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- 2026-03-19 04:06:25
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- Pharmaceuticals, growth rate to be cut in half
- by Eo, Yun-Ho Mar 17, 2020 06:28am
- Major National Pharmacy Sales Trend [Source: IQVIA]It was analyzed that the domestic pharmaceutical industry would be suffered hard from the aftermath of COVID-19. Drug market research firm IQVIA predicted that the growth of the Korean pharmaceutical market this year will be only 4.4%, half of the previous year due to the spread of COVID-19. This analysis compared changes found in major institutions and organizations in healthcare, including pharmaceutical companies, hospitals, pharmacies, and drug wholesalers, before and after the outbreak of COVID-19. Initially, IQVIA estimated the growth rate of the pharmaceutical market to be similar to 8.6% in 2019, but the situation changed due to the spread of COVID-19. According to IQVIA, the number of outpatient prescriptions may decrease as the number of patients visiting the hospital decreases in the aftermath of COVID-19, which in turn may reduce drug production and sales. Since the spread of COVID-19, the number of patients visiting hospitals and pharmacies in Daegu and Gyeongbuk areas has decreased significantly. Looking at each region, Daegu and Gyeongbuk accounted for about 85% of all COVID-19 confirmed patients, and the proportion of deaths was more than 90%, so the short-term impact in the region was the largest. It is estimated that the impact of COVID-19 on Daegu and Gyeongbuk sales will be 1.25 times greater than that of other regions, and as a result, it is expected that the usage of medicines in Daegu and Gyeongbuk in the first half of this year will likely be less than last year's level. Changes in over-the-counter drug sales [Source: IQVIA]In addition, as a result of questioning 300 pharmacists, the number of patients visiting pharmacies decreased by 23% compared to before the COVID-19 spread. Sales of 11 major drug wholesalers also fell by an average of 13%. Drug wholesale sales fell 8% less and 30% more. However, with the spread of COVID-19, sales of various hygiene products such as masks and hand sanitizers increased. As a result of analyzing the sales of 540 domestic pharmacies, the sales volume and proportion of masks and hand sanitizers began to increase on January 20, when the first COVID-19 confirmed in Korea. The sales volume of hygiene products, which had been faltering for a moment due to the lack of masks and the increase in the number of confirmed patients, has jumped since February 18, when the 31st confirmed patient occurred. This trend was prominent in pharmacies in Daegu. Masks and hand sanitizers accounted for less than 1% of the total sales of pharmacies in Daegu, but increased to 30% at the end of last month. It was analyzed that sales portion was expanded since the 18th of last month when the first COVID-19 confirmed patient occurred in Sincheonji Daegu Church. IQVIA said that sales of over-the-counter drugs at pharmacies, except for outpatient prescriptions, have decreased significantly since the occurrence of COVID-19, and sales of all products across all over-the-counter drugs, not specific products, have been analyzed to be attributed to a decrease in overall patient visits.
- Company
- Supect by Il-Yang Pharm reduces COVID-19 by 70%
- by Jung, Hye-Jin Mar 17, 2020 06:27am
- Research has shown that Il-Yang Pharm's 'Supect' has the effect of reducing the COVID-19. Il-Yang Pharm announced on the 13th that as a result of experimenting with COVID-19 received from the KCDC, the virus in the group using Supect decreased by 70% within 48 hours. Supect (Radotinib) by Il-Yang Pharm is a leukemia treatment agent. This study was conducted in an in vitro test method in the Biosafety Level 3 Laboratory (BSL-3) at the Biosafety Center of Korea University College of Medicine. The experimental group that used Supect for the virus and the control group that did not, were compared. As a result, the firm explained that 70% of viruses were reduced in the Supect group compared to the control group, which is superior to that of the HIV treatment 'Kaletra' and the flu treatment 'Avigan'. Result of Supect experiment Experimental results of candidate drugs for MERS treatment In addition, Il-Yang Pharm also revealed that five candidate substances that are being developed as MERS treatments reduced COVID-19 by more than 99% within 24 hours in the same experiment. candidates for MERS are IY1209, IY1471, IY1472, IY1901, and IY1209 from substances discovered through the research project of the next-generation applied ohmic 'source technology development of new and variant virus (MERS) treatment' hosted by the Korea Research Foundation under the Ministry of Science and ICT. "Supect is a commercially proven drug that can shorten the development period quickly compared to other candidates. If COVID-19 is declared a pandemic and even considers seasonal infectious diseases that come every winter, therapeutic development will be the most powerful weapon to protect humanity from disease".
- Company
- Herceptin market recovers ￦100 billion in three years
- by An, Kyung-Jin Mar 16, 2020 06:31am
- (From the left) Herzuma, Herceptin, and Sampenet Domestically developed biosimilars enter the blockbuster anti-cancer drug 'Herceptin' market. The market share of the two products 'Herzuma' and 'Sampenet' exceeded 28%. The market size of Trastuzumab that Celltrion developed as 'Herjuma' shrank with the expansion of the biosimilar market has recovered to the level before drug price cuts. According to the drug research agency IQVIA on the 11th, the market size of Trastuzumab in the fourth quarter of last year was ￦27 billion, up 19.8% from the same period last year. Last year's cumulative sales were ￦104 billion. It surpassed the record of ￦103.4 billion in 2016 before the biosimilar was released. Trastuzumab market quarterly trend in 2015-2019 (Unit: ￦100 million, Source: IQVIA) Trastuzumab is generic for Roche's targeted anticancer drug 'Herceptin'. It is prescribed for metastatic breast cancer and gastric cancer that show positive human epithelial factor receptor 2 (HER2). In Korea, after the patent expiration of the original product Herceptin, two types of biosimilar products, such as Celltrion’s 'Herzuma' and Samsung Bioepis' Sampenet, began to be sold. The original product, 'Herceptin', sold for ￦19.4 billion in the fourth quarter of last year. Herceptin's upper limit of insurance fell by 20% from ￦517,628 to ￦414,103 based on 150mg two months after Celltrion listed 'Herzuma' on the health insurance benefits list in April 2017. Since the drug price cut, it have been maintaining quarterly sales of around ￦20 billion. In principle, in the domestic drug price system, biosimilars can receive up to 70% of the original drug price before the patent expires. Starting in October 2016, 'innovative pharmaceutical companies, equivalent companies, domestic pharmaceutical companies, and products developed by companies that have entered into a joint contract between foreign companies or products that are the country's first licensed country or those produced in Korea' are guaranteed up to 80%. When the biosimilar is released, the patented expiration of the original drug will automatically lower the insurance price to 70-80%. Quarterly sales of Trastuzumab products in 2015-2019 (Unit: ￦100 million, Source: IQVIA) Biosimilar products led the recent expansion of the Trastuzumab market. Celltrion Herzuma's sales in the fourth quarter of last year were ￦6.8 billion, up 115.4% from the same period last year. Herzuma began to generate sales in earnest in the third quarter of 2017, surpassing ￦5 billion in the second quarter of last year as sales continued to rise. Last year's cumulative sales amounted to ￦23 billion, a three-fold increase from a year ago. On the other hand, Samsung Bioepis' Sampenet does not show market presence. Sampenet sold ￦800 million in the fourth quarter of last year. Last year's cumulative sales were ￦2.2 billion. Daewoong Pharmaceutical is responsible for the sale of Sampenet. Biosimilar has greatly increased its share in the Trastuzumab market within two years of starting domestic sales. In the fourth quarter of last year, the share of the two biosimilars in the Trastuzumab ingredient market expanded to 28.2%. Herzuma's market share was 25.3% and Sampenet's 2.9%. In fact, Herzuma led the expansion of the biosimilar market. 'Herzuma 150mg' was added to the reimbursed list with an upper limit of ￦372,692, which is 72% of Herceptin before patent expiration in April 2017. In February 2018, Samsung Bioepis registered an insurance premium of 'Sampenet 150mg' at ￦291,942. This is 56.4% of the price of Herceptin. Since then, in March 2018, Celltrion's insurance price was reduced by 21.7% from ￦372,692 to ￦291,942, making it the same price as Sampenet. The market size of Trastuzumab is similar to that of three years ago, but the actual usage has increased significantly considering the launch of low-cost biosimilar products and the price cuts of original products. This means that the advent of biosimilar, which has the same effect as the original medicine and is inexpensive, has a positive effect on improving patient accessibility.
- Company
- Why Ezetimibe combination drug for dyslipidemia?
- by Eo, Yun-Ho Mar 16, 2020 06:30am
- Professor Chae In-ho For some diseases, combination drugs are vastly preferred than the other. Dipeptidyl peptidase-4 inhibitor plus metformin combination for patients with diabetes, and angiotensin II receptor blocker (ARB) plus calcium channel blocker (CCB) plus alpha combination for patients with hypertension haven taken over significant part of respective overall prescription volumes. And combination drug is also on the rise for dyslipidemia treatment sector for last few years. The combination of statin and ezetimibe is the case. Despite many of specialists’ skepticism on ezetimibe, the drug has proven its catchphrase ‘the lower the LDL-C the better the benefit for cardiovascular system’ in the IMPROVE-IT trial that unveiled in 2015. Since then, the combination drug has gained popularity fast. Basically, ezetimibe-based combination drugs with either rosuvastatin or atorvastatin have shifted the market previously dominated by statin. Daily Pharm interviewed Executive Officer Chae In-ho of Korean Society of Interventional Cardiology (KSIC) (Director of Cardiology Center at Seoul National University Bundang Hospital) about the benefits of combination drugs and ezetimibe. -Do you prefer to prescribe ezetimibe-based combination drug? It would be safe to say the combination drugs have taken deep root as effective dyslipidemia treatment. For a long while, hyperlipidemia treatment was solely relying on statin and used high dosage. But nowadays, non-statin combination therapies previously marginalized have stolen the limelight again. Compared to same dose of statin, ezetimibe combination therapy has similar incidents of side effects but shows even more benefit in reducing LDL-C. When higher dose of statin is used, a patient’s LCL-C level at 100 mg/ dL would fall to 90 mg/ DL, but using ezetimibe combination the numbers fall even lower to 70 mg/ dL. -Is there any other reason why you would prefer the combination drug over the single drug? First of all, it would the convenience for sure. Administration convenience is far superior and drug compliance is also very high. Patients tend to ask a lot more questions than before when they get additional number of pills and they come prepared with basic online research. The patients are happy to hear my explanation about the combination drug not increasing the number of pills but resulting in better effect. Besides, the price of combination drugs in Korea are inexpensive than in other countries. Patients with chronic disease get sensitive about the cost, so the health insurance system is a plus factor for preferring a combination drug. -For the combination drug, there is a choice between rosuvastatin and atorvastatin. Is there a deciding factor when prescribing the combination drug? I don’t personally see a big difference. But I prefer prescribing rosuvastatin plus ezetimibe for a stronger effect. Using 20 mg of rosuvastatin and 40 mg of atorvastatin show similar level of effect, but I feel rosuvastatin lowers LDL-C better in combination. Of course, pharmaceutical companies could say otherwise. Anyway, now atorvastatin has more options with 80 mg dose added to combination option. -Is it possible to use ezetimibe combination on dyslipidemia patient as first-line therapy? Yes. For patients with high risk in acute coronary syndrome (ACS), myocardial infarction (MI) and unstable angina, a combination drug is used for an initial treatment. But for a relatively young patient with risk of arteriosclerosis, high-dose combination drug is used. As diabetic patient tend to have accelerated absorption of cholesterol, ezetimibe could demonstrate more dramatic effect. Because statin causes diabetes more frequently than ezetimibe, it would be more effective to specific patient group with high blood sugar level. Diabetes is treated not only with medication, but also with lifestyle. Cholesterol, relatively more controllable with medicine, should be managed with pharmaceutical push as much as it can. -Regardless, the 2018 dyslipidemia treatment guideline recommended ezetimibe therapy as a second-line therapy. And when the U.S. and Europe recommended LDL-C level of the mentioned groups with very high risk to be lowered to 55 mg/ dL and 40 mg/ dL, respectively, Korea recommended the level to be lowered to 70 mg/ dL. Basically, I agree with the phrase, “The lower the better.” But a guideline is merely a guideline in the end. Using the combination drug for first-line treatment means it’s targeting even more effective LDL-C reduction benefit, which coincides with the mechanism of ‘the lower the better.’ But if you’re asking whether to target 70 mg/ dL or 55 mg/ dL, it would be different case by case. I would be skeptical to prescribe higher dose or stronger drug to lower LDL-C of 80 mg/ dL in a patient with high risk, but who works out regularly and manages body weight. Probably 70 percent of clinicians in Korea and 25 percent in the U.S. would consider the guideline’s recommendation. Ultimately, it is a matter for a physician to judge and decide from their experience and expertise. Ezetimibe combination drug has diversified the choices, and it would be more frequently used as it accumulates prescription history.
- Company
- Handok tops KRW 30 bln PAH treatment market
- by Nho, Byung Chul Mar 16, 2020 06:27am
- (From left) PAH treatment Uptravi, Traclear and Opsumit by Handok Korean pharmaceutical industry is closely paying attention to Handok’s market share constantly growing in pulmonary arterial hypertension (PAH) treatment sector. In 2019, Korean PAH treatment market volume was recorded at 30.7 billion won with 20 percent bump from the previous year. In the market, Handok’s PAH line up—Traclear (6.2 billion won), Opsumit (11 billion won), Uptravi (1.6 billion won)—has taken up 61 percent of the market share generating overall 18.8 billion won together. Opsumit and Traclear are dominating 80 percent of the endothelin receptor antagonists (ERA) PAH treatment market share. And among prostacyclins, Uptravi owns 35 percent of the market share. Products in the general prostacyclin class have soared in the PAH market share. The specific class has grown 56 percent in 2019 from the previous year, where Uptravi’s volume skyrocketed by 128 percent (700 million won to 1.6 billion won). After releasing Traclear in 2006, Handok has launched follow-on drugs, Opsumit and Uptravi in 2016 and 2017, respectively, that are now successfully competing in the PAH treatment market. The company’s effort to raise awareness of PAH since 2010 by organizing a forum and various academic conferences has soundly propelled the business. PAH is a rare disease causing high blood pressure in pulmonary artery, which comes with symptoms of dyspnoea, fainting, anasarca and even the motor nerve could be seriously affected. According to overseas studies, average time of survival after diagnosis has been reported to be around two to three years, and it takes about average of 1.5 years to get diagnosed. PAH treatments are divided into three types—oral, inhalant, and injection. The oral medications are again divided into three types. Traclear (bosentan), Opsumit (macitentan), and Volibris (ambrisentan) are categorized as ERA. Pahtension (sildenafil) and Cialis (tadalafil) are phosphodiesterase type 5 inhibitor (PDE5i). And lastly Uptravi (selexipag) is prostacyclin. Most popularly prescribed PAH treatment, Opsumit has conducted two-year-long trial SERAPHIN, unprecedentedly long for oral PAH medication, and clinically confirmed the lowered risk of mortality and morbidity and reduced hospitalization rate in patients with PAH. According to the study with 742 patients with PAH, an arm administered with 10 mg of Opsumit demonstrated mortality and morbidity 45 percent lower than the placebo arm, and the arm’s death and hospitalization by PAH was reduced by 50 percent. The incidents of side effects, such as increase in hepatoxicity and peripheral edema, were on par with the placebo group, confirming outstanding safety profiled. Unlike other PAH treatment in ERA class, Opsumit has advantages of not requiring monthly hepatoxicity test, and convenience with once-daily administration. And with special case reimbursement for rare disease treatment, the treatment can be provided with various medical aid benefits. Most recently launched Uptravi is the first oral prostacyclin. Unlike other existing options, the medication works selectively on IP receptor that induces vasolidation, and it has been consolidating its position in the PAH treatment market as a combination therapy option since its release. PAH treatment trend in 2008 to 2016 analyzed by Health Insurance Review and Assessment Service (HIRA) found three-year survival in Korea is at 54 percent, which is lower than the U.S. (2006-2007) at 68 percent. As combination therapy rate in Korea is at 18 percent, far lower than 52 percent in the U.S., the figure implies promoted use of combination therapy is needed. In GRPIHON study, extended up to three years with 1,156 patients with PAH, Uptravi has confirmed reduction in mortality and morbidity. Against placebo group (80 percent already administered with ERA or PDE5i), patient group treated with Uptravi combination therapy had 40 percent lower relative risk of mortality and morbidity, showing clinical efficacy in patients who are already in treatment with other options. In Korea, insurance reimbursement is granted on both sequential double and triple combination of PAH treatments. Patients, who used to take either ERA or PDE5i monotherapy or ERA plus PDE5i double combination therapy, could receive reimbursement when combining with Uptravi. As stipulated by PAH treatment’s general reimbursement standard for early combination therapy taken in effect from last June, patients who have been administered with ERA plus PDE5i combination for over three months may receive reimbursement for taking Uptravi as third combination.
- Company
- “Lynparza now available for unmet medical needs in TNBC"
- by Eo, Yun-Ho Mar 13, 2020 06:32am
- Professor Sohn Joohyuk “Breast cancer has various treatment options.” True, but not always for all types of breast cancer. Since the release of Herceptin (trastuzumab), human epidermal growth factor receptor 2-positive (HER2+) breast cancer treatment paradigm has been shifted and follow-on targeted therapies are continuing to enter the market. The launch of Ibrance (palbociclib) has also brought new approach to hormone receptor positive (HR+) and HER2- breast cancer treatment scene. However, triple-negative breast cancer (TNBC), negative in all receptors including estrogen, progesterone and HER2, still has treatment needs unmet. For a long time, chemotherapy has been the only treatment option for TNBC. Although Roche’s targeted therapy Avastin (bevacizumab) has won the indication to treat TNBC for the first time in Korea, the treatment has not been listed for reimbursement, yet. And recently a targeted therapy option was introduced to the TNBC treatment market. AstraZeneca’s Lynparza (olaparib), first indicated to treat patients with ovarian cancer, has released tablet form and expanded its indication. Poly ADP ribose polymerase (PARP) inhibitor Lynparza has heightened the anticipation among patients with gBRCA-mutated TNBC, who have been treated with chemotherapy. Daily Pharm interviewed Professor Sohn Joohyuk of Medical Oncology Division at Severance Hospital about the effect of Lynparza. -What would be the reason behind sluggish development of TNBC treatment? Disease with clear biomarker has treatments developed accordingly, and also developing a treatment requires predictable marketability. 70 percent of breast cancer patients are HR+ patients, and 15 percent of breast cancer is HER2+. But TNBC patients only take up 15 percent of all breast cancer types. And even if a patient is categorized to have TNBC based on diagnosis of exclusion, they could be categorized again into various subtypes. With such diversity in breast cancer types, developing a treatment was surely challenging. But as most of breast cancer treatments these days are in development focusing on TNBC, we could expect to see more of new and promising findings in the future. -In the OlympiAD study, Lynparza-treated patient group demonstrated median progression-free survival (mPFS) of 7.0 months. It is arguable the difference against chemotherapy group with 4.2 months was barely noticeable, which proves the point the treatment for TNBC patient is highly difficult. Despite all, could we say the release of Lynparza is remarkable? It is apparent that TNBC itself is quite aggressive and expecting as effective treatment as HR and HER2+ treatment is not so easy due to diverse types of the cancer. The second-line therapy, after failing first-line therapy through existing anthracycline and taxane options, was limited to chemotherapy to treat TNBC. And because it was so limited that the median overall survival was at around one to 1.5 years. On the other hand, Lynparza has demonstrated significantly longer PFS in OlympiAD study, and response rate was also higher. From clinical point of view, high response rate is always considered crucial factor of consideration, so Lynparza can be viewed as a good option. -Based on the said clinical findings, Lynparza entered the market technically as a second-line treatment. Do you think it has the potential to become a first-line PARP inhibitor option? Sure. OlympiAD trial was designed to test on patients, who have been previously treated with anthracycline and taxane. The study combined patients taking first, second and third-line therapies. -Recently, immunotherapy Tecentriq (atezolizumab) has been approved as a fist-line therapy in combination with paclitaxel. As for a healthcare provider, now you are given two options. How would you utilize the options? For a patient diagnosed with BRCA mutation, I would first use PARP inhibitor on the patient who has been treated with anthracycline and taxane, as a supplementary therapy prior to a surgery. And because doctors have not reached a consensus on prescribing either immunotherapy or PARP inhibitor for TNBC patients, the effective treatment for respective patient could differ case by case. -If PD-L1 is expressed and BRCA is mutated simultaneously, would it possible to combine immunotherapy plus PARP inhibitor plus chemotherapy? At the moment, immunotherapy plus PARP inhibitor combination has an ongoing clinical study, but triple combination has not started a clinical study so it is not easy to say. -PARP inhibitor products in same class are launched one after another. Are there differences between those products? The reported clinical data between Lynparza and Talzenna (talazoparib) were not too far off. Their efficacy and safety profile could be considered on par. A candidate medicine, 'ABT-888' has unveiled meaningful clinical findings. But it is too early to talk about actually using the medicine at this point. Only because they are in a same class, it is not to say there is no difference. But the clinical data disclosed so far showed similar level of effect between Lynparza and talazoparib. -Do you agree Lynparza needs reimbursed prescription? The patients and doctors’ needs for Lynparza-like treatments have been unmet, and patients with TNBC lacked a good treatment option so far. To improve access to Lynparza, we need to both list the drug for reimbursement and improve access to BRCA mutation test. -Lastly, would you like to give us an advice on enhancing breast cancer treatment environment in Korea? To say the least, the current treatment environment has gotten much better. But it would be still helpful to build a better treatment environment by reflecting specialists’ opinions on apparent grey areas. For instance, there is a debate over the timing of using Herceptin, Kadcyla (trastuzumab emtansine), Perjeta (pertuzumab), and docetaxel. The mentioned drugs could be used after a year since the surgery as a supplementary therapy. While using trastuzumab, it is difficult to use TPH when the condition relapses or any other emergency occurs. And sometimes taxane has to be prescribed inevitably to use Kadcyla. More flexible reimbursement listing is needed to appropriate use available options. Although Korea has a wider choice of reimbursed options than in other Asian countries, the country lacks flexibility in listing reimbursement.
- Company
- Vibramycin & Cefdana are out of stock
- by Jung, Hye-Jin Mar 13, 2020 06:30am
- Some of rescription medicines are sold out. In particular, since Vibramycin-N sold out 500 tablets units in 2018, it is expected that units of 100 tablets will be out of stock, which will cause inconvenience to the prescription site. According to the distribution industry on the 11th, the re-supply of both 100 tablets unit and 500 tablets unit of Pfizer’s Vibramycin 100mg has been delayed. Pfizer Pharmaceuticals delayed the re-supply time from January to May of this year. The reason for the supply delay is the production schedule of the manufacturer. Vibramycin 500 tablets units have been delayed in re-supply since 2018. As the 500 tablets units were sold out, it seems that the supply and demand of 100 tablets units have been unbalanced since November 2018. Both 100 units and 500 tablets units are currently out of stock. The supply of 100 tablets units of Daewoong Bio's antibacterial drug 'Cefdana' are also insufficient. Daewoong Bio asked hospitals and pharmacies to order 30 tablets units. Packaging of 100 tablets will be released after April 20th. Korea Pfizer's hypertension treatment, Nitropress 2ml/vial type is also out of stock. It is expected to be available again later this month. The supply of 10mg, 30mg, 50mg, and 60mg of Bisphentin CR cap, a central nervous system stimulant of Mundipharma, was temporarily discontinued. This is due to the export license delay for original developers in Canada, and supply is expected to resume after April 21st. Some prescription drugs and some OTC were discontinued. The decision was made to discontinue 10 bottles units of Pocral Syrup 10ml, by Hanlim’s psychotropic drug, Hanlim announced that supply was discontinued after the final arrival in the second week of April due to difficulties in maintaining product production by consignment company, Kolmar’s situation, consignment company. Pocral syrup 10ml units were released in June 2018 upon the request of many hospitals. However, the leak problem occurred again in the bottle and lid joint, and the company tried to improve it by changing the glass bottle specification and investing in nozzle equipment, but the problem was not resolved, so the decision was made to discontinue production. Samil Pharmaceutical's disinfectant 'Potadin Surgical Scrub' 7.5% 4L packaging is also discontinued. It is a generic drug for Povidone-Iodine solution. Pharmbio Korea announced that there is no plan to re-supply RIBON 150mg 1 tablet units, an osteoporosis treatment.
- Company
- The Thai government has eased regulations on fillers
- by Kim, Jin-Gu Mar 13, 2020 06:30am
- Export of Hyaluronic acid filler to Thailand becomes easy. This is due to the Thai government's classification of hyaluronic acid fillers as medical devices, not pharmaceuticals, in Thailand starting tomorrow (11th). It is expected that domestic companies' entry into Thailand will accelerate as related certification requirements ease. According to KOTRA (Korea Trade-Investment Promotion Agency) on the 11th, Thailand will change the supervision of Hyaluronic acid fillers from the current FDA's Drug Management Bureau to the Medical Device Management Bureau. The classification of products is changed to 'Licensed Medical Devices' from 'Risk or Specially Managed Drugs among Drugs'. According to the Thai medical device classification, licensed medical devices include contact lenses, disposable syringes, surgical gloves, condoms, and HIV diagnostic devices. However, it is limited to products intended for skin treatment. Fillers used in addition to skin, such as knee pain treatment, are classified as pharmaceuticals as in the past. Hyaluronic acid filler's export certification requirements will likely ease as the classification system is changed. In the case of pharmaceuticals, certification requirements for safety and effectiveness were more difficult than medical devices. To export drugs to Thailand, A license to manufacture, import, and sell drugs from the Thai FDA must be obtained, and separately, Certification from the Food and Drug Administration for individual drugs must be obtained, too. At this time, documents such as the results of the non-clinical and clinical tests, chemical composition, manufacturing formula, quality control, and labeling should be submitted. In the case of medical devices, it is the same to obtain manufacturing, import, and sales licenses. However, the required documents are the application for permission, the sales certificate proved by the producing country, and documents related to side effects. As of 2018, a total of 35,018 cosmetic non-surgery methods in Thailand were counted. The proportion of Hyaluronic acid filler treatment is 27.1%, the second after Botulinum toxin treatment (58.7%). Hyaluronic Acid Filler Import Trend in Thailand as of 2019 (Data: KOTRA)Last year, Thailand's imports of Hyaluronic acid fillers amounted to $255.3 million. The share of French fillers is the highest at 25.7%. It is said that some brands from France, Sweden and Canada have a high share. Korea's share is 6.5%, ranking seventh. The amount is $16.69 million. An official from Kotra predicted that the change in the classification system would be particularly beneficial for Korean pharmaceutical companies. An official of KOTRA explained, "To date, the market of Hyaluronic acid filler in Thailand has a very high share of brands in some countries such as France and Sweden". He said, “But this change would make it easier for Korea to export to Thailand, Especially, it is expected to act advantageously for entry of Korean products with excellent quality and competitive prices”. He said, "Europe and Canada do not have an FTA with Thailand, so they have to pay 30% of the general import taxes, but in Korea, the Korea-ASEAN FTA Agreement is applicable so that they can enter the Thai market without taxes". Among domestic pharmaceutical companies, Medytox, Daehan New Pharm, Yooyoung pharmaceutical, Dongkook, and Hugel have been confirmed to have entered or are entering the Thai filler market.
- Company
- Bukwang “Levovir as effective as Kaletra on COVID-19”
- by Lee, Seok-Jun Mar 13, 2020 06:30am
- On Mar. 10, Bukwang Pharmaceutical announced its new treatment for hepatitis B Levovir (clevudine) has demonstrated treament effect on par with HIV drug Kaletra, also used to treat COVID-19. According to the Korean company, Levovir has been tested in vitro on virus extracted from Korean COVID-19 patient’s samples. Kaletra’s active pharmaceutical ingredient was used as positive control group. In plaque reduction neutralization test and real-time PCR, Levovir showed similar level of treatment effect with Kaletra. Clevudine is antiviral agent developed by Bukwang Pharmaceutical. The drug was released as a fourth hepatitis B virus treatment in the world and first in Asia. As a nucleoside analogue, clevudine has a mechanism to inhibit replication of virus DNA. Bukwang Pharmaceutical official said, “Based on the findings, the company would discuss with Ministry of Food and Drug Safety about further development plan like follow-up clinical trial.”
- Company
- Venclexta will be prescribed in major hospitals soon
- by Eo, Yun-Ho Mar 12, 2020 06:07am
- Venclaxta, which is ready for insurance benefits, will be prescribed at a general hospital soon. According to the related industry, Abbvie's Chronic Lymphocytic Leukemia (CLL) treatment, Venclexta (Venetoclax), passed DC (drug committee) of 5 big major Hospitals such as Seoul National University Hospital, Seoul St. Mary's Hospital, Severance Hospital, and Asan Medical Center. This drug is the first and only oral inhibitor of B-cell lymphoma-2 (BCL-2) in Korea. Recently, it concluded a drug price negotiation with the NHIS and is expected to be presented to the Health Insurance Policy Deliberative Committee. Reimbursed prescriptions will be available as early as April. Venclexta inhibits excessive expression of BCL-2 protein, which inhibits apoptosis in chronic lymphocytic leukemia, in which lymphocytes in the blood are significantly increased. It selectively binds to the BCL-2 protein and inhibits its function to induce apoptosis, a new mechanism of treatment that prevents cancer cells from proliferating and worsening abnormally. Authorization is based on the results of the M14-032 study for phase II clinical trial to evaluate the efficacy in patients with chronic lymphocytic leukemia who have a history of treatment with Imbruvica (Ibrutinib) or Zydelig (Idelalisib). As a result, the overall response rate (ORR) of 127 Venclexta-treated patients was 70%. According to the latest results, the number of leukemia cells remaining in the peripheral blood or bone marrow analyzed the patient group with a minimal residual disease (MRD), which is an indicator of the remission and risk of recurrence. In patients without disease, the median progression-free survival (PFS) was more than 2 years (24.7 months). Jin-seok Kim, professor of hematology at Severance Hospital, said, "The introduction of Venclexta has opened the way for patients who are old or have failed or relapsed to continue treatment".
