2016, the sales volume increased 2.6 times over the past four years. 'Four types of EGFR-TKI, including Iressa (Gefitinib), Tarceva (Erlotinib HCl), Giotrif (Afatinib), and Tagrisso (Osimertinib), formed a domestic market worth ₩57.6 billion in 2016. In 2017, the growth slowed down to ₩55.4 billion, but after nearly doubling to ₩104.3 billion in 2018, it is a new record for 3 consecutive years. The third-generation drug Tagrisso (Osimertinib) was listed, driving the expansion of the EGFR-TKI market. EGFR-TKI is a targeted anticancer drug prescribed for patients with metastatic non-small cell lung cancer (NSCLC) with EGFR mutation. EGFR mutations occur between exons 18 and 21. It is a very common genetically modified cancer observed in 30% to 40% of non-small cell lung cancer, which accounts for 80% to 85% of lung cancer, and is known to have a higher incidence rate in Asians than in Westerners. This means that there is a lot of demand for prescriptions in Asia including Korea. Tagrisso's sales were ₩106.5 billion in the domestic market last year. It increased 34.5% compared to the previous year, setting a record high. The market share of'Tagrisso' based on last year's cumulative sales reached 70.1%. It maintains an overwhelming market gap with Iressa, the second-largest item. Tagrisso received marketing approval from the MFDS in May 2016 for local advanced or metastatic non-small cell lung cancer patients with EGFR-T790M mutation confirmed after administration of EGFR-TKI in May 2016. It is used as a secondary treatment for patients with non-small cell lung cancer who developed resistance after administration of the existing 1st and 2nd generation EGFR-TKI such as Iressa, Tarceva, and Giotrif. Tagrisso's sales surged as it was reimbursed as a second-line treatment in December 2017. Tagrisso sales, which started at ₩2.3 billion in the first year and ₩10.3 billion in 2017, jumped 5.8 times in a year to ₩59.4 billion in 2018. Since then, it has maintained a steep growth rate of more than 30%. In December 2018, a first-line therapy indication was added in Korea, but the expansion of benefits has been pending for more than two years. Sales of EGFR-TKI were sluggish excluding Tagrisso. Iressa's sales last year were ₩19.6 billion, down 30.7% from the previous year. Iressa's market share, which occupied 51.1% in 2016, fell 38.2%p in 4 years to 12.9%. Last year, Roche Tarceva's sales fell 10.9% year-on-year to ₩7.3 billion. Compared to ₩17.3 billion in 2016, the scale of sales has halved in four years. Boehringer Ingelheim's Giotrif's sales last year were ₩18.6 billion, up 12.2% from the previous year. Sales are increasing from ₩8.6 billion in 2016 to ₩10.9 billion in 2017 and ₩13.6 billion in 2018. However, the market share decreased by 2.7 percentage points from 14.9% in 2016 to 12.2% in 2020. Even though it was a second-generation drug, it did not overcome the resistance that occurred after the first-generation EGFR-TKI treatment and did not secure differentiation. The industry observes that there will be a big change in the EGFR-TKI market this year. Pfizer's Vizimpro, a second-generation drug, was listed at the end of last year, and it became possible to prescribe a general hospital. In February of last year, Vizimpro received item approval from the MFDS as a primary treatment for'local advanced or metastatic non-small cell lung cancer with EGFR exon 19 defect or exon 21 L858R substitution mutation. Tagrisso's rival drug, Yuhan's Leclaza, can also be prescribed within the year. Leclaza, a third-generation drug, was approved by the MFDS in January as a treatment for patients with EGFR T790M mutation-positive local progressive or metastatic non-small cell lung cancer who had previously been treated with EGFR-TKI.
- Policy
- Jardiance generics win approvals one after another
- by Lee, Jeong-Hwan Mar 04, 2021 06:10am
- A series of generics of Boehringer Ingelheim Korea’s antidiabetic sodium-glucose co-transporter-2 (SGLT2) inhibitor Jardiance (empagliflozin) seem to be receiving the market authorization one after another. On Mar. 3, South Korea’s Ministry of Food and Drug Safety (MFDS) authorized Korea Prime Pharm’s Empazin 10 mg and 20 mg tablets. As a result, three South Korean companies—Kukje Pharma, Dongkoo Bio & Pharma and Korea Prime Pharm—have Jardiance generics ready for the market. The health authority green lit Kukje Pharma and Dongkoo Bio & Pharma’s Jardiance generics, Glinace and Empance, on Feb. 24. These were the first Jardiance generics to be approved in the country. Jardiance can be administered as a supplementary to diet and exercise therapies for adult patients with type 2 diabetes to control their blood sugar level. Although the three items have been cleared for marketing, the Jardiance generic cannot be released immediately. The product patent in Jardiance expiring in 2025 has not been challenged successfully. In other words, the approved companies have presumably submitted a patent certification to MFDS that they agree to launch the products after October 2025, when Jardiance patent expires. A company releasing the generic before the patent expiration would be penalized and lose the authorization. The patent expiring on Oct. 23, 2025, ‘the use of and production of glucopyranosyl-substituted benzol derivatives and drug containing the compound,’ has been challenged by Dong-A ST attempting to nullify the patent in 2015, but it was eventually dismissed in 2018. However, 52 South Korean pharmaceutical companies have successfully requested negative confirmation and evaded Jardiance’ crystalline form patent expiring in 2026. Ultimately, the generic makers can either nullify the other patent, or launch the generics after Oct. 23, 2025 after the patent expiration. Similar to Kukje Pharma, Dongkoo Bio & Pharma and Korea Prime Pharm, the other patent-evaded companies would highly likely to seek for the marketing authorization in advance. Pharmaceutical market research data UBIST on outpatient prescription volume found Jardiance has generated 29.2 billion won and 35.4 billion won in 2019 and 2020, respectively.
- Company
- Roche has applied for insurance benefits of Polivy
- by Eo, Yun-Ho Mar 04, 2021 06:10am
- According to related industries, Roche Korea has submitted an application for Polivy (Polatuzumab), an antibody-drug conjugate (ADC) that is used in combination with conventional BR therapy (Bendamustine+Rituximab) for the treatment of Diffuse Large B-Cell Lymphoma and DLBCL. DLBCL, which accounts for the highest proportion of Non-Hodgkin lymphomas, is an aggressive lymphoma that requires immediate treatment due to its rapid disease progression. More than half of the patients have a good response rate to the extent of reaching remission, but 30-40% of patients do not respond to the standard therapy R-CHOP or experience recurrence after the first treatment. Relapsed/refractory DLBCL has not been an effective treatment option so far, although most patients experience recurrence within 2 years and the survival period is only 6 months. Polivy is the first ADC drug that targets CD79b, and has a mechanism to induce apoptosis by binding to CD79b expressed in B cells. Polivy was validated in a phase 1b/2 clinical study that confirmed the clinical efficacy and safety of Polivy combination therapy in 80 patients with relapsed/refractory DLBCL who were unable to receive hematopoietic stem cell transplantation and had more than one treatment experience. It was designated as an orphan drug in Korea in October of last year. As a result of the study, Polivy combination therapy group had higher complete remission rate (CR, Complete Response) and overall survival (OS, Overall Survival) longer than BR therapy (Bendamustine+Rituximab) group. Professor Ko Young-il, hematology and oncology at Seoul National University Hospital, said, "DLBCL patients who are difficult to transplant hematopoietic stem cells have a poor prognosis, and if they recur after hematopoietic stem cell transplantation, the survival period is only about 6 months. "Polivy has been clinically proven to be useful and is a recommended treatment option in international guidelines. It is significant in that it presents a new alternative to the previously limited relapsed/refractory DLBCL treatment," he added.
- Company
- Samsung Bioepis enters phase 1 of Stelara
- by Lee, Seok-Jun Mar 04, 2021 06:10am
- Samsung Bioepis has begun phase 1 clinical trial of the 10th biosimilar pipeline SB17. SB17 is a biosimilar for Stelara (Ustekinumab). Samsung Bioepis launched Phase 1 in February to confirm the pharmacokinetics, safety, and immunogenicity of SB17 for 201 healthy volunteers in France. Stelara is a treatment for autoimmune diseases such as psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis sold by Johnson & Johnson in the United States. The volume of global sales in 2020 is about ₩8.4 trillion. Samsung Bioepis was founded in 2012, and has developed three types of autoimmune diseases (SB2: biosimilar for Remicade, SB4: biosimilar for Enbrel, SB5: biosimilar for Humira) and two anticancer drugs (SB3: biosimilar for Herceptin & SB8: biosimilar for Avastin). It is also developing treatments for eye diseases (SB11: biosimilar for Lucentis, SB15: biosimilar for Eylea), blood diseases (SB12: biosimilar for Soliris), and skeletal diseases (SB16: biosimilar for Prolia).
- Policy
- Single-dose Janssen COVID-19 vaccine requests authorization
- by Lee, Tak-Sun Mar 04, 2021 06:10am
- Janssen’s COVID-19 vaccine to be introduced to South Korea in the second quarter has officially requested for authorization to the Ministry of Food and Drug Safety (MFDS). Following AstraZeneca and Pfizer, the multinational company would be a third company to apply for the authorization on COVID-19 vaccine in the country. On Feb. 27, MFDS official announced Janssen (Johnson & Johnson) has submitted an application for approval on COVID-19 vaccine (code name: Ad26.COV2S). The vaccine was one of a part the South Korean government’s vaccination plan. While AstraZeneca and Pfizer’s vaccines need double doses for a full vaccination, Janssen’s vaccine only requires single dose and the government chose the vaccine for its convenience. Janssen’s vaccine uses the mechanism of a virus vector vaccine, which injects adenovirus via virus vector to human body to generate the antigen in the body inducing the adequate immune response. The same mechanism is used by ‘AstraZeneca Korea Covid-19 Vaccine.’ MFDS stated the submitted quality, non-clinical, clinical and Good Manufacturing Practice (GMP) data would be closely reviewed, and it would decide on the approval based on the COVID-19 safety and efficacy review by the Advisory Panel, Central Pharmaceutical Affairs Deliberation Committee and Final Inspection Committee. Janssen has already gone through preliminary review on the vaccine based on the non-clinical data and quality assurance evidence from Dec. 22, 2020. Meanwhile, the U.S. Food and Drug Administration (FDA) announced its Vaccines and Related Biological Products Advisory Committee (VRBPAC) has granted an emergency use authorization (EUA) for Janssen COVID-19 vaccine on Feb. 26 as a third vaccine to be authorized in the U.S.
- Policy
- How GC Pharma obtained the copyright of Moderna vaccine?
- by Lee, Jeong-Hwan Mar 04, 2021 06:10am
- Moderna signed distribution agreement with GC Pharma for its COVID-19 vaccine in Korea, and GC Pharma has the final copyright. On the 26th, GC Pharma was a successful bidder as a domestic pharmaceutical company in charge of licensing and distribution of Moderna’s mRNA-1273 vaccine. GC Pharma's CEO Eun-cheol Huh bids for ₩34.2 billion. GC Pharma has completed the procedure for approval by the MFDS and national lot release for the domestic market approval of Moderna vaccine in the future. And it will be in charge of supplying 40 million doses of government vaccines. GC Pharma is expected to distribute vaccines sold to the general market in addition to the government's 20 million vaccines through an additional contract with Moderna in the future. GC Pharma is the only domestic pharmaceutical company to win the domestic copyright of Moderna vaccine. How did GC Pharma get the domestic copyright for Moderna vaccine? According to the pharmaceutical and bio-industry, Moderna carefully analyzed the expertise of the MFDS for the distribution of COVID-19 vaccine in Korea, the understanding of the pharmaceutical and bio-industry fields such as mRNA vaccines, and the sales force for the distribution of vaccines. It was evaluated and reviewed the vaccine expertise of domestic pharmaceutical and bio companies including GC Pharma. It is known that GC Pharma has secured Moderna's licensing and distribution rights with its strengths by strongly appealing to the understanding of biologics licensing and maintaining and strengthening the vaccine pipeline since its inception. In particular, there is an evaluation that the reliability of the vaccine field that GC Pharma has built up due to the involvement of a number of government ministries such as Cheongwadae, the MOHW, the MFDS, and the KCDA has influenced the successful bid. The pharmaceutical industry predicts that Moderna will struggle with whether to import the finished product for domestic distribution and consignment production after approval for COVID-19 vaccine. In the case of consignment production of mRNA vaccines in Korea, the transfer of the original technology is inevitable, and there are not many pharmaceutical companies that have sufficiently secured the domestic mRNA production process, so these factors are expected to determine whether Moderna's finished vaccine imports and consignment production. An industry insider said, "Moderna does not mention anything about consignment production while pursuing licensing and domestic distribution contracts. Because the domestic vaccination schedule is not close enough, Moderna may not think about consignment production itself."
- InterView
- There is still an unmet demand for antiviral drugs
- by Eo, Yun-Ho Mar 03, 2021 06:26am
- CEO Seung-Woo LeeCurrently, vaccines developed by AstraZeneca, Pfizer and others are a hot issue, but in the first half of last year, Remdesivir was ranked first as a keyword related to COVID-19. Gilead, the developer of Veklury (Remdesivir), is a pharmaceutical company specializing in antiviral drugs. It is leading and has pipelines in a variety of fields, from hepatitis B and C to HIV. Last year, the company is expanding its anticancer treatment portfolio by acquiring Forty Seven, an anticancer drug company, and Immunomedics, an ADC development company. This is the story of Lee Seung-woo ( 64 years old), CEO of Gilead, who has both'the original good and the latest trend' like killing two birds with one stone, celebrating the 10th anniversary of the foundation of the Korean subsidiary. -You've been very busy in 2020 with Remdesivir? Last year, as an antivirus company, I felt a great sense of responsibility and mission from the beginning of COVID-19. Upon receiving the news of the 'Wuhan virus' in January of last year, a clinical trial of Remdesivir in the headquarters' Asset Library began. At the same time, we developed and expanded production in a short time, taking all risks. Researchers have participated in various clinical studies in Korea, and many researchers around the world have contributed to the derivation of meaningful research results. Based on these results, we have obtained approvals in various countries such as the United States and Korea, and in Korea, we are grateful that the MFDS, the KCDA, and other related ministries and medical staff have worked together to ensure smooth supply. -Are there any problems with supply of Remdesivir? It is still supplying through consultation with the KCDA. The situation has improved a lot since last October, but treatment is still important because the vaccine supply is not smooth yet. Although there are difficulties due to the continuing pandemic, we will do our best to cooperate with the KCDA to provide a smooth supply. -Remdesivir also had price issues In the early days, it was supplied free of charge to many countries, including Korea. In the process of commercialization, fast supply was more important than anything else. Accordingly, advanced countries, including Korea, are supplying them at the most reasonable price. During the period designated by the WHO as a pandemic, it has been supplied to developing countries such as India and 129 low-income countries according to two price policies, which are provided at a low price without a license fee. -Gilead is recognized as an antiviral company. It has powerful pipelines such as Viread, Sovaldi, Harvoni, and Truvada. However, diseases such as hepatitis B, hepatitis C, and HIV are now well managed The company believes that there is still unmet demand for the diseases mentioned. Viread improved the quality of life of hepatitis B patients and improved prognosis, but has not yet reached a cure. Gilead is not satisfied with the current treatment options, and is still undergoing clinical trials aiming to cure hepatitis B in many countries, including Korea. There are good treatments for HIV as well, but they are investing more in research and thinking more about ways to cure them like hepatitis C. It is also preparing to build a new pipeline. In addition, in the anticancer field, it is carrying out various R&D through mergers and acquisitions of several specialized companies. In addition, they are continuously working on research and development in areas such as inflammatory drugs and NASH. -Is there an anticancer drug pipeline that is imminent for commercialization? Yescarta, which was introduced through the acquisition of Kite Pharma, is showing excellent treatment results based on good data. This treatment is also under consideration for introduction to Korea. Trodelvy, a breast cancer treatment acquired through the acquisition of Immunomedics, is also a breakthrough treatment, and Magrolimab, obtained through Forty Seven last year, is still in the clinical stage, but has high potential in the field of blood cancer. -It seems that Gilead's drugs have not been postponed in registration of insurance benefits in Korea. When communicating with the global headquarters, are there any cases of crisis such as Korea Passing? Any company has a global pricing policy, and I think it is important to create a balance for accessibility. So far, drugs for hepatitis B, hepatitis C, and HIV have been well listed according to the domestic price policy. And we will try to coordinate the products that will come in the future so that there is no disruption in the supply. There are many good things about the domestic medical system, but there are also some difficulties in setting prices for new drugs. I think the industry and the government should work together.
