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- 2026-06-24 15:53:08
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- Clopidogrel mkt exceeds KRW 500 bil for the first time
- by Kim, Jin-Gu Feb 19, 2024 05:45am
- Photo of Plavix, produced by Handok and marketed by Sanofi in KoreaThe antiplatelet market for clopidogrel has grown to exceed KRW 500 billion in Korea. Although 25 years have passed since the original drug, Sanofi's Plavix, was released in Korea, its market is still showing growth. Last year, the growth of generic products stood out in the market. The combined prescription sales of generic products increased by more than 10% year-on-year. Major generic products from Samjin Pharmaceutical, Daewoong Pharmaceutical, Chong Kin Dang, Jeil Pharmaceutical, and Yuhan Corp also showed prescription growth of over 10%. Clopidogrel prescription market exceeds KRW 500 billion…still shows growth 25 years after original’s launch According to the market research institution UBIST on the 16th, the outpatient prescription market for clopidogrel antiplatelet drugs was KRW 532.7 billion last year. This is a 7.9% increase from KRW 493.5 billion it had posted in 2022. The market hit the KRW 400 billion mark in 2019. Since then, it has continued to grow at around 7%, even during the prolonged COVID-19 pandemic. Prescription changes of clopidogrel original and generics (Unit: KRW 100 million, Data: UBIST) The original product, Plavix, was released in 1999. Generic versions of the drug joined the market in bulk in 2005-2007. Although more than 25 years have passed since the original’s launch and 20 years after the entry of its generics, the drug is still widely prescribed in the field. The drug is prescribed to improve symptoms of atherosclerosis in patients with ischemic stroke and myocardial infarction. It is also prescribed as maintenance therapy after stenting procedures. it is analyzed that the prescription of clopidogrel-based drugs has increased with the steady rise in the number of stent procedures in Korea in recent years. Sales growth of original Plavix slows down...sales of major generic products grow together The market leader is Plavix. Last year, prescriptions for Plavix and Plavix A totaled KRW 126 billion. This is a 1.9% increase from the KRW 123.4 billion in 2022. Plavix A is a combination of clopidogrel and aspirin. However, in the case of Plavix, its sales growth has slowed down significantly recently. In fact, prescription sales of Plavix have grown annually at a growth rate of 7.2% for 4 years, from KRW 91.4 billion in 2018 to KRW 128.4 billion in 2022, but only rose 2% last year. Sanofi has started copromoting Plavix with GC Pharma since February last year. GC Pharma took charge of local sales and Sanofi of large hospitals. Changes in the prescription performance of leading clopidogrel products (Unit: KRW 100 million, Data: UBIST) On the other hand, generic products have seen steady growth in general. Last year, the combined prescription performance of generic products was KRW 401.8 billion, up 10.1% from KRW 365.1 billion in 2022. Last year was the first time since 2018 that prescription growth for generics exceeded 10%. Prior to that, the average annual growth rate was 6.6%. Therefore, major generic products saw a significant increase in prescription sales. Sales of Samjin Pharmaceutical's 'Platless', the second largest product in the market, increased 10.4% from KRW 75 billion in 2022 to KRW 82.8 billion in 2023. Dong-A ST’s ‘Plavitor’ increased by 6.8% from KRW 27.3 billion to KRW 29.2 billion. During the same period, Jeil Pharmacuetical’s ‘Pilgrel’ and ‘Clopirin’ increased from KRW 24.1 billion to KRW 25.8 billion, and Chong Kun Dang’s ‘Pregrel’ and ‘Copregrel’ increased from KRW 13.5 billion to KRW 20.4 billion. Clopirin and Copregrel are both clopidogrel-aspirin combination drugs. Sales of Daewoong Pharmaceutical's ‘Cloart’ have been growing very rapidly recently. Prescriptions of Cloart, which remained at KRW 9.9 billion in 2020, nearly doubled in 3 years to KRW 19.6 billion last year. Jinyang Pharmaceutical's 'Krivix' also saw its sales nearly double from KRW 5.3 billion in 2020 to KRW 10.4 billion last year.
- Company
- K-made new stroke drugs accelerate towards commercialization
- by Son, Hyung-Min Feb 19, 2024 05:45am
- New candidate products for ischemic stroke developed by Korean pharmaceutical companies are proving to be effective. As global pharmaceutical companies have faced difficulties in development, attention is drawn to the possibility of commercializing new stroke drugs made in Korea. According to industry experts on the 17th, Phase 3 clinical demonstrated the efficacy of Nelonemdaz, a new ischemic candidate product developed by the bioventure company GNT Pharma. Nelonemdaz is a derivative of aspirin and sulfasalazine, selectively inhibiting the NR2B subunit of the N-methyl-D-aspartate (NMDA) receptor, a receptor of glutamate. This drug can prevent neuronal injury after surgical thrombectomy by blocking NMDA-receptor-mediated neurotoxicity and reactive oxygen species. A Phase 3 clinical study investigating the efficacy of Nelonemdaz included 496 patients with moderate ischemic stroke who required surgical thrombectomy within 12 hours of contracting ischemia. The patients were randomly assigned to two groups: a group receiving high doses of Nelonemdaz and another receiving a placebo. After receiving the medication, patients underwent surgical thrombectomy. The primary endpoint was a change in the modified Rankin Scale (mRS) score, used to measure the degree of disability in stroke patients, at 90 days after the first dose. The clinical outcome showed no significant difference in mRS changes between the Nelonemdaz group and the placebo group. However, among 47 patients who received the medication within one hour of emergency room arrival, there was 4.93 times greater mRS improvement in the Nelonemdaz group compared to the placebo group. This result demonstrates that administering Nelonemdaz to patients with acute ischemic stroke upon early arrival at the emergency room may provide significant benefits. GNT Pharma announced that it would complete the study this year and aims to launch Nelonemdaz in Korea. GNT Pharma is preparing for a Phase 3 study of Nelonemdaz for indications beyond ischemic stroke, including cardiac arrest. Can Korean pharma succeed in developing new stroke drugs, where global pharma companies have failed in the past? The potential commercialization of new stroke drugs draws attention because global pharmaceutical companies have repeatedly failed in clinical trials. When assessing the probability of a stroke recurrence within 90 days after an ischemic stroke, AstraZeneca’s Brilinta, an antiplatelet medication, did not show a significant reduction compared to aspirin. Merck’s vorapaxar, an antiplatelet medication, was unsuccessful in demonstrating efficacy, as the clinical study revealed an increased risk of intracranial hemorrhage in stroke patients. Several biopharmaceutical companies in Korea are investigating the potential development of disease-modifying candidate products, including Natural Killer (NK) or stem cell therapies. NK cells can detect malignant cells and kill them via necrosis. They can directly attack malignant cells or secret cytokines to induce T cells and B cells to attack. NKMAX explained that the new Alzheimer’s candidate product SNK01 is also effective in stroke patients. NKMAX reports a significant improvement in language ability and overall energy level in stroke patients in Mexico when administering SNK01. Furthermore, Phase 1a/2 clinical studies using cord-derived mesenchymal stem cell therapy ‘CordSTEM-ST,’ developed by CHA Biotech, have shown the inhibition of anti-inflammatory cytokines in stroke patients. Regarding acute stroke, it is well-established that neuronal repair is impaired after a stroke. However, CordSTEM-ST treatment has been found to strongly inhibit such inflammatory responses, thereby reducing neuronal damage. Due to confirming the CordSTEM-ST effect, Cha Biotech plans to proceed to the later stages of clinical trials.
- Company
- Can we expect Darzalex to receive expanded reimb this year?
- by Eo, Yun-Ho Feb 19, 2024 05:45am
- Janssen Korea’s Darzalex (daratumumab). A multiple myeloma drug, ‘Darzalex,’ garners attention as to whether it could receive expanded use this year. Janssen Korea’s Darzalex (daratumumab) is under discussion for expanding reimbursement into multiple indications. It is categorized into two types of therapies. The first is the DVTd (daratumumab, bortezomib, thalidomide, and dexamethasone) combination therapy, which cleared the Cancer Drug Review Committee of the Health Insurance Review and Assessment Service (HIRA) last May as the first-line treatment of multiple myeloma. Another is a combination therapy, including DRd (daratumumab, lenalidomide, and dexamethasone), DVd (daratumumab, bortezomib, and dexamethasone), and DKd (daratumumab, carfilzomib, and dexamethasone), for second-line treatment, which passed the first review of the year by the Cancer Drug Review Committee. There has been a long-standing demand for hospitals to use combinations indicated for the first- and second-line treatments. However, the process of expanding reimbursement has been delayed until now. These expanded indications were approved in Korea in 2019. However, patients must pay 100% out-of-pocket expenses for Darzalex, except when receiving it as ‘Monotherapy of fourth-line treatment or more in patients with recurrent and refractory disease who have received three or more types of treatment, including PI inhibitors and immune inhibitors.” Although the Cancer Drug Review Committee approved the combination strategy as a second-line treatment in January, the drug has not been considered for review for almost 10 months due to unestablished reimbursement criteria last March. Therefore, it remains to be seen whether the indications that have passed the Cancer Drug Review Committee will receive reimbursement from the 2024 Drug Reimbursement Committee review. Currently, the National Comprehensive Cancer Network (NCCN) and the European Society for Medical Oncology (ESMO) recommend the Darzalex combination as standard therapy for first and second-line treatments. They also recommend the use of DVTd four-drug combination for first-line treatment in patients who are eligible for hematopoietic stem cell transplantation. Darzalex’s active ingredient daratumumab is a human monoclonal antibody that targets ‘CD-38,’ a cell surface protein that is overexpressed on multiple myeloma cells. This drug can directly induce cancer cell death through several underlying mechanisms, including the following: ▲Complement-dependent cytotoxicity (CDC), ▲Antibody-dependent cell-mediated cytotoxicity (ADCC), and ▲Antibody-dependent cellular phagocytosis (ADCP).
- Company
- Administration cycle restriction on Xospata will be lifted
- by Eo, Yun-Ho Feb 19, 2024 05:44am
- The reimbursement restrictions set on the number of administration cycles set for the acute myeloid leukemia treatment 'Xospata' is expected to be lifted soon. According to Dailypharm’s coverage, Astellas Korea recently finalized drug pricing negotiations with the National Health Insurance Service to expand reimbursement coverage for its Xospata (gilteritinib), a treatment used for relapsed or refractory acute myeloid leukemia (AML) with an FLT3 mutation. This will accordingly allow greater prescribing flexibility for Xospata. Under the current reimbursement standards, the use of Xospata is reimbursed for up to 2 cycles as induction therapy for patients with FLT3-mutated AML who are refractory to prior therapy or have relapsed and are candidates for an allogeneic stem cell transplant. However, in consideration of the preparation period for allogeneic stem cell transplantation, an additional 2 cycles of Xospata is reimbursable but only for patients who achieve a partial response or better after 2 cycles and are pre-approved for allogeneic stem cell transplantation (or submit evidence of such). Therefore, Xostapa’s use is restricted to a maximum of 4 cycles. Complaints about the restriction in the number of cycles have risen ever since its initial listing in March 2022. Astellas had submitted an application for Xospata’s coverage expansion in November of the same year, which passed the Cancer Disease Review Committee in May last year, the Drug Reimbursement Evaluation Committee in November, and the final hurdle, the drug pricing negotiations, this time. Other than the financial issues, there are no specific reasons to limit the number of administration cycles for Xospata. In the ADMIRAL trial, Xospata was used without limiting the treatment period, and the NCCN guidelines also issued a ‘Category 1’ recommendation for the drug without restricting its treatment period. The current best option to cure AML patients is hematopoietic stem cell transplantation, but this is accompanied by a high risk of recurrence, and transplantation is not an option for the large number of elderly AML patients that exist. Xospata targets both types of FLT3 mutations, FLT3-ITD and FLT3-TKD, and may be self-administered at home as a single oral tablet once daily without frequent hospital visits. Also, Xostapa has demonstrated improved safety and efficacy compared with existing chemotherapy.
- Company
- Keytruda sales expected to surpass 300 billion won
- by Nho, Byung Chul Feb 16, 2024 06:25am
- (Photos, clockwise from upper left) Keytruda, Yerboy, Opdivo, and Tecentriq. Keytruda holds a blockbuster position in the immune checkpoint inhibitors sector, with analysts expecting its sales to surpass 300 billion won. According to the distribution performance report, MSD’s Keytruda recorded 289.8 billion won, leading its sector. It was followed by BMS-Ono’s Opdivo, which accumulated 99.3 billion won up to 3Q 2023. In the same period, Roche Korea’s Tecentriq, AstraZeneca’s Imfinzi, BMS’s Yervoy, and Merck’s Bavencio reached sales of 70.7 billion won, 55.5 billion won, 10.6 billion won, and 2.1 billion won, respectively. The sales of Keytruda and Tecentriq have shown remarkable growth. Keytruda demonstrated a 132% sales growth, accumulating 124.7 billion won in 2019 to 289.8 billion won in 3Q 2023. In the same period, Tecentriq showed 374% sales growth, accumulating 14.9 billion won to 70.7 billion won. The growth in Keytruda sales is attributed to its high pricing per volume and having the most significant number of indications among immune checkpoint inhibitors. Keytruda, with its active ingredient pembrolizumab, obtained 15 indications, including non-small cell lung cancer (NSCLC), head and neck cancer, Hodgkin lymphoma, urothelial carcinoma, esophageal cancer, melanoma, renal cell carcinoma, endometrial cancer, gastric cancer, small intestine cancer, ovarian cancer, pancreatic cancer, cholangiocarcinoma, colorectal cancer, and triple-negative breast cancer. Opdivo demonstrated efficacy in treating 10 types of cancer, including melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma, Hodgkin lymphoma, head and neck cancer, urothelial carcinoma, gastric cancer, and oesophageal squamous cell carcinoma. Tecentriq has shown effectiveness in treating urothelial carcinoma, non-small cell lung cancer (NSCLC), small-cell carcinoma, hepatocellular cancer, and triple-negative breast cancer. The main immune checkpoint inhibitors are categorized into CTLA-4 (ipilimumab), PD-1 inhibitors (nivolumab and pembrolizumab), PD-L1 inhibitors (atezolizumab, avelumab, and durvalumab). Although Yerboy, with active ingredient ipilimumab, received FDA approval in 2011 as the first among immune checkpoint inhibitors, Keytruda, with active ingredient pembrolizumab, has achieved the highest sales in the immune checkpoint inhibitor sector, experiencing its prime time. The global marketing of the efficacy and effectiveness of Keytruda received a significant boost following former president of the United States Jimmy Carter declared cancer-free from metastatic melanoma, further increasing popularity. Keytruda, which received FDA approval for melanoma in 2015, expanded to include 15 cancer indications seven years after entering the Korean market. Immune checkpoint inhibitors are highly valued for their long-term effectiveness due to the memory capability of immune cells. Meanwhile, the insurance prices for Keytruda 4ml are at around 2.1 million won, Yervoy 40ml at 14 million won, Opdivo 10ml at 1.11 million won, Tecentriq 20ml at 2.27 million won, Imfinzi 10ml at 3.34 million won, and Bavencio 10ml at 850,000 won.
- Company
- Sobi, Handok’s partner has built competitive pipelines
- by Son, Hyung-Min Feb 16, 2024 06:03am
- Sobi, a biopharmaceutical company headquartered in Sweden, announced that it will launch its new drugs for treating rare diseases, including primary hemophagocytic lymphohistiocytosis (HLH), immune thrombocytopenia (ITP), and alkaptonuria (AKU), in Korea. Sobi and Handok have entered into a business agreement to launch in Korea. According to the pharmaceutical industry, on the 14th, Swedish Orphan Biovitrum (Sobi) decided to establish a local joint venture with Handok. The duo has announced plans to set up a firm in the first half of this year and to launch treatments for rare diseases in Korea. Sobi, a global biopharmaceutical company headquartered in Sweden, specializes in rare diseases and provides innovative treatments in hematology, immunology, and specialized therapies. Handok will start with new rare disease drugs, Empaveli and Doptelet, to obtain domestic approval Sobi has built diverse rare diseases pipelines: ‘Gamifant’ targeting primary hemophagocytic lymphohistiocytosis (HLH), ‘Doptelet’ targeting immune thrombocytopenia (ITP), ‘Vonjo’ targeting myelofibrosis, ‘Synagis’ targeting respiratory syncytial virus (RSV), ‘Altuviio, Alprolix, and Elocta’ targeting hemophilia, ‘Empaveli’ targeting paroxysmal nocturnal haemoglobinuria (PNH), ‘Orfadin’ targeting alkaptonuria (AKU), ‘Zynlonta’ targeting blood cancer, and ‘Kineret’ targeting rheumatoid arthritis (RA). Handok will first focus on obtaining domestic approval for two treatments, Empaveli and Doptelet, from Sobi’s pipelines. Handok and Sobi entered into a strategic partnership last October to introduce these two treatments. Handok anticipates that both treatments will obtain approval within this year. Empaveli has received approval for treating paroxysmal nocturnal haemoglobinuria (PNH) in the United States, Europe, Australia, and Japan. Empaveli is developed by Apellis Pharmaceuticals in the United States and Sobi has exclusive commercialization rights of the drug outside the United States. Empaveli is the first treatment for PNH that targets the C3 complement. It is designed to inhibit the process of C3 fragmentation, thereby preventing intravascular hemolysis and extravascular hemolysis. Results from a phase 3 PEGASUS clinical trial confirmed the efficacy of Empaveli. Empaveli demonstrated higher hemoglobin levels compared to Soliris, a C5 complement inhibitor. Empaveli’s strength is in expanding indications. In the previous year, Empaveli was approved in the United States for the treatment of geographic atrophy (GA) associated with macular degeneration. Retinal GA is a condition that occurs in the late-stages macular degeneration, which causes damage to the center of the macular and leads to the death of retinal cells. The clinical trial demonstrated that Empaveli significantly reduced the GA lesion growth by 22% at 24 months compared to a placebo. Handok has an advantage in entering the domestic PNH market because it already has experience selling C5 complement inhibitors, Soliris and Ultomiris. Handok sold Soliris and Ultomiris until 2022. However, AstraZeneca decided to sell Alexion Pharmaceuticals and retrieved the sales rights. Doptelet is an orally administered thrombopoietin receptor agonist (TPO-RA) used to treat adult patients with primary chronic immune thrombocytopenia (ITP). ITP, a type of bleeding disorder, is an autoimmune disorder in which the immune system attacks and destroys platelets. In a 6-month trial, Doptelet elevated platelet levels to more than 50,000 counts for 12 weeks. Based on these results, Doptelet received approval in the United States, Europe, Australia, and Japan. Sobi has built diverse rare diseases pipelines In addition to Empaveli and Doptelet, Sobi’s pipelines include ‘Elocta, Alprolix, Altuviio’ for treating patients with hemophilia, ‘Gamifant’ for treating primary hemophagocytic lymphohistiocytosis (HLH), ‘Vonjo’ for treating myelofibrosis, ‘Synagis’ for treating respiratory syncytial virus (RSV), a new alkaptonuria (AKU) drug ‘Orfadin’, a CD19-directed antibody drug conjugate (ADC) ‘Zynlonta’, and a new rheumatoid arthritis (RA) drug ‘Kineret’. Sobi has partnered with Sanofi to distribute three types of drugs in the hemophilia field jointly. The two companies secured FDA approval for the new hemophilia drug, Altuviio, in the United States, alongside the already available hemophilia treatments Elocta (marketed as Eloctate in Korea) and Alprolix. Altuviio can be used for routine prophylaxis and perioperative management of bleeding. During clinical trials, patients receiving Altuviio reported no bleeding episodes for a year. Sobi also sells RSV treatments. In 2018, the company successfully acquired the sales rights for Synagis, which was developed by multinational pharmaceutical company AstraZeneca. Synagis is a monoclonal antibody that was approved as an alternative to prevent lower respiratory tract infection caused by respiratory syncytial virus (RSV) globally. Sobi also focuses on developing new ADC drugs, which are trending globally. Zynlonta is an antibody-drug conjugate (ADC) targeting CD19, which is highly expressed in a B cell surface. The drug was approved in the United States and Europe. Zynlonta faces competition from chimeric antigen receptor T cell (CAR-T) therapy and dual-specific antibodies. In addition, Sobi has experience in successfully launching new drugs for rare diseases with unmet needs, including primary hemophagocytic lymphohistiocytosis (HLH) and alkaptonuria (AKU).
- Policy
- Hanmi launches Zytiga generic combo after first generic
- by Lee, Tak-Sun Feb 16, 2024 06:00am
- Hanmi Pharmaceutical, which attracted wide attention by launching the first generic version of the prostate cancer treatment Zytiga last year, set out to target the market again by quickly developing a combination drug. On the 14th, the Ministry of Food and Drug Safety approved Hanmi Pharmaceutical's Abiteron Duo Tab 500/2.5mg. The product is a combination drug that combines abiraterone and prednisolone. The original drug is Janssen’s ‘Zytiga Tab 500mg (abiraterone acetate).’ Hanmi Pharmaceutical received approval for the first generic version of Zytiga, ‘Abiteron Tab 500mg,’ last year, and released the drug at a more economical price than the original in October of the same year. Currently, Zytiga costs KRW 11,746 per tablet, while Abiteron costs KRW 8,537. From November last year, the co-payment rate for abiraterone drugs was reduced from 30% to 5%. This is expected to reduce the financial burden on the patients and increase their usage. In this context, Hanmi Pharmaceutical introduced a new combination drug that even the original company did not have. The newly approved ‘Abiteron Duo Tab’ is used in combination with androgen deprivation therapy (ADT) for the treatment of patients newly diagnosed with high-risk metastatic hormone-sensitive prostate cancer (mHSPC). It is administered once daily, and the dosage is two tablets. Hanmi’s Zytiga generic was released last yearThe fact is that Zytiga and Abiteron are both used in combination with prednisolone, a steroidal hormone that is synthesized in the adrenal cortex. Therefore, patients taking Zytiga or Abiteron must take two 500 mg tablets per day, plus an additional 5 mg of prednisolone. This is a total of three tablets, but those who take Abiteron Duo need to only take two tablets, which shows improved convenience. Hanmi Pharmaceutical will focus on increasing its market share with both its single-agent generic Abiteron and combination generic Abiteron Duo. Zytiga is a blockbuster drug that posted KRW 18.3 billion in outpatient prescriptions last year (source: UBIST), and if Hanmi, a latecomer to the market, can secure its competitiveness by improving product quality, its generic version is also expected to post high sales.
- Company
- GI makes bid with its new anticancer drug as combo therapy
- by Son, Hyung-Min Feb 16, 2024 06:00am
- Korean pharmaceutical bio venture company GI Innovation is working to identify the commercialization potential of its immuno-oncology drug in combination with an NK cell therapy. GI Innovation, which succeeded in licensing out its allergy drug candidate last year, plans to show results in the field of anticancer drugs this year. According to the pharmaceutical and bio-industry sources on the 15th, GI Innovation recently submitted an IND to the Ministry of Food and Drug Safety for a Phase Ib/IIa clinical trial of GI-101A, an immuno-oncology drug candidate, in combination with NK cell therapy from its affiliate, GI Cell. GI-101A is the first anticancer drug candidate being developed by GI Innovation. The clinical trial will evaluate the efficacy and safety of the combination in patients with recurrent or refractory solid tumors. GI-101A has a mechanism of action that acts on CD80 and interleukin (IL)-2. IL-2 is involved in immune cell proliferation and activation, and CD80 blocks CTLA4, a receptor that inhibits immune cells that attack cancer cells. GI-101A is a new drug candidate that has improved stability and half-life by increasing the sialic acid content in the company’s existing GI-101 production process. Currently, GI Innovation is conducting Phase I/II clinical trials of GI-101A in combination with the immuno-oncology drug Keytruda in Korea and the United States. In addition to Keytruda, GI Innovation plans to increase the possibility of exporting GI-101A’s technology by demonstrating its use in combination with NK cell therapies. GI Cell’s NK cell therapy, T.O.P. NK, can be mass cultured and has maximized tumor targeting ability and cancer cell killing efficiency. T.O.P. NK has shown encouraging results in a Phase I monotherapy clinical trial in patients with relapsed/refractory solid and hematologic cancers, achieving complete response (CR). GI-101·GI-102 development status. Source: GI Innovation Larger strides made for NK cell therapies…seeks combined use with GI-102 GI Innovation plans to check the potential of combining T.O.P NK with GI-102 as well. The GI-102 pipeline was engineered to further reduce alpha receptor binding compared to GI-101A. Higher alpha receptor binding is known to increase regulatory T cells and reduce the anticancer effect. GI-102 is being developed as both intravenous (IV) and subcutaneous (SC) formulations. GI-102 has also shown promise in a monotherapy trial. Recently, the company's Phase I/IIa data showed an objective response rate (ORR) of 43% when GI-102 was administered to patients with melanoma. In addition, lymphocyte proliferation was favorably affected by GI-102 treatment, and no serious drug toxicity was observed. GII Innovation expects the drug to be more effective when combined with an NK cell therapy. In non-clinical studies, the company confirmed that GI-102’s use in combination with T.O.P. NK maintained persistence in the body for 1 month and showed increased anti-cancer efficacy compared to T.O.P. NK alone. In addition, GI Innovation is also planning to conduct a clinical trial of GI-102 in combination with CAR-T therapy in diffuse large B-cell lymphoma (DLBCL). The company aims to obtain conditional approval for GI-102 while confirming the possibility of exporting its technology. The clinical results of the combination therapy are also being closely watched as GI Innovation has set a goal to export its immuno-oncology candidate within this year.
- Policy
- MFDS will inspect growth hormones and cold chains this year
- by Lee, Hye-Kyung Feb 16, 2024 05:59am
- The Ministry of Food and Drug Safety has included 'medical institutions and pharmacies handling growth hormone drugs' and 'cold chain compliance of high-risk items such as vaccines' in this year's planned inspections. The ' Biopharmaceuticals and Herbal Medicine Bureau’s Basic Plan for Manufacturing and Distribution Management in 2024,' which was released by the MFDS on the 15th, contains this year's planned joint surveillance for biopharmaceutical manufacturers and importers, drug advertisers, and wholesalers. The planned joint surveillance program is designed to preemptively respond to hazardous factors that threaten public safety, including growth hormone drugs, which became an issue during last year's National Assembly inspections. At the NA audit, Rep. Young-Joo Kim of the Democratic Party of Korea pointed out that “Growth hormone drugs are being misused on children and adolescents who are a little shorter than their peers to grow taller, which is not the purpose of the approved indication.” And requested a follow-up report on its abuse and misuse. In Korea, growth hormone drugs are indicated for: ▲ growth failure in children due to pituitary growth hormone secretion disorder ▲ idiopathic short stature (ISS) in children ▲ growth failure in children whose bone ends are not closed and confirmed as Turner syndrome by chromosomal analysis ▲ growth disorder in short children born small for gestational age (SGA), however, most of them are used off-label on-site as 'height growth injections'. According to data from the MFDS, the National Health Insurance Service, and the Health Insurance Review and Assessment Service, of the 10.66 million growth hormone injections supplied to 5,761 medical institutions nationwide from September 2021 to September 2023, only 3%, 307,000 were prescribed to patients with reimbursement, and the other 97% were prescribed without reimbursement for height growth. As a result, the MFDS plans to include false and exaggerated advertisements of growth hormone drugs as a target for joint surveillance this year and check whether hospitals, clinics, pharmacies, etc. are directly promoting 'injections to increase height' in their advertisements. The MFDS conducts year-round monitoring of social issue items, including mass advertising of specialized drugs and illegal distribution. This year, the MFDS plans to expand the scope of online advertisements to include social media in the joint monitoring of growth hormone drugs, as well as false and exaggerated advertisements. In addition, the cold chain management status of wholesalers handling high-risk products such as vaccines and refrigerated and frozen storage products will be intensively checked. For this year's regular monitoring of biopharmaceuticals, the authorities included the decision to continuously monitor the data integrity of biopharmaceuticals. The MFDS assesses the risk of domestic manufacturing plants twice a year using independent risk assessment indicators tailored to the characteristics of biopharmaceuticals. This year, 22 sites are scheduled for regular inspections. The company is notified 7 days in advance of the surveillance in accordance with the Framework Act on Administrative Investigation, without coordinating the schedule in advance.
- Company
- Booming atopic dermatitis market, Adtralza nears reimb
- by Eo, Yun-Ho Feb 16, 2024 05:59am
- Adtralza (tralokinumab), a treatment for atopic dermatitis, is anticipated to be included in the reimbursement listing. Adtralza, a treatment for atopic dermatitis, is expected to be the listed for insurance reimbursement. According to the industry, LEO Pharma has completed the price negotiations with the National Health Insurance Service (NHIS) for Adtralza (tralokinumab), a treatment for atopic dermatitis with an underlying mechanism of neutralizing interleukin-13 (IL-13). Reimbursement for Adtralza will be available as soon as March, and the company is preparing for its official launch in May. Adtralza was approved in Korea last August and passed the Cancer Drug Review Committee of the Health Insurance Review and Assessment Service (HIRA). Adtralza is indicated for adults (18 years of age and over) and children (12-17 years of age) with moderate to severe atopic dermatitis that is not adequately managed by topical treatments or for whom topical treatments are not advised. Adtralza’s recommended initial dose is 600 mg (given as four injections of 150 mg) followed by 300 mg (given as two injections of 150 mg) every two weeks. Adtralza provides a convenient dosing option for patients with moderate to severe atopic dermatitis. At the doctor’s discretion, patients who achieve clear or almost clear skin after 16 weeks of treatment may consider dosing every fourth week. This drug is a biopharmaceutical that specifically targets IL-13. While Sanofi-aventis Korea’s Dupixent (dupilumab) targets both IL-4 and IL-13, it is difficult to compare the mechanism of actions of the two drugs directly. To what extent Adtralza's entry will impact the atopic dermatitis market competition remains to be seen. The clinical efficacy and safety profile of Adtralza were confirmed in four Phase 3 clinical trials (ECZTRA 1, ECZTRA 2, ECZTRA 3, ECZTRA 6). These trials enrolled 2265 patients with moderate to severe atopic dermatitis, including adults and children from Korea and internationally. The ECZTRA 3 clinical trial compared a patient group administered Topical Corticosteroids (TCS) in combination with Adtralza every two weeks to a placebo group. The results have shown that 38.9% of patients in the intervention group achieved an Investigator’s Global Assessment (IGA) score of 0 to 1 at week 16, which was 12.7% higher than that of a placebo group. The clinical trial demonstrated a significant improvement with Adtralza, as 56.0% of patients achieved a 75% or greater reduction in Eczema Area and Severity Index (EASI) score, compared to 35.7% of those receiving a placebo. Patients who adjusted their treatment schedule to every two weeks dosing or extended it to four weeks after showing improved conditions at week 16 also reached EASI-75 scores of 90% or greater at week 32. Son Sang Wook, a professor in the Department of Dermatology at Korea University Ansan Hospital, said, “Atopic dermatitis is a disorder that requires new treatment options to manage patients’ various conditions effectively. This new treatment option, which offers clinical benefits and dosing convenience, gives hope.”
