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- 2025-12-25 19:20:53
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- Medication imports in July are the largest ever
- by Kim, Jin-Gu Aug 17, 2021 05:53am
- Pharmaceutical exports of ₩700 billion have remained strong since last year. In July, domestic drug imports reached ₩1 trillion, the highest record ever. It is analyzed that it is a phenomenon caused by the full-fledged import of vaccines from Pfizer and Moderna. ◆Monthly import amount is close to ₩1 trillion, up 25% year-on-year According to the Korea Customs Service on the 16th, Korea's drug imports amounted to $819.58 million in July, the highest ever. Compared to $657.91 million in July last year, it rose by 25%. It is analyzed that the increase in COVID vaccines has affected. In fact, imports of vaccines (export and import codes 3002.20) in Korea averaged only $28.77 million (approximately ₩34 billion) last year, but this year, it started to increase rapidly. When Pfizer vaccine began to be imported in earnest, it increased to $49.82 million (about ₩58 billion) in March and ₩120 billion in June, when moderna vaccine began to be imported in earnest. In July, the figure nearly doubled to $211.62 million. Monthly drug imports, excluding vaccine imports, are maintaining around $600 million, similar to last year's. ◆₩710 billion in exports in July Drug exports amounted to $611.09 million, up 20% from July. Domestic pharmaceutical exports have been steadily rising since last year. The monthly average amount of drug exports last year was $574.46 million, which is more than $646.71 million until July this year. Like last year, biosimilar is leading drug exports. Celltrion recorded ₩789.5 billion in exports through Celltrion Healthcare in the first half of this year. Compared to ₩777.2 billion in the first half of last year, it increased by 2%. The sales of Remsima and Remsima SC totaled ₩337.3 billion, Truxima's sales of ₩273.3 billion, and Herzuma's sales of ₩102.2 billion. Although Samsung Biologics' sales performance in the first half of the year is not specific yet, considering that its provisional sales in the first half of the year increased 31% year-on-year, CMO exports centered on biosimilars are also expected to have increased significantly. In addition, domestic diagnostic kits were exported to $77.34 million in July, up 14% from a year earlier. Exports of diagnostic kits have been maintained at $70 million to $80 million this year. Exports of domestic botulinum toxin in July amounted to $16.67 million, which was not much different from the same period last year ($16.96 million).
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- Insulin·GLP-1 combo Xultophy lands in ‘Big 5’ hospitals
- by Eo, Yun-Ho Aug 17, 2021 05:52am
- The insulin and GLP-1 receptor agonist combination drug ‘Xultophy’ can now be prescribed in general hospitals. According to industry sources, Xultophy FlexTouch inj., a fixed-ration combination of Novo Nordisk Korea’s insulin Tresiba (insulin degludec)’ and the GLP receptor antagonist ‘Victoza (liraglutide injection),' has passed the drug review of drug committees (DCs) of 50 medical institutions in Korea, including the Big-5 general hospitals - Seoul National University Hospital (SNUH), Asan Medical Center (AMC), Seoul St. Mary’s Hospital, Samsung Medical Center (SMC), and Severance Hospital. The drug is reaching practice quickly after being listed for insurance benefits in May. Xultophy was approved in August 2019 in Korea for the treatment of patients with insufficiently controlled type 2 diabetes even after taking a combination of GLP-1 receptor agonist and oral hypoglycemic agents or basal insulin and oral hypoglycemic agents. The drug demonstrated superiority or noninferiority in reducing HbA1c levels, reduced incidence of hypoglycemic episodes, and better weight control in various DUAL clinical trials (DUAL I ~ IX) over control groups using the unique complementary mechanism of action brought from the insulin degludec and liraglutide combination. In particular, In the 26-week DUALⅤstudy that was conducted on 557 Type 2 diabetes patients with type 2 diabetes inadequately controlled by insulin glargine U100 and metformin, Xultophy showed superior HbA1c lowering effect over basal insulin, significant weight loss control effect, and a significant decrease in the incidence of hypoglycemia events with a lower dose of daily insulin. In the DUAL V study, the Xultophy-administered group showed a superior HbA1c level reduction effect of -1.81% over the insulin glargine U100-administered group’s -1.13%. Also, in weight change, the Xultophy arm's weight loss was -1.4kg compared to the +1.8kg of the insulin glargine U100 arm, amounting to a total of -3.2kg weight loss in total. Also, Xultophy reduced hypoglycemic episodes by 57% compared to the insulin glargine U100 arm. Xultophy is a pen-type injector that contains a combination of basal insulin and GLP-1 analogue that can be administered once daily at any time of the day, with or without meals. The maximum daily dose of Xultophy is 50 dose steps, and for those transferring from insulin therapy that includes a basal insulin component, the recommended starting dose of Xultophy is 16 dose steps, after which dose adjustment is required based on the individual’s fasting blood glucose level.
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- Reimb. to be expanded for PARP inhibitor Lynparza and Zejula
- by Eo, Yun-Ho Aug 13, 2021 05:58am
- The PARP inhibitors ‘Lynparza’ and ‘Zejula’ both crossed the last hurdle in extending their insurance benefits. According to industry sources, AstraZeneca Korea and Takeda Pharmaceuticals Korea have both completed drug pricing negotiations with the National Health Insurance Service (NHIS) to expand their PARP (poly ADP ribose polymerase) inhibitor Lynparza (olaparib) and Zejula (niraparib)’s indications to first-line maintenance treatment in ovarian cancer. Negotiation for the two drugs concluded at the same time because Lynparza’s negotiation period had been extended once. Upon passing the Ministry of Health and Welfare’s Health Insurance Policy Deliberative Committee meeting this month, the insurance benefit of the two drugs is expected to be extended without difficulty. The approvals are also expected to quickly translate into actual prescriptions. In April, AstraZeneca has already completed the landing procedures for the Lynparza tablet formulation that will be used for the new extended indication in the ‘Big 5’ general hospitals - Seoul National University Hospital (SNUH), Asan Medical Center (AMC), Seoul St. Mary’s Hospital, Samsung Medical Center (SMC), and Severance Hospital. Zejula’s formulation does not differ by indication, therefore, its prescription code has already been inserted in most medical institutions. However, the expanded reimbursement coverage will not benefit the BRCA-negative patients that account for 80-90% of the total ovarian cancer population. The Lynparza tablet had been approved as a maintenance treatment in the BRCA-positive patient population from the start. Zejula had applied for an ‘All-Comer’ indication regardless of the BRCA mutation status, however, HIRA’s Cancer Disease Deliberation Committee only approved the BRCA-positive indication. Faced with the high barrier to reimbursement, Takeda Pharmaceuticals decided to take the safe road and be first listed for the BRCA-positive indication. Lynparza and Zejula both own the BRCA-negative indication as a second-line or later maintenance therapy, however, reimbursement for these indications was not passed yet. Professor Jae-won Kim of the Obstetrics and Gynecology Department at SNUH said, “Using a drug as maintenance therapy in the first-line and second-line or higher-line is very different, and using the drug earlier will increase the rate of survival. Personally, I believe that coverage for the PARP inhibitors as maintenance treatment should be extended to benefit as many patients as possible in the first-line.” Zejula was first listed for insurance benefit at ₩76,400 under the Risk-sharing agreement (RSA) scheme, and was determined cost-effective over its substitute, Astrazeneca’s ‘Lynparza (olaparib).’ However, as Lynparza was listed through the PE exemption track, both were applied the RSA Expenditure cap type of reimbursement.
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- Alvogen is targeting patents for Roche's Avastin
- by Kim, Jin-Gu Aug 13, 2021 05:58am
- Avastin Alvogen Korea has started patenting Roche's blockbuster anti-cancer drug Avastin (Bevacizumab). Two types of Avastin biosimilar are already licensed in Korea. According to the pharmaceutical industry on the 12th, Alvogen Korea recently filed an invalid trial on Roche's two patents of Avastin. Roche is registering a total of four patents with Avastin, including one material patent and three use patents. Material patent registered in Korea has already expired in April 2018. Two out of three patents are related to ovarian cancer treatment, and the other one is related to combined therapy. There are two patents related to single therapy that Alvogen is targeting. If Alvogen overcomes this patent, it will be able to release its product in Korea. Two Avastin biosimilars have been licensed so far. Samsung Bioepis' Onbevezy and Pfizer's Jairabeve. Boryung was in charge of domestic sales of Onbevezy. Both companies are expected to officially release them in the second half of this year. More companies are competing in the global market. Mvasi, co-developed by Amgen and Allergan, is competing with Avastin. In addition, Boehringer Ingelheim, Biocon, Astrazeneca, Kyowa Kirin Korea, Celltrion, Prestige BioPharma, and others are developing biosimilars. Avastin is used for metastatic colon or rectal cancer, non-squamous, non-small cell lung cancer, metastatic breast cancer, glioblastoma (GBM), metastatic renal cell carcinoma. As of 2019, it recorded about ₩8.8 trillion in sales in the global market. It recorded ₩118 billion in sales in the domestic market last year.
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- SGLT-2 inhibitor Forxiga lands in Korea with CKD indication
- by Eo, Yun-Ho Aug 12, 2021 06:05am
- An SLGT-2 inhibitor is soon expected to be available for use in chronic kidney disease (CKD) patients in Korea. According to industry sources, the indication of AstraZeneca’s diabetes treatment ‘Forxiga(dapagliflozin)’ will be expanded to ‘the treatment of chronic kidney disease in patients at risk of progression with and without type-2 diabetes' within a few days. After receiving approval from the US FDA in April, the company had immediately begun the approval process in other major countries including Korea. In September, the company received EMA approval for the additional indication in September. With the indication, Forxiga can be used to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, onset of end-stage kidney disease (ESKD), or risk of cardiovascular (CV) or hospitalization for HF (hHF). The approval of Forxiga’s CKD indication is based on positive results from the DAPA-CKD Phase III trial. The FDA had granted Priority Review for Forxiga earlier this year. In the DAPA-CKD trial, Forxiga reduced the relative risk of worsening of renal function, onset of end-stage kidney disease (ESKD), or risk of cardiovascular (CV) or renal death by 39% compared to placebo in patients with CKD Stages 2-4 and elevated urinary albumin excretion (UAE) levels. The absolute risk reduction of Forxiga was 5.3% in the 2.4 year median study period. CKD is a progressive condition that affects around 700 million patients around the world. With only a limited amount of treatment options available for CKD patients at present, a new treatment option had been necessary in the field as CKD increases the incidence of cardiovascular events such as heart failure and the risk of premature deaths. Forxiga is currently used as a treatment for Type 2 diabetes and chronic kidney disease. Its competitor, Boehringer Ingelheim’s ‘Jardiance (empagliflozin)’ also received the fast-track designation in the first half of last year and the company is conducting the EMPA-KIDNEY trial to expand the drug's indication like Forxiga. Unlike Forxiga’s DAPA-CKD trial, Jardiance's EMPA-KIDNEY trial includes severe CKD patients.
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- Eybelis can be prescribed at general hospitals
- by Eo, Yun-Ho Aug 11, 2021 05:58am
- The new glaucoma treatment ‘Eybelis’ that has been released can now be prescribed at general hospitals in Korea. According to industry sources, Santen Pharmaceutical Korea’s selective EP2 receptor Eybelis Ophthalmic Solution (Omidenepag Isopropyl) has recently passed the review of drug committees (DC) in two of the ‘Big 5’ major hospitals in Korea - the Seoul National University Hospital and the Samsung Medical Center. Eybelis is a treatment for open-angle glaucoma and ocular hypertension that contains the active pharmaceutical ingredient omidenepag isopropyl, which has a non-prostaglandin structure that lowers intraocular pressure with a new mechanism of action. Omidenepag Isopropyl is a receptor agonist that selectively works on EP2, a type of prostanoid receptor. The omidenepag ingredient reduces intraocular pressure by binding to the EP2 receptor and improving drainage of uveoscleral and trabecular outflow. Eybelis has the benefit of not developing cosmetic side effects such as prostaglandin-associated periorbitopathy (PAP), which includes upper eyelid ptosis, hyperpigmentation of the skin, elongation of eyelashes, and changes in iris color that occur with the long-term use of FP receptor antagonists that are most commonly used as first-line treatment. Also, the company explained that in glaucoma patients that require long-term treatment, Eybelis has the advantage of providing a superior intraocular pressure-lowering effect while improving the development of cosmetic side effects compared to existing treatments with a convenient, once-daily administration as a monotherapy. Eybelis has been listed for insurance benefit in Korea at a price cap of ₩13,628 since February.
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- Changes after Pfizer and Moderna vaccines' full approval
- by Aug 11, 2021 05:58am
- Expectations are rising that COVID-19 vaccines of multinational pharmaceutical companies such as Pfizer-BioNTech and Moderna will receive full regulatory approval early next month. If the vaccines are formally approved, what changes will we see in the current landscape where people worldwide are already receiving vaccinations under the EUA? Pfizer and Moderna’s COVID-19 vaccines are the most widely used vaccines around the globe. Both have received the Emergency Use Authorization (EMA) from the US Food and Drug Administration (FDA) in December last year. Janssen’s vaccine also received the EUA approval in February this year. However, no COVID-19 vaccine has been formally approved after submitting a Biologic License Application (BLA) to the FDA. Among the three EUA-issued vaccines, Pfizer and Moderna have been taking steps for the full regulatory approval of their drugs since May and June, respectively. EUA is granted when no preventive therapies or treatments are currently available, and a product in development is known to be effective or has potential benefits that outweigh the known and potential risks. However, the EUA only remains effective during a public health emergency. In other words, when the government lifts the declaration of the COVID-19 pandemic, vaccines that are not fully approved cannot be used for vaccination. A company seeking a BLA for its product must demonstrate that the product is “safe, pure, and potent,” which generally means completing robust, well-controlled clinical trials. Unlike EUAs, the procedure requires extensive paperwork, which takes months to review. Unlike EUAs that only require a minimum of two months’ worth of follow-up data, the full approval requires at least six months of follow-up data. In addition, the regulatory authorities require more detailed CMC data in the manufacturing process and quality control in a BLA submission. Simply put, the full approval process with a BLA requires an average of ten times more data than the EUA submission. Nevertheless, perks do exist for receiving full regulatory approval. If one vaccine receives full approval, it can enjoy exclusivity. The EUA system is operated under the premise that there are no adequate or available vaccines, therefore, with a rollout of qualified, fully approved vaccines, the FDA will not be able to issue EUAs to latecomer vaccines. The fully approved vaccines can also be considered for off-label prescriptions. Physicians, under their own discretion, may choose to prescribe vaccines off-label to subjects that are not indicated under the EUA, such as adolescents under the age of 12. Also, the fully approved vaccines can be used regardless of the pandemic period, and if Pfizer and Moderna have a fully approved vaccine, the companies will have an easier time receiving approval for their booster shots that are in development. In particular, a full approval by the FDA may greatly influence approvals and reviews in other countries. Also, from the health authorities’ perspective, a fully approved vaccine can improve a nation’s vaccination rate, as the ‘full stamp of approval’ works as grounds for persuading some portion of the public that were reluctant in receiving vaccinations due to concerns over side effects. Also, vaccination cannot be mandated under EUA, but if a vaccine is fully approved, it will speed up mandating vaccines in companies, schools, and government agencies. For these reasons, the US FDA is speeding up its review process to fully approve the first COVID-19 vaccine in early September. The FDA is comprehensively reviewing the COVID-19 vaccines’ real-world data such as the efficacy, immune response, reduction over time, new infections in clinical trial participants, etc., as well as factory inspection data for the BLA. The authorities are also reviewing the use of booster shots on whom and when the booster shots are needed, and what vaccines may be used as booster shots. An official from the Korea Biotechnology Industry Organization explained, “The full approval may bring various ripple effects in terms of increasing the vaccination rate and market expansion. That is why pharmaceutical companies spend the additional cost and time to seek full approval and why the Biden administration supports BLA submissions."
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- Reimbursement for Kymriah will be deliberated by CDRC
- by Eo, Yun-Ho Aug 10, 2021 05:54am
- The discussions on listing the ultra-high-priced, one-shot treatment ‘Kymriah’ for health insurance benefits will begin. According to industry sources, Novartis Korea’s first-in-class CAR-T (chimeric antigen receptor-T) treatment will be put as an agenda for deliberation in September at Health Insurance Review and Assessment Service’s Cancer Disease Review Committee (CDRC) meeting. Kymriah, which was approved in March in Korea, used the ‘approval-benefit appraisal linkage system’ to promptly apply for insurance benefits. However, the agenda was not put up for deliberation by the Cancer Disease Review Committee last month, which gave rise to harsh criticism from the Korea Leukemia Patients Organization (KLPO) to the government and Novartis on the delay in reimbursement. Kymriah will be put as an agenda for deliberation at the next CDRC meeting, but what the results will be is difficult to predict. With a single shot of the drug costing 500 million won, whether the agreement can be reached smoothly between the government and the pharmaceutical company remains unclear. However, if Kymriah is listed for insurance benefits, the drug is expected to be quickly prescribed at hospitals. Among the ‘Big-5’ tertiary hospitals of Korea, Seoul National University Hospital (SNUH), Asan Medical Center (AMC), Seoul St. Mary’s Hospital, Samsung Medical Center (SMC), and Severance Hospital are in the process of acquiring the ‘human cell management business approval’ from the Ministry of Food and Drug Safety, and the Samsung Medical Center (SMC) already obtained approval. As such, hospitals have been rapidly preparing the environment to prescribe Kymriah. In the Seoul National University Hospital, Kymriah (tisagenlecleucel) passed the drug committee (DC) review in April, and the drug is also expected to land in Samsung Medical Center in May. Kymriah developer Novartis has allowed general hospitals to receive payment for the ancillary costs by establishing Kymriah centers in their institutions. SMC and SNUH will open their Kymriah centers in May, and other tertiary hospitals are expected to follow. To establish the center, hospitals are first required to receive a permit for the human cell management business under the newly implemented ‘Advance Regenerative Bio Act.’ CAR-T therapy takes a different approach in its method of treatment. Unlike conventional drugs that are produced as finished products, for CAR-T, the hospital first collects T cells from the patient's white blood cells, then freezes and sends them to a manufacturing facility. At the facility, the T cells are genetically engineered to express the chimeric antigen receptors (CARs) that allow the T cells to recognize tumor cells, cultivated, then sent back to the hospital. In other words, after the hospital sends the raw material (patient’s T cells) to the company, the company makes the finished ‘Kymriah’ product with the raw material and sends it back to the hospital. The hospital maximizes the effect of Kymriah by using lymphodepleting chemotherapy to reduce the white blood cell count in advance. After 4-5 weeks, the processes are all complete, and Kymriah is finally infused into the patient. “Relapsed/refractory ALL patients are very rare in Korea, however, these few young patients that are diagnosed every year are in the fight for their lives,” said Chuhl Joo Lyu, professor of pediatric Hematology-Oncology at Severance Hospital. “As in the cases seen overseas, the government, pharmaceutical company, and the medical community should work together to create an environment for these young patients to enable timely treatment with Kymriah.” Kymriah is the first CAR-T therapy and the most expensive drug in Korea up to date. The drug is indicated for adult patients with diffuse large B cell lymphoma (DLBCL) and young adult and pediatric patients with acute lymphoblastic leukemia (ALL). Both indications are for late-stage patients that are in relapse post-transplant or in second or later relapse after two or more lines of therapy.
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- Marken establishs a cGMP cold-chain center in Korea
- by Nho, Byung Chul Aug 10, 2021 05:54am
- Image of Marken’s cold-chain logistics center that will be established near the Incheon Airport in October this year A cGMP compliant cold-chain center for the distribution of pharmaceuticals that will soon be complete in Korea is receiving attention. According to industry sources, the global biopharmaceutical·clinical trial logistics company Marken and its parent company UPS have worked together to establish a 1,000-pyeong cold chain storage and distribution center in Korea. The center will be completed in October. The importance of the cold-chain system has emerged in the process of distributing COVID-19 mRNA vaccines. Marken’s establishment of the new distribution center near the Incheon Airport is expected to contribute to the establishment of an upgraded biopharmaceutical distribution standard in Korea. An official from Marken Korea said, “To respond quickly to the surge in demand for cold-chain storage and shipping of pharmaceuticals in Korea and abroad, the company had begun construction of a GMP-compliant pharmaceutical storage and distribution center in June, which will be complete in October this year.” The Marken Cold-chain Distribution Center will be around 3305 square meters (approximately 1000 pyeong) and be equipped with various facilities suited for storage of clinical drug products, medical devices, vaccines, and biologics that require temperature control at room temperature (+15 to +8°C) or refrigeration (+2 to +8°C), freezing (15 to -25°C), and cryogenic (-80°C) storage. In addition, a liquid nitrogen (LN2) storage unit will also be prepared for the exclusive storage of cell and gene therapies. Marken has a logistics network in 17 countries in the Asia-Pacific region. With the opening of the Incheon Airport logistics center, the company will have a total of 7 GMP cold-chain drug storage facilities, 4 liquid nitrogen filling locations, and 2 clinical kit production facilities in Asia. Marken currently manages 110,000 cold-chain drug product and biological sample shipments every month in more than 220 countries around the globe. The company uses a GPS tracking system to track the route of all products in real-time and operates a 24-hour global control center that monitors and manages the tracking system. Also, the company offers differentiated and specialized services such as validation for the full course from storage, distribution to shipment of pharmaceuticals, and regulatory and compliance consulting services for each country. For more information on the storage and distribution of pharmaceuticals products in Korea and overseas, please contact info@marken.com.
- Company
- Antengen Korea's blood cancer treatment Xpovio is approved
- by Eo, Yun-Ho Aug 09, 2021 06:02am
- The Chinese pharmaceutical company Antengene’s blood cancer drug ‘Xpovio’ has entered the domestic market. According to industry sources, Antengene Korea’s first-in-class XPO1 inhibitor Xpovio (Selinexor) was approved by the Ministry of Food and Drug Safety (MFDS) on the 29th of last month. The drug had been previously designated an Orphan Drug in Korea through a priority review process. Xpovio is a first-in-class drug that selectively inhibits the XPO1 nuclear export protein that was approved ▲ in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (rrMM) who have received at least 4 prior therapies and whose disease is refractory to at least 2 proteasome inhibitors, at least 2 immunomodulatory agents, and 1 anti-CD38 monoclonal antibody; and ▲ as a monotherapy for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL) who have received at least 2 prior lines of treatment. XPO1 inhibitors are expected to be used in combination with other various therapies (drugs) to improve treatment outcomes in various diseases. Currently, 5 therapies that contain Xpovio are recommended under the National Comprehensive Cancer Network (NCCN®) Guidelines. Most patients with MM eventually suffer from relapse or become refractory diseases. For Diffuse large B-cell lymphoma (DLBCL) patients that failed systemic therapy, their prognosis and the chance of cure or long-term disease-free survival declines every time the condition worsens after treatment. Therefore, a dire need had existed for safer and more effective therapies to treat rrMM and rrDLBCL. Minyoung Kim, General Manager of Antengene Korea said, “I am confident that this oral selective inhibitor of nuclear export protein will improve the quality of life of patients with rrMM and rrDLBCL in South Korea, and bring renewed hope to this patient population.” Xpovio’s approval was based on the two Phase II studies - STORM and SADAL. In the STORM study, Xpovio achieved a 26% Overall response rate (ORR) and a clinical benefit rate (CBR) of 39.9% in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies. In the SADAL study that was conducted on relapsed DLBCL patients who have received two or more prior therapies, Xpovio monotherapy demonstrated an overall response rate (ORR) of 28.3% and a complete response (CR) rate of 11.8%.
