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- 2026-04-14 03:36:12
- Company
- CKD-701 demonstrated the validity in phase III trials
- by Chon, Seung-Hyun Jul 14, 2021 06:03am
- Chong Kun Dang announced on the 12th that Lucentis’ biosimilar CKD-701 proved equivalent to the original drug in Phase 3 trials. Chong Kun Dang will apply to the MFDS for CKD-701. Lucentis, sold by Roche and Novatis, is a drug used to treat eye diseases such as wet age-related macular degeneration (AMD) and diabetic retinopathy. Lucentis' annual global sales amount to about ₩4.6 trillion. From September 2018 to March this year, Chong Kun Dang conducted clinical trials for the first purpose of proving the validity of CKD-701 and Lucentis in patients with wet macular degeneration. Clinical trials showed that the proportion of patients with vision loss of less than 15 characters at BCVA at 3 months' time compared to basal was 97.95% in the CKD-701 group, which met the equivalence range compared to the Lucentis administration group (98.62%). As a secondary validation variable, CKD-701 was found to have similar treatment effects to Lucentis in terms of maximum calibration vision at the time of 3, 6, and 12 months, the ratio of patients with 15 or more letters of improvement in vision at the maximum calibration. Most of the adverse reactions reported during CKD-701 administration were reported in previous studies of Lucentis with similar tendency to manifest. No significant differences between administered groups have been identified in the rate of adverse reactions. "CKD-701 has proven its treatment effect to be equivalent to Lucentis in wet macular degeneration patients," Chong Kun-dang said. "We expect that macular degeneration patients will be able to provide diversity in treatment drug choices and expand treatment opportunities."
- Company
- Omipalisib is 200 times more effective than Remdesivir
- by Kim, Jin-Gu Jul 13, 2021 11:09pm
- Attention is focusing on Omipalisib, which was newly discovered by Korean researchers as a candidate material for COVID-19. In particular, as laboratory studies show that candidate substance is more than 200 times more effective than Veklury (Remdesivir), some are optimistic that it will be a "game changer" for the corona crisis. Some pharmaceutical industries are wary of expanding interpretation of anti-virus effects. Laboratory findings do not indicate actual clinical efficacy. #Sb◆Ompalisib, new anti-cancer drug candidate for PI3K suppression mechanism KAIST and Institut Pasteur Korea announced on the 8th that they have discovered Omipalisib as a candidate material for COVID-19 treatment. The researchers explained that they explored 6,218 types of substances with a virtual drug library, and confirmed the effects of the antiviruses in seven of them. Among them, Omipalisib emphasized that "the anti-virus activity was more than 200 times higher than that of Remdesivir." Omipalisib is a drug that GSK is developing as an anti-cancer drug or an idiopathic treatment for pulmonary fibrosis. Phase I clinical trials are currently under way. It is a mechanism that inhibits "PI3K" (phosphatidylositol-3-kinase), known as cancer-causing substance. PI3K inhibitors are a new line of anti-cancer drugs that have recently attracted worldwide attention. Many global pharmaceutical companies are actively developing it. Gilead Science's Zydelig(Idelalisib), Novartis' Piqray(Alpelisib), and Bayer's Aliqopa(Copanlisib) were licensed. In addition, research and development are also in full swing in U.S. bio-ventures such as Verastem Oncology and TG Therapeutics ◆↑Interested in Nafamostat last year, failed to validate in actual clinical trials However, pharmaceutical industries are wary that laboratory results and actual effectiveness may be different. Even if clinical trials are conducted through Drug Repositioning, there is a high possibility that expected results will not come out. Institut Pasteur Korea, for example, said in May last year that it found 600 times more powerful drugs than Remdesivir through its own experiments. ▲Nafabelltan At that time, Institut Pasteur Korea explained that it conducted experiments on human lung cells by selecting drugs that could help treat COVID-19 among drugs approved by the U.S. Food and Drug Administration (FDA). The company was able to find and experiment with candidate materials in a similar way as this time. The substance that came out of this process was Nafamostat. At that time, Remdesivir was the only treatment for COVID-19, so interest in the drug, which was previously approved as a pancreatitis treatment, soared. Finally, Chong Kun-dang entered the clinical trial of Nafamostat (Nafabelltan). Chong Kun Dang conducted clinical phase II of 104 patients with severe corona in Russia. Based on this, the company filed for Conditional Marketing Authorization with the MFDS in April. However, receiving Conditional Marketing Authorization failed. Remdesivir is still the only drug developed and licensed treatment for corona through Drug Repositioning. It is a drug previously developed by Gilliard Science as an Ebola treatment.
- Company
- Dong-A ST has received the right of DA-4501 from AbbVie
- by An, Kyung-Jin Jul 13, 2021 11:08pm
- View of Dong-A ST headquarters buildingDong-A ST has received the right of MerTK inhibitor from AbbVie for the first time in five years. Dong-A ST has terminated two large technology export contracts with global pharmaceutical companies. Dong-A ST plans to review new possibilities based on joint research data that has been conducted for the past five years. Starting with biosimilar for Stelara, it is seeking new growth engines by combining its own pipeline R&D and active open innovation strategies such as diabetes and dementia. ◆AbbVie, returning rights to new drugs in five years "Not meeting internal standards" Dong-A ST announced on the 9th that it had been notified by AbbVie that it had returned the rights of the MerTK inhibitor DA-4501. The official reason for the return of rights is lack of validity. Dong-A ST explained, "We conducted a joint study on preclinical candidate materials after exporting the technology before deriving candidate materials, but the right was returned because we could not find any preclinical candidate materials satisfying AbbVie's internal standards." Dong-A ST signed a contract with AbbVie Biotechnology, a subsidiary of AbbVie, in December 2016 to transfer the global rights of MerTK inhibitor DA-4501 (excluding Korea). It is a contract worth up to $525 million, including development, approval, and milestones, in addition to $40 million in down payment that has no obligation to return. Dong-A ST received $40 million in down payment in January of the following year and recognized it in installments for 36 months. MerTK inhibitors are new mechanisms that inhibit MerTyrosine Kinase (MERTK) protein activity to help boost the immune system. Even though it was in the process of searching for candidate materials at the time, the total contract size was not only large, but also the pre-contract fee accounted for nearly 8% of the total conditions were unconventional. Industries were interested in whether pre-clinical testing would be possible, but the contract was terminated after AbbVie decided to return the rights. However, even after the termination of the contract, the down payment does not need to be refunded. ◆Donga ST, the contract for global technology export has been terminated twice. A bad relationship with Allergan This is not the first time that Dong-A ST has terminated its technology export contract with a global pharmaceutical company. Dong-A ST also received the right to develop Evogliptin, a non-alcoholic hepatitis drug, in November 2017. The acquisition of Tobira Therapheutics, the first contractor, by Allergan changed the R&D strategy. Dong-A ST's contract amount with Tobira Therapheutics in April 2016 was up to $61.5 million, including a down payment that had no obligation to return. At that time, Tobira expressed its willingness to target NASH adaptation by developing its own composites and Cenicriviroc, which was being developed in addition to Dong-A ST's single ingredient in Evogliptin, a diabetes treatment. However, Allergan is said to have decided to return the rights of Evogliptin developed by Tobira Therapheutics because it was slower than the NASH treatment developed jointly with Novartis. At the time, a Dong-A ST official said, "The decision is based on Allergan's own research and development strategy, and it has nothing to do with effectiveness or development as a treatment for Evogliptin." The recent termination of two major contracts involved Allergan. AbbVie, which notified the termination of the contract, spent a total of ₩63 billion to acquire Allergan in 2019. It is planning to make new inroads into medical aesthetic businesses such as botulinium through acquisition of Allergan. AbbVie launched a subsidiary dedicated to Allergan's cosmetic products, including Botox and filler, the following year.
- Policy
- Benefit plan of Keytruda & Tecentriq will be discussed
- by Moon, sung-ho Jul 13, 2021 11:08pm
- Keytruda (Pembrolizumab) and Tecentriq (Atezolizumab) from global pharmaceutical companies are challenging to expand their benefits as primary drugs for lung cancer. According to the pharmaceutical industry and the medical community on the 10th, the HIRA's Cancer Drugs Benefit Apparel Committee will discuss ways to expand the benefits of the two drugs at its fifth meeting in 2021. In the case of MSD Korea's Keytruda, five benefit expansion proposals were proposed at the fourth Cancer Drugs Benefit Appraisal Committee meeting in May, and two of them were passed. Benefit needs for urinary epithelial cancer secondary therapy and Hodgkin's lymphoma non-responsive secondary and recurrent fourth or higher therapy were acknowledged. Three strongly desired primary care treatments for lung cancer have been put on hold ▲ Primary treatment of progressive non-small cell lung cancer positive to PD-L1 and free from EGFR or ALK mutations (Solo therapy)▲ Primary treatment of metastatic non-flat cell lung cancer without EGFR or ALK mutation (Combination of Pmetrexed and Platinum)▲Transferable squamous non-small cell lung cancer primary treatment (Parclitaxel/Carboplatin combination). The government has put on hold all the expansion of benefits to primary treatments, which require a lot of funding for health insurance, and analysts say it did not recognize the financial sharing plan proposed by MSD. The Cancer Drugs Benefit Appraisal Committee will discuss expanding the benefit of rival drug Roche Korea's Tecentriq at its fifth meeting scheduled to take place on the 14th. According to a senior official at the Cancer Drugs Benefit Appraisal Committee, it was originally planned to be discussed with Tecentriq in this order regardless of Keytruda's introduction to the conference. In a related development, Roche Korea is said to have applied for Tecentriq (Atezolizumab)'s first solo treatment for non-small cell lung cancer shortly after obtaining a certificate of adaptation in April. Not only the pharmaceutical industry but also the medical community are watching this with interest. The ministry also suggested Keytruda be discussed at the Cancer Drugs Benefit Appraisal Committee in July. According to the report, members of the Cancer Drugs Benefit Appraisal Committee believe that Tecentriq's initial treatment financial sharing plan in the past would be the basis for benefit expansion. Health authorities estimate that refunds of initial treatments are equivalent to 25 to 30% of the effect of a reduction in drug prices. It seems impossible to increase benefit unless the pharmaceutical company presents another corresponding sharing plan. "An analysis of Roche's initial financial sharing plan has shown tremendous effect in terms of health insurance finance," said a member of the Cancer Drugs Benefit Appraisal Committee. "Based on clinical trials, the application of three of the nine cycles as a way for pharmaceutical companies to share, actually has a significant cost-cutting effect," he explained. "Moreover, real world data is difficult to produce the efficacy and effectiveness of drugs equivalent to clinical trials. "Like clinical trials, pharmaceutical companies pay for three cycles for drugs that only work for seven weeks, not nine." "The latecomers should come up with corresponding measures, given that the starter accepted the benefit at the expense of considerable damage," he stressed. Another concern is whether combination therapy of Keytruda and Tecentriq will be passed. This is due to Avastin (Bevacizumab), which also affects the patent expiration. The Cancer Drugs Benefit Appraisal Committee is also interested in which of Keytruda's and Tecentriq's primary use of lung cancer can be more effective. "No matter how much Tecentriq lowers its price, Avastin makes it difficult to match Keytruda's combination therapy," said a member of the Cancer Drugs Benefit Apparel Committee. "In the end, we have no choice but to determine which of the two combination therapies can contribute to insurance."
- Company
- Venclexta combo in the spotlight as a new lymphoma Tx option
- by Jul 13, 2021 05:59am
- The treatment landscape for elderly patients with acute myeloid leukemia (AML), which has a 5-year relative survival rate of less than 10%, is changing with the introduction of a new drug that addresses the unmet needs and improves survival rate. AML is one of the most common types of leukemia in adults with a high unmet need in patients and HCPs alike. As one of the more aggressive types of leukemia in adults, around 140,000 new cases occur globally every year, of which around 100,000 cases end in deaths. With the same treatment being used in AML for over 40 years, not much improvement has been made in the overall survival (OS) until recently. The 5-year survival rate was at a mere 29% and was even lower for older patients. According to a study by the National Cancer Center, the relative survival rate of AML patients was very low in elderly patients - less than 10% for patients over the age of 65 and 0% for those 80 years and older. Considering that the average age of AML patients is 67 and that one-third of the patients are 75 years old, the urgency and need for an appropriate treatment was high in this respect. Also, there had been a high demand for treatment with improved efficacy and lower toxicity that can be used in older patients. Experts advised that intensive chemotherapy, the main treatment used for AML, is unsuitable in elderly patients who are likely to have comorbidities and are not generally in good condition. Venclexta combination therapy provides new opportunities for elderly AML patients The most important goal in treating AML patients is improving the overall survival period. With active R&D being conducted in the field recently, the treatment environment has improved to allow more options from combination therapy to targeted therapies to be provided according to each patient’s condition. A new treatment option is also available for the elderly patients who were not considered candidates for intensive chemotherapy. Among the new drugs that were recently introduced to the field, Abbvie’s ‘Venclexta (venetoclax)’ in combination with azacytidine, or decitabine, or low-dose cytarabine is being considered the most appropriate therapy for patients who have difficulty receiving intensive chemotherapy. Venclexta, which was approved by the Ministry of Food and Drug Safety in January, may be used in combination with azacytidine or decitabine in ‘newly-diagnosed AML adult patients aged 75 or more, or who have comorbidities that preclude the use of intensive induction chemotherapy.’ Results of the Phase III VIALE-A trial that evaluated the safety and efficacy of the Venclexta and azacitidine combination showed that the combination’s median OS was 14.7 months, 5 months longer than the 9.6 months found in the control group (placebo+ azacitidine combination). The Phase I M14-35 trial that evaluated the safety and efficacy of the Venclexta in combination with decitabine also showed that the median OS was 16.2 months. Also, the median time to first complete remission(CR) or CR with incomplete count recovery (Cri) was shorter for the Venclexta and azacitidine combination (1.3 months) than the control group (2.3 months), showing that the responses to the combination therapy occurred quickly in elderly patients as well. Also, over 60% of the patients achieved transfusion independence, raising expectations that the treatment could reduce the burden of treatment in elderly patients. Joon Ho Jang, Professor of Hematology and Oncology at the Samsung Medical Center said, “It is encouraging that a treatment that dramatically improved overall survival was introduced in the ALK treatment environment, a field where no new treatment option had been available for a long period of time. The new treatment option could provide opportunities for the difficult-to-treat patient population, such as those who are older or have comorbidities. We expect an improvement in the overall patients’ quality of life as the Venclexta+hypomethylating agent combination is effective not only in improving OS but has a short period to CR and can lower transfusion dependence. Professor Jang continued, “I hope that accessibility to these new treatment options is improved as soon as possible in consideration of the poor physical and economic conditions of patients suffering from AML in Korea."
- Company
- “Reimburse Vyndamax, the only hope for amyloidosis”
- by Eo, Yun-Ho Jul 13, 2021 05:59am
- The hATTR Patients Association came forward to call for the reimbursement approval of ‘Vyndamax’ The patient group recently delivered a ‘Statement for the insurance benefit of Vyndamax' to the Ministry of Health and Welfare and the National Health Insurance Services. The move arose among patients with the reimbursement discussions being delayed on Vyndamax (Tafamidis 61mg), which is virtually the only drug approved for the treatment of ATTR-CM (ATTR amyloidosis with cardiomyopathy). After failing to receive the essential drug designation for Vyndamzx, Pfizer, its developer, conducted a PE evaluation on its drug and applied for reimbursement again in April this year. The company hopes to receive reimbursement benefits through the Risk Sharing Agreement (RSA) scheme. However, no solid discussion or progress has been made for the drug yet. And the patients are the ones most pressed for time. ATTR-CM is a life-threatening condition with a poor treatment outcome due to a lack of treatment and is often mistaken for simple heart failure. If not treated properly, patients with ATTR-CM have a survival period of only 2 to 3.5 years. In the Phase III ATTR-ACT study, Vyndamax had reduced cardiovascular events in ATTR-CM patients and improved their functional athletic ability in the six-minute walk test, demonstrating the drug's benefit in the area with a dire need. Based on such findings, healthcare professionals in Korea are also stressing the need to prescribe Vyndamax. In the statement, the patient group said, “We ask the government to show determination for improving the treatment environment for ATTR-CM. Please help us and establish an environment where we can devote ourselves to treatment." In the ATTR-ACT study, 441 patients were randomly assigned in a 2:1:2 ratio to receive the tafamidis 80 mg dose, tafamidis 20 mg dose, or placebo, respectively. The primary endpoint of the study was the hierarchical combination of all-cause mortality and frequency of cardiovascular-related hospitalizations. The key secondary endpoints were the change from baseline to month 30 for the 6-minute walk test and the score on the Kansas City Cardiomyopathy Questionnaire–Overall Summary (KCCQ-OS), in which higher scores indicate better health status. Study results showed that the tafamidis demonstrated a statistically significant reduction in all-cause mortality and frequency of cardiovascular-related hospitalizations compared to placebo.
- InterView
- MSD "Will care for employees and new drug reimbursement"
- by Eo, Yun-Ho Jul 13, 2021 12:59am
- Keven Peters, Managing Director at MSD KoreaApart from its positives and negatives, MSD (known as Merck in the U.S.) is a company apt at ‘adaptation.’ MSD, which first cut its appearance in circulatory, respiratory drugs, and vaccines, became a leader in the field of diabetes in the 2000s with the introduction of its Januvia(sitagliptin), a DPP-4 inhibitor. In 2010, MSD became a sensation with the release of its PD-1 inhibitor ‘Keytruda(pembrolizumab),’ marking the start of the era of cancer immunotherapies. MSD’s forward-looking eye that allowed for the launch and success of various first-in-class drugs regardless of the disease area, is an undeniable strength of MSD. However, MSD had also been in the throes of change from the adaptation process. Last year, the company had officially announced the completion of its spin-off of Organon. In the process of the spinoff, MSD suffered considerable labor-management conflict. Also, MSD is in a 3-year back and forth with the authorities regarding the reimbursement expansion of its lead product Keytruda to first-line treatment in lung cancer. Amid such change, MSD Korea had welcomed a new head to its office in November last year. Keven Peters, the new Managing Director at MSD Korea, who has come to head the Korean subsidiary after serving in the Thailand subsidiary, had jumped in to resolve the pending issues, signing a collective agreement with the union and holding meetings with the government to allow for the reimbursement of Keytruda. Dailypharm met with the new Managing Director Kevin Peters to hear about his seven months in office. -You have been very busy since you took office. Let’s first discuss the labor-management conflict issue. What efforts have you made to resolve the conflict that arose in the spinoff process? As you know, we have signed the 1st collective agreement in January. I am proud that we were able to reach a mutual agreement after close discussions with the labor union. Also, I plan to visit our 4 local offices in Daegu, Gwangju, Daejeon, and Busan to communicate with the employees there starting early July. I will be sharing the company’s stories there and will hold an ear out to what our local employees have to say on each matter. Also, I plan to humbly take the advice that they may have to offer. My top priority is to have employees take an interest in our company and engage them in company activities. I am doing my best to listen to what all our stakeholders have to say. -You should be quite well-read on Korea’s drug pricing policy due to the situation with Keytruda. What do you think about Korea’s policy? From my 7 months of experience here, I felt that the HCPs and the government in Korea have a strong will to reimburse drugs. Of course, there’s the wish that reimbursements could be discussed more quickly. As you know, we are in the process of discussing increasing the accessibility of Keytruda. With lung cancer patients in 52 countries around the globe already using Keytruda as first-line therapy, I hope that our Korean patients can also have improved access to the drug as soon as possible. Increasing accessibility of Keytruda is an issue for consideration for all governments around the world. I think it is important for the key stakeholders including the government, companies, and HCPs to cooperate and collaborate to find a better way to increase the accessibility of the drug. -It seems that you have some regrets regarding the ‘quickness’ of the reimbursement approval process in Korea. In fact, reimbursement discussions for Keytruda first-line have been ongoing for over 3 years now. Efforts both ways, not only the government but the company’s efforts, are also required for a successful resolution of the issue. And as you know, there have been many arguments over the inadequacy of the cost-sharing plan that was proposed by the company. What I can promise now is that MSD will continue to cooperate with the government and healthcare officials to ensure that our patients can receive the optimal treatment. The company has submitted a financial sharing plan to the Review Committee for Cancer Diseases that proposes an unprecedented level of cost-sharing by the company, based on which we hope to see progress in Keytruda’s reimbursement expansion within a few weeks. -From what I know, the global investment in Keytruda is nearly 15 trillion won. Domestic investment (15 billion won) seems to be small in comparison to the global amount invested. MSD Korea is ranked no.1 in terms of R&D investment size in the MSD Asia-Pacific region. Our number of new clinical trials approved in Korea over the past four years was at a leading level among multinational companies, and the amount invested in R&D last year increased by 66% compared to the previous year. Quality data and infrastructure are key considerations used for making investment decisions in rclinical research. Korea owns excellent resources in this regard. We are continuously looking for institutions to collaborate with in Korea, and plan to further expand our collaboration in the future. In particular, an unprecedented number of clinical trials are underway in the field of oncology. There are 1,400 clinical trials in the world related to Keytruda, of which more than 900 are combination therapy studies. -What other products do MSD Korea plan to introduce in Korea? I cannot share specificities regarding releases of drugs before their approval, but we are preparing to introduce a chronic cough treatment, HIV treatment, antibiotic, and pneumococcal vaccine among others. Also, a Phase III trial is ongoing for our oral antiviral ‘molnupiravir’ that is expected to contribute to bringing an end to the COVID-19 pandemic. Also in the mid-to-long term, we own an extensive portfolio ranging from PARP inhibitors, VEGF TKIs, HER2 TKIs, antibody-drug conjugates (ADCs), to antibiotics.
- Company
- Takeda's innovation in Korea
- by Eo, Yun-Ho Jul 12, 2021 06:20pm
- Moon Hee-seok, CEO of Takeda Korea Takeda Korea, which sold off OTC division & DM division, which was the company's symbol. On the occasion of the 10th anniversary of the corporation's launch, constraints have once again confirmed their commitment to pursuing innovation. Marking the 240th anniversary of Takeda Pharmaceutical's headquarters and Korea Takeda's 10th Anniversary, 'Takeda has achieved innovative growth for patients,' it held an online press conference. At this press conference, Take Korea is in line with four key treatment areas: anti-cancer, gastrointestinal disease, nervous system disease, and rare diseases.The general managers of the four major pharmaceutical businesses announced major portfolios and core strategies of each business unit. Takeda Pharmaceutical sold its DM division and OTC division to Celltrion, a South Korean company, last year. The company's Actos is a representative TZD-based drug that survived the Avandia crisis, and Whituben and Albothyl are brand OTCs that everyone knows. Takeda Pharmaceutical has prepared in advance for this change. Takeda conducted four mergers and acquisitions, including Millenium Pharmaceutical in 2008, Nycomed in 2012, ARIAD Pharmaceuticals in 2017, and Shire in 2018. Through this process, it has been strengthening major pipelines in areas such as anticancer drugs, rare diseases, and gastrointestinal diseases. It quickly responded to rapidly changing market conditions. At the press conference, Takeda announced that she would focus on the specialty care sector in line with her global strategy, signaling a more innovative drug launch.It presented a vision for the future of pharmaceuticals. Kim Jung-hun, the first speaker, introduced the "3P (Patient, People, Product)" strategy under the title "Oncology Division's 3P Strategy for Domestic Cancer Patients." The oncology division introduced solid cancer treatments Alunbrig(Brigatinib) and Zejula(Niraparib) as notable products, saying they are generating various results by prioritizing patients first. Under the theme of "Focus on Inflammatory Bowel Diseases and Fire Extinguisher Division," Kim Tae-hoon then introduced the major portfolios of the division, Kynteles(Vedolizumab) and Mezavant (Mesalazine), and he expressed his ambition to continue activities to raise awareness of the disease in the domestic market, where competition is intensifying, and to become a company specializing in treating inflammatory bowel diseases. Under the title of "Korea's Rare Genetic Disease Treatment Partnership, Genetic Disease Division," Ji Chang-deok introduced Fabri's disease treatment drugs "Replagal (Agalsidase Alfa)" and Gaucher's disease treatment "Vpriv (Velaglucerase Alfa)" to improve treatment environment in Korea. Finally, General Manager Kim Na-kyung introduced hemophilia treatments such as Adavate(Blood Coagulation Factor Ⅷ) & Adynovate(Rurioctocog Alfa Pegol) under the theme of "Pioneer in improving the domestic hemophilia treatment environment, Hemophilia treatment division." Moon Hee-seok, CEO of Takeda, said, "Takeda for the past 240 years has worked on creating an environment that can change patients' lives as treatment partners around the world with a series of passionate challenges and dedication to patients. The company, which marks the 10th anniversary of its launch in Korea this year, will once again move forward, preparing for another 10 years through patient-centered realization and innovative treatments." Takeda celebrated its 240th anniversary on June 11th. Pharmaceuticals entered the top 10 multinational pharmaceutical companies in terms of total sales in 2019 and has become a leading global bio pharmaceutical company through intensive strategies and value-based research and development for specialty care.
- Company
- Byfavo can be prescribed in general hospitals
- by Eo, Yun-Ho Jul 12, 2021 06:19pm
- The anesthetic drug Byfavo can be prescribed at a general hospital. According to related industries, Hana Pharm's Byfavo (Remimazolam Besylate) passed DC of Big 5 general hospitals, including Seoul National University Hospital and Asan Medical Center, and will also be able to be prescribed it at major advanced general hospitals this month. Byfavo is a new anesthetic drug released more than 30 years after the approval of the general anesthetic Propofol. Launched in March, Byfavo secured manufacturing rights and exclusive sales rights from German company Paion in 2013. It has completed phase 3 of clinical trials for 198 subjects that will carry out general anesthesia in South Korea since 2018. The main indication is the induction and maintenance of general anesthesia in adults. Byfavo is a anesthetic drug that does not cause pain, and has the pharmacological advantages of conventional general anesthesia such as Propofol and Midazolam. Hana Pharm's the new Hagil plant is under construction, and expected to operate in 2023, equipped with German-made freeze-drying facilities and designed to supply Byfavo to advanced markets. The company acquired additional rights from six Southeast Asian countries to Byfavo from the original developer Germany Paion, and completed internal work to receive permission documents from these countries. Hana Pharm CEO Lee Yoon-ha said, "We are doing our best to secure supply rights in Korea and Southeast Asia, as well as in advanced markets in the future." "We are implementing strategies to enter markets by countries with a focus on partnership structure that can be supplied with expensive finished products as mid- to long-term tasks."
- Policy
- Evrenzo has been approved in Korea
- by Lee, Tak-Sun Jul 12, 2021 06:11pm
- A new oral drug that can treat anemia, one of the complications of patients with chronic kidney disease, has been approved in Korea. Until now, the standard therapy for treating the disease has been administered with a red blood cell production stimulating injection called EPO (Erythropoietin) or ESA (Erythropoiesis stimulating agent), and attention is being paid to whether a new oral drug with high convenience will replace ESA. The MFDS approved AstraZeneca Korea's (Roxadustat) 5 items on the 9th. This drug is used to treat syndrome anemia in patients with chronic nephropathy. In particular, patients who are or are not on dialysis can also be used. It can also replace the ESA injections that have been used. People with chronic nephropoientin develop anemia due to fewer kidney-generated Erythropoientin. This is because hematopoietic hormones are involved in the process of making red blood cells in the bone marrow. The hematopoietic hormone preparation made by recombination technology is ESA. The first generation of ESA required injections every two to three days, but the latest ESA has been improved to allow injections once a month. One of the most popular injections is Roche's Mircera. Mircera is a blockbuster drug that sold ₩18.8 billion (IQVIA) in South Korea last year. Other ESAs are also being used in addition to Mircera. Since oral oral medicine is more convenient to take than injections, attention is being paid to whether Evrenzo, which is approved this time, will replace existing ESA drugs. Roxadustat has a mechanism to activate hypoxia-inducible factors (HIFs) that regulate gene expression by engaging in red blood cell formation. By reversibly inhibiting HIF-PH, which targets HIFs and decomposes them under normal oxygen conditions, Roxadustat induces a response similar to the body's natural response to hypoxia. High efficacy was confirmed in three clinical trials (ANDES, OLYMPUS, and ALPS) and maintained the hemoglobin concentration in patients switching from conventional ESA therapy. Roxadustat, co-developed by AstraZeneca and FibroGen, was first approved in China in December 2018, and was also approved in Japan the following year. European EMA and the U.S. FDA are also likely to approve it soon. Attention is expected to continue to be paid to whether the existing market structure will be reorganized with the release of the drug.
